Dispos. Hyperbaric Oxygen Cush/Traum
FDA 510(k) K831825 · Hospitak, Inc.
510(k) numberK831825
Submission
- Device name
- Dispos. Hyperbaric Oxygen Cush/Traum
- Applicant
- Hospitak, Inc.
Mchenry, IL, US - Received
- June 7, 1983
- Decision date
- October 27, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KPJ – Chamber, Oxygen, Topical, Extremity
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5650
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code KPJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250188 | Wound Treatment System (VHT-200)KPJ · Special | Vaporox, Inc. | 03/10/2025SE |
| K212121 | VHT-200 Wound Treatment SystemKPJ · Traditional | Vaporox, Inc. | 03/23/2023SE |
| K190742 | EPIFLO-28KPJ · Traditional | Neogenix, LLC Dba Ogenix | 12/13/2019SE |
| K112634 | Natrox Topical Oxygen Delivery System with IodpKPJ · Traditional | Inotec Amd , Ltd. | 07/03/2012SE |
| K120764 | Epiflo(R)KPJ · Special | Neogenix, LLC | 04/27/2012SE |
| K090681 | Tanscu O2KPJ · Abbreviated | Electrochemical Oxygen Concepts, Inc. | 08/12/2009SE |
| K080966 | Hyper-Box Topical Wound Oxygen SystemKPJ · Traditional | Aoti , Ltd. | 08/06/2008SE |
| K050156 | WHS-1000 Wound Healing SystemKPJ · Traditional | Iyia Technologies, Inc. | 06/17/2005SE |
| K023456 | Oxybox SystemKPJ · Traditional | Oxyfast Corporation | 02/24/2003SE |
| K022028 | VX-400 Topical Hyperbaric Oxygen ChamberKPJ · Traditional | Vascular One, Inc. | 12/17/2002SE |
More from Vascular One, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K955483 | Trach Mask Model (245, 246)BYF · Traditional | 02/28/1996SE |
| K954787 | IlluminatorCCW · Traditional | 01/31/1996SE |
| K953620 | Warm N Wet Hmef W/Luer AdapterBYD · Traditional | 08/25/1995SE |
| K953619 | Warm N Wet Hme W/Luer AdapterBYD · Traditional | 08/25/1995SE |
| K915750 | Disposable Bacterial Breathng FilterCAH · Traditional | 11/30/1994SE |
| K920842 | Aerosol Delivery SystemsLRD · Traditional | 05/15/1992SE |
| K915228 | Disposable CO2 Gas Sampling/Oxygen Delivery CannulCCK · Traditional | 02/11/1992SE |
| K873286 | Disposable, Manual Pulmonary ResuscitatorBTM · Traditional | 10/26/1987SE |
| K853600 | Inflatable Air SplintsFZF · Traditional | 09/19/1985SE |
| K844328 | Oxygen ConcentratorCAW · Traditional | 12/04/1984SE |
Questions and answers
When was Dispos. Hyperbaric Oxygen Cush/Traum cleared by the FDA?
Dispos. Hyperbaric Oxygen Cush/Traum (K831825) received a 510(k) decision of Substantially Equivalent on October 27, 1983, 142 days after the submission was received.
What is the product code of K831825?
The FDA product code is KPJ – Chamber, Oxygen, Topical, Extremity, a Class II (moderate risk) device regulated under 21 CFR 878.5650.