510(k) · Cleared

Cleared

The Unballoon Non-Occlusive Catheter; the Unballoon Non-Occlusive Modeling Catheter

K110891510(k) TraditionalCleared Sep 13, 2011167-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 Sep 13, 2011 as substantially equivalent to K032869 (Cook, Inc., 2003) and 2 other predicates after a 167-day review. Its family tree reaches back 3 generations to 2001. 3 later devices descend from it.

Decided: Sep 13, 2011
Review: 167 days
Class: Class II
Product code: DQY
Recalls: None
Predicates: 3

Its longest line of descent runs back 3 generations to K003495 (2001). 6 ancestors in all. 3 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 3 generations backK003495 Ancure Lliac Balloon CatheterGuidant Cardiac and Vascular Surgery · 2001
2 generations backK032869 Cook Coda Balloon CatheterCook, Inc. · 2003
1 generation backK050038 Reliant Stent Graft Balloon CatheterMedtronic Endovascular Innovations · 2005
This deviceK110891 The Unballoon Non-Occlusive Catheter; the Unballoon Non-Occlusive…LeMaitre Vascular, Inc. · 2011
Descendant · cites it directly · 2 of its ownK121839 Unballoon Non-Occlusive Modeling CatheterLeMaitre Vascular, Inc. · 2012
Descendant · cites it directly · 1 of its ownK123531 Unballoon Non-Occlusive Modeling CatheterLeMaitre Vascular, Inc. · 2012
Descendant · cites it directly · 0 of its ownK133026 Unballoon Non-Occlusion Modeling CatheterLeMaitre Vascular, Inc. · 2013

Most influential descendants

Showing 3 of 3 · See all

K121839Unballoon Non-Occlusive Modeling CatheterLeMaitre Vascular, Inc. · 2012 · cites it directly2descendants
K123531Unballoon Non-Occlusive Modeling CatheterLeMaitre Vascular, Inc. · 2012 · cites it directly1descendant
K133026Unballoon Non-Occlusion Modeling CatheterLeMaitre Vascular, Inc. · 2013 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	2	0
2013	1	0

FIG. 1 — Lineage of K110891, 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

Get a 510(k) Report

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
*	K032869	Cook Coda Balloon Catheter Summary page 1 …ommon Name: Modeling Catheter Classification Name: Percutaneous Catheter Cook Coda Balloon Cathetcr - K032869 Predicate Devices: Mcdtronic Reliant Balloon Catheter - K050038 Gore Tri-Lobe Ba…	Cook, Inc.	2003	—
*	K050038	Reliant Stent Graft Balloon Catheter Summary page 1 …Percutaneous Catheter Cook Coda Balloon Cathetcr - K032869 Predicate Devices: Mcdtronic Reliant Balloon Catheter - K050038 Gore Tri-Lobe Balloon Catheter - K033670 The UnBalloon Non-Oc…	Medtronic Endovascular Innovations	2005	—
*	K033670	Gore Tri-Lobe Balloon Catheter Summary page 1 …loon Cathetcr - K032869 Predicate Devices: Mcdtronic Reliant Balloon Catheter - K050038 Gore Tri-Lobe Balloon Catheter - K033670 The UnBalloon Non-Occlusive Modeling Catheter consists of an…	W. L. Gore & Associates, Inc.	2004	—

Also cleared against K032869: 8 other devices →

What descends from it? (3)

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

Number	Device	Applicant	Decided	Descendants
K121839	Unballoon Non-Occlusive Modeling Catheter	LeMaitre Vascular, Inc.	2012	2
K123531	Unballoon Non-Occlusive Modeling Catheter	LeMaitre Vascular, Inc.	2012	1
K133026	Unballoon Non-Occlusion Modeling Catheter	LeMaitre Vascular, Inc.	2013	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?

The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
1 of the 6 ancestors has a recall of any class.
Of its descendants, K121839 (LeMaitre Vascular, Inc., 2012) has gone furthest, with 2 descendants of its own.
8 other devices also cite its predicate K032869.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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/K110891 · printed Nov 5, 2026

Cite this page

510(k) Report. “K110891: The Unballoon Non-Occlusive Catheter; the Unballoon Non-Occlusive Modeling Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110891

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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