KPJ · Class II · 21 CFR 878.5650

FDA Product Code KPJ: Chamber, Oxygen, Topical, Extremity

Leading manufacturers include Vaporox, Inc., Hospitak, Inc. and Neogenix, LLC Dba Ogenix.

23
Total
23
Cleared
199d
Avg days
1983
Since
Stable submission activity - 1 submissions in the last 2 years
Review times improving: avg 47d recently vs 206d historically

FDA 510(k) Cleared Chamber, Oxygen, Topical, Extremity Devices (Product Code KPJ)

23 devices
1–23 of 23
Cleared Mar 10, 2025
Wound Treatment System (VHT-200)
K250188
Vaporox, Inc.
General & Plastic Surgery · 47d
Cleared Mar 23, 2023
VHT-200 Wound Treatment System
K212121
Vaporox, Inc.
General & Plastic Surgery · 624d
Cleared Dec 13, 2019
EPIFLO-28
K190742
Neogenix, LLC Dba Ogenix
General & Plastic Surgery · 266d
Cleared Jul 03, 2012
NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP
K112634
Inotec Amd , Ltd.
General & Plastic Surgery · 298d
Cleared Apr 27, 2012
EPIFLO(R)
K120764
Neogenix, LLC
General & Plastic Surgery · 45d
Cleared Aug 12, 2009
TANSCU O2
K090681
Electrochemical Oxygen Concepts, Inc.
General & Plastic Surgery · 149d
Cleared Aug 06, 2008
HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM
K080966
Aoti , Ltd.
General & Plastic Surgery · 124d
Cleared Jun 17, 2005
WHS-1000 WOUND HEALING SYSTEM
K050156
Iyia Technologies, Inc.
General & Plastic Surgery · 144d
Cleared Feb 24, 2003
OXYBOX SYSTEM
K023456
Oxyfast Corporation
General & Plastic Surgery · 132d
Cleared Dec 17, 2002
VX-400 TOPICAL HYPERBARIC OXYGEN CHAMBER
K022028
Vascular One, Inc.
General & Plastic Surgery · 179d
Cleared May 08, 2002
HEC 1000
K020466
Metro Medical Equipment, Inc.
General & Plastic Surgery · 85d
Cleared Oct 25, 2001
OXYGENATOR
K002632
Adjunctive Therapeutics, Inc.
General & Plastic Surgery · 428d
Cleared Feb 03, 1999
NUMOBAG
K981949
Numotech, Inc.
General & Plastic Surgery · 245d
Cleared Nov 07, 1997
O2 BOOT
K971507
Gwr Medical, Llp
General & Plastic Surgery · 196d
Cleared Aug 29, 1997
LIFETECH CASSETTE
K960756
Lifetech Systems, Inc.
General & Plastic Surgery · 553d
Cleared Jul 28, 1997
HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100
K963777
Stephenson Industries, Inc.
General & Plastic Surgery · 311d
Cleared Nov 28, 1988
O2 CARE
K882461
Ballard Medical Products
General & Plastic Surgery · 166d
Cleared Apr 25, 1984
DISPOSABLE, HYPERBARIC OXYGEN CHAMBER
K840817
Hospitak, Inc.
General & Plastic Surgery · 61d
Cleared Oct 27, 1983
DISPOS. HYPERBARIC OXYGEN CUSH/TRAUM
K831825
Hospitak, Inc.
General & Plastic Surgery · 142d

About Product Code KPJ - Regulatory Context

510(k) Submission Activity

23 total 510(k) submissions under product code KPJ since 1983, with 23 receiving FDA clearance (average review time: 199 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA 510(k) Review Time - KPJ Product Code

Recent submissions under KPJ have taken an average of 47 days to reach a decision - down from 206 days historically, suggesting improved FDA processing for this classification.

KPJ devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →