# Gish Biomedical, Inc.

- Location (FDA's records): Santa Ana, CA
- FDA decisions: 75 (1983–2009): 75 510(k) clearances
- Product codes: DTN (16), DTR (10), DQY (7), DTZ (6), DTL (4), DTM (4), DTP (3), LJT (2), DTS (2), DWF (2), CAC (2), GCX (1)
- Predicates its devices cite: 30 (21 its own); citations of its devices by later devices: 34 (21 its own)
- Recalls linked to its devices: 26 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Terumo Corp.: 2 (https://510kreport.com/company/terumo)
- Cobe Laboratories, Inc.: 1 (https://510kreport.com/company/cobe-laboratories)
- Sorin Biomedica, Fiat, USA, Inc.: 1 (https://510kreport.com/company/sorin-biomedica-fiat-usa)
- Sorin Biomedical, Inc.: 1 (https://510kreport.com/company/sorin-biomedical)
- Terumo Medical Corp.: 1 (https://510kreport.com/company/terumo-medical)
- Terumo Cardiovascular Systems Corp.: 1 (https://510kreport.com/company/terumo-cardiovascular-systems)
- Circulatory Technology, Inc.: 1 (https://510kreport.com/company/circulatory-technology)
- International Biophysics Corp.: 1 (https://510kreport.com/company/international-biophysics)

## Firms that cite its devices most
- Medos Medizintechnik AG: 3 (https://510kreport.com/company/medos-medizintechnik)
- Olson Medical Sales, Inc.: 2 (https://510kreport.com/company/olson-medical-sales)
- Medtronic Cardiac Surgery, Medtronic, Inc.: 2 (https://510kreport.com/company/medtronic-cardiac-surgery-medtronic)
- Vortex Medical, Inc.: 2 (https://510kreport.com/company/vortex-medical)
- Polystan A/S: 1 (https://510kreport.com/company/polystan-a-s)
- Maquet Cardiopulmonary, AG: 1 (https://510kreport.com/company/maquet-cardiopulmonary)
- Terumo Cardiovascular Systems Corp.: 1 (https://510kreport.com/company/terumo-cardiovascular-systems)
- Qura S.R.L: 1 (https://510kreport.com/company/qura)

## Its most-cited devices
- K961530: Gish Reliance Oxygenator (Model Hfo) (1996), cited by 3
- K964973: Gish Cap VRF45 Cardiotomy/Venous Reservoir (1997), cited by 3
- K833322: Tubing Connectors EC-2XXX Series (1983), cited by 2
- K955046: Soft Venous Reservoir (1996), cited by 2
- K024065: Soft Venous Reservoir (Svrxx) with GBS Coating (2003), cited by 2
- K883923: Cardiotomy/Venous Reservoir NO.: CVR Series (1988), cited by 2

## Recent decisions
- K090450: Medos Hilite Pediatric Oxygenator, Models 2800, 2400 LT (Sep 18, 2009)
- K090449: Medos Hilite Infant Oxygenator, Model 1000, 800 LT (Sep 18, 2009)
- K091062: Medos Hilite Infant Reservoir, Model MVC 0730 (Aug 4, 2009)
- K083131: Medos Hilite Reservoir, Model: 4030 (Jul 30, 2009)
- K082403: Medos Hilite Oxygenator, Model 7000 & 7000 LT (May 15, 2009)
- K081947: Gish CAPVRF44 Hardshell Venous Reservoir with HA Coating (Feb 4, 2009)
- K082082: Gish SVR Soft Venous Reservoirs with HA Coating (Feb 4, 2009)
- K080708: Vision Hollow Fiber Oxygenator with HA Coating (Feb 2, 2009)

Source page: https://510kreport.com/company/gish-biomedical