# Bio-Dyne, Inc.

- Location (FDA's records): La Mesa, CA
- FDA decisions: 3 (1987–1990): 3 510(k) clearances
- Product codes: GEC (1), BZQ (1), LKX (1)
- Predicates its devices cite: 0 (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

## Recent decisions
- K900691: Biodyne Instrument Wipes (Mar 8, 1990)
- K883984: Hemorx Cold Pack (Dec 22, 1988)
- K864261: Model 3500 Infant Respiration & Heart Rate Monitor (Mar 27, 1987)

Source page: https://510kreport.com/company/bio-dyne