510(k) · Cleared

Cleared

Cobe VVR 4000 Filtered Hardshell Venous Reservoir

K990239510(k) TraditionalCleared May 25, 1999120-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

Cobe Cardiovascular, Inc. · DTN Reservoir, Blood, Cardiopulmonary Bypass

Cleared on May 25, 1999 as substantially equivalent to K984456 (Cobe Cardiovascular, Inc., 1999) after a 120-day review. Its family tree reaches back 2 generations to 1997.

Decided: May 25, 1999
Review: 120 days
Class: Class II
Product code: DTN
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K971669 (1997). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK971669 Cobe HVR 4000 Filtered and Nonfiltered Hardshell Venous ReservoirCobe Cardiovascular, Inc. · 1997
1 generation backK984456 Cobe HVR 4000 Filtered Hardshell Venous ReservoirCobe Cardiovascular, Inc. · 1999
This deviceK990239 Cobe VVR 4000 Filtered Hardshell Venous ReservoirCobe Cardiovascular, Inc. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K971669	Cobe HVR 4000 Filtered and Nonfiltered Hardshell Venous Reservoir	Cobe Cardiovascular, Inc.	1997	—
−1	K984456	Cobe HVR 4000 Filtered Hardshell Venous Reservoir	Cobe Cardiovascular, Inc.	1999	—
0 (this device)	K990239	Cobe VVR 4000 Filtered Hardshell Venous Reservoir	Cobe Cardiovascular, Inc.	1999	—

FIG. 1 — Lineage of K990239, 1997–1999Source: 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? (3)

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
*	K984456	Cobe HVR 4000 Filtered Hardshell Venous Reservoir Summary page 2 …RISON The COBE® VVR 4000™ Filtered Hardshell Venous Reservoir is substantially equivalent to the currently marketed COBE® HVR™ 4000 Filtered Hardshell Venous Reservoir (K984456). The two devices are identical except that the COBE® VVR 4000™ Filtered Hardshell Venous Reservoir has a gasketed lid joint, ven…	Cobe Cardiovascular, Inc.	1999	—
*	—	Baxter/Bentley BMR-4500G Filtered Venous Reservoir Named without a submission number			—
*	—	Baxter/Bentley HSR-4000 Filtered Venous Reservoir Named without a submission number			—

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 2 years and passes through 1 company; a new generation was cleared every 1.5 years on median.
None of the 2 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 COBE® VVR 4000™ Filtered Hardshell Venous Reservoir is intended to be used in adult surgical procedures requiring cardiopulmonary bypass for periods of up to six hours, and for postoperative chest drainage collection and autotransfusion.

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/K990239 · printed Nov 6, 2026

Cite this page

510(k) Report. “K990239: Cobe VVR 4000 Filtered Hardshell Venous Reservoir.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990239

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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