510(k) Report

510(k) · Cleared

Cleared

Edwards Peripheral Dilation Catheter

K052149510(k) SpecialCleared Sep 2, 200525-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

Edwards Lifesciences, LLC · DQY Catheter, Percutaneous

Cleared on Sep 2, 2005 as substantially equivalent to K032587 (Edwards Lifesciences, LLC, 2003) and 1 other predicate after a 25-day review. Its family tree reaches back 3 generations to 2000. 47 later devices descend from it.

Decided
Sep 2, 2005
Review
25 days
Class
Class II
Product code
DQY
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K993720 (2000). 8 ancestors in all. 47 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2004: 1 other ancestor2003: 2 other ancestors2002: 1 other ancestor2008: 1 descendant cleared2012: 3 descendants cleared2010: 1 descendant cleared2014: 2 descendants cleared2019: 2 descendants cleared2011: 1 descendant cleared2017: 3 descendants cleared2025: 4 descendants cleared2016: 2 descendants cleared2022: 5 descendants cleared2024: 7 descendants cleared2013: 2 descendants cleared2015: 3 descendants cleared2026: 4 descendants cleared2020: 3 descendants cleared2018: 2 descendants cleared2021: 2 descendants clearedK993720 · Cordis Maxi LD Large Diameter Balloon Dilatation Catheter · Cordis Corp. · 2000K023907 · Cordis Maxi LD Large Diameter Balloon Dilatation Catheter, Cordis Maxi LD Pta Balloon Dilation Catheter · Cordis Corp. · 2002K032587 · Edwards Peripheral Dilatation Catheter · Edwards Lifesciences, LLC · 2003200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 3 other ancestors3 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 4 descendants3 generations forward: 9 descendants4 generations forward: 9 descendants5 generations forward: 9 descendants6 generations forward: 7 descendants7 generations forward: 6 descendants8 generations forward: 1 descendant K032587 · Edwards Peripheral Dilatation Catheter · Edwards Lifesciences, LLC · 2003K023907 · Cordis Maxi LD Large Diameter Balloon Dilatation Catheter, Cordis Maxi LD Pta Balloon Dilation Catheter · Cordis Corp. · 2002K993720 · Cordis Maxi LD Large Diameter Balloon Dilatation Catheter · Cordis Corp. · 20000+5
  1. Root · 3 generations backK993720 Cordis Maxi LD Large Diameter Balloon Dilatation CatheterCordis Corp. · 2000
  2. 2 generations backK023907 Cordis Maxi LD Large Diameter Balloon Dilatation Catheter, Cordis…Cordis Corp. · 2002
  3. 1 generation backK032587 Edwards Peripheral Dilatation CatheterEdwards Lifesciences, LLC · 2003
  4. This deviceK052149 Edwards Peripheral Dilation CatheterEdwards Lifesciences, LLC · 2005
  5. Descendant · cites it directly · 44 of its ownK083657 Conquest Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2008 · Recalled
  6. Descendant · 2 generations on · 36 of its ownK103459 Vascutrak Pta Dilatation CatheterC.R. Bard, Inc. · 2010
  7. Descendant · 3 generations on · 29 of its ownK112182 Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2011
  8. Descendant · 4 generations on · 28 of its ownK122685 Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2013
  9. Descendant · 3 generations on · 24 of its ownK133998 Angiosculpt Pta Scoring Balloon with Hydrocross CaotingAngioscore, Inc. · 2014

Showing 5 of 47 descendants. See all descendants

Descendants cleared per year

2008: 12010: 12011: 12012: 32013: 22014: 22015: 32016: 22017: 32018: 22019: 22020: 32021: 22022: 52024: 72025: 42026: 4
2008high 7 (2024) · low 0 (2009)2026

