DEVICE CLASS
Class II
REGULATION
21 CFR 880.5860
MEDICAL SPECIALTY
General Hospital
REVIEW PANEL
HO
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
23
510(K)/PMA CLEARANCES
510k: 23
0
RECALL ENTRIES
Recent clearances
K260208embecta Medical II, LLC · 510k2026-07-13
K253110Sol-Millennium Medical, Inc. · 510k2026-06-18
K260514CMT Health PTE., Ltd. · 510k2026-06-12
K253112Hlb Lifescience Co., Ltd. · 510k2026-05-21
K252279Chirana T.Injecta,A.S. · 510k2026-04-17
K253068CMT Health PTE., Ltd. · 510k2026-02-23
K253769Instylla, Inc. · 510k2025-12-22
K252518Duopross Meditech Corporate · 510k2025-12-17
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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