510(k) Report

510(k) · Cleared

Cleared

Terumo Angiogtaphic Catheter

K915414510(k) TraditionalCleared Feb 4, 199264-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

Terumo Medical Corp. · DQO Catheter, Intravascular, Diagnostic

Cleared on Feb 4, 1992 after a 64-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 66 later devices descend from it.

Decided
Feb 4, 1992
Review
64 days
Class
Class II
Product code
DQO
Recalls
None
Predicates
0

66 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 1999: 2 descendants cleared2010: 1 descendant cleared2006: 1 descendant cleared2009: 4 descendants cleared2011: 3 descendants cleared2013: 2 descendants cleared2019: 3 descendants cleared2003: 1 descendant cleared2008: 3 descendants cleared2020: 5 descendants cleared2024: 5 descendants cleared2004: 1 descendant cleared2018: 6 descendants cleared2017: 3 descendants cleared2015: 3 descendants cleared2021: 5 descendants cleared2012: 4 descendants cleared2014: 1 descendant cleared2016: 3 descendants cleared2022: 3 descendants cleared2023: 4 descendants cleared2026: 2 descendants cleared2025: 1 descendant cleared1990200020102020
  1. This deviceK915414 Terumo Angiogtaphic CatheterTerumo Medical Corp. · 1992
  2. Descendant · cites it directly · 32 of its ownK992051 Radifocus OptitorqueTerumo Medical Corp. · 1999
  3. Descendant · 2 generations on · 18 of its ownK082561 Spectranetics Quick-Cross Extreme Support CathetersSpectranetics Corp. · 2008
  4. Descendant · cites it directly · 14 of its ownK981359 GT LeggieroTerumo Medical Corp. · 1999
  5. Descendant · 3 generations on · 13 of its ownK092396 Spectranetics Quick Cross Extreme Support CathetersSpectranetics Corp. · 2009
  6. Descendant · 2 generations on · 13 of its ownK033583 ProgreatTerumo Medical Corp. · 2003

Showing 5 of 66 descendants. See all descendants

Descendants cleared per year

1999: 22003: 12004: 12006: 12008: 32009: 42010: 12011: 32012: 42013: 22014: 12015: 32016: 32017: 32018: 62019: 32020: 52021: 52022: 32023: 42024: 52025: 12026: 2
1999high 6 (2018) · low 0 (2000)2026

Most influential descendants

Showing 5 of 66 · See all
  • K992051Radifocus OptitorqueTerumo Medical Corp. · 1999 · cites it directly32descendants
  • K082561Spectranetics Quick-Cross Extreme Support CathetersSpectranetics Corp. · 2008 · 2 generations on18descendants
  • K981359GT LeggieroTerumo Medical Corp. · 1999 · cites it directly14descendants
  • K092396Spectranetics Quick Cross Extreme Support CathetersSpectranetics Corp. · 2009 · 3 generations on13descendants
  • K033583ProgreatTerumo Medical Corp. · 2003 · 2 generations on13descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K915414Terumo Angiogtaphic CatheterTerumo Medical Corp.1992—
+1K992051Radifocus OptitorqueTerumo Medical Corp.1999—
+2K082561Spectranetics Quick-Cross Extreme Support CathetersSpectranetics Corp.2008—
+1K981359GT LeggieroTerumo Medical Corp.1999—
+3K092396Spectranetics Quick Cross Extreme Support CathetersSpectranetics Corp.2009—
+2K033583ProgreatTerumo Medical Corp.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199920
200310
200410
200610
200830
200940
201010
201130
201240
201320
201410
201530
201630
201730
201860
201930
202050
202150
202230
202340
202450
202510
202620
FIG. 1 — Lineage of K915414, 1992–2026Source: 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.

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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (66)

See all 66

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

NumberDeviceApplicantDecidedDescendants
K992051Radifocus OptitorqueTerumo Medical Corp.199932
K981359GT LeggieroTerumo Medical Corp.199914
K090040Radifocus Glidecath (or Radifocus Glidecath XP)Terumo Medical Corp.200911
K093004Impress Angiographic Catheter with Hydrophilic CoatingMerit Medical Systems, Inc.20104
K060666Carotid Access KitTerumo Medical Corp.20060

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, K992051 (Terumo Medical Corp., 1999) has gone furthest, with 32 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 Terumo Medical Corp.

143 FDA decisions under this applicant name. See the company

  • K111606Pinnacle Precision Access SystemTerumo Medical Corp. · 20111 recall
  • K111556Glidecross Support CatheterTerumo Medical Corp. · 2011
  • K110540Terumo Support CatheterTerumo Medical Corp. · 2011
  • K102008GlidesheathTerumo Medical Corp. · 20101 recall
  • K091329Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 20091 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/K915414 · printed Nov 6, 2026

Cite this page

510(k) Report. “K915414: Terumo Angiogtaphic Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K915414

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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