510(k) · Cleared

Cleared

Passage Hemostasis Valve

K143429510(k) SpecialCleared Dec 22, 201421-day reviewClass II21 CFR 870.4290

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Merit Medical Systems, Inc. · DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Cleared on Dec 22, 2014 as substantially equivalent to K925419 (Merit Medical Systems, Inc., 1993) after a 21-day review. Its family tree reaches back 1 generation to 1993.

Decided: Dec 22, 2014
Review: 21 days
Class: Class II
Product code: DTL
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K925419 (1993). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK925419 Passage Hemostasis ValveMerit Medical Systems, Inc. · 1993
This deviceK143429 Passage Hemostasis ValveMerit Medical Systems, Inc. · 2014

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K925419	Passage Hemostasis Valve	Merit Medical Systems, Inc.	1993	—
0 (this device)	K143429	Passage Hemostasis Valve	Merit Medical Systems, Inc.	2014	—

FIG. 1 — Lineage of K143429, 1993–2014Source: 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 DTL? 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
*	K925419	Passage Hemostasis Valve Summary page 4 …Name: 21 CFR 870.4290 Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Premarket Notification: K925419 Predicate Manufacturer: Merit Medical Systems, Inc. Device Reference Device #2:…	Merit Medical Systems, Inc.	1993	—
†	K140475	Rotating Adapters	Merit Medical Systems, Inc.	2014	—

Also cleared against K925419: 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?

Its one ancestor has no recall.
2 other devices also cite its predicate K925419.

How does its category compare?

All DTL devices

DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · DTL

1in 2015

2007high 8 (2012) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTL

36in 2012

2007high 115 (2010) · low 36 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DTL

1in 2025

2007high 3 (2010) · low 0 (2007)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · DTL

110in 2025

2007high 452 (2024) · low 16 (2008)2025

MAUDE reports naming product code DTL, 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	1	—	0	37
2008	5	85	1	16
2009	2	—	0	62
2010	4	115	3	148
2011	0	—	1	160
2012	8	36	2	53
2013	1	—	1 (1)	67
2014	2	—	1	80
2015	1	—	0	89
2016	0	—	0	67
2017	0	—	2	106
2018	0	—	0	84
2019	0	—	0	76
2020	0	—	0	53
2021	0	—	0	55
2022	0	—	2	48
2023	0	—	0	46
2024	0	—	0	452
2025	0	—	1	110
2026	0	—	3 (3)	—

What is it indicated for?

The Passage Hemostasis Valve is recommended for maintaining a fluid-tight seal around percutaneous transluminal angioplasty catheters and guidewires.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K143429 · printed Nov 6, 2026

Cite this page

510(k) Report. “K143429: Passage Hemostasis Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143429

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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