DEVICE CLASS
Class II
REGULATION
21 CFR 870.2800
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
CV
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
7
510(K)/PMA CLEARANCES
510k: 7
0
RECALL ENTRIES
Recent clearances
K260157LifeLens Technologies, Inc. · 510k2026-07-09
K252389Smwmed, Inc. · 510k2026-04-23
K253293Vitalograph , Ltd. · 510k2025-12-03
K243650iRhythm Technologies, Inc. · 510k2025-08-15
K243603Aevice Health Pte. , Ltd. · 510k2025-05-05
K242583Atsens Co., Ltd. · 510k2025-05-02
K232670MEZOO Co., Ltd. · 510k2024-09-20
Related on SPEQ
Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
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