# Healthdyne Cardiovascular, Inc.

- Location (FDA's records): Irvine, CA
- FDA decisions: 5 (1989–1990): 5 510(k) clearances
- Product codes: KXO (2), DXT (1), HIO (1), FXX (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
- K901643: Isoflo (TM) Amniocentesis Tray (Jul 25, 1990)
- K901382: Isoflo (TM) High Pressure Injection Lines (Jul 19, 1990)
- K901084: Isoflo Intrauterine Pressure Monitoring & Amnio. (Jun 1, 1990)
- K900665: Dressing Change Kit (May 14, 1990)
- K895763: Isoflo and Isotec Intrauterine Pressure Monitoring (Dec 22, 1989)

Source page: https://510kreport.com/company/healthdyne-cardiovascular