K212121 is an FDA 510(k) clearance for the VHT-200 Wound Treatment System. This device is classified as a Chamber, Oxygen, Topical, Extremity (Class II - Special Controls, product code KPJ).
Submitted by Vaporox, Inc. (Centennial, US). The FDA issued a Cleared decision on March 23, 2023, 624 days after receiving the submission on July 7, 2021.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5650.
| 510(k) Number | K212121 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 07, 2021 |
| Decision Date | March 23, 2023 |
| Days to Decision | 624 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | KPJ - Chamber, Oxygen, Topical, Extremity |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.5650 |