510(k) Report

510(k) · Cleared

Cleared

Soft Venous Reservoir

K955046510(k) TraditionalCleared Jan 11, 199669-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 Jan 11, 1996 after a 69-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Jan 11, 1996
Review
69 days
Class
Class II
Product code
DTN
Recalls
None
Predicates
0

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

Descendants, by year cleared 2003: 1 descendant cleared2009: 1 descendant cleared2005: 1 descendant cleared1995200020052010201520202025
  1. This deviceK955046 Soft Venous ReservoirGish Biomedical, Inc. · 1996
  2. Descendant · cites it directly · 2 of its ownK024065 Soft Venous Reservoir (Svrxx) with GBS CoatingGish Biomedical, Inc. · 2003
  3. Descendant · cites it directly · 0 of its ownK082082 Gish SVR Soft Venous Reservoirs with HA CoatingGish Biomedical, Inc. · 2009
  4. Descendant · 2 generations on · 0 of its ownK050195 V-Bag with GBS CoatingGish Biomedical, Inc. · 2005

Most influential descendants

Showing 3 of 3 · See all
  • K024065Soft Venous Reservoir (Svrxx) with GBS CoatingGish Biomedical, Inc. · 2003 · cites it directly2descendants
  • K082082Gish SVR Soft Venous Reservoirs with HA CoatingGish Biomedical, Inc. · 2009 · cites it directly0descendants
  • K050195V-Bag with GBS CoatingGish Biomedical, Inc. · 2005 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K955046Soft Venous ReservoirGish Biomedical, Inc.1996—
+1K024065Soft Venous Reservoir (Svrxx) with GBS CoatingGish Biomedical, Inc.2003—
+1K082082Gish SVR Soft Venous Reservoirs with HA CoatingGish Biomedical, Inc.2009—
+2K050195V-Bag with GBS CoatingGish Biomedical, Inc.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200510
200910
FIG. 1 — Lineage of K955046, 1996–2009Source: 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), 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?

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

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K024065Soft Venous Reservoir (Svrxx) with GBS CoatingGish Biomedical, Inc.20032
K082082Gish SVR Soft Venous Reservoirs 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?

  • Of its descendants, K024065 (Gish Biomedical, Inc., 2003) has gone furthest, with 2 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/K955046 · printed Nov 4, 2026

Cite this page

510(k) Report. “K955046: Soft Venous Reservoir.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955046

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
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026