510(k) · Cleared

Cleared

Medos Hilite Infant Reservoir, Model MVC 0730

K091062510(k) TraditionalCleared Aug 4, 2009112-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 Aug 4, 2009 as substantially equivalent to K022115 (Terumo Corp., 2002) after a 112-day review. Its family tree reaches back 2 generations to 1985.

Decided: Aug 4, 2009
Review: 112 days
Class: Class II
Product code: DTN
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K842908 (1985). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK842908 Variable Prime Cobe Membrane LungCobe Laboratories, Inc. · 1985
1 generation backK022115 Capiox RX05 Hollow Fiber Oxygenator W/Without Hardshell ReservoirTerumo Corp. · 2002
This deviceK091062 Medos Hilite Infant Reservoir, Model MVC 0730Gish Biomedical, Inc. · 2009

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K842908	Variable Prime Cobe Membrane Lung	Cobe Laboratories, Inc.	1985	—
−1	K022115	Capiox RX05 Hollow Fiber Oxygenator W/Without Hardshell Reservoir	Terumo Corp.	2002	—
0 (this device)	K091062	Medos Hilite Infant Reservoir, Model MVC 0730	Gish Biomedical, Inc.	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0

FIG. 1 — Lineage of K091062, 1985–2009Source: 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
*	K022115	Capiox RX05 Hollow Fiber Oxygenator W/Without Hardshell Reservoir Summary page 1 …Cardiopulmonary Bypass Blood Reservoir 3. Predicate Devices: CAPIOX ® RX05 Hollow Fiber Oxygenator with Hardshell Reservoir, K022115, manufactured by Terumo Cardiovascular Systems Corporation. 4. Classifications Names & Citations:…	Terumo Corp.	2002	—

Also cleared against K022115: 7 other devices →

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 24 years and passes through 3 companies; a new generation was cleared every 17.7 years on median.
None of the 3 ancestors has a recall.
7 other devices also cite its predicate K022115.

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. 2009, this device’s year, is highlighted.

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 MEDOS HILITE MVC 0730 Hardshell Venous Reservoir is 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. The MVC 0730 is a neonate, infant reservoir intended for use in procedures at a maximum flow rate of 1.2 liters per minute for periods up to six hours (6.0) hours.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K091062 · printed Nov 5, 2026

Cite this page

510(k) Report. “K091062: Medos Hilite Infant Reservoir, Model MVC 0730.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091062

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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