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

Support, Breathing Tube

21 CFR 868.5280 / Anesthesiology
FDA source (opens on fda.gov)

JAY is the FDA product code for Support, Breathing Tube, a class I device type, regulated under 21 CFR 868.5280. As of , FDA records hold 19 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
JAY
Device name
Support, Breathing Tube
Regulation
21 CFR 868.5280
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
19
Ingested recalls
2

Clearances, product code JAY

By decision year
19 clearances under product code JAY with a decision year between 1977 and 1995, 1983 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code JAY by decision year
YearClearances
19772
19781
19793
19801
19835
19842
19852
19861
19871
19951

Applicants with the most clearances

Product code JAY
Applicants holding the most 510(k) clearances under product code JAY
ApplicantClearances
Ackrad Laboratories2
Dale Medical Products, Inc.2
Equilibrated Bio Systems, Inc.2
Instrumentation Industries, Incorporated2
Sontek Industries, Inc.2
B & B Medical Technologies, Inc.1
Custom Medical Specialties, Inc.1
Exidyne, Inc.1
Medical Innovations, Inc.1
Olympic Medical Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 69 companies shown, in name order