# Biolectron, Inc.

- Location (FDA's records): Hackensack, NJ
- FDA decisions: 1 (1997–1997): 1 510(k) clearance
- Product codes: HSZ (1)
- Predicates its devices cite: 4 (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
- Romano Surgical Instrumentation, Inc.: 2 (https://510kreport.com/company/romano-surgical-instrumentation)
- 3M Health Care, Ltd.: 1 (https://510kreport.com/company/3m-health-care)
- Synthes (Usa): 1 (https://510kreport.com/company/synthes-usa)

## Recent decisions
- K972860: Curvtek TSR System (Oct 31, 1997)

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