The clinical method, made personal.
Leiko's watch is an FDA-listed Class II blood-pressure device, cleared through the FDA 510(k) process. Here's what that means, what it doesn't mean, and how we built a premium product around boring regulatory truth.
FDA-listed Class II
A non-invasive blood-pressure measurement device, in the FDA's Class II category.
Cleared via FDA 510(k)
Cleared for market through the FDA's 510(k) premarket process — the pathway for Class II devices.
Oscillometric method
The same non-invasive measurement principle used by clinical blood-pressure monitors.
A real inflating cuff
A micro-cuff that inflates, holds, and releases — a real reading, not an optical estimate.
The Leiko watch is an FDA-listed Class II blood-pressure device, cleared through the FDA 510(k) process. We reference that status generically and don't make clinical-accuracy claims without independent trial data.
What "clinical method" actually means.
Most smartwatches that claim blood pressure use optical sensors — the same green LEDs that read your pulse — to estimate BP from waveform analysis. The estimates drift. They get worse when you're warm, after caffeine, when you've been moving, when the seasons change.
Leiko's watch has a real inflating micro-cuff inside it. When you take a reading, the cuff inflates, holds, and releases — capturing the pressure points the way the cuff at your doctor's office does. The method is called oscillometric measurement — the same method used in clinical blood-pressure monitors.
It takes about 30 seconds. It works whether you're warm or cold, after coffee or before. It is the real thing on your wrist.
Leiko
Oscillometric micro-cuff
Most smartwatches
Optical pulse estimation
What Leiko is not.
Leiko is a personal health monitoring companion. It is not a substitute for medical care, a diagnostic device, a prescription tool, or an emergency response service.
Leiko does not diagnose conditions. It does not treat conditions. It does not replace a doctor, a clinic, or an emergency room. It does not detect atrial fibrillation, take an electrocardiogram, sense skin temperature, or track menstrual cycles.
When something in your readings looks important, Leiko surfaces it calmly and recommends you talk to your doctor. That recommendation is the limit of what we will do. Your doctor is the one who decides what comes next.
If you or someone you're watching over is experiencing a medical emergency — chest pain, severe shortness of breath, sudden weakness, slurred speech, or any symptom that worries you — stop reading this website and call your local emergency number. In the U.S., call 911. In the U.K., call 999. In Nigeria, call 112 or 767. Leiko is not an emergency service.
Your readings are yours.
Leiko encrypts your data in transit and at rest. We never sell your readings. We never share them without your explicit, per-recipient consent. When AI features generate insights, the data we send to language models is scrubbed of identifying information and quantised to the day, never the sample-second.
Read the full Privacy Policy →- Encrypted in transit (TLS 1.3) and at rest (AES-256)
- HIPAA-aligned data handling (full BAA where required)
- Family data isolated by row-level security — your numbers are visible only to people you invite
- Reading values never appear in analytics — only category states ("in pattern," "calm-concerned")
- AI calls scrub identifying data before egress
- Delete your account, delete your data — fully, on request, no friction
The Founder cohort is claiming their watches.
Founder Edition from $185 — ships within days. Or pre-order the next batch at retail.