510(k) Report

510(k) · Cleared

Cleared

4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters

K181836510(k) SpecialCleared Aug 8, 201829-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, A Cardinal Health Company · DQO Catheter, Intravascular, Diagnostic

Cleared on Aug 8, 2018 as substantially equivalent to K960975 (Cordis Corp., 1996) and 2 other predicates after a 29-day review. Its family tree reaches back 2 generations to 1992.

Decided
Aug 8, 2018
Review
29 days
Class
Class II
Product code
DQO
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K921310 (1992). 8 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1999: 1 other ancestor1997: 2 other ancestors1996: 2 other ancestors1993: 1 other ancestorK921310 · Cordis 6 French Paragon Angiographic Catheter · Cordis Corp. · 1992K960975 · 1-4F Infiniti Angiographic Catheter · Cordis Corp. · 1996 · recalled1990199520002005201020152020
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 4 other ancestors K960975 · 1-4F Infiniti Angiographic Catheter · Cordis Corp. · 1996 · recalledK921310 · Cordis 6 French Paragon Angiographic Catheter · Cordis Corp. · 19920
  1. Root · 2 generations backK921310 Cordis 6 French Paragon Angiographic CatheterCordis Corp. · 1992
  2. 1 generation backK960975 1-4F Infiniti Angiographic CatheterCordis Corp. · 1996 · Recalled
  3. This deviceK181836 4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography…Cordis, A Cardinal Health Company · 2018
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K921310Cordis 6 French Paragon Angiographic CatheterCordis Corp.1992—
−1K9609751-4F Infiniti Angiographic CatheterCordis Corp.19961
0 (this device)K1818364F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F &…Cordis, A Cardinal Health Company2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199620
199720
199910
FIG. 1 — Lineage of K181836, 1992–2018Source: 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 DQO? 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? (3)

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
*K9609751-4F Infiniti Angiographic Catheter
Summary page 4
…ation Name: Diagnostic intravascular catheter (21 CFR §870.1200) Regulatory Class: Class II Product Code: DQO III. PREDICATE DEVICE 4F InfinitiTM Angiographic Catheter, K960975 for subject 4F InfinitiTM Angiographic Catheter…
Cordis Corp.19961
*K9716464F Nylex Angiography Catheter/5F Nylex Angiography Catheter
Summary page 5
…4F & 5F NYLEX ANGIOGRAPHY CATHETERS 4F & 5F TEMPO ANGIOGRAPHY CATHETERS 4F & 5F NylexTM Angiography Catheters, K971646 for subject 4F & 5F NylexTM Angiography Catheters 4F TempoTM Angiography Catheter, K991673 for subject 4F & 5F TempoTM Angiograp…
Cordis Corp.1997—
*K991673Cordis Tempo Angiography Catheter
Summary page 5
…F & 5F TEMPO ANGIOGRAPHY CATHETERS 4F & 5F NylexTM Angiography Catheters, K971646 for subject 4F & 5F NylexTM Angiography Catheters 4F TempoTM Angiography Catheter, K991673 for subject 4F & 5F TempoTM Angiography Catheters. IV. DEVICE DESCRIPTION The 4F InfinitiTM Angiographic Catheter is a single…
Cordis Corp.1999—

Also cleared against K960975: 4 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 26 years and passes through 2 companies; a new generation was cleared every 22.3 years on median.
  • 1 of the 8 ancestors has a recall of any class.
  • 4 other devices also cite its predicate K960975.

How does its category compare?

All DQO devices

DQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

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)—

What is it indicated for?

The Cordis 4F Infiniti™ Angiographic Catheters are intended for the delivery of radiopaque contrast medium to selected sites in the vascular system.

Cordis Nylex™ Angiography Catheters are designed to deliver radiopaque contrast medium to selected sites in the vascular system.

Cordis Tempo™ Angiography Catheters are intended for the delivery of radiopaque contrast medium to selected sites in the vasculature.

Indications for use as stated in the FDA summary.

Also cleared against K960975

4 other devices cite the same predicate.

  • K051561Asahi Angiographic CatheterAsahi Intecc Co., Ltd. · 2005
  • K992051Radifocus OptitorqueTerumo Medical Corp. · 1999
  • K982077Selector Diagnostic CatheterBoston Scientific Scimed, Inc. · 1998
  • K9708545 FR and 6 FR Infiniti Angiographic CatheterCordis Corp. · 19971 Class I recall

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/K181836 · printed Nov 6, 2026

Cite this page

510(k) Report. “K181836: 4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181836

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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