510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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BSKClass II

Cuff, Tracheal Tube, Inflatable

21 CFR 868.5750 / Anesthesiology
FDA source (opens on fda.gov)

BSK is the FDA product code for Cuff, Tracheal Tube, Inflatable, a class II device type, regulated under 21 CFR 868.5750. As of , FDA records hold 40 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
BSK
Device name
Cuff, Tracheal Tube, Inflatable
Regulation
21 CFR 868.5750
Device class
Class II
Review panel
Anesthesiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
40
Ingested recalls
4

Clearances, product code BSK

By decision year
40 clearances under product code BSK with a decision year between 1979 and 2026, 1988 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code BSK by decision year
YearClearances
19791
19832
19884
19891
19903
19912
19931
19951
19971
20081
20101
20113
20122
20131
20151
20164
20182
20191
20202
20211
20221
20231
20252
20261

Applicants with the most clearances

Product code BSK
Applicants holding the most 510(k) clearances under product code BSK
ApplicantClearances
Hospitech Respiration4
Instrumentation Industries, Incorporated3
Aw Technologies ApS2
Tracoe Medical GmbH2
Arm Medical Devices, Inc.1
Bio-Med Devices, Inc.1
Biovo Technologies, Ltd.1
Medtronic, Inc.1
Dhd Medical Products Div. Diemolding Corp.1
Diemolding Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 42 companies shown, in name order