510(k) · Cleared

Cleared

Numed Mullins Pta Catheter

K013601510(k) SpecialCleared Jan 3, 200264-day reviewClass II21 CFR 870.1250

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

NuMED, Inc. · DQY Catheter, Percutaneous

Cleared on Jan 3, 2002 as substantially equivalent to K931009 (NuMED, Inc., 1993) after a 64-day review. Its family tree reaches back 1 generation to 1993. 2 later devices descend from it.

Decided: Jan 3, 2002
Review: 64 days
Class: Class II
Product code: DQY
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K931009 (1993). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK931009 Tyshak Peripheral Balloon Dilation CatheterNuMED, Inc. · 1993 · Recalled
This deviceK013601 Numed Mullins Pta CatheterNuMED, Inc. · 2002
Descendant · cites it directly · 1 of its ownK040830 Pta, PTV, Atrioseptostomy, Angiographic, Sizing CathetersNuMED, Inc. · 2004
Descendant · 2 generations on · 0 of its ownK153069 Edwards Balloon CatheterEdwards Lifesciences · 2016

Most influential descendants

Showing 2 of 2 · See all

K040830Pta, PTV, Atrioseptostomy, Angiographic, Sizing CathetersNuMED, Inc. · 2004 · cites it directly1descendant
K153069Edwards Balloon CatheterEdwards Lifesciences · 2016 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K931009	Tyshak Peripheral Balloon Dilation Catheter	NuMED, Inc.	1993	1
0 (this device)	K013601	Numed Mullins Pta Catheter	NuMED, Inc.	2002	—
+1	K040830	Pta, PTV, Atrioseptostomy, Angiographic, Sizing Catheters	NuMED, Inc.	2004	—
+2	K153069	Edwards Balloon Catheter	Edwards Lifesciences	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2016	1	0

FIG. 1 — Lineage of K013601, 1993–2016Source: 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 DQY? 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 DQY device

#1 K234115 APRO 55 Catheterscore 17.5 · 6 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? (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
*	K931009	Tyshak Peripheral Balloon Dilation Catheter Our OCR of the scanned summary read “K931009” beside “510(k)”; FDA’s K931009 is the only number that fits it and carries the summary’s name for the device. Summary page 1 …balloons of the NuMED, Inc. MULLINS™ PTA Catheter is made of a non- compliant polymeric material and are the same balloons that are used on the approved Z- MED Catheter (K931009, K991977, and K011557). The two laminate balloon system is designed to inflate to a specific diameter at a given pressure. The ch…	NuMED, Inc.	1993	1

Also cleared against K931009: 3 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K040830	Pta, PTV, Atrioseptostomy, Angiographic, Sizing Catheters	NuMED, Inc.	2004	1

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 a recall.
Of its descendants, K040830 (NuMED, Inc., 2004) has gone furthest, with 1 descendant of its own.
3 other devices also cite its predicate K931009.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQY

21in 2025

2007high 37 (2009) · low 16 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQY

115in 2025

2007high 127 (2014) · low 66 (2008)2026

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

Recalls per year · DQY

1in 2025

2007high 36 (2013) · low 0 (2022)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · DQY

3,056in 2025

2007high 3,190 (2024) · low 313 (2007)2025

MAUDE reports naming product code DQY, 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	16	85	6	313
2008	31	66	12	496
2009	37	73	17	819
2010	22	74	32	1,293
2011	36	71	6	1,211
2012	30	87	2	1,191
2013	32	92	36 (1)	1,352
2014	19	127	3	1,497
2015	27	118	3	2,337
2016	22	117	22 (7)	2,252
2017	26	113	8	2,489
2018	25	106	2	2,855
2019	30	111	1	2,902
2020	20	120	2	2,889
2021	18	81	2	3,006
2022	18	74	0	2,643
2023	18	114	17	3,049
2024	16	87	1	3,190
2025	21	115	1 (1)	3,056
2026	11	30	2 (1)	—

What is it indicated for?

This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries.

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/K013601 · printed Nov 4, 2026

Cite this page

510(k) Report. “K013601: Numed Mullins Pta Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013601

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026