← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

CBK — Ventilator, Continuous, Facility Use

DEVICE CLASS
Class II
REGULATION
21 CFR 868.5895
MEDICAL SPECIALTY
Anesthesiology
REVIEW PANEL
AN
— Implant✓ Life-sustaining— GMP-exempt— Third-party review eligible
11
510(K)/PMA CLEARANCES
510k: 11
0
RECALL ENTRIES

Recent clearances

K253647Draegerwerk AG & CO Kgaa · 510k2026-05-07
K252663Iconic Solutions by Murcia, SL · 510k2026-04-14
K251888Hsiner Co., Ltd. · 510k2026-03-12
K232365Oconnell Regulatory Consultants, Inc. · 510k2025-12-19
K252173Fisher & Paykel Healthcare, Ltd. · 510k2025-09-10
K243767Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 510k2025-08-28
K251133Telesair, Inc. · 510k2025-05-08
K243394Respironics, Inc. · 510k2024-12-30

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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