510(k) Report

510(k) · Cleared

Cleared

Nylex Catheters

K930479510(k) TraditionalCleared Apr 21, 199382-day reviewClass II21 CFR 870.1200

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

Cordis Corp. · DQO Catheter, Intravascular, Diagnostic

Cleared on Apr 21, 1993 after an 82-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 44 devices in its family, counting itself, has a Class I recall. 43 later devices descend from it.

Decided
Apr 21, 1993
Review
82 days
Class
Class II
Product code
DQO
Recalls
None
Predicates
0

43 later devices descend from it, 2 citing it directly. 1 of the 44 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 1997: 2 descendants cleared, 1 with a Class I recall11996: 1 descendant cleared2018: 4 descendants cleared1998: 1 descendant cleared1999: 1 descendant cleared2005: 1 descendant cleared2008: 3 descendants cleared2010: 1 descendant cleared2023: 3 descendants cleared2011: 2 descendants cleared2020: 3 descendants cleared2009: 3 descendants cleared2019: 1 descendant cleared2021: 4 descendants cleared2012: 2 descendants cleared2014: 1 descendant cleared2015: 1 descendant cleared2016: 1 descendant cleared2013: 2 descendants cleared2024: 2 descendants cleared2022: 2 descendants cleared2026: 1 descendant cleared2025: 1 descendant cleared1990200020102020
  1. This deviceK930479 Nylex CathetersCordis Corp. · 1993
  2. Descendant · cites it directly · 41 of its ownK960975 1-4F Infiniti Angiographic CatheterCordis Corp. · 1996 · Recalled
  3. Descendant · 2 generations on · 32 of its ownK992051 Radifocus OptitorqueTerumo Medical Corp. · 1999
  4. Descendant · 3 generations on · 18 of its ownK082561 Spectranetics Quick-Cross Extreme Support CathetersSpectranetics Corp. · 2008
  5. Descendant · 4 generations on · 13 of its ownK092396 Spectranetics Quick Cross Extreme Support CathetersSpectranetics Corp. · 2009
  6. Descendant · 3 generations on · 9 of its ownK082736 Radifocus Optitorque Angiographic CatheterTerumo Medical Corp. · 2008

Showing 5 of 43 descendants. See all descendants

Descendants cleared per year

1996: 11997: 21998: 11999: 12005: 12008: 32009: 32010: 12011: 22012: 22013: 22014: 12015: 12016: 12018: 42019: 12020: 32021: 42022: 22023: 32024: 22025: 12026: 1
1996high 4 (2018) · low 0 (2000)2026

Class I recalls in this family

  • K970854 5 FR and 6 FR Infiniti Angiographic Catheter2 generations on · 1997

Most influential descendants

Showing 5 of 43 · See all
  • K9609751-4F Infiniti Angiographic CatheterCordis Corp. · 1996 · cites it directly41descendants
  • K992051Radifocus OptitorqueTerumo Medical Corp. · 1999 · 2 generations on32descendants
  • K082561Spectranetics Quick-Cross Extreme Support CathetersSpectranetics Corp. · 2008 · 3 generations on18descendants
  • K092396Spectranetics Quick Cross Extreme Support CathetersSpectranetics Corp. · 2009 · 4 generations on13descendants
  • K082736Radifocus Optitorque Angiographic CatheterTerumo Medical Corp. · 2008 · 3 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K930479Nylex CathetersCordis Corp.1993—
+1K9609751-4F Infiniti Angiographic CatheterCordis Corp.19961
+2K992051Radifocus OptitorqueTerumo Medical Corp.1999—
+3K082561Spectranetics Quick-Cross Extreme Support CathetersSpectranetics Corp.2008—
+4K092396Spectranetics Quick Cross Extreme Support CathetersSpectranetics Corp.2009—
+3K082736Radifocus Optitorque Angiographic CatheterTerumo Medical Corp.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199721
199810
199910
200510
200830
200930
201010
201120
201220
201320
201410
201510
201610
201840
201910
202030
202140
202220
202330
202420
202510
202610
FIG. 1 — Lineage of K930479, 1993–2026Source: 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), 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 DQO device

  1. #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (43)

See all 43

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

NumberDeviceApplicantDecidedDescendants
K9609751-4F Infiniti Angiographic CatheterCordis Corp.199641
K9716464F Nylex Angiography Catheter/5F Nylex Angiography CatheterCordis Corp.19971

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.

  • K9708545 FR and 6 FR Infiniti Angiographic CatheterCordis Corp. · 1997 · 2 generations on · ◆ in the 1997 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K960975 (Cordis Corp., 1996) has gone furthest, with 41 descendants of its own.

How does its category compare?

All DQO devices

DQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQO

2in 2025

2007: 82008: 32009: 82010: 72011: 62012: 152013: 22014: 32015: 102016: 42017: 102018: 102019: 62020: 32021: 12022: 42023: 42024: 42025: 22026 (partial year): 3
2007high 15 (2012) · low 1 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQO

148in 2024

2007: 106 days median2008: 80 days median2009: 58 days median2010: 137 days median2011: 74 days median2012: 94 days median2014: 109 days median2015: 209 days median2016: 89 days median2017: 176 days median2018: 234 days median2019: 113 days median2020: 30 days median2022: 181 days median2023: 73 days median2024: 148 days median2026 (partial year): 85 days median
2007high 234 (2018) · low 30 (2020)2026

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

Recalls per year · DQO

1in 2023

2007: 142008: 42009: 72010: 112011: 72012: 22013: 12015: 1, 1 Class I2016: 2, 1 Class I2017: 12018: 22019: 712020: 4, 4 Class I2022: 12023: 1, 1 Class I2026 (partial year): 24, 4 Class I
2007high 71 (2019) · low 0 (2014)2026

Class I (11 since 2007) Class II/III not classified

Adverse event reports per year · DQO

656in 2025

2007: 5642008: 7262009: 9332010: 5562011: 6252012: 5322013: 7532014: 6012015: 6282016: 6142017: 8732018: 7772019: 3862020: 3122021: 3382022: 3792023: 3912024: 5112025: 656
2007high 933 (2009) · low 312 (2020)2025

MAUDE reports naming product code DQO, 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
2007810614564
20083804726
20098587933
2010713711556
20116747625
201215942532
20132—1753
201431090601
2015102091 (1)628
20164892 (1)614
2017101761873
2018102342777
2019611371386
20203304 (4)312
20211—0338
202241811379
20234731 (1)391
202441480511
20252—0656
202638524 (4)—

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 DQO

The DQO category page

  • K261455Arterial Pressure Monitoring Set/TraySpectrum Vascular · 2026
  • K252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF…Bioptimal International Pte., Ltd. · 2026
  • K254278Arterial Pressure Monitoring Set/TraySpectrum Vascular · 2026
  • K250751DualView CatheterTerumo Corporation · 2025
  • K242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLC · 20251 recall

https://510kreport.com/device/K930479 · printed Nov 6, 2026

Cite this page

510(k) Report. “K930479: Nylex Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K930479

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026