510(k) Report

510(k) · Cleared

Cleared

Metricath System

K042685510(k) TraditionalCleared Nov 18, 200450-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

Angiometrx, Inc. · DQO Catheter, Intravascular, Diagnostic

Cleared on Nov 18, 2004 after a 50-day review. The FDA summary names no predicate by number. 2 later devices descend from it.

Decided
Nov 18, 2004
Review
50 days
Class
Class II
Product code
DQO
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2014: 1 descendant cleared200020052010201520202025
  1. This deviceK042685 Metricath SystemAngiometrx, Inc. · 2004
  2. Descendant · cites it directly · 1 of its ownK091780 Guided Measurement Catheter (GMC)Mediguide, Ltd. · 2009
  3. Descendant · 2 generations on · 0 of its ownK142235 CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled…St Jude Medical · 2014

Most influential descendants

Showing 2 of 2 · See all
  • K091780Guided Measurement Catheter (GMC)Mediguide, Ltd. · 2009 · cites it directly1descendant
  • K142235CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner CatheterSt Jude Medical · 2014 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K042685Metricath SystemAngiometrx, Inc.2004—
+1K091780Guided Measurement Catheter (GMC)Mediguide, Ltd.2009—
+2K142235CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner…St Jude Medical2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201410
FIG. 1 — Lineage of K042685, 2004–2014Source: 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?

The FDA summary names no predicate by number.

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K091780Guided Measurement Catheter (GMC)Mediguide, Ltd.20091

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, K091780 (Mediguide, Ltd., 2009) has gone furthest, with 1 descendant 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 Metricath System is indicated for use as an adjunct to conventional angiographic procedures to provide measurements of arterial lumen cross sectional area and diameter of the coronary, renal, iliac and femoral arteries. The Metricath Balloon Catheter is indicated for use in patients who are candidates for percutaneous, transluminal interventional procedures to make arterial lumen measurements proximal to a lesion, or within a stented section of artery.

Indications for use as stated in the FDA summary.

More from Angiometrx, Inc.

3 FDA decisions under this applicant name. See the company

  • K051042Metricath Gemini-P Balloon Catheter, Models RX2515S-P, RX3015S-P, RX3515S-P, RX4015S-P, Metricath Console…Angiometrx, Inc. · 2005
  • K024000Metricath System Comprised of Metricath 1000 Console & Metricath Balloon CatheterAngiometrx, Inc. · 2003

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/K042685 · printed Nov 5, 2026

Cite this page

510(k) Report. “K042685: Metricath System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042685

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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