510(k) · Cleared

Recalled · 2003

Gish Reliance Oxygenator (Model Hfo)

K961530510(k) TraditionalCleared Dec 5, 1996227-day reviewClass II21 CFR 870.4350Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Gish Biomedical, Inc. · DTZ Oxygenator, Cardiopulmonary Bypass

Cleared on Dec 5, 1996 as substantially equivalent to K923272 (Cobe Laboratories, Inc., 1993) and 1 other predicate after a 227-day review. Its family tree reaches back 1 generation to 1992. 10 later devices descend from it. It has been recalled once.

Decided: Dec 5, 1996
Review: 227 days
Class: Class II
Product code: DTZ
Recalls: 1
Predicates: 2

Its longest line of descent runs back 1 generation to K922933 (1992). 2 ancestors in all. 10 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK922933 Sorin Monolyrh Integrated Membrane LungSorin Biomedica, Fiat, USA, Inc. · 1992
This deviceK961530 Gish Reliance Oxygenator (Model Hfo)Gish Biomedical, Inc. · 1996
Descendant · cites it directly · 6 of its ownK082403 Medos Hilite Oxygenator, Model 7000 & 7000 LTGish Biomedical, Inc. · 2009
Descendant · 2 generations on · 5 of its ownK133261 Medos Hilite 7000 & 7000 LT OxygenatorMedos Medizintechnik AG · 2014
Descendant · 3 generations on · 3 of its ownK191407 Novalung SystemFresenius Medical Care Renal Therapies Group, LLC · 2020 · Recalled
Descendant · cites it directly · 2 of its ownK023381 Vision Hollow Fiber Oxygenator with Guardian CoatingGish Biomedical, Inc. · 2003 · Recalled
Descendant · 4 generations on · 1 of its ownK240880 VitalFlow Set with Balance BiosurfaceMedtronic, Inc. · 2024

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2003high 2 (2003) · low 0 (2004)2026

Most influential descendants

Showing 5 of 10 · See all

K082403Medos Hilite Oxygenator, Model 7000 & 7000 LTGish Biomedical, Inc. · 2009 · cites it directly6descendants
K133261Medos Hilite 7000 & 7000 LT OxygenatorMedos Medizintechnik AG · 2014 · 2 generations on5descendants
K191407Novalung SystemFresenius Medical Care Renal Therapies Group, LLC · 2020 · 3 generations on3descendants
K023381Vision Hollow Fiber Oxygenator with Guardian CoatingGish Biomedical, Inc. · 2003 · cites it directly2descendants
K240880VitalFlow Set with Balance BiosurfaceMedtronic, Inc. · 2024 · 4 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K922933	Sorin Monolyrh Integrated Membrane Lung	Sorin Biomedica, Fiat, USA, Inc.	1992	—
0 (this device)	K961530	Gish Reliance Oxygenator (Model Hfo)	Gish Biomedical, Inc.	1996	—
+1	K082403	Medos Hilite Oxygenator, Model 7000 & 7000 LT	Gish Biomedical, Inc.	2009	—
+2	K133261	Medos Hilite 7000 & 7000 LT Oxygenator	Medos Medizintechnik AG	2014	—
+3	K191407	Novalung System	Fresenius Medical Care Renal Therapies Group, LLC	2020	2
+1	K023381	Vision Hollow Fiber Oxygenator with Guardian Coating	Gish Biomedical, Inc.	2003	2
+4	K240880	VitalFlow Set with Balance Biosurface	Medtronic, Inc.	2024	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	2	0
2009	2	0
2014	1	0
2020	1	0
2024	2	0
2026	2	0

FIG. 1 — Lineage of K961530, 1992–2026Source: 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 DTZ? 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 DTZ device

#1 K240934 Quantum Perfusion Blood Oxygenator ECC…score 14.3 · 12 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
*	K923272	Cobe CMS-HF Hollow Fiber Membrane Oxygenator Summary page 1 …4.553.7390 (FAX) Jack W. Brown President DEVICE NAME MODEL NUMBER Gish Reliance™ Oxygenator HFO NAME OF PREDICATE OR LEGALLY MARKETED DEVICE COBE Optima Oxygenator (K923272) and Sorin MONOLYTH Oxygenator (K922933). DESCRIPTION OF DEVICE The Gish Reliance™ Oxygenator is designed to control blood gase…	Cobe Laboratories, Inc.	1993	—
*	K922933	Sorin Monolyrh Integrated Membrane Lung Summary page 1 …t DEVICE NAME MODEL NUMBER Gish Reliance™ Oxygenator HFO NAME OF PREDICATE OR LEGALLY MARKETED DEVICE COBE Optima Oxygenator (K923272) and Sorin MONOLYTH Oxygenator (K922933). DESCRIPTION OF DEVICE The Gish Reliance™ Oxygenator is designed to control blood gases in the extracorporeal circuit during c…	Sorin Biomedica, Fiat, USA, Inc.	1992	—

What descends from it? (10)

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

Number	Device	Applicant	Decided	Descendants
K082403	Medos Hilite Oxygenator, Model 7000 & 7000 LT	Gish Biomedical, Inc.	2009	6
K023381	Vision Hollow Fiber Oxygenator with Guardian Coating	Gish Biomedical, Inc.	2003	2
K080708	Vision Hollow Fiber Oxygenator with HA Coating	Gish Biomedical, Inc.	2009	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 31, 2003	Not classified	Z-0780-03	Other	Two reports of leakage.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 2 ancestors has a recall.
Of its descendants, K082403 (Gish Biomedical, Inc., 2009) has gone furthest, with 6 descendants of its own.

How does its category compare?

All DTZ devices

DTZ Oxygenator, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DTZ

2in 2025

2007high 9 (2009) · low 2 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTZ

124in 2024

2007high 336 (2021) · low 28 (2013)2026

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

Recalls per year · DTZ

1in 2025

2007high 14 (2012) · low 0 (2009)2026

Class I (3 since 2007) Class II/III not classified

Adverse event reports per year · DTZ

976in 2025

2007high 976 (2025) · low 52 (2009)2025

MAUDE reports naming product code DTZ, 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	4	55	7	134
2008	3	88	5	105
2009	9	210	0	52
2010	2	—	1	119
2011	4	160	13	190
2012	9	90	14	215
2013	9	28	0	346
2014	5	28	2	764
2015	9	134	0	658
2016	3	62	1	443
2017	2	—	0	388
2018	3	72	2 (2)	320
2019	5	90	1	489
2020	5	93	3	442
2021	5	336	1 (1)	595
2022	2	—	6	559
2023	5	145	0	738
2024	3	124	0	535
2025	2	—	1	976
2026	3	137	0	—

What is it indicated for?

The Gish Reliance™ Oxygenator is indicated for use in procedures requiring the extracorporeal oxygenation of, and carbon dioxide removal from, human blood. It is designed to operate at blood flow rates of one half (0.5) to eight (8.0) liters per minute for periods of up to six (6.0) hours.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K961530 · printed Nov 4, 2026

Cite this page

510(k) Report. “K961530: Gish Reliance Oxygenator (Model Hfo).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961530

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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