Product code KPJ— General, Plastic Surgery
DISPOS. HYPERBARIC OXYGEN CUSH/TRAUM
- Classification name
- Chamber, Oxygen, Topical, Extremity
- Device class
- Class 2
- Regulation
- 21 CFR 878.5650
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 23
- First cleared
- Most recent
Market context for product code KPJ
FDA has cleared devices under product code KPJ between 1983 and 2025, filed by 19 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2025
- 2023
- 2019
- 2012
- 2009
- 2008
- 2005
- 2003
- 2002
- 2001
- 1999
- 1997
- 1992
- 1989
- 1988
Top applicants under product code KPJ
Recent clearances under product code KPJ
- K250188 — Wound Treatment System (VHT-200)
- K212121 — VHT-200 Wound Treatment System
- K190742 — EPIFLO-28
- K112634 — NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP
- K120764 — EPIFLO(R)
- K090681 — TANSCU O2
- K080966 — HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM
- K050156 — WHS-1000 WOUND HEALING SYSTEM
- K023456 — OXYBOX SYSTEM
- K022028 — VX-400 TOPICAL HYPERBARIC OXYGEN CHAMBER
- K020466 — HEC 1000
- K002632 — OXYGENATOR
- K981949 — NUMOBAG
- K971507 — O2 BOOT
- K960756 — LIFETECH CASSETTE
- K963777 — HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100
- K920948 — TOPICAL SACRAL HYPERBARIC OXYGEN CHAMBER
- K883848 — KMI OXY-BAN
- K882461 — O2 CARE
- K861593 — TOPICAL HYPERBARIC OXYGEN CHAMBER
- K861101 — THE NEW FLEXIBLE COLLAPSIBLE CHAMBER
- K840817 — DISPOSABLE, HYPERBARIC OXYGEN CHAMBER
- K831825 — DISPOS. HYPERBARIC OXYGEN CUSH/TRAUM
Data sourced from openFDA. This site is unofficial and independent of the FDA.