DEVICE CLASS
Class II
REGULATION
21 CFR 868.5440
MEDICAL SPECIALTY
Anesthesiology
REVIEW PANEL
AN
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
18
510(K)/PMA CLEARANCES
510k: 18
0
RECALL ENTRIES
Recent clearances
K252399Honsun (Nantong) Co., Ltd. · 510k2026-06-17
K252965Oxytek Medical Technology Co., Ltd. · 510k2026-05-29
K252407Mv Life, LLC · 510k2026-04-23
K253549Devilbiss Healthcare, LLC · 510k2026-03-26
K251534Foshan Kycare Medical Equipment Co., Ltd. · 510k2025-12-29
K251764Qingdao Kingon Medical Science and Technology Co., Ltd. · 510k2025-12-22
K252616Shenzhen Homed Medical Device Co., Ltd. · 510k2025-12-22
K252268Shenzhen Harveymed Technology Co., Ltd. · 510k2025-12-16
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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