510(k) Report

510(k) · Cleared

Cleared

Gish CAPVRF44 Hardshell Venous Reservoir with HA Coating

K081947510(k) TraditionalCleared Feb 4, 2009211-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 Feb 4, 2009 as substantially equivalent to K964973 (Gish Biomedical, Inc., 1997) and 1 other predicate after a 211-day review. Its family tree reaches back 3 generations to 1988.

Decided
Feb 4, 2009
Review
211 days
Class
Class II
Product code
DTN
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K883923 (1988). 5 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1993: 1 other ancestor1989: 1 other ancestorK883923 · Cardiotomy/Venous Reservoir NO.: CVR Series · Gish Biomedical, Inc. · 1988K964973 · Gish Cap VRF45 Cardiotomy/Venous Reservoir · Gish Biomedical, Inc. · 1997K030726 · Gish CAPVRF44 Hardshell Venous Reservoir with GBS Coating · Gish Biomedical, Inc. · 2003198519901995200020052010
Other ancestors, by generation 2 generations back: 2 other ancestors K030726 · Gish CAPVRF44 Hardshell Venous Reservoir with GBS Coating · Gish Biomedical, Inc. · 2003K964973 · Gish Cap VRF45 Cardiotomy/Venous Reservoir · Gish Biomedical, Inc. · 1997K883923 · Cardiotomy/Venous Reservoir NO.: CVR Series · Gish Biomedical, Inc. · 19880
  1. Root · 3 generations backK883923 Cardiotomy/Venous Reservoir NO.: CVR SeriesGish Biomedical, Inc. · 1988
  2. 2 generations backK964973 Gish Cap VRF45 Cardiotomy/Venous ReservoirGish Biomedical, Inc. · 1997
  3. 1 generation backK030726 Gish CAPVRF44 Hardshell Venous Reservoir with GBS CoatingGish Biomedical, Inc. · 2003
  4. This deviceK081947 Gish CAPVRF44 Hardshell Venous Reservoir with HA CoatingGish Biomedical, Inc. · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K883923Cardiotomy/Venous Reservoir NO.: CVR SeriesGish Biomedical, Inc.1988—
−2K964973Gish Cap VRF45 Cardiotomy/Venous ReservoirGish Biomedical, Inc.1997—
−1K030726Gish CAPVRF44 Hardshell Venous Reservoir with GBS CoatingGish Biomedical, Inc.2003—
0 (this device)K081947Gish CAPVRF44 Hardshell Venous Reservoir with HA CoatingGish Biomedical, Inc.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199310
FIG. 1 — Lineage of K081947, 1988–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 12.4 · 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? (2)

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
*K964973Gish Cap VRF45 Cardiotomy/Venous Reservoir
Summary page 1
…oamer Cardiopulmonary bypass blood reservoir 3. Predicate Devices: Gish CAPVRF45 Hardshell Venous Reservoir, K964973 and Gish CAPVRF44 Hardshell Venous Reservoir with GBSTM Coating, K030726. Both manufactured by Gish B…
Gish Biomedical, Inc.1997—
*K030726Gish CAPVRF44 Hardshell Venous Reservoir with GBS Coating
Summary page 1
…3. Predicate Devices: Gish CAPVRF45 Hardshell Venous Reservoir, K964973 and Gish CAPVRF44 Hardshell Venous Reservoir with GBSTM Coating, K030726. Both manufactured by Gish Biomedical, Inc. 4. Classifications Names & Citations: 21 CFR 870.…
Gish Biomedical, Inc.2003—

Also cleared against K964973: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • The line of descent spans 21 years and passes through 1 company; a new generation was cleared every 6.2 years on median.
  • None of the 5 ancestors has a recall.
  • 2 other devices also cite its predicate K964973.

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. 2009, this device’s year, is highlighted.

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 CAPVRF44 Hardshell Venous Reservoirs are indicated for use during cardiopulmonary bypass surgery as a storage reservoir for gravity and augmented venous return blood and to filter and defoam intrathoracic suctioned blood prior to its return to the extracorporeal circuit at flow rates of one (1.0) to eight (8.0) liters per minute for periods up to six hours (6.0) hours. The Gish CAPVRF44 Hardshell Venous Reservoirs are also indicated for the collection and autotransfusion of the same patients post operative shed blood with the addition of the Postoperative Conversion Pack with water seal/manometer.

Indications for use as stated in the FDA summary.

Also cleared against K964973

2 other devices cite the same predicate.

  • K083131Medos Hilite Reservoir, Model: 4030Gish Biomedical, Inc. · 2009
  • K030726Gish CAPVRF44 Hardshell Venous Reservoir with GBS CoatingGish Biomedical, Inc. · 2003

More from Gish Biomedical, Inc.

75 FDA decisions under this applicant name. See the company

  • K090449Medos Hilite Infant Oxygenator, Model 1000, 800 LTGish Biomedical, Inc. · 2009
  • K090450Medos Hilite Pediatric Oxygenator, Models 2800, 2400 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/K081947 · printed Nov 6, 2026

Cite this page

510(k) Report. “K081947: Gish CAPVRF44 Hardshell Venous Reservoir with HA Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081947

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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