510(k) · Cleared

Cleared

Ibc Vent Valve, Model 1400

K992964510(k) TraditionalCleared Nov 19, 199978-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

International Biophysics Corp. · MNJ Valve, Pressure Relief, Cardiopulmonary Bypass

Cleared on Nov 19, 1999 after a 78-day review. The FDA summary names its predicate without a number.

Decided: Nov 19, 1999
Review: 78 days
Class: Class II
Product code: MNJ
Recalls: None
Predicates: 0

The FDA summary names its predicate without a number.

FIG. 1 — Lineage of K992964Source: FDA 510(k) database · 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 MNJ? 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? (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
*	—	American Omni Vent Valve 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.

How does its category compare?

All MNJ devices

MNJ Valve, Pressure Relief, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MNJ

FDA has decided no MNJ device since 2007.

Median 510(k) review, days · MNJ

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

Recalls per year · MNJ

1in 2013

2007high 1 (2013) · low 0 (2007)2026

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

Adverse event reports per year · MNJ

1in 2022

2007high 3 (2009) · low 0 (2007)2025

MAUDE reports naming product code MNJ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	0	0
2009	—	0	3
2010	—	0	0
2011	—	0	0
2012	—	0	0
2013	—	1	0
2014	—	0	0
2015	—	0	0
2016	—	0	0
2017	—	0	0
2018	—	0	0
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	1
2023	—	0	0
2024	—	0	0
2025	—	0	0
2026	—	0	—

What is it indicated for?

The Cardiotomy Vent Valve is indicated for use to maintain a low level of vacuum in cardiotomy reservoirs.

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/K992964 · printed Nov 6, 2026

Cite this page

510(k) Report. “K992964: Ibc Vent Valve, Model 1400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992964

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Page last updated Nov 3, 2026