510(k) Report

FDA applicant

Gish Biomedical, Inc.

Santa Ana, CA75 decisions1983–200926 recalls

FDA records 75 decisions for Gish Biomedical, Inc. (Santa Ana, CA) from 1983 to 2009: 75 510(k) clearances. Most are in product codes DTN (Reservoir, Blood, Cardiopulmonary Bypass) and DTR (Heat-Exchanger, Cardiopulmonary Bypass). Its devices cite 30 predicates, 21 of them its own earlier devices. 26 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Gish Biomedical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

11in 2009

2009: 11
2007high 11 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

19in 2020

2012: 22019: 12020: 19
2007high 19 (2020) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Gish Biomedical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Gish Biomedical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DTNReservoir, Blood, Cardiopulmonary Bypass16decisions
  • DTRHeat-Exchanger, Cardiopulmonary Bypass10decisions
  • DQYCatheter, Percutaneous7decisions
  • DTZOxygenator, Cardiopulmonary Bypass6decisions
  • DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass4decisions
  • DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line4decisions

Also: DTP (3), LJT (2), DTS (2), DWF (2), CAC (2), GCX (1).

Whose devices does it build on?

Its devices cite 30 predicates; 21 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 34 times; 21 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K961530Gish Reliance Oxygenator (Model Hfo)Gish Biomedical, Inc. · 19963cite it
  • K964973Gish Cap VRF45 Cardiotomy/Venous ReservoirGish Biomedical, Inc. · 19973cite it
  • K833322Tubing Connectors EC-2XXX SeriesGish Biomedical, Inc. · 19832cite it
  • K955046Soft Venous ReservoirGish Biomedical, Inc. · 19962cite it
  • K024065Soft Venous Reservoir (Svrxx) with GBS CoatingGish Biomedical, Inc. · 20032cite it
  • K883923Cardiotomy/Venous Reservoir NO.: CVR SeriesGish Biomedical, Inc. · 19882cite it

What has FDA decided for it lately?

  • K090450Medos Hilite Pediatric Oxygenator, Models 2800, 2400 LTGish Biomedical, Inc. · 2009
  • K090449Medos Hilite Infant Oxygenator, Model 1000, 800 LTGish Biomedical, Inc. · 2009
  • K091062Medos Hilite Infant Reservoir, Model MVC 0730Gish Biomedical, Inc. · 2009
  • K083131Medos Hilite Reservoir, Model: 4030Gish Biomedical, Inc. · 2009
  • K082403Medos Hilite Oxygenator, Model 7000 & 7000 LTGish Biomedical, Inc. · 2009
  • K081947Gish CAPVRF44 Hardshell Venous Reservoir with HA CoatingGish Biomedical, Inc. · 2009
  • K082082Gish SVR Soft Venous Reservoirs with HA CoatingGish Biomedical, Inc. · 2009
  • K080708Vision Hollow Fiber Oxygenator with HA CoatingGish Biomedical, Inc. · 2009

All 75 as Gish Biomedical, Inc. →

What has been recalled?

26 recalls linked to its devices; the latest:

  • K833322Sterile Disposable Connectors ASY S CONN 3/16X1/8 RDR ANLD24 REF/ GTIN for Insert…Apr 24, 2020Class II
  • K833322Sterile Disposable Connectors ASY CONN Y 1/2X1/2X3/8 STR 24. REF/ GTIN for Insert…Apr 24, 2020Class II
  • K833322Sterile Disposable Connectors ASY ASY STR CONN 3/8 STRLE 24 REF/ GTIN for Insert…Apr 24, 2020Class II
  • K833322Sterile Disposable Connectors ASY CONN REDUCER 1/2 X 3/8 24 REF/ GTIN for Insert…Apr 24, 2020Class II
  • K833322Sterile Disposable Connectors ASY S/1/4 TO 3/16 RED 24 REF/ GTIN for Insert…Apr 24, 2020Class II
  • K833322Sterile Disposable Connectors ASY Y CONN 1/4 X 1/4 X 1/4 24 REF/ GTIN for Insert…Apr 24, 2020Class II