510(k) Report

510(k) · Cleared

Cleared

Radifocus Optitorque

K992051510(k) SpecialCleared Aug 10, 199953-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 Aug 10, 1999 as substantially equivalent to K863137 (Terumo Medical Corp., 1986) and 2 other predicates after a 53-day review. Its family tree reaches back 2 generations to 1992. 32 later devices descend from it.

Decided
Aug 10, 1999
Review
53 days
Class
Class II
Product code
DQO
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K921310 (1992). 5 ancestors in all, the oldest K863137 (1986). 32 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1992: 1 other ancestor1986: 1 other ancestor1993: 1 other ancestor2008: 3 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: 1 descendant cleared2018: 3 descendants cleared2024: 2 descendants cleared2022: 2 descendants cleared2011: 1 descendant cleared2023: 2 descendants cleared2026: 1 descendant cleared2025: 1 descendant clearedK921310 · Cordis 6 French Paragon Angiographic Catheter · Cordis Corp. · 1992K960975 · 1-4F Infiniti Angiographic Catheter · Cordis Corp. · 1996 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 10 descendants3 generations forward: 9 descendants4 generations forward: 6 descendants5 generations forward: 2 descendants6 generations forward: 1 descendant K960975 · 1-4F Infiniti Angiographic Catheter · Cordis Corp. · 1996 · recalledK921310 · Cordis 6 French Paragon Angiographic Catheter · Cordis Corp. · 19920+5
  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 deviceK992051 Radifocus OptitorqueTerumo Medical Corp. · 1999
  4. Descendant · cites it directly · 18 of its ownK082561 Spectranetics Quick-Cross Extreme Support CathetersSpectranetics Corp. · 2008
  5. Descendant · 2 generations on · 13 of its ownK092396 Spectranetics Quick Cross Extreme Support CathetersSpectranetics Corp. · 2009
  6. Descendant · cites it directly · 9 of its ownK082736 Radifocus Optitorque Angiographic CatheterTerumo Medical Corp. · 2008
  7. Descendant · 3 generations on · 6 of its ownK110540 Terumo Support CatheterTerumo Medical Corp. · 2011
  8. Descendant · 2 generations on · 4 of its ownK150232 Radifocus Optitorque Angiographic CatheterAshitaka Factory of Terumo Corp. · 2015

Showing 5 of 32 descendants. See all descendants

Descendants cleared per year

2008: 32009: 32011: 12012: 22013: 12014: 12015: 12016: 12018: 32019: 12020: 32021: 42022: 22023: 22024: 22025: 12026: 1
2008high 4 (2021) · low 0 (2010)2026

Most influential descendants

Showing 5 of 32 · See all
  • K082561Spectranetics Quick-Cross Extreme Support CathetersSpectranetics Corp. · 2008 · cites it directly18descendants
  • K092396Spectranetics Quick Cross Extreme Support CathetersSpectranetics Corp. · 2009 · 2 generations on13descendants
  • K082736Radifocus Optitorque Angiographic CatheterTerumo Medical Corp. · 2008 · cites it directly9descendants
  • K110540Terumo Support CatheterTerumo Medical Corp. · 2011 · 3 generations on6descendants
  • K150232Radifocus Optitorque Angiographic CatheterAshitaka Factory of Terumo Corp. · 2015 · 2 generations on4descendants
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)K992051Radifocus OptitorqueTerumo Medical Corp.1999—
+1K082561Spectranetics Quick-Cross Extreme Support CathetersSpectranetics Corp.2008—
+2K092396Spectranetics Quick Cross Extreme Support CathetersSpectranetics Corp.2009—
+1K082736Radifocus Optitorque Angiographic CatheterTerumo Medical Corp.2008—
+3K110540Terumo Support CatheterTerumo Medical Corp.2011—
+2K150232Radifocus Optitorque Angiographic CatheterAshitaka Factory of Terumo Corp.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
199210
199310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200830
200930
201110
201220
201310
201410
201510
201610
201830
201910
202030
202140
202220
202320
202420
202510
202610
FIG. 1 — Lineage of K992051, 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), 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
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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
*K863137Terumo Radifocus Angiographic Catheter
Summary page 1
…delivers radiopaque media and therapeutic agents to selected sites in the vascular system. Note: This is the same intended use as the RADIFOCUS® Angiographic Catheter, K863137/A. Device Description The RADIFOCUS® Optitorque Angiographic Catheter is a two-layer construction comprised of a stainless stee…
Terumo Medical Corp.1986—
*K915414Terumo Angiogtaphic Catheter
Summary page 1
…e, design, technology/principles of operation, materials, and performance to the cleared RADIFOCUS® Angiographic Catheter, (K863137/A), the Terumo Angiographic Catheter (K915414) and the Cordis Infiniti Angiographic Catheter (K960975). Principle Of Operation / Technology The RADIFOCUS® Optitorque Angiogr…
Terumo Medical Corp.1992—
*K9609751-4F Infiniti Angiographic Catheter
Summary page 1
…, and performance to the cleared RADIFOCUS® Angiographic Catheter, (K863137/A), the Terumo Angiographic Catheter (K915414) and the Cordis Infiniti Angiographic Catheter (K960975). Principle Of Operation / Technology The RADIFOCUS® Optitorque Angiographic Catheter is operated manually or by a manual proce…
Cordis Corp.19961

What descends from it? (32)

See all 32

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

NumberDeviceApplicantDecidedDescendants
K082561Spectranetics Quick-Cross Extreme Support CathetersSpectranetics Corp.200818
K082736Radifocus Optitorque Angiographic CatheterTerumo Medical Corp.20089
K082559Spectranetics Cross-Pilot Turbo Elite Support CatheterSpectranetics Corp.20081
K193647Superpipe Angiographic CatheterSuzhou Hengrui Disheng Medical Co., Ltd.20200

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 7 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
  • 1 of the 5 ancestors has a recall of any class.
  • Of its descendants, K082561 (Spectranetics Corp., 2008) has gone furthest, with 18 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)—

What is it indicated for?

The RADIFOCUS® Optitorque Angiographic Catheter is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the vascular system.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

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/K992051 · printed Nov 6, 2026

Cite this page

510(k) Report. “K992051: Radifocus Optitorque.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992051

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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