← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

CCK — Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

DEVICE CLASS
Class II
REGULATION
21 CFR 868.1400
MEDICAL SPECIALTY
Anesthesiology
REVIEW PANEL
AN
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
8
510(K)/PMA CLEARANCES
510k: 8
0
RECALL ENTRIES

Recent clearances

K261633Affirm Medical Technologies II, LLC · 510k2026-07-14
K253030Covidien, LLC · 510k2026-05-01
K250148Prior Care Science Technology, Ltd. · 510k2025-08-28
K243956Nihon Kohden Corporation · 510k2025-06-10
K251216Barbaras Development, Inc. · 510k2025-06-04
K240937Inventeur, LLC · 510k2024-12-16
K230915Vyaire Medical, Inc. · 510k2024-11-12
K212425Exostat Medical, Inc. · 510k2024-11-07

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

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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