510(k) · Cleared

Cleared

Cobe Vacuum Relief Check Valve

K982406510(k) AbbreviatedCleared Oct 7, 199889-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. · MJJ Cpb Check Valve, Retrograde Flow, In-Line

Cleared on Oct 7, 1998 as substantially equivalent to K820297 (C.R. Bard, Inc., 1982) and 1 other predicate after an 89-day review. Its family tree reaches back 1 generation to 1982.

Decided: Oct 7, 1998
Review: 89 days
Class: Class II
Product code: MJJ
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K820297 (1982). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK820297 WM. Harvey Overpressure Safety ValveC.R. Bard, Inc. · 1982 · Recalled
This deviceK982406 Cobe Vacuum Relief Check ValveCobe Cardiovascular, Inc. · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K820297	WM. Harvey Overpressure Safety Valve	C.R. Bard, Inc.	1982	4
0 (this device)	K982406	Cobe Vacuum Relief Check Valve	Cobe Cardiovascular, Inc.	1998	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1986	1	0

FIG. 1 — Lineage of K982406, 1982–1998Source: 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 MJJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin 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
*	K820297	WM. Harvey Overpressure Safety Valve Summary page 1 …E: Cardiopulmonary Bypass Adaptor, Stopcock, Manifold, or Fitting (21 CFR 870.4290) PREDICATE DEVICES: C.R. Bard, Inc. William Harvey® #H-130 Overpressure Safety Valve (K820297) American Omni Medical, Inc. #RLV-2100 Non-adjustable Suction Control Valve (K861428) INDICATIONS FOR USE The COBE® Vacuum Rel…	C.R. Bard, Inc.	1982	4
*	K861428	Suction Control Valve (Nonadjustable) Cat.RLV-2100 Summary page 1 …REDICATE DEVICES: C.R. Bard, Inc. William Harvey® #H-130 Overpressure Safety Valve (K820297) American Omni Medical, Inc. #RLV-2100 Non-adjustable Suction Control Valve (K861428) INDICATIONS FOR USE The COBE® Vacuum Relief Check Valve is indicated for use during cardiopulmonary bypass surgery to help pre…	American Omni Medical, Inc.	1986	—

Also cleared against K820297: 1 other device →

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?

1 of the 2 ancestors has a recall of any class.
1 other device also cites its predicate K820297.

How does its category compare?

All MJJ devices

MJJ Cpb Check Valve, Retrograde Flow, In-Line: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MJJ

1in 2018

2007high 1 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MJJ

Too few MJJ 510(k)s in any year since 2007 to give a median.

Recalls per year · MJJ

36in 2011

2007high 36 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MJJ

1in 2019

2007high 4 (2018) · low 0 (2007)2025

MAUDE reports naming product code MJJ, 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	0	—	0	0
2008	0	—	0	0
2009	0	—	0	0
2010	0	—	0	0
2011	0	—	36	1
2012	0	—	0	0
2013	0	—	0	0
2014	0	—	0	0
2015	1	—	0	2
2016	0	—	0	1
2017	0	—	0	3
2018	1	—	0	4
2019	0	—	0	1
2020	0	—	0	0
2021	0	—	0	0
2022	0	—	0	0
2023	0	—	0	0
2024	0	—	0	0
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

The COBE® Vacuum Relief Check Valve is intended to be used during cardiopulmonary bypass surgery to help prevent the buildup of excessive vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent flow of air into the heart.

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/K982406 · printed Nov 4, 2026

Cite this page

510(k) Report. “K982406: Cobe Vacuum Relief Check Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982406

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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