# Biovalve Technologies, Inc.

- Location (FDA's records): Westborough, MA
- FDA decisions: 3 (2004–2005): 3 510(k) clearances
- Product codes: KZE (2), LZG (1)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 2 (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
- Bioject, Inc.: 2 (https://510kreport.com/company/bioject)
- Insulet Corporation: 1 (https://510kreport.com/company/insulet)

## Firms that cite its devices most
- Valeritas, LLC: 1 (https://510kreport.com/company/valeritas)
- Calibra Medical, Inc.: 1 (https://510kreport.com/company/calibra-medical)

## Its most-cited devices
- K050971: Biovalve Insulin Delivery Systems (Bids) (2005), cited by 2

## Recent decisions
- K051985: Biovalve Mini-Ject Needlefree Injector (Aug 17, 2005)
- K050971: Biovalve Insulin Delivery Systems (Bids) (Aug 16, 2005)
- K032976: Biovalve Miniject Needle-Free Injection System, Model FG-01-001 (Apr 16, 2004)

Source page: https://510kreport.com/company/biovalve-technologies