# Biomerics Nle

- Location (FDA's records): Brooklyn Park, MN
- FDA decisions: 2 (2023–2024): 2 510(k) clearances
- Product codes: DQX (2)
- 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
- Vascular Solutions, Inc.: 1 (https://510kreport.com/company/vascular-solutions)
- Ashitaka Factory of Terumo Corp.: 1 (https://510kreport.com/company/ashitaka-factory-of-terumo)

## Recent decisions
- K232662: BNLE Hydrophilic Jacketed Peripheral Guidewire (May 14, 2024)
- K221390: BNLE Access Guidewire (Apr 28, 2023)

Source page: https://510kreport.com/company/biomerics-nle