# Disa Medinotec

- Location (FDA's records): Johannesburg, ZA
- FDA decisions: 2 (2021–2025): 2 510(k) clearances
- Product codes: OZT (1), KTI (1)
- Predicates its devices cite: 2 (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
- C.R. Bard, Inc.: 1 (https://510kreport.com/company/cr-bard)
- Boston Scientific Corp: 1 (https://510kreport.com/company/boston-scientific)

## Recent decisions
- K241562: OutFlo Aortic Valve Dilatation Balloon Catheter (Mar 11, 2025)
- K211894: Trachealator (Nov 24, 2021)

Source page: https://510kreport.com/company/disa-medinotec