# VacHeal Negative Pressure Wound Therapy System (K254160): 510(k) cleared for VacHeal, LLC

**Predicate Speed & CAPA Advisory Opportunity Score:** 55/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K254160 |
| Device | VacHeal Negative Pressure Wound Therapy System |
| Applicant | VacHeal, LLC |
| Specialty / panel | General, Plastic Surgery |
| Product code | OKO |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2025-12-22 |
| Decision date | 2026-09-18 |
| Review time (days) | 270 |
| Third-party review | No |
| Applicant location | Ardmore, PA, US |

## Why this score
- A long 270-day review suggests additional-information requests: a firm likely to value regulatory help next time.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254160). Last refreshed: 2026-11-03T18:05:14.713Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.