Five devices, checked against the manufacturers' own documents and the FDA's own databases. What each one really measures, what none of them can establish, and the five-year price nobody puts on the box.
The short answer. Not yet — and the gap between what these devices measure and what people assume they measure is wide enough to matter. Every one of the five is sold as a wellness product, and every one of them says so in its own fine print. None holds an FDA clearance for what it does.
That is not an accusation. Wellness products are legal, useful and honestly labelled here. The problem is the distance between the label and the impression — a device that tells you blood is present is doing something real, but the recognised medical response to blood is a colonoscopy, not an app notification.
Everything below comes from the manufacturer's own store or support pages, or from an FDA database. Where a manufacturer does not publish something, we say so rather than estimate it — the blanks are findings too.
| Device | Status | What it measures | Validation published | FDA clearance | 5-year cost |
|---|---|---|---|---|---|
| Withings U-Scan Calci / Nutrio |
Shipping | Urine chemistry via replaceable cartridge. Nutrio: pH, specific gravity, ketones, vitamin C. Calci: calcium, pH, specific gravity. | Yes, for Nutrio. Analytical repeatability 78–100% exact match by analyte, on 113 human samples, with interfering substances listed. No equivalent document for Calci. No clinical outcome study. | None for U-Scan. Withings holds 510(k) clearances — for an ECG and oximeter (K201456), a different device class. | $2,679 Intensive: $5,669 |
| Kohler Dekoda | Shipping | Optical. Hydration, stool colour and amount, and presence of blood in the bowl. Fingerprint sensor identifies the user. | None published. | None found. | $949–$1,379 estimate only |
| Throne One | Shipping · US only | Camera, sound and motion. Bristol Stool Scale, stool frequency, hydration from urine colour, voided volume, flow rate, night-time frequency. | Figures without a study. "89% accuracy" on hydration and "tested against 5 board-certified gastroenterologists" — no sample size, no method, no publication. | None found. | $749 |
| Vivoo Smart Toilet | Pre-order | Hydration only, via urine specific gravity. No cartridges. | None for this device. The 99.62% figure the brand publishes belongs to its paper test strips, a different product. | None. Two FDA Class 2 recalls of Vivoo urine test strips in 2026, cause: "No Marketing Application." | $488 launch tier: $269 |
| Gutsi | Pre-order · UK/EU | Camera with on-device AI. Stool consistency, hydration cues, bowel habits, visit duration. | None published — and the medical statement explicitly disclaims any warranty of accuracy. | None found. UK/EU product. | £399 no USD price |
| TOTO NEOREST LS-W / AS-W |
Japan only | "Stool Scan" sensor in the washlet measures stool form (7 types), colour (3 categories) and volume during the fall. | Not applicable — sold as a lifestyle-insight feature. | Not sold in the US. | — |
Last verified 3 August 2026. Prices are US list unless stated. Five-year totals assume one user in continuous use; the calculator below lets you change every assumption.
Almost every device in this category advertises the hardware and spreads the rest across subscriptions and cartridges. That is not deceptive on its own — it is just the number people do not add up. So add it up.
Nothing you enter here is stored, sent anywhere or recorded in our analytics. The arithmetic runs in your browser and nowhere else.
This is the part the category gets wrong most often — usually not by lying, but by letting an association do the work. Below, the left column is what people hope the device answers, and the right column is what medicine actually uses to answer it.
| You want to know about | What a toilet device can do | What actually establishes it |
|---|---|---|
| Chronic kidney disease | Nothing that qualifies. No consumer toilet monitor measures either required value. | Urine albumin-to-creatinine ratio and eGFR calculated from a blood creatinine test, both persisting over three months. A dipstick is explicitly not the diagnostic measurement because it is uncorrected for how concentrated your urine is. |
| Kidney stones | Track urine pH, calcium and volume as trends. Genuinely relevant — but as management, not detection. | Imaging, usually CT, finds a stone. For people who already form stones repeatedly, guidelines specify one or two 24-hour collections analysed for at least nine analytes — with creatinine used to check the collection was complete. A single-void reading is not that test. |
| Type 2 diabetes | Report urine ketones as a wellness value. | A1C ≥6.5%, fasting plasma glucose ≥126 mg/dL, or a glucose tolerance test — blood, and usually confirmed twice. Urine ketones appear nowhere in the diagnostic criteria. They also rise in fasting, low-carb diets, hard exercise, late pregnancy and breastfeeding. And the standard strip does not measure beta-hydroxybutyrate, the ketone that dominates in severe cases. |
| Colorectal cancer | Classify the shape and colour of stool. | Colonoscopy, CT colonography, sigmoidoscopy, or a stool test that chemically detects occult blood or DNA markers. "Occult" means invisible. A photograph of normal-looking stool carries no information about it. |
| Blood in the bowl | Kohler's Dekoda reports the presence of blood — the manufacturer's words are "detection of blood in the toilet bowl." | The device may well see it. But the recognised response to visible rectal bleeding is clinical evaluation, in most cases colonoscopy, regardless of other symptoms. For blood in urine, guidelines reject even a chemical dipstick as sufficient and require microscopy, then risk-stratified imaging. |
| Urinary tract infection | Notice a change in frequency or urine appearance. | Symptoms plus urine culture and sensitivity. Urology guidelines explicitly advise against dipstick analysis to diagnose or guide treatment, and against testing people with no symptoms at all. Cloudy or odorous urine on its own is named as an inappropriate reason to test. |
| Dehydration | This one is fair. Specific gravity above about 1.020 does indicate concentrated urine. | There is no gold-standard test; serum osmolality above 295 mOsm/kg is what is commonly used, alongside body weight loss of 2% or more. A review in older patients found urine specific gravity unreliable as a diagnostic tool used alone. Concentrated urine is a fact about your urine, not a diagnosis of you. |
Withings holds genuine FDA 510(k) clearances. They are for an electrocardiograph and oximeter — a cardiovascular device, cleared under a cardiovascular regulation. Nothing in that clearance concerns urine analysis, and no clearance naming U-Scan was found in any FDA database.
