510(k) · Cleared

Cleared

Flow Control Valve, Cat. NO. Acv-38

K922356510(k) TraditionalCleared Feb 12, 1993269-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

American Omni Medical, Inc. · MJJ Cpb Check Valve, Retrograde Flow, In-Line

Cleared on Feb 12, 1993 after a 269-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 31 later devices descend from it.

Decided: Feb 12, 1993
Review: 269 days
Class: Class II
Product code: MJJ
Recalls: None
Predicates: 0

31 later devices descend from it, 3 citing it directly.

This deviceK922356 Flow Control Valve, Cat. NO. Acv-38American Omni Medical, Inc. · 1993
Descendant · cites it directly · 28 of its ownK032411 JS Vascular Guide Wire Vise/Torque DeviceJs Vascular, Inc. · 2003
Descendant · 2 generations on · 22 of its ownK060745 Asahi Tornus Support Catheter with Torque Device AccessoryAsahi Intecc Co., Ltd. · 2006
Descendant · 3 generations on · 21 of its ownK083313 Wildcat 7F Guidewire Support CatheterAvinger, Inc. · 2009
Descendant · 4 generations on · 18 of its ownK102022 Wildcat 6F Guidewire Support Catheter Model W400L and W400SAvinger, Inc. · 2010
Descendant · 5 generations on · 17 of its ownK111338 Wildcat CatheterAvinger, Inc. · 2011

Showing 5 of 31 descendants. See all descendants

Descendants cleared per year

2003high 5 (2012) · low 0 (2004)2026

Most influential descendants

Showing 5 of 31 · See all

K032411JS Vascular Guide Wire Vise/Torque DeviceJs Vascular, Inc. · 2003 · cites it directly28descendants
K060745Asahi Tornus Support Catheter with Torque Device AccessoryAsahi Intecc Co., Ltd. · 2006 · 2 generations on22descendants
K083313Wildcat 7F Guidewire Support CatheterAvinger, Inc. · 2009 · 3 generations on21descendants
K102022Wildcat 6F Guidewire Support Catheter Model W400L and W400SAvinger, Inc. · 2010 · 4 generations on18descendants
K111338Wildcat CatheterAvinger, Inc. · 2011 · 5 generations on17descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K922356	Flow Control Valve, Cat. NO. Acv-38	American Omni Medical, Inc.	1993	—
+1	K032411	JS Vascular Guide Wire Vise/Torque Device	Js Vascular, Inc.	2003	—
+2	K060745	Asahi Tornus Support Catheter with Torque Device Accessory	Asahi Intecc Co., Ltd.	2006	—
+3	K083313	Wildcat 7F Guidewire Support Catheter	Avinger, Inc.	2009	—
+4	K102022	Wildcat 6F Guidewire Support Catheter Model W400L and W400S	Avinger, Inc.	2010	—
+5	K111338	Wildcat Catheter	Avinger, Inc.	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2006	1	0
2009	1	0
2010	3	0
2011	2	0
2012	5	0
2014	2	0
2015	2	0
2016	3	0
2017	2	0
2018	2	0
2020	2	0
2021	1	0
2022	2	0
2023	2	0

FIG. 1 — Lineage of K922356, 1993–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (31)

See all 31

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K032411	JS Vascular Guide Wire Vise/Torque Device	Js Vascular, Inc.	2003	28
K182442	MiniGuard Arterial Safety Valve	Quest Medical, Inc.	2018	0
K142500	One Way Soft Valve	Terumo Cardiovascular Systems Corporation	2015	0

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?

Of its descendants, K032411 (Js Vascular, Inc., 2003) has gone furthest, with 28 descendants of its own.

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	—

https://510kreport.com/device/K922356 · printed Nov 5, 2026

Cite this page

510(k) Report. “K922356: Flow Control Valve, Cat. NO. Acv-38.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K922356

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026