# Pendracare

- Location (FDA's records): Leek, NL
- FDA decisions: 2 (2025–2026): 2 510(k) clearances
- Product codes: DQY (1), DYB (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
- Pendracare International, B.V.: 1 (https://510kreport.com/company/pendracare-international)
- Terumo Medical Corp.: 1 (https://510kreport.com/company/terumo-medical)

## Recent decisions
- K261242: SimplGuide (Jun 25, 2026)
- K250972: Primum Hydrophilic Guiding Catheter (Jun 29, 2025)

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