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

Mask, Oxygen, Non-Rebreathing

21 CFR 868.5570 / Anesthesiology
FDA source (opens on fda.gov)

KGB is the FDA product code for Mask, Oxygen, Non-Rebreathing, a class I device type, regulated under 21 CFR 868.5570. As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and 8 recalls.

Classification record

Product code
KGB
Device name
Mask, Oxygen, Non-Rebreathing
Regulation
21 CFR 868.5570
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
13
Ingested recalls
8

Clearances, product code KGB

By decision year
13 clearances under product code KGB with a decision year between 1978 and 1997, 1994 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code KGB by decision year
YearClearances
19781
19792
19881
19921
19932
19944
19961
19971

Applicants with the most clearances

Product code KGB
Applicants holding the most 510(k) clearances under product code KGB
ApplicantClearances
Airlife, Inc.2
Hans Rudolph, Inc.2
BD Becton Dickinson Vacutainer Systems Preanalytic1
Cheen Houng Ent. Co. Ltd.1
Fittydent-Altwirth & Schmitt GmbH1
Gam Industries, Inc.1
Laerdal Medical a/S1
Medic One1
Specialty Packaging Producs, Inc.1
Vital Signs, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 150 companies shown, in name order