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

Bottle, Blow

21 CFR 868.5220 / Anesthesiology
FDA source (opens on fda.gov)

BYO is the FDA product code for Bottle, Blow, a class I device type, regulated under 21 CFR 868.5220. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
BYO
Device name
Bottle, Blow
Regulation
21 CFR 868.5220
Device class
Class I
Review panel
Anesthesiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
4
Ingested recalls
0

Clearances, product code BYO

By decision year
4 clearances under product code BYO with a decision year between 1978 and 1993, 1978 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code BYO by decision year
YearClearances
19782
19921
19931

Applicants with the most clearances

Product code BYO
Applicants holding the most 510(k) clearances under product code BYO
ApplicantClearances
B & F Medical Products, Inc.1
Concord/Portex1
Kist Intl.1
Travenol Laboratories, S.A.1

Companies listing this code with FDA

Companies whose registered establishments list this code