DEVICE CLASS
Class II
REGULATION
21 CFR 870.1875
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
CV
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
8
510(K)/PMA CLEARANCES
510k: 8
0
RECALL ENTRIES
Recent clearances
K252915Ai Health Highway India Pvt., Ltd. · 510k2026-05-22
K252089Tyto Care , Ltd. · 510k2026-03-12
K252076Kneevoice, Inc. · 510k2026-02-06
K252284Csd Labs · 510k2025-12-19
K252595Sparrow Acoustics, Inc. · 510k2025-09-12
K251494Eko Health, Inc. · 510k2025-08-12
K242971Heroic Faith International , Ltd. · 510k2024-11-25
K240901Sparrow Acoustics, Inc. · 510k2024-09-19
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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