Atlas FDA

KPJ

23 FDA 510(k) clearances · Product code

162 daysmedian time to decision
428 days90th percentile
23clearances measured

FDA profile

Official device name
Chamber, Oxygen, Topical, Extremity
Device class
Class II (moderate risk)
Regulation
21 CFR 878.5650
Medical specialty
General, Plastic Surgery
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Wound Treatment System (VHT-200) (K250188)Vaporox, Inc.2025-03-10
VHT-200 Wound Treatment System (K212121)Vaporox, Inc.2023-03-23
EPIFLO-28 (K190742)Neogenix, LLC Dba Ogenix2019-12-13
NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP (K112634)Inotec Amd , Ltd.2012-07-03
EPIFLO(R) (K120764)Neogenix, LLC2012-04-27
TANSCU O2 (K090681)Electrochemical Oxygen Concepts, Inc.2009-08-12
HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM (K080966)Aoti , Ltd.2008-08-06
WHS-1000 WOUND HEALING SYSTEM (K050156)Iyia Technologies, Inc.2005-06-17
OXYBOX SYSTEM (K023456)Oxyfast Corporation2003-02-24
VX-400 TOPICAL HYPERBARIC OXYGEN CHAMBER (K022028)Vascular One, Inc.2002-12-17
HEC 1000 (K020466)Metro Medical Equipment, Inc.2002-05-08
OXYGENATOR (K002632)Adjunctive Therapeutics, Inc.2001-10-25
NUMOBAG (K981949)Numotech, Inc.1999-02-03
O2 BOOT (K971507)Gwr Medical, Llp1997-11-07
LIFETECH CASSETTE (K960756)Lifetech Systems, Inc.1997-08-29
HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100 (K963777)Stephenson Industries, Inc.1997-07-28
TOPICAL SACRAL HYPERBARIC OXYGEN CHAMBER (K920948)Topox Therapeuutic Rentals, Inc.1992-08-11
KMI OXY-BAN (K883848)Knight Medical, Inc.1989-03-02
O2 CARE (K882461)Ballard Medical Products1988-11-28
TOPICAL HYPERBARIC OXYGEN CHAMBER (K861593)Stephenson Industries, Inc.1986-05-12
THE NEW FLEXIBLE COLLAPSIBLE CHAMBER (K861101)Stephenson Industries, Inc.1986-05-06
DISPOSABLE, HYPERBARIC OXYGEN CHAMBER (K840817)Hospitak, Inc.1984-04-25
DISPOS. HYPERBARIC OXYGEN CUSH/TRAUM (K831825)Hospitak, Inc.1983-10-27

Track KPJ automatically

Every clearance here is in the API, with alerts when new ones post.