510(k) Report

510(k) · Cleared

Cleared

Cordis Maxi LD Large Diameter Balloon Dilatation Catheter, Cordis Maxi LD Pta Balloon Dilation Catheter

K023907510(k) SpecialCleared Dec 18, 200223-day reviewClass II21 CFR 876.5365

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cordis Corp. · KNQ Dilator, Esophageal

Cleared on Dec 18, 2002 as substantially equivalent to K993720 (Cordis Corp., 2000) after a 23-day review. Its family tree reaches back 1 generation to 2000. 52 later devices descend from it.

Decided
Dec 18, 2002
Review
23 days
Class
Class II
Product code
KNQ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K993720 (2000). 52 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2008: 2 descendants cleared2005: 1 descendant cleared2010: 2 descendants cleared2011: 2 descendants cleared2012: 3 descendants cleared2014: 2 descendants cleared2019: 2 descendants 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. · 2000200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 2 descendants4 generations forward: 4 descendants5 generations forward: 9 descendants6 generations forward: 9 descendants7 generations forward: 9 descendants8 generations forward: 7 descendants9 generations forward: 6 descendants10 generations forward: 1 descendant K993720 · Cordis Maxi LD Large Diameter Balloon Dilatation Catheter · Cordis Corp. · 20000+5+10
  1. Root · 1 generation backK993720 Cordis Maxi LD Large Diameter Balloon Dilatation CatheterCordis Corp. · 2000
  2. This deviceK023907 Cordis Maxi LD Large Diameter Balloon Dilatation Catheter, Cordis…Cordis Corp. · 2002
  3. Descendant · cites it directly · 48 of its ownK032587 Edwards Peripheral Dilatation CatheterEdwards Lifesciences, LLC · 2003
  4. Descendant · 2 generations on · 47 of its ownK052149 Edwards Peripheral Dilation CatheterEdwards Lifesciences, LLC · 2005
  5. Descendant · 3 generations on · 44 of its ownK083657 Conquest Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2008 · Recalled
  6. Descendant · 4 generations on · 36 of its ownK103459 Vascutrak Pta Dilatation CatheterC.R. Bard, Inc. · 2010
  7. Descendant · 5 generations on · 29 of its ownK112182 Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2011

Showing 5 of 52 descendants. See all descendants

Descendants cleared per year

2003: 12005: 12008: 22010: 22011: 22012: 32013: 22014: 22015: 32016: 22017: 32018: 22019: 22020: 32021: 22022: 52024: 72025: 42026: 4
2003high 7 (2024) · low 0 (2004)2026

Most influential descendants

Showing 5 of 52 · See all
  • K032587Edwards Peripheral Dilatation CatheterEdwards Lifesciences, LLC · 2003 · cites it directly48descendants
  • K052149Edwards Peripheral Dilation CatheterEdwards Lifesciences, LLC · 2005 · 2 generations on47descendants
  • K083657Conquest Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2008 · 3 generations on44descendants
  • K103459Vascutrak Pta Dilatation CatheterC.R. Bard, Inc. · 2010 · 4 generations on36descendants
  • K112182Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2011 · 5 generations on29descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K993720Cordis Maxi LD Large Diameter Balloon Dilatation CatheterCordis Corp.2000—
0 (this device)K023907Cordis Maxi LD Large Diameter Balloon Dilatation Catheter, Cordis Maxi LD Pta…Cordis Corp.2002—
+1K032587Edwards Peripheral Dilatation CatheterEdwards Lifesciences, LLC2003—
+2K052149Edwards Peripheral Dilation CatheterEdwards Lifesciences, LLC2005—
+3K083657Conquest Pta Balloon Dilatation CatheterC.R. Bard, Inc.20082
+4K103459Vascutrak Pta Dilatation CatheterC.R. Bard, Inc.2010—
+5K112182Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200510
200820
201020
201120
201230
201320
201420
201530
201620
201730
201820
201920
202030
202120
202250
202470
202540
202640
FIG. 1 — Lineage of K023907, 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 KNQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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
*K993720Cordis Maxi LD Large Diameter Balloon Dilatation Catheter
Summary page 1
…ation Catheter are substantially equivalent to the predicate Cordis Maxi LD Large Diameter Balloon Dilatation Catheter (see 510(k) #K993720). In short, the subject device represents a line extension of the additional 22 & 25 mm balloon diameters to t…
Cordis Corp.2000—
*—B. Braun IMPACT Balloon Dilatation Catheter
Named without a submission number
—

