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

Device, Fixation, Tracheal Tube

21 CFR 868.5770 / Anesthesiology
FDA source (opens on fda.gov)

CBH is the FDA product code for Device, Fixation, Tracheal Tube, a class I device type, regulated under 21 CFR 868.5770. As of , FDA records hold 47 510(k) clearances under this code, the most recent dated , and 12 recalls.

Classification record

Product code
CBH
Device name
Device, Fixation, Tracheal Tube
Regulation
21 CFR 868.5770
Device class
Class I
Review panel
Anesthesiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
47
Ingested recalls
12

Clearances, product code CBH

By decision year
47 clearances under product code CBH with a decision year between 1978 and 2014, 1990 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code CBH by decision year
YearClearances
19781
19801
19812
19821
19831
19852
19862
19874
19883
19907
19913
19924
19934
19946
19954
19971
20141

Applicants with the most clearances

Product code CBH
Applicants holding the most 510(k) clearances under product code CBH
ApplicantClearances
B & B Medical Technologies, Inc.8
Dale Medical Products, Inc.3
Respironics, Inc.3
Ackrad Laboratories2
Blake Medical, Inc.2
Rotek Corp.2
Salter Labs2
Aga Medical Products, Inc.1
Aircare Systems1
Applied Medical Technology Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 137 companies shown, in name order