# Healthdyne, Inc.

- Location (FDA's records): Marietta, GA
- FDA decisions: 35 (1978–1995): 35 510(k) clearances
- Product codes: BZQ (8), CBK (6), CAW (5), DRT (2), CGA (1), OLV (1), BZD (1), DSF (1), CAP (1), BZB (1), BYE (1), BZE (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 7 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Respironics, Inc.: 2 (https://510kreport.com/company/respironics)
- Ferguson Medical: 1 (https://510kreport.com/company/ferguson-medical)
- Flaem Nuova S.P.A.: 1 (https://510kreport.com/company/flaem-nuova)
- Devilbiss Health Care, Inc.: 1 (https://510kreport.com/company/devilbiss-health-care)
- 3A Health Care S.R.L.: 1 (https://510kreport.com/company/3a-health-care)
- Respironics Georgia, Inc.: 1 (https://510kreport.com/company/respironics-georgia)

## Its most-cited devices
- K922623: Nebulizer System (1992), cited by 3
- K892006: Healthdyne's Apnea/Heart Monitor, Model 900S (1989), cited by 2
- K922106: ALICE (1994), cited by 1
- K950331: Pressure Support Ventilatory Assist System (Psvas) (1995), cited by 1

## Recent decisions
- K950331: Pressure Support Ventilatory Assist System (Psvas) (Sep 21, 1995)
- K922106: ALICE (Jul 6, 1994)
- K942357: H-500 Alliance Oxygen Concentrator (May 27, 1994)
- K934502: Flow Spirometer (Apr 4, 1994)
- K924146: OH-500 Oxygen Concentrator (Jan 7, 1993)
- K922623: Nebulizer System (Dec 1, 1992)
- K910118: Data Recorder (Feb 14, 1991)
- K903287: Model 900S Apnea/Heart Monitor (Aug 17, 1990)

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