← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

CBI — Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)

DEVICE CLASS
Class II
REGULATION
21 CFR 868.5740
MEDICAL SPECIALTY
Anesthesiology
REVIEW PANEL
AN
— Implant✓ Life-sustaining— GMP-exempt— Third-party review eligible
2
510(K)/PMA CLEARANCES
510k: 2
0
RECALL ENTRIES

Recent clearances

K251950Hangzhou Tappa Medical Technology Co., Ltd. · 510k2026-03-20
K253096Pulmonx Corporation · 510k2026-02-13

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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