DEVICE CLASS
Class II
REGULATION
21 CFR 868.5160
MEDICAL SPECIALTY
Anesthesiology
REVIEW PANEL
AN
— Implant✓ Life-sustaining— GMP-exempt— Third-party review eligible
3
510(K)/PMA CLEARANCES
510k: 3
0
RECALL ENTRIES
Recent clearances
K253330Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 510k2026-06-25
K252746Drägerwerk AG Co. Kgaa · 510k2026-05-21
K251352Codonics.Incorporated · 510k2025-07-11
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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