510(k) · Cleared
ClearedMetricath System Comprised of Metricath 1000 Console & Metricath Balloon Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Angiometrx, Inc. · DQO Catheter, Intravascular, Diagnostic
Cleared on Jun 26, 2003 after a 204-day review. The FDA summary names its predicate without a number. 10 later devices descend from it.
- Decided
- Jun 26, 2003
- Review
- 204 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 1 citing it directly.
- This deviceK024000 Metricath System Comprised of Metricath 1000 Console & Metricath…Angiometrx, Inc. · 2003
- Descendant · cites it directly · 9 of its ownK092174 Enabler-P Catheter System, Model 3000Endocross, Ltd. · 2009
- Descendant · 2 generations on · 8 of its ownK121763 Multicross Support CatheterRoxwood Medical, Inc. · 2012
- Descendant · 3 generations on · 3 of its ownK140910 Centercross CatheterRoxwood Medical, Inc. · 2014
- Descendant · 4 generations on · 2 of its ownK152456 CenterCross Ultra CatheterRoxwood Medical, Inc. · 2016
- Descendant · 3 generations on · 2 of its ownK143608 NovaCross MicrocatheterNitiloop, Ltd. · 2015
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K092174Enabler-P Catheter System, Model 3000Endocross, Ltd. · 2009 · cites it directly9descendants
- K121763Multicross Support CatheterRoxwood Medical, Inc. · 2012 · 2 generations on8descendants
- K140910Centercross CatheterRoxwood Medical, Inc. · 2014 · 3 generations on3descendants
- K152456CenterCross Ultra CatheterRoxwood Medical, Inc. · 2016 · 4 generations on2descendants
- K143608NovaCross MicrocatheterNitiloop, Ltd. · 2015 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K024000 | Metricath System Comprised of Metricath 1000 Console & Metricath Balloon… | Angiometrx, Inc. | 2003 | — |
| +1 | K092174 | Enabler-P Catheter System, Model 3000 | Endocross, Ltd. | 2009 | — |
| +2 | K121763 | Multicross Support Catheter | Roxwood Medical, Inc. | 2012 | — |
| +3 | K140910 | Centercross Catheter | Roxwood Medical, Inc. | 2014 | — |
| +4 | K152456 | CenterCross Ultra Catheter | Roxwood Medical, Inc. | 2016 | — |
| +3 | K143608 | NovaCross Microcatheter | Nitiloop, Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
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 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Galaxy Intravascular Ultrasound System (Boston Scientific) Named without a submission number | |
| * | — | UltraCross 2.9,30MHz Coronary Imaging Catheter (Boston Scientific) Named without a submission number | |
| * | — | Equinox Occlusion Balloon Catheter (Micro Therapeutics) Named without a submission number | |
| * | — | Amplatzer Sizing Balloon (AGA Medical) Named without a submission number |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092174 | Enabler-P Catheter System, Model 3000 | 2009 | 9 |
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, K092174 (Endocross, Ltd., 2009) has gone furthest, with 9 descendants of its own.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQO
148in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQO
1in 2023
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · DQO
656in 2025
MAUDE reports naming product code DQO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | 106 | 14 | 564 |
| 2008 | 3 | 80 | 4 | 726 |
| 2009 | 8 | 58 | 7 | 933 |
| 2010 | 7 | 137 | 11 | 556 |
| 2011 | 6 | 74 | 7 | 625 |
| 2012 | 15 | 94 | 2 | 532 |
| 2013 | 2 | — | 1 | 753 |
| 2014 | 3 | 109 | 0 | 601 |
| 2015 | 10 | 209 | 1 (1) | 628 |
| 2016 | 4 | 89 | 2 (1) | 614 |
| 2017 | 10 | 176 | 1 | 873 |
| 2018 | 10 | 234 | 2 | 777 |
| 2019 | 6 | 113 | 71 | 386 |
| 2020 | 3 | 30 | 4 (4) | 312 |
| 2021 | 1 | — | 0 | 338 |
| 2022 | 4 | 181 | 1 | 379 |
| 2023 | 4 | 73 | 1 (1) | 391 |
| 2024 | 4 | 148 | 0 | 511 |
| 2025 | 2 | — | 0 | 656 |
| 2026 | 3 | 85 | 24 (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 vasculature. 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 an artery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024000 · printed Nov 3, 2026
Cite this page
510(k) Report. “K024000: Metricath System Comprised of Metricath 1000 Console & Metricath Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024000
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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