Most influential descendants

Showing 5 of 47 · See all
  • K083657Conquest Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2008 · cites it directly44descendants
  • K103459Vascutrak Pta Dilatation CatheterC.R. Bard, Inc. · 2010 · 2 generations on36descendants
  • K112182Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2011 · 3 generations on29descendants
  • K122685Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2013 · 4 generations on28descendants
  • K133998Angiosculpt Pta Scoring Balloon with Hydrocross CaotingAngioscore, Inc. · 2014 · 3 generations on24descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K993720Cordis Maxi LD Large Diameter Balloon Dilatation CatheterCordis Corp.2000—
−2K023907Cordis Maxi LD Large Diameter Balloon Dilatation Catheter, Cordis Maxi LD Pta…Cordis Corp.2002—
−1K032587Edwards Peripheral Dilatation CatheterEdwards Lifesciences, LLC2003—
0 (this device)K052149Edwards Peripheral Dilation CatheterEdwards Lifesciences, LLC2005—
+1K083657Conquest Pta Balloon Dilatation CatheterC.R. Bard, Inc.20082
+2K103459Vascutrak Pta Dilatation CatheterC.R. Bard, Inc.2010—
+3K112182Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc.2011—
+4K122685Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc.2013—
+3K133998Angiosculpt Pta Scoring Balloon with Hydrocross CaotingAngioscore, Inc.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200210
200320
200410
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201010
201110
201230
201320
201420
201530
201620
201730
201820
201920
202030
202120
202250
202470
202540
202640
FIG. 1 — Lineage of K052149, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K234115 APRO 55 Catheterscore 17.5 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K032587Edwards Peripheral Dilatation Catheter
Summary page 1
…Peripheral Dilation Catheter 6. Device Classification Name: Catheter, percutaneous (DQY), Class II 7. Predicate Devices: Edwards Peripheral Dilation Catheter (K032587) and LifeStent Turbo Biliary Stent System (K050627) Edwards Lifesciences LLC Special 510(k) for the Edwards Peripheral Dil…
Edwards Lifesciences, LLC2003—
*K050627Lifestent Turbo Biliary Stent Systems
Summary page 1
…cation Name: Catheter, percutaneous (DQY), Class II 7. Predicate Devices: Edwards Peripheral Dilation Catheter (K032587) and LifeStent Turbo Biliary Stent System (K050627) Edwards Lifesciences LLC Special 510(k) for the Edwards Peripheral Dilation Catheter…
Edwards Lifesciences, LLC2005—

What descends from it? (47)

See all 47

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

NumberDeviceApplicantDecidedDescendants
K083657Conquest Pta Balloon Dilatation CatheterC.R. Bard, Inc.200844
K120722Rival Pta Dilatation CatheterBard Peripheral Vascular, Inc.20121

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 5 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
  • 1 of the 8 ancestors has a recall of any class.
  • Of its descendants, K083657 (C.R. Bard, Inc., 2008) has gone furthest, with 44 descendants of its own.

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

2007: 162008: 312009: 372010: 222011: 362012: 302013: 322014: 192015: 272016: 222017: 262018: 252019: 302020: 202021: 182022: 182023: 182024: 162025: 212026 (partial year): 11
2007high 37 (2009) · low 16 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQY

115in 2025

2007: 85 days median2008: 66 days median2009: 73 days median2010: 74 days median2011: 71 days median2012: 87 days median2013: 92 days median2014: 127 days median2015: 118 days median2016: 117 days median2017: 113 days median2018: 106 days median2019: 111 days median2020: 120 days median2021: 81 days median2022: 74 days median2023: 114 days median2024: 87 days median2025: 115 days median2026 (partial year): 30 days median
2007high 127 (2014) · low 66 (2008)2026

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

Recalls per year · DQY

1in 2025

2007: 62008: 122009: 172010: 322011: 62012: 22013: 36, 1 Class I2014: 32015: 32016: 22, 7 Class I2017: 82018: 22019: 12020: 22021: 22023: 172024: 12025: 1, 1 Class I2026 (partial year): 2, 1 Class I
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

2007: 3132008: 4962009: 8192010: 1,2932011: 1,2112012: 1,1912013: 1,3522014: 1,4972015: 2,3372016: 2,2522017: 2,4892018: 2,8552019: 2,9022020: 2,8892021: 3,0062022: 2,6432023: 3,0492024: 3,1902025: 3,056
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200716856313
2008316612496
2009377317819
20102274321,293
2011367161,211
2012308721,191
2013329236 (1)1,352
20141912731,497
20152711832,337
20162211722 (7)2,252
20172611382,489
20182510622,855
20193011112,902
20202012022,889
2021188123,006
2022187402,643
202318114173,049
2024168713,190
2025211151 (1)3,056
202611302 (1)—

What is it indicated for?

The Edwards Peripheral Dilation Catheter is intended to:

* dilate stenoses in peripheral arteries,

* treat obstructive lesions of native or synthetic A-V fistulae and/or

* re-expand endoluminal stent graft elements in the aorta and iliac arteries

Indications for use as stated in the FDA summary.

More from Edwards Lifesciences, LLC

1,326 FDA decisions under this applicant name. See the company

  • P140031/S202Edwards SAPIEN 3 Ultra™ RESILIA Transcatheter Heart ValveEdwards Lifesciences, LLC · 2026
  • P150048/S100INSPIRIS RESILIA Aortic Valve; MITRIS RESILIA Mitral ValveEdwards Lifesciences, LLC · 2026
  • P220003/S032PASCAL Precision Transcatheter Valve Repair SystemEdwards Lifesciences, LLC · 2026
  • P230013/S033EVOQUE Tricuspid Valve Replacement SystemEdwards Lifesciences, LLC · 2026
  • P220003/S029PASCAL Precision Transcatheter Valve Repair SystemEdwards Lifesciences, LLC · 2026

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https://510kreport.com/device/K052149 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052149: Edwards Peripheral Dilation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052149

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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