510(k) Report

510(k) · Cleared

Cleared

Advance 14RX Rapid Exchange Pta Balloon Catheter

K090822510(k) SpecialCleared Apr 27, 200932-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. · DQY Catheter, Percutaneous

Cleared on Apr 27, 2009 after a 32-day review. The FDA summary names its predicate without a number. 13 later devices descend from it.

Decided
Apr 27, 2009
Review
32 days
Class
Class II
Product code
DQY
Recalls
None
Predicates
0

13 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2013: 4 descendants cleared2017: 1 descendant cleared2016: 3 descendants cleared2014: 2 descendants cleared2015: 2 descendants cleared2025: 1 descendant cleared20052010201520202025
  1. This deviceK090822 Advance 14RX Rapid Exchange Pta Balloon CatheterCook, Inc. · 2009
  2. Descendant · cites it directly · 8 of its ownK123544 Rapidcross Pta Rapid Exchange, Balloon Dilatation CatheterEv3, Inc. · 2013
  3. Descendant · 2 generations on · 7 of its ownK130911 Rapidcross Pta Rapid Exchange Balloon Dilatation CatheterEv3, Inc. · 2013
  4. Descendant · 3 generations on · 6 of its ownK132777 Nanocross Elite .14 Over-the-Wire Pta, Balloon Dilation CatheterEv3, Inc. · 2013
  5. Descendant · 4 generations on · 5 of its ownK141118 Nanocross Eite 0.014 Over-the-Wire Pta Balloon Dilatation CatheterEv3, Inc. · 2014 · Recalled
  6. Descendant · cites it directly · 2 of its ownK122940 Advance Micro 14 Ultra Low Profile Balloon Dilatation Catheter Model…Cook, Inc. · 2013

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2013: 42014: 22015: 22016: 32017: 12025: 1
2013high 4 (2013) · low 0 (2018)2026

Most influential descendants

Showing 5 of 13 · See all
  • K123544Rapidcross Pta Rapid Exchange, Balloon Dilatation CatheterEv3, Inc. · 2013 · cites it directly8descendants
  • K130911Rapidcross Pta Rapid Exchange Balloon Dilatation CatheterEv3, Inc. · 2013 · 2 generations on7descendants
  • K132777Nanocross Elite .14 Over-the-Wire Pta, Balloon Dilation CatheterEv3, Inc. · 2013 · 3 generations on6descendants
  • K141118Nanocross Eite 0.014 Over-the-Wire Pta Balloon Dilatation CatheterEv3, Inc. · 2014 · 4 generations on5descendants
  • K122940Advance Micro 14 Ultra Low Profile Balloon Dilatation Catheter Model PTA3Cook, Inc. · 2013 · cites it directly2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K090822Advance 14RX Rapid Exchange Pta Balloon CatheterCook, Inc.2009—
+1K123544Rapidcross Pta Rapid Exchange, Balloon Dilatation CatheterEv3, Inc.2013—
+2K130911Rapidcross Pta Rapid Exchange Balloon Dilatation CatheterEv3, Inc.2013—
+3K132777Nanocross Elite .14 Over-the-Wire Pta, Balloon Dilation CatheterEv3, Inc.2013—
+4K141118Nanocross Eite 0.014 Over-the-Wire Pta Balloon Dilatation CatheterEv3, Inc.20141
+1K122940Advance Micro 14 Ultra Low Profile Balloon Dilatation Catheter Model PTA3Cook, Inc.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201340
201420
201520
201630
201710
202510
FIG. 1 — Lineage of K090822, 2009–2025Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*—PTA Balloon Catheter
Named without a submission number
—

What descends from it? (13)

See all 13

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

NumberDeviceApplicantDecidedDescendants
K123544Rapidcross Pta Rapid Exchange, Balloon Dilatation CatheterEv3, Inc.20138
K122940Advance Micro 14 Ultra Low Profile Balloon Dilatation Catheter Model PTA3Cook, Inc.20132
K170193Advance 14LP Low Profile PTA Balloon Dilatation CatheterCook Incorporated20170

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?

  • Of its descendants, K123544 (Ev3, Inc., 2013) has gone furthest, with 8 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. 2009, this device’s year, is highlighted.

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?

For percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Indications for use as stated in the FDA summary.

More from Cook, Inc.

285 FDA decisions under this applicant name. See the company

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  • P020018/S068Zenith (Flex) AAA Endovascular Graft; Zenith Renu AAA Ancillary Graft; Zenith Fenestrated AAA Endovascular…Cook, Inc. · 2026
  • P020018/S067Zenith Flex AAA Endovascular Graft Bifurcated Main Body; Zenith Renu AAA Ancillary Graft Converter; Zenith…Cook, Inc. · 2026
  • P020018/S066Zenith Flex AAA Endovascular System and Zenith Iliac BranchCook, Inc. · 2026

Recent decisions in DQY

The DQY category page

  • K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc. · 2026
  • K260559NHanceITIMDS Operation B.V. · 2026
  • K262392APRO 35 Swift CatheterAlembic, LLC · 2026
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https://510kreport.com/device/K090822 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090822: Advance 14RX Rapid Exchange Pta Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090822

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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