510(k) · Cleared
ClearedOrion Micro Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro Therapeutics, Inc. · KRA Catheter, Continuous Flush
Cleared on Aug 1, 2012 as substantially equivalent to K993672 (Micro Therapeutics, Inc., 2000) and 1 other predicate after a 268-day review. Its family tree reaches back 4 generations to 1995. 3 later devices descend from it.
- Decided
- Aug 1, 2012
- Review
- 268 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K945904 (1995). 10 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK945904 Scimed (R) Venture (TM) II Infusion CatheterScimed Peripheral Interventions · 1995
- 3 generations backK972518 Transit/Rapidtransit/Speedster/Prowler Infusion CatheterCordis Neurovascular, Inc. · 1997
- 2 generations backK020680 Prowler Select 10 and 14 Infusion Catheters with and Without…Cordis Neurovascular, Inc. · 2002
- 1 generation backK021591 Prowler Select (10, 14, and Plus) Infusion Catheters with and…Cordis Neurovascular, Inc. · 2002 · Recalled
- This deviceK113289 Orion Micro CatheterMicro Therapeutics, Inc. · 2012
- Descendant · cites it directly · 2 of its ownK150894 VIA 21 MicrocatheterSequent Medical, Inc. · 2015
- Descendant · 2 generations on · 1 of its ownK162565 VIA 17 MicrocatheterSequent Medical, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK192135 VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA…MicroVention, Inc. · 2019 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K150894VIA 21 MicrocatheterSequent Medical, Inc. · 2015 · cites it directly2descendants
- K162565VIA 17 MicrocatheterSequent Medical, Inc. · 2017 · 2 generations on1descendant
- K192135VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27)…MicroVention, Inc. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K945904 | Scimed (R) Venture (TM) II Infusion Catheter | Scimed Peripheral Interventions | 1995 | — |
| −3 | K972518 | Transit/Rapidtransit/Speedster/Prowler Infusion Catheter | Cordis Neurovascular, Inc. | 1997 | — |
| −2 | K020680 | Prowler Select 10 and 14 Infusion Catheters with and Without Pre-Shaped Tips | Cordis Neurovascular, Inc. | 2002 | — |
| −1 | K021591 | Prowler Select (10, 14, and Plus) Infusion Catheters with and Without… | Cordis Neurovascular, Inc. | 2002 | 2 |
| 0 (this device) | K113289 | Orion Micro Catheter | Micro Therapeutics, Inc. | 2012 | — |
| +1 | K150894 | VIA 21 Microcatheter | Sequent