# Infrasonics Corp.

- Location (FDA's records): San Diego, CA
- FDA decisions: 20 (1984–1995): 20 510(k) clearances
- Product codes: CBK (10), BZO (2), BZC (2), BZD (1), GZJ (1), BTI (1), CAF (1), BZR (1), CAH (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 6 (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 that cite its devices most
- Sensor Medics Corp.: 2 (https://510kreport.com/company/sensor-medics)
- Respironics California, Inc.: 1 (https://510kreport.com/company/respironics-california)
- Puritan Bennett Corp.: 1 (https://510kreport.com/company/puritan-bennett)
- Hamilton Medical AG: 1 (https://510kreport.com/company/hamilton-medical)
- Maquet Critical Care AB: 1 (https://510kreport.com/company/maquet-critical-care)

## Its most-cited devices
- K884521: Star Sync (1989), cited by 1
- K905272: Adult Star, Modification (1991), cited by 1
- K840865: Infant Star Ventilator (1984), cited by 1
- K920954: Air Star (1992), cited by 1
- K922654: Ventilator Adult Star Modification (1992), cited by 1
- K923704: Infant Star Series 500 (1992), cited by 1

## Recent decisions
- K943106: Adult Ventilator (Dec 28, 1995)
- K952878: Oxy/Star Low Flow Blender (Sep 25, 1995)
- K934753: Star Breathing Circuits (Oct 27, 1993)
- K922654: Ventilator Adult Star Modification (Dec 1, 1992)
- K923704: Infant Star Series 500 (Oct 22, 1992)
- K922477: Model 105 Ventilator, Modification (Aug 24, 1992)
- K920954: Air Star (Aug 3, 1992)
- K911804: Infrasonics Ventilator Adult Star, Modification (Jun 11, 1992)

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