510(k) Report

510(k) · Cleared

Cleared

Gish Cap VRF45 Cardiotomy/Venous Reservoir

K964973510(k) TraditionalCleared Mar 10, 199788-day reviewClass II21 CFR 870.4400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Gish Biomedical, Inc. · DTN Reservoir, Blood, Cardiopulmonary Bypass

Cleared on Mar 10, 1997 as substantially equivalent to K890504 (Gish Biomedical, Inc., 1989) and 2 other predicates after an 88-day review. Its family tree reaches back 1 generation to 1988. 3 later devices descend from it.

Decided
Mar 10, 1997
Review
88 days
Class
Class II
Product code
DTN
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K883923 (1988). 3 ancestors in all. 3 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1993: 1 other ancestor1989: 1 other ancestor2009: 2 descendants cleared2003: 1 descendant clearedReference device: K874924 · Cap-35 and CAP35 F · Gish Biomedical, Inc. · 1988Reference device: K870792 · Thorastat Atr-XXXX · Gish Biomedical, Inc. · 1987K883923 · Cardiotomy/Venous Reservoir NO.: CVR Series · Gish Biomedical, Inc. · 19881990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 3 descendants K883923 · Cardiotomy/Venous Reservoir NO.: CVR Series · Gish Biomedical, Inc. · 19880
  1. Root · 1 generation backK883923 Cardiotomy/Venous Reservoir NO.: CVR SeriesGish Biomedical, Inc. · 1988
  2. This deviceK964973 Gish Cap VRF45 Cardiotomy/Venous ReservoirGish Biomedical, Inc. · 1997
  3. Descendant · cites it directly · 1 of its ownK030726 Gish CAPVRF44 Hardshell Venous Reservoir with GBS CoatingGish Biomedical, Inc. · 2003
  4. Descendant · cites it directly · 0 of its ownK083131 Medos Hilite Reservoir, Model: 4030Gish Biomedical, Inc. · 2009
  5. Descendant · cites it directly · 0 of its ownK081947 Gish CAPVRF44 Hardshell Venous Reservoir with HA CoatingGish Biomedical, Inc. · 2009

Most influential descendants

Showing 3 of 3 · See all
  • K030726Gish CAPVRF44 Hardshell Venous Reservoir with GBS CoatingGish Biomedical, Inc. · 2003 · cites it directly1descendant
  • K083131Medos Hilite Reservoir, Model: 4030Gish Biomedical, Inc. · 2009 · cites it directly0descendants
  • K081947Gish CAPVRF44 Hardshell Venous Reservoir with HA CoatingGish Biomedical, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K883923Cardiotomy/Venous Reservoir NO.: CVR SeriesGish Biomedical, Inc.1988—
0 (this device)K964973Gish Cap VRF45 Cardiotomy/Venous ReservoirGish Biomedical, Inc.1997—
+1K030726Gish CAPVRF44 Hardshell Venous Reservoir with GBS CoatingGish Biomedical, Inc.2003—
+1K083131Medos Hilite Reservoir, Model: 4030Gish Biomedical, Inc.2009—
+1K081947Gish CAPVRF44 Hardshell Venous Reservoir with HA CoatingGish Biomedical, Inc.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200920
FIG. 1 — Lineage of K964973, 1988–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DTN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DTN device

