510(k) · Cleared

Cleared

Unballoon Non-Occlusion Modeling Catheter

K133026510(k) TraditionalCleared Dec 31, 201396-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

LeMaitre Vascular, Inc. · DQY Catheter, Percutaneous

Cleared on Dec 31, 2013 as substantially equivalent to K123531 (LeMaitre Vascular, Inc., 2012) and 2 other predicates after a 96-day review. Its family tree reaches back 6 generations to 2001.

Decided: Dec 31, 2013
Review: 96 days
Class: Class II
Product code: DQY
Recalls: None
Predicates: 3

Its longest line of descent runs back 6 generations to K003495 (2001). 9 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 6 generations backK003495 Ancure Lliac Balloon CatheterGuidant Cardiac and Vascular Surgery · 2001
5 generations backK032869 Cook Coda Balloon CatheterCook, Inc. · 2003
4 generations backK050038 Reliant Stent Graft Balloon CatheterMedtronic Endovascular Innovations · 2005
3 generations backK110891 The Unballoon Non-Occlusive Catheter; the Unballoon Non-Occlusive…LeMaitre Vascular, Inc. · 2011
2 generations backK121839 Unballoon Non-Occlusive Modeling CatheterLeMaitre Vascular, Inc. · 2012
1 generation backK123531 Unballoon Non-Occlusive Modeling CatheterLeMaitre Vascular, Inc. · 2012
This deviceK133026 Unballoon Non-Occlusion Modeling CatheterLeMaitre Vascular, Inc. · 2013

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K003495	Ancure Lliac Balloon Catheter	Guidant Cardiac and Vascular Surgery	2001	—
−5	K032869	Cook Coda Balloon Catheter	Cook, Inc.	2003	—
−4	K050038	Reliant Stent Graft Balloon Catheter	Medtronic Endovascular Innovations	2005	—
−3	K110891	The Unballoon Non-Occlusive Catheter; the Unballoon Non-Occlusive Modeling…	LeMaitre Vascular, Inc.	2011	—
−2	K121839	Unballoon Non-Occlusive Modeling Catheter	LeMaitre Vascular, Inc.	2012	—
−1	K123531	Unballoon Non-Occlusive Modeling Catheter	LeMaitre Vascular, Inc.	2012	—
0 (this device)	K133026	Unballoon Non-Occlusion Modeling Catheter	LeMaitre Vascular, Inc.	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	1	0
2004	1	0

FIG. 1 — Lineage of K133026, 2001–2013Source: 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? (3)

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
*	K123531	Unballoon Non-Occlusive Modeling Catheter Summary page 2 …-Occlusive Modeling Catheter is intended to assist in the modeling of self- expanding endoprostheses in large diameter vessels. Predicate Device: 5 10(k): K123531 Device Name: UnBalloon Non-Occlusion Modeling Catheter SE1 Date: 12/14/2012 Regulation Number: 2ICFR §870…	LeMaitre Vascular, Inc.	2012	—
*	K121839	Unballoon Non-Occlusive Modeling Catheter Summary page 2 …theter SE1 Date: 12/14/2012 Regulation Number: 2ICFR §870.1250 Device Class Name: Catheter, Percutaneous Device Class: 2 5 10(k): K121839 Device Name: UnBalloon Non-OccIlusive M%,odeling Catheter SE Date: 08/08/201 2 Regulation Number: 2I1CFR…	LeMaitre Vascular, Inc.	2012	—
*	K110891	The Unballoon Non-Occlusive Catheter; the Unballoon Non-Occlusive Modeling Catheter Summary page 2 …ter SE Date: 08/08/201 2 Regulation Number: 2I1CFR §870.1250 Device Class Name: Catheter, Percutaneous Device Class: 2) 51 0(k): K 110891 Device Name: UnBalloon Non-OccIlusive Modeling Catheter SE Date: 09/13/2011 Regulation Number: 21 CFR §8…	LeMaitre Vascular, Inc.	2011	—

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?

The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
1 of the 9 ancestors has a recall of any class.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

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?

The UnBalloon Non-Occlusive Modeling Catheter is intended to assist in the modeling of self-expanding endoprostheses in large diameter vessels.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K133026 · printed Nov 6, 2026

Cite this page

510(k) Report. “K133026: Unballoon Non-Occlusion Modeling Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133026

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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