DEVICE CLASS
Class II
REGULATION
21 CFR 868.1890
MEDICAL SPECIALTY
Anesthesiology
REVIEW PANEL
CH
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
7
510(K)/PMA CLEARANCES
510k: 7
0
RECALL ENTRIES
Recent clearances
K254102Glytec, LLC · 510k2026-05-27
K260910Glooko, Inc. · 510k2026-05-01
K253512Medtronic Minimed · 510k2026-01-08
K253281Updoc, Inc. · 510k2025-12-23
K252104Comerge AG · 510k2025-08-20
K241088Monarch Medical Technologies · 510k2024-12-11
K242775Medtronic Minimed · 510k2024-11-12
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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