510(k) · Cleared

Cleared

Gish CAPVRF44 Hardshell Venous Reservoir with GBS Coating

K030726510(k) TraditionalCleared May 30, 200384-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 May 30, 2003 as substantially equivalent to K964973 (Gish Biomedical, Inc., 1997) after an 84-day review. Its family tree reaches back 2 generations to 1988. 1 later device descends from it.

Decided: May 30, 2003
Review: 84 days
Class: Class II
Product code: DTN
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K883923 (1988). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 2 generations backK883923 Cardiotomy/Venous Reservoir NO.: CVR SeriesGish Biomedical, Inc. · 1988
1 generation backK964973 Gish Cap VRF45 Cardiotomy/Venous ReservoirGish Biomedical, Inc. · 1997
This deviceK030726 Gish CAPVRF44 Hardshell Venous Reservoir with GBS CoatingGish Biomedical, Inc. · 2003
Descendant · cites it directly · 0 of its ownK081947 Gish CAPVRF44 Hardshell Venous Reservoir with HA CoatingGish Biomedical, Inc. · 2009

Most influential descendants

Showing 1 of 1 · See all

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

Generation	Number	Device	Applicant	Decided	Recalls
−2	K883923	Cardiotomy/Venous Reservoir NO.: CVR Series	Gish Biomedical, Inc.	1988	—
−1	K964973	Gish Cap VRF45 Cardiotomy/Venous Reservoir	Gish Biomedical, Inc.	1997	—
0 (this device)	K030726	Gish CAPVRF44 Hardshell Venous Reservoir with GBS Coating	Gish Biomedical, Inc.	2003	—
+1	K081947	Gish CAPVRF44 Hardshell Venous Reservoir with HA Coating	Gish Biomedical, Inc.	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1993	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0

FIG. 1 — Lineage of K030726, 1988–2009Source: 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? (1)

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
*	K964973	Gish Cap VRF45 Cardiotomy/Venous Reservoir Summary page 1 …Cardiopulmonary bypass blood reservoir 3. Predicate Devices: Gish CAPVRF45 Hardshell Venous Reservoir, Gish Biomedical, Inc., K964973. 4. Classifications Names & Citations: 5. 21 CFR 870.4230, 21 CFR 870.4400, Extracorporeal circuit blood defoamer,…	Gish Biomedical, Inc.	1997	—

Also cleared against K964973: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K081947	Gish CAPVRF44 Hardshell Venous Reservoir with HA Coating	Gish Biomedical, Inc.	2009	0

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 15 years and passes through 1 company; a new generation was cleared every 8.3 years on median.
None of the 4 ancestors has a recall.
Of its descendants, K081947 (Gish Biomedical, Inc., 2009) has gone furthest, with 0 descendants of its own.
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.

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 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 .O) 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 SeaVmanometer.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030726 · printed Nov 5, 2026

Cite this page

510(k) Report. “K030726: Gish CAPVRF44 Hardshell Venous Reservoir with GBS Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030726

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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