This is the same pattern we found when auditing water filters, where a manufacturer's real certifications sat on entirely different models from the one being sold for lead. Brand-level trust is not product-level evidence, and it is the single easiest mistake to make in any of these categories.
Two FDA Class 2 recalls were posted in February 2026 covering Vivoo pH, sodium, vitamin C and hydration test strips. The FDA-determined cause is recorded as "No Marketing Application" — the devices required a 510(k) and were distributed before they could be legally marketed in the US. The recall record states the risk in plain terms: they "may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention."
Be precise about what this does and does not cover. The recall concerns the paper strips, not the Smart Toilet sensor, which is a separate pre-order product. But the accuracy figure Vivoo publishes — 99.62% — belongs to those same strips, not to the toilet device. If you were relying on that number to justify the toilet, it does not apply to it.
Every device here labels itself a general wellness product, and each publishes a version of the same disclaimer: not intended to diagnose, treat, cure or prevent disease. That is a real regulatory category with real criteria. The FDA's current guidance, updated in January 2026, states that products are not general wellness products when they are "intended to measure, estimate, or report physiologic values for medical or clinical purposes, including screening, diagnosis, monitoring, alerting, or management of a disease or condition."
We are not regulators and we are not saying any of these products crosses that line. We are pointing out that the line exists, that it mentions alerting specifically, and that when a device offers an alert about blood and an explanation of "what it could mean for your health", a buyer is entitled to know exactly which side of that line the manufacturer says it is on. All five say wellness.
You are putting a sensor — in three of the five cases a camera — inside a toilet bowl, in the room where you have the strongest expectation of privacy. What we found:
Worth knowing: consumer health apps are frequently not covered by HIPAA once data sits with an independent app rather than a healthcare provider. The FTC's Health Breach Notification Rule can apply instead. Neither is a reason to panic; both are reasons to read the policy before the device is installed rather than after.
If you want hydration tracking — that is the one thing in this category with a defensible measurement, and it is also the cheapest. Specific gravity genuinely indicates concentrated urine.
If you form kidney stones repeatedly and your doctor tracks your urine chemistry — U-Scan Calci is the only device here doing real chemistry rather than looking at things, and there is a coherent argument for trend data between clinic visits. Ask your doctor first, because the guideline test is a 24-hour collection and this is not that. And note that Withings publishes its validation data for the Nutrio cartridge, not the Calci one.
If you want to know whether you have a disease — none of these. Not one. That is not us being cautious; it is what every one of these manufacturers says about its own product in its own documentation.
If you have seen blood — close this page and phone a doctor. That is the entire recommendation, and no device changes it.
We run calculators that work out whether you need a product at all. Sometimes the honest answer is no. This is one of those times, for now — and saying so is more useful than the alternative, which is a ranked list of the best smart toilets written by someone who has not read a single certification document.
There is no affiliate link on this page and no buy button. That is deliberate. The moment a page like this carries a purchase button next to a health claim, it stops being a reference and starts being a sales pitch, and you would be right to read it differently. If that changes — if a device earns a real clearance and we join a programme — we will say so here, in this paragraph, on the day it happens.
The technology is not fake and it is not going nowhere. Research prototypes at Stanford and Duke have shown that urinalysis, flow measurement and stool classification can be integrated into a toilet. TOTO ships a stool scanner in Japan today. What does not yet exist is a consumer device with validation you can check, for a condition that matters, with a clinical pathway behind it. When that arrives, this page will change.
Every claim above traces to one of these. We would rather you check us than trust us.