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

Chamber, Oxygen, Topical, Extremity

21 CFR 878.5650 / General, Plastic Surgery
FDA source (opens on fda.gov)

KPJ is the FDA product code for Chamber, Oxygen, Topical, Extremity, a class II device type, regulated under 21 CFR 878.5650. As of , FDA records hold 23 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
KPJ
Device name
Chamber, Oxygen, Topical, Extremity
Regulation
21 CFR 878.5650
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
23
Ingested recalls
2

Clearances, product code KPJ

By decision year
23 clearances under product code KPJ with a decision year between 1983 and 2025, 1997 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code KPJ by decision year
YearClearances
19831
19841
19862
19881
19891
19921
19973
19991
20011
20022
20031
20051
20081
20091
20122
20191
20231
20251

Applicants with the most clearances

Product code KPJ
Applicants holding the most 510(k) clearances under product code KPJ
ApplicantClearances
Stephenson Industries, Inc.3
Hospitak, Inc.2
Vaporox, Inc.2
Adjunctive Therapeutics, Inc.1
Aoti, Ltd.1
Ballard Medical Products1
Electrochemical Oxygen Concepts1
GWR Medical, Inc.1
Inotec AMD Ltd.1
Iyia Technologies, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 17 companies shown, in name order