DeviceClearance

Product code BSK— Anesthesiology

PILOT TUBE REPAIR KIT

Classification name
Cuff, Tracheal Tube, Inflatable
Device class
Class 2
Regulation
21 CFR 868.5750
Advisory panel
Anesthesiology
Total cleared
40
First cleared
Most recent

Market context for product code BSK

FDA has cleared 40 devices under product code BSK between 1979 and 2026, filed by 33 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code BSK

Recent clearances under product code BSK

Data sourced from openFDA. This site is unofficial and independent of the FDA.