Also cleared against K993720: 1 other device →

What descends from it? (52)

See all 52

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

NumberDeviceApplicantDecidedDescendants
K032587Edwards Peripheral Dilatation CatheterEdwards Lifesciences, LLC200348
K082114Electrocautery Dilation Balloon, Models: Edb-0018-00, Edb-0020-00, Edb-0022-00Apollo Endosurgery, Inc.20082

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?

  • Its one ancestor has no recall.
  • Of its descendants, K032587 (Edwards Lifesciences, LLC, 2003) has gone furthest, with 48 descendants of its own.
  • 1 other device also cites its predicate K993720.

How does its category compare?

All KNQ devices

KNQ Dilator, Esophageal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KNQ

1in 2012

2009: 32012: 1
2007high 3 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KNQ

121in 2009

2009: 121 days median
2007high 121 (2009)2026

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

Recalls per year · KNQ

14in 2007

2007: 142026 (partial year): 4
2007high 14 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KNQ

282in 2025

2007: 222008: 1282009: 3912010: 1762011: 2512012: 2512013: 2282014: 1642015: 2042016: 1542017: 2312018: 3962019: 3882020: 3642021: 3512022: 2742023: 3192024: 2682025: 282
2007high 396 (2018) · low 22 (2007)2025

MAUDE reports naming product code KNQ, 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
20070—1422
20080—0128
200931210391
20100—0176
20110—0251
20121—0251
20130—0228
20140—0164
20150—0204
20160—0154
20170—0231
20180—0396
20190—0388
20200—0364
20210—0351
20220—0274
20230—0319
20240—0268
20250—0282
20260—4—

What is it indicated for?

The Cordis Maxi LD Large Balloon Dilatation Catheter is intended for use in the dilatation of strictures of the esophagus.

Indications for use as stated in the FDA summary.

Also cleared against K993720

1 other device cites the same predicate.

  • K082114Electrocautery Dilation Balloon, Models: Edb-0018-00, Edb-0020-00, Edb-0022-00Apollo Endosurgery, Inc. · 2008

More from Cordis Corp.

551 FDA decisions under this applicant name. See the company

  • P020026/S086Cypher Sirolimus-Eluting Coronary StentCordis Corp. · 2014
  • K130981Flexstent Biliary Self Expanding Stent System; S.M.a.R.T. RE-Flex Biliary Elf-Expanding Stent SystemCordis Corp. · 2014
  • K112797Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corp. · 2012
  • P020026/S082Cypher Sirolimus-Eluting Coronary StentCordis Corp. · 2012
  • P020026/S085Cypher Sirolimus-Eluting Coronary StentCordis Corp. · 2012

Recent decisions in KNQ

The KNQ category page

  • K122924Cre Fixed Wire Ballon Dilation CatheterBoston Scientific Corp · 2012
  • K093236Ethicon Endo-Surgeryoptical DilatorEthicon Endo-Surgery, Inc. · 2009
  • K090183Hercules 3 Stage Wire Guided Dilation BalloonCook Endoscopy · 2009
  • K082995Smart DilatorSafestitch Medical · 2009
  • K061937Cook Endoscopy Esophageal Dilation BalloonCook Endoscopy · 2006

https://510kreport.com/device/K023907 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023907: Cordis Maxi LD Large Diameter Balloon Dilatation Catheter, Cordis Maxi LD Pta Balloon 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/K023907

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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