510(k) · Cleared

Cleared

Numed Tyshak Mini Pediatric PTV Catheter

K032591510(k) SpecialCleared Sep 25, 200334-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 Sep 25, 2003 as substantially equivalent to K003276 (NuMED, Inc., 2000) after a 34-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it.

Decided: Sep 25, 2003
Review: 34 days
Class: Class II
Product code: DQY
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K003276 (2000). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK003276 Tyshak Mini Pediatric PTV Catheter, Model 107NuMED, Inc. · 2000
This deviceK032591 Numed Tyshak Mini Pediatric PTV CatheterNuMED, Inc. · 2003
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	K003276	Tyshak Mini Pediatric PTV Catheter, Model 107	NuMED, Inc.	2000	—
0 (this device)	K032591	Numed Tyshak Mini Pediatric PTV Catheter	NuMED, Inc.	2003	—
+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 K032591, 2000–2016Source: 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

Get a 510(k) Report

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
*	K003276	Tyshak Mini Pediatric PTV Catheter, Model 107 Summary page 1 …mpatibilitv Testing: The materials used in the N-uMED Tyshak Mini Pediatric PTV Catheter are the same as those used in the already approved Tyshak Mini Catheter (510(k) #K003276) which were tested for biocompatibility in compliance with the Tripartite Biocompatibility Guidance for Medical Devices. Test re…	NuMED, Inc.	2000	—

Also cleared against K003276: 1 other device →

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 no recall.
Of its descendants, K040830 (NuMED, Inc., 2004) has gone furthest, with 1 descendant of its own.
1 other device also cites its predicate K003276.

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 Valvuloplasty (PTV) of the

pulmonary valve in Pediatric applications.

. A patient with isolated pulmonary stenosis.

. A patient with valvular pulmonary stenosis with other minor congenital heart disease

that does not require surgical intervention.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032591 · printed Nov 5, 2026

Cite this page

510(k) Report. “K032591: Numed Tyshak Mini Pediatric PTV Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032591

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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