# VacHeal, LLC

- Location (FDA's records): Ardmore, PA
- FDA decisions: 1 (2026–2026): 1 510(k) clearance
- Product codes: OKO (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Spiracur, Inc.: 1 (https://510kreport.com/company/spiracur)

## Recent decisions
- K254160: VacHeal Negative Pressure Wound Therapy System (Sep 18, 2026)

Source page: https://510kreport.com/company/vacheal