510(k) · Cleared
ClearedIntraNovo Microcatheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Texasmedical Technologies, Inc. · DQO Catheter, Intravascular, Diagnostic
Cleared on Jan 13, 2016 as substantially equivalent to K142817 (Texasmedical Technologies, Inc., 2015) after a 76-day review. Its family tree reaches back 4 generations to 1992.
- Decided
- Jan 13, 2016
- Review
- 76 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K915414 (1992). No later device cites it as a predicate yet.
- Root · 4 generations backK915414 Terumo Angiogtaphic CatheterTerumo Medical Corp. · 1992
- 3 generations backK981359 GT LeggieroTerumo Medical Corp. · 1999
- 2 generations backK033583 ProgreatTerumo Medical Corp. · 2003
- 1 generation backK142817 IntraNovo 25 MicrocatheterTexasmedical Technologies, Inc. · 2015
- This deviceK153125 IntraNovo MicrocatheterTexasmedical Technologies, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K915414 | Terumo Angiogtaphic Catheter | Terumo Medical Corp. | 1992 | — |
| −3 | K981359 | GT Leggiero | Terumo Medical Corp. | 1999 | — |
| −2 | K033583 | Progreat | Terumo Medical Corp. | 2003 | — |
| −1 | K142817 | IntraNovo 25 Microcatheter | Texasmedical Technologies, Inc. | 2015 | — |
| 0 (this device) | K153125 | IntraNovo Microcatheter | Texasmedical Technologies, Inc. | 2016 | — |
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? (1)
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 |
|---|---|---|---|
| * | K142817 | IntraNovo 25 MicrocatheterSummary page 4…ascular Catheter Regulation Number: 21 CFR 870.1200 Product Code: DQO Device Class: Class II 510(k) Number: K142817 4. Device Description The IntraNovo Microcatheter (the “IntraNovo 21” or the “Microcatheter”) is an infusion cathete… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 2 companies; a new generation was cleared every 7.0 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
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 IntraNovo Microcatheter is intended for the infusion of contrast media into all peripheral vessels up to and including the cervical vessels, all vessels in the lower and upper extremities, and all coronary vessels. The Microcatheter is also intended for drug infusion in intra-arterial therapy and infusion of embolic materials for hemostasis. The Microcatheter should not be used in cerebral vessels.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K153125 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153125: IntraNovo Microcatheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153125
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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