  1. #1 K251783 Inspire HCR and HCR DUAL cardiotomy reservoirsscore 12.3 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K890504Cardiotomy/Autotransfusion/Pleural Drainage Venous
Summary page 1
…L NUMBER CAP VRF45 Cardiotomy/Venous Reservoir CAP VRF45 NAME OF PREDICATE OR LEGALLY MARKETED DEVICE Gish Cardiotomy/Autotransfusion/Pleural Drainage Venous Reservoir; K890504 Gish Cardiotomy/Venous Reservoir: K883923 Terumo CAPIOX SX; K922799 DESCRIPTION OF DEVICE Consistent with the intended use desc…
Gish Biomedical, Inc.1989—
*K883923Cardiotomy/Venous Reservoir NO.: CVR Series
Summary page 1
…voir CAP VRF45 NAME OF PREDICATE OR LEGALLY MARKETED DEVICE Gish Cardiotomy/Autotransfusion/Pleural Drainage Venous Reservoir; K890504 Gish Cardiotomy/Venous Reservoir: K883923 Terumo CAPIOX SX; K922799 DESCRIPTION OF DEVICE Consistent with the intended use described in K883923 and K890504, the Gish CAP…
Gish Biomedical, Inc.1988—
*K922799Capiox SX Hollow Fiber Oxygenator
Summary page 1
…DICATE OR LEGALLY MARKETED DEVICE Gish Cardiotomy/Autotransfusion/Pleural Drainage Venous Reservoir; K890504 Gish Cardiotomy/Venous Reservoir: K883923 Terumo CAPIOX SX; K922799 DESCRIPTION OF DEVICE Consistent with the intended use described in K883923 and K890504, the Gish CAP VRF45 is a disposable dev…
Terumo Medical Corp.1993—
†K874924Cap-35 and CAP35 FGish Biomedical, Inc.1988—
†K870792Thorastat Atr-XXXXGish Biomedical, Inc.1987—

What descends from it? (3)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K030726Gish CAPVRF44 Hardshell Venous Reservoir with GBS CoatingGish Biomedical, Inc.20031
K083131Medos Hilite Reservoir, Model: 4030Gish Biomedical, Inc.20090
K081947Gish CAPVRF44 Hardshell Venous Reservoir with HA CoatingGish Biomedical, Inc.20090

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K030726 (Gish Biomedical, Inc., 2003) has gone furthest, with 1 descendant of its own.

How does its category compare?

All DTN devices

DTN Reservoir, Blood, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DTN

1in 2025

2007: 22008: 12009: 72010: 12011: 22013: 42014: 32015: 22017: 22023: 12024: 22025: 1
2007high 7 (2009) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTN

38in 2014

2009: 211 days median2013: 79 days median2014: 38 days median
2007high 211 (2009) · low 38 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DTN

2in 2018

2007: 12008: 12009: 12011: 12016: 12017: 12018: 2
2007high 2 (2018) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DTN

8in 2025

2007: 102008: 82009: 102010: 182011: 102012: 172013: 472014: 522015: 272016: 62017: 32018: 42019: 112020: 62021: 122022: 72023: 82024: 102025: 8
2007high 52 (2014) · low 3 (2017)2025

MAUDE reports naming product code DTN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—110
20081—18
20097211110
20101—018
20112—110
20120—017
2013479047
2014338052
20152—027
20160—16
20172—13
20180—24
20190—011
20200—06
20210—012
20220—07
20231—08
20242—010
20251—08
20260—0—

What is it indicated for?

The Gish CAP VRF45 is indicated for use during cardiopulmonary bypass surgery as a storage reservoir for venous return blood and to filter and defoam intrathoracic suctioned blood prior to its return to the extracorporeal circuit. The CAP VRF4S is indicated for the collection and autotransfusion of the same patient’s postoperative shed blood.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Gish Biomedical, Inc.

75 FDA decisions under this applicant name. See the company

  • 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

Recent decisions in DTN

The DTN category page

  • K251783Inspire HCR and HCR DUAL cardiotomy reservoirsSorin Group Italia S.R.L. · 2025
  • K241206Quantum Perfusion Hybrid SystemSpectrum Medical S.R.L. · 2024
  • K241053MVR™ Venous Reservoir Bag 800 mL; MVR™ Venous Reservoir Bag 1600 mL; MVR™ Venous Reservoir Bag with Cortiva™…Medtronic Cardiac Surgery · 2024
  • K223361BMR 1900 PhisioSorin Group Italia S.R.L. · 2023
  • K170583Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive SurfaceMedtronic, Inc. · 2017

https://510kreport.com/device/K964973 · printed Nov 6, 2026

Cite this page

510(k) Report. “K964973: Gish Cap VRF45 Cardiotomy/Venous Reservoir.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964973

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026