510(k) · Cleared

Cleared

V-Bag with GBS Coating

K050195510(k) TraditionalCleared Mar 17, 200549-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 17, 2005 as substantially equivalent to K001822 (Circulatory Technology, Inc., 2000) and 1 other predicate after a 49-day review. Its family tree reaches back 2 generations to 1996.

Decided: Mar 17, 2005
Review: 49 days
Class: Class II
Product code: DTN
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K955046 (1996). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK955046 Soft Venous ReservoirGish Biomedical, Inc. · 1996
1 generation backK024065 Soft Venous Reservoir (Svrxx) with GBS CoatingGish Biomedical, Inc. · 2003
This deviceK050195 V-Bag with GBS CoatingGish Biomedical, Inc. · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K955046	Soft Venous Reservoir	Gish Biomedical, Inc.	1996	—
−1	K024065	Soft Venous Reservoir (Svrxx) with GBS Coating	Gish Biomedical, Inc.	2003	—
0 (this device)	K050195	V-Bag with GBS Coating	Gish Biomedical, Inc.	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0

FIG. 1 — Lineage of K050195, 1996–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K251783 Inspire HCR and HCR DUAL cardiotomy reservoirsscore 12.4 · 7 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K001822	The V-Bag Summary page 2 …M T characteristics as the predicate devices, The V-Bag, Circulatory Technology, Inc., K001 822. 10. Test Data: The Circulatory Technology Inc. V-BAG with GBS® Coating has been subjected tosystems…	Circulatory Technology, Inc.	2000	—
*	K024065	Soft Venous Reservoir (Svrxx) with GBS Coating Summary page 1 …TM . K(001 822 and Gish Soft Venous Reservoir SVR with GBS TM Coating, K024065, 4. Classifications Names & Citations: 5. 21 CFR 870.4400, Reservoir, blood, cardiopulmonary bypass, Class I…	Gish Biomedical, Inc.	2003	—

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 9 years and passes through 1 company; a new generation was cleared every 7.1 years on median.
None of the 3 ancestors has a recall.

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

2007high 7 (2009) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTN

38in 2014

2007high 211 (2009) · low 38 (2014)2026

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

Recalls per year · DTN

2in 2018

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	2	—	1	10
2008	1	—	1	8
2009	7	211	1	10
2010	1	—	0	18
2011	2	—	1	10
2012	0	—	0	17
2013	4	79	0	47
2014	3	38	0	52
2015	2	—	0	27
2016	0	—	1	6
2017	2	—	1	3
2018	0	—	2	4
2019	0	—	0	11
2020	0	—	0	6
2021	0	—	0	12
2022	0	—	0	7
2023	1	—	0	8
2024	2	—	0	10
2025	1	—	0	8
2026	0	—	0	—

What is it indicated for?

The Circulatory Technology Inc. V-BAG with GBS® Coating is a disposable soft shell venous reservoir that accepts venous and cardiotomy blood and facilitates the removal of air bubbles during surgical procedures requiring extracorporeal support for up to six hours. When used with the Vac-Box, it can be used for Vacuum Assisted Venous Drainage (VAVD).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050195 · printed Nov 4, 2026

Cite this page

510(k) Report. “K050195: V-Bag with GBS Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050195

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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