510(k) · Cleared

Cleared

Advance 34LP Low Profile Pta Balloon Dilatation Catheter

K132020510(k) SpecialCleared Oct 25, 2013116-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

Cook, Inc. · LIT Catheter, Angioplasty, Peripheral, Transluminal

Cleared on Oct 25, 2013 as substantially equivalent to K091527 (Cook, Inc., 2009) after a 116-day review. Its family tree reaches back 1 generation to 2009. 1 of the 3 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.

Decided: Oct 25, 2013
Review: 116 days
Class: Class II
Product code: LIT
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K091527 (2009). 1 later device descends from it, 1 citing it directly. 1 of the 3 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK091527 Advance 35LP Low Profile Pta Balloon Dilatation CatheterCook, Inc. · 2009 · Recalled
This deviceK132020 Advance 34LP Low Profile Pta Balloon Dilatation CatheterCook, Inc. · 2013
Descendant · cites it directly · 0 of its ownK141322 Advance Enforcer 35 Focal Force Pta Balloon CatheterCook Incorporated · 2015 · Recalled (Class I)

Class I recalls in this family

K141322 Advance Enforcer 35 Focal Force Pta Balloon…cites it directly · 2015

Most influential descendants

Showing 1 of 1 · See all

K141322Advance Enforcer 35 Focal Force Pta Balloon CatheterCook Incorporated · 2015 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K091527	Advance 35LP Low Profile Pta Balloon Dilatation Catheter	Cook, Inc.	2009	1
0 (this device)	K132020	Advance 34LP Low Profile Pta Balloon Dilatation Catheter	Cook, Inc.	2013	—
+1	K141322	Advance Enforcer 35 Focal Force Pta Balloon Catheter	Cook Incorporated	2015	Class I

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	1	1

FIG. 1 — Lineage of K132020, 2009–2015Source: 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.

1 device in this family has a Class I recall. 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 LIT device

#1 K241040 Amethyst HP PTA OTW 0.035 Catheterscore 13.9 · 9 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
*	K091527	Advance 35LP Low Profile Pta Balloon Dilatation Catheter Summary page 1 …cluded. The device, subject of this submission, is substantially equivalent to the Advance® 35LP Low Profile PTA Balloon Dilatation Catheters cleared under 510(k) number K09 1527. Comparison to Predicate Device: It has been demonstrated that the Advance® 35LP Low Profile PTA Balloon Dilatation Catheters a…	Cook, Inc.	2009	1

Also cleared against K091527: 1 other device →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K141322	Advance Enforcer 35 Focal Force Pta Balloon Catheter Class I	Cook Incorporated	2015	0

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K141322Advance Enforcer 35 Focal Force Pta Balloon CatheterCook Incorporated · 2015 · Cites it directly · ◆ in the 2015 descendants bar of FIG. 13 Class I recalls

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K141322 (Cook Incorporated, 2015) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K091527.

How does its category compare?

All LIT devices

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

FDA decisions per year · LIT

3in 2025

2007high 19 (2012) · low 3 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LIT

90in 2025

2007high 205 (2026) · low 29 (2009)2026

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

Recalls per year · LIT

1in 2025

2007high 3 (2014) · low 0 (2007)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · LIT

2,073in 2025

2007high 2,492 (2021) · low 513 (2008)2025

MAUDE reports naming product code LIT, 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	6	64	0	577
2008	8	53	0	513
2009	7	29	2	623
2010	13	78	1	809
2011	10	82	0	857
2012	19	29	0	1,277
2013	14	79	2 (2)	1,242
2014	12	90	3	1,178
2015	19	112	0	1,279
2016	11	116	1	1,529
2017	9	57	0	2,081
2018	6	118	2	2,188
2019	4	40	3	2,405
2020	9	125	0	2,443
2021	4	61	1	2,492
2022	8	122	0	2,155
2023	6	167	0	1,807
2024	6	43	2	1,913
2025	3	90	1	2,073
2026	4	205	0	—

What is it indicated for?

The Advanceo 35LP Low Profile PTA Balloon Dilatation Catheter has been designed for

percutaneous transluniinal angioplasty (PTA) of lesions in peripheral arteries including iliac,

renal, popliteal, infrapopliteal, t'emoral and iliofemoral as well as obstructive lesions of native or

synthetic arteriovenous dialysis fistulae.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K132020 · printed Nov 3, 2026

Cite this page

510(k) Report. “K132020: Advance 34LP Low Profile Pta Balloon Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K132020

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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