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BSK

Cuff, Tracheal Tube, Inflatable

Product code
BSK
Device name
Cuff, Tracheal Tube, Inflatable
Device class
Class 2
21 CFR
21 CFR 868.5750
Medical specialty
Anesthesiology
Marketing pathway
510(K)
Flag
Life-sustaining / life-supporting
Flag
Third-party review eligible
510(k) clearances (last 3 years)
3
Summaries archived here
2 (direct download)
510(k) clearances (all years, FDA)
40 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2026-08-13.

NumberDecision dateApplicantDevice nameSummary
K2614992026-08-13Aw Technologies ApsTrachFlushPDF
K2435622025-08-12IdmedCuffGuardFDA
K2426422025-03-07Shanghai Longmann Tech Co., Ltd.CuffTrekPDF

2 summaries are archived here for direct download.

Official FDA classification page: BSK
Classification and pathway per current FDA publications. Data from openFDA (CC0).