510(k) Report

510(k) · Cleared

Cleared

Cardiotomy/Venous Reservoir NO.: CVR Series

K883923510(k) TraditionalCleared Nov 4, 198849-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 Nov 4, 1988 after a 49-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.

Decided
Nov 4, 1988
Review
49 days
Class
Class II
Product code
DTN
Recalls
None
Predicates
0

5 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared1997: 1 descendant cleared2009: 2 descendants cleared2003: 1 descendant cleared1990200020102020
  1. This deviceK883923 Cardiotomy/Venous Reservoir NO.: CVR SeriesGish Biomedical, Inc. · 1988
  2. Descendant · cites it directly · 3 of its ownK964973 Gish Cap VRF45 Cardiotomy/Venous ReservoirGish Biomedical, Inc. · 1997
  3. Descendant · 2 generations on · 1 of its ownK030726 Gish CAPVRF44 Hardshell Venous Reservoir with GBS CoatingGish Biomedical, Inc. · 2003
  4. Descendant · 2 generations on · 0 of its ownK083131 Medos Hilite Reservoir, Model: 4030Gish Biomedical, Inc. · 2009
  5. Descendant · 2 generations on · 0 of its ownK081947 Gish CAPVRF44 Hardshell Venous Reservoir with HA CoatingGish Biomedical, Inc. · 2009
  6. Descendant · cites it directly · 0 of its ownK022281 Safe Maxi Venous/Cardiotomy Reservior, Model 016045Polystan A/S · 2002

Most influential descendants

Showing 5 of 5 · See all
  • K964973Gish Cap VRF45 Cardiotomy/Venous ReservoirGish Biomedical, Inc. · 1997 · cites it directly3descendants
  • K030726Gish CAPVRF44 Hardshell Venous Reservoir with GBS CoatingGish Biomedical, Inc. · 2003 · 2 generations on1descendant
  • K083131Medos Hilite Reservoir, Model: 4030Gish Biomedical, Inc. · 2009 · 2 generations on0descendants
  • K081947Gish CAPVRF44 Hardshell Venous Reservoir with HA CoatingGish Biomedical, Inc. · 2009 · 2 generations on0descendants
  • K022281Safe Maxi Venous/Cardiotomy Reservior, Model 016045Polystan A/S · 2002 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K883923Cardiotomy/Venous Reservoir NO.: CVR SeriesGish Biomedical, Inc.1988—
+1K964973Gish Cap VRF45 Cardiotomy/Venous ReservoirGish Biomedical, Inc.1997—
+2K030726Gish CAPVRF44 Hardshell Venous Reservoir with GBS CoatingGish Biomedical, Inc.2003—
+2K083131Medos Hilite Reservoir, Model: 4030Gish Biomedical, Inc.2009—
+2K081947Gish CAPVRF44 Hardshell Venous Reservoir with HA CoatingGish Biomedical, Inc.2009—
+1K022281Safe Maxi Venous/Cardiotomy Reservior, Model 016045Polystan A/S2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200210
200310
200920
FIG. 1 — Lineage of K883923, 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (5)

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

NumberDeviceApplicantDecidedDescendants
K964973Gish Cap VRF45 Cardiotomy/Venous ReservoirGish Biomedical, Inc.19973
K022281Safe Maxi Venous/Cardiotomy Reservior, Model 016045Polystan A/S20020

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?

  • Of its descendants, K964973 (Gish Biomedical, Inc., 1997) has gone furthest, with 3 descendants 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—

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/K883923 · printed Nov 6, 2026

Cite this page

510(k) Report. “K883923: Cardiotomy/Venous Reservoir NO.: CVR Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K883923

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026