DEVICE CLASS
Class II
REGULATION
21 CFR 868.5665
MEDICAL SPECIALTY
Anesthesiology
REVIEW PANEL
AN
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
4
510(K)/PMA CLEARANCES
510k: 4
0
RECALL ENTRIES
Recent clearances
K252849Tactile Medical · 510k2026-04-30
K250860Exemplar Medical, LLC · 510k2025-10-02
K242063Synchrony Medical , Ltd. · 510k2024-12-19
K240959Chongqing Moffy Innovation Technology Co., Ltd. · 510k2024-12-18
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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