FDA 510(k) · PulseAI
K254226: PulseAPI SmartWatch (PulseAI, Ltd.)
PulseAI, Ltd. received FDA 510(k) K254226 for PulseAPI SmartWatch, with a decision date of Oct 27, 2026 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K254226 |
|---|---|
| Pathway | 510(k) |
| Applicant | PulseAI, Ltd. |
| Device name | PulseAPI SmartWatch |
| Product code | DQK: Computer, Diagnostic, Programmable |
| Regulation (21 CFR) | 870.1425 |
| Device class | Class 2 |
| Date received | Dec 29, 2025 |
| Decision date | Oct 27, 2026 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: FDA's 510(k) database page (checked by hand; not yet in openFDA), data through Nov 9, 2026.
Indications for use parsed from FDA documents
We could not extract the indications for this record (no summary PDF was processed). Check the FDA record for its summary or statement.
Predicates parsed from FDA documents
No predicate numbers were parsed for this record. The FDA summary, if available, names the predicate.
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code DQK is "Computer, Diagnostic, Programmable", class 2, 21 CFR 870.1425.
Our labels for filtering: claim Other, sensor Unknown. These are heuristics, not FDA fields.