← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

BTR — Tube, Tracheal (W/Wo Connector)

DEVICE CLASS
Class II
REGULATION
21 CFR 868.5730
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

K253437Spiro Robotics · 510k2026-06-12
K250173Covidien, LLC · 510k2025-10-06
K243785Covidien, LLC · 510k2025-09-25
K243579Pipeline Medical Products, LLC · 510k2025-08-13
K251499William Cook Europe Aps · 510k2025-06-11
K250243Flexicare Medical Limited. · 510k2025-05-20
K242495Teleflex Medical · 510k2025-04-29
K241451Teleflex Incorporated · 510k2025-02-11

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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