510(k) · Cleared

Cleared

Medos Hilite Reservoir, Model: 4030

K083131510(k) TraditionalCleared Jul 30, 2009280-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 Jul 30, 2009 as substantially equivalent to K964973 (Gish Biomedical, Inc., 1997) after a 280-day review. Its family tree reaches back 2 generations to 1988.

Decided: Jul 30, 2009
Review: 280 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. No later device cites it as a predicate yet.

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 deviceK083131 Medos Hilite Reservoir, Model: 4030Gish Biomedical, Inc. · 2009

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)	K083131	Medos Hilite Reservoir, Model: 4030	Gish Biomedical, Inc.	2009	—

Other ancestors by year cleared

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

FIG. 1 — Lineage of K083131, 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 12.3 · 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 …d Defoamer Cardiopulmonary Bypass Blood Reservoir 3. Predicate Devices: Gish CAPVRF45 Hardshell Venous Reservoir, K964973, manufactured by Gish Biomedical, Inc. 4. Classifications Names & Citations: 21 CFR 870.4230, 21 CFR…	Gish Biomedical, Inc.	1997	—

Also cleared against K964973: 2 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 21 years and passes through 1 company; a new generation was cleared every 12.4 years on median.
None of the 4 ancestors has a recall.
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. 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 4030 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 at flow rates of one (1.0) to seven (7.0) 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/K083131 · printed Nov 6, 2026

Cite this page

510(k) Report. “K083131: Medos Hilite Reservoir, Model: 4030.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083131

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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