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

Mouthpiece, Breathing

21 CFR 868.5620 / Anesthesiology
FDA source (opens on fda.gov)

BYP is the FDA product code for Mouthpiece, Breathing, a class I device type, regulated under 21 CFR 868.5620. As of , FDA records hold 25 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
BYP
Device name
Mouthpiece, Breathing
Regulation
21 CFR 868.5620
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
25
Ingested recalls
0

Clearances, product code BYP

By decision year
25 clearances under product code BYP with a decision year between 1977 and 1996, 1979 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code BYP by decision year
YearClearances
19772
19795
19801
19811
19822
19842
19855
19862
19872
19891
19941
19961

Applicants with the most clearances

Product code BYP
Applicants holding the most 510(k) clearances under product code BYP
ApplicantClearances
Medipart Jerry Alexander4
Mem Medical, Inc.3
Monaghan Medical Corp.3
Airlife, Inc.2
Kinetix2
Boehringer Ingelheim Pharmaceuticals, Inc.1
Dhd Medical Products Div. Diemolding Corp.1
Diemolding Corp.1
E-Z-EM, Inc1
Hospitak, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 164 companies shown, in name order