PulseAPI SmartWatch— 510(k) K254226

Name: FDA 510(k) clearance K254226
Creator: U.S. Food and Drug Administration
Published: 2026-10-27

Substantially Equivalent

PulseAI, Ltd.

FDA 510(k) clearance K254226 for PulseAPI SmartWatch, Substantially Equivalent on 2026-10-27. Applicant: PulseAI, Ltd.. Device class: 2.

Clearance details

Applicant: PulseAI, Ltd.
Product code: Product code DQK
Device class: Class 2
Regulation: 21 CFR 870.1425
Advisory panel: Cardiovascular
Date received: 2025-12-29
Decision date: 2026-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Belfast, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code DQK

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K261886 — VIVO (9002)2026-10-30
K263380 — STAR Apollo Mapping System2026-10-23
K263016 — Intra-Operative Positioning System (IOPS) and IOPS Visionary System2026-10-01
K254255 — S-Patch CardioAI2026-09-25
K261729 — EnSite X EP System2026-09-17

Adverse events under product code DQK

product code DQK

Death: 10
Injury: 225
Malfunction: 2,123
Other: 2
Total: 2,360

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.