510(k) Report

510(k) · Cleared

Recalled · 2010

Modification to Softouch Diagnostic Intravascular Cat

K000659510(k) SpecialCleared Mar 29, 200030-day reviewClass II21 CFR 870.1200Recalls 1

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

Merit Medical Systems, Inc. · DQO Catheter, Intravascular, Diagnostic

Cleared on Mar 29, 2000 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 18 later devices descend from it. It has been recalled once.

Decided
Mar 29, 2000
Review
30 days
Class
Class II
Product code
DQO
Recalls
1
Predicates
0

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

Descendants, by year cleared 2010: 4 descendants cleared2006: 1 descendant cleared2009: 2 descendants cleared2015: 2 descendants cleared2007: 1 descendant cleared2012: 1 descendant cleared2013: 1 descendant cleared2024: 2 descendants cleared2008: 1 descendant cleared2019: 1 descendant cleared2014: 1 descendant cleared2026: 1 descendant cleared200020052010201520202025
  1. This deviceK000659 Modification to Softouch Diagnostic Intravascular CatMerit Medical Systems, Inc. · 2000
  2. Descendant · cites it directly · 10 of its ownK053171 Merit Impress Diagnostic CatheterMerit Medical Systems, Inc. · 2006
  3. Descendant · 2 generations on · 4 of its ownK093004 Impress Angiographic Catheter with Hydrophilic CoatingMerit Medical Systems, Inc. · 2010
  4. Descendant · 2 generations on · 3 of its ownK120158 Coronary Sinus Guide and Lateral Vein Introducer KitsThomas Medical Products, Inc. · 2012 · Recalled
  5. Descendant · 3 generations on · 2 of its ownK191608 Impress Angiographic CatheterMerit Medical Systems, Inc. · 2019
  6. Descendant · cites it directly · 2 of its ownK062627 Innerchange Micro-Introducer Catheter, Models 7900 Through 7905Vascular Solutions, Inc. · 2007

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2006: 12007: 12008: 12009: 22010: 42012: 12013: 12014: 12015: 22019: 12024: 22026: 1
2006high 4 (2010) · low 0 (2011)2026

Most influential descendants

Showing 5 of 18 · See all
  • K053171Merit Impress Diagnostic CatheterMerit Medical Systems, Inc. · 2006 · cites it directly10descendants
  • K093004Impress Angiographic Catheter with Hydrophilic CoatingMerit Medical Systems, Inc. · 2010 · 2 generations on4descendants
  • K120158Coronary Sinus Guide and Lateral Vein Introducer KitsThomas Medical Products, Inc. · 2012 · 2 generations on3descendants
  • K191608Impress Angiographic CatheterMerit Medical Systems, Inc. · 2019 · 3 generations on2descendants
  • K062627Innerchange Micro-Introducer Catheter, Models 7900 Through 7905Vascular Solutions, Inc. · 2007 · cites it directly2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000659Modification to Softouch Diagnostic Intravascular CatMerit Medical Systems, Inc.2000—
+1K053171Merit Impress Diagnostic CatheterMerit Medical Systems, Inc.2006—
+2K093004Impress Angiographic Catheter with Hydrophilic CoatingMerit Medical Systems, Inc.2010—
+2K120158Coronary Sinus Guide and Lateral Vein Introducer KitsThomas Medical Products, Inc.20122
+3K191608Impress Angiographic CatheterMerit Medical Systems, Inc.2019—
+1K062627Innerchange Micro-Introducer Catheter, Models 7900 Through 7905Vascular Solutions, Inc.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200710
200810
200920
201040
201210
201310
201410
201520
201910
202420
202610
FIG. 1 — Lineage of K000659, 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), 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (18)

See all 18

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

NumberDeviceApplicantDecidedDescendants
K053171Merit Impress Diagnostic CatheterMerit Medical Systems, Inc.200610
K062627Innerchange Micro-Introducer Catheter, Models 7900 Through 7905Vascular Solutions, Inc.20072
K091367GDS-DCSGuided Delivery Systems20091
K143604Alvision Interventional Cardiology Diagnostic Catheter, Alvicath Endovascular Diagnostic…Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S20150
K101625Cohen Crossover CatheterVascular Solutions, Inc.20100

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
May 5, 2010Not classifiedZ-1731-2010Process controlMarker bands on angiographic catheters may not be properly attached, allowing movement of the bands.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K053171 (Merit Medical Systems, Inc., 2006) has gone furthest, with 10 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)—

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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/K000659 · printed Nov 6, 2026

Cite this page

510(k) Report. “K000659: Modification to Softouch Diagnostic Intravascular Cat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000659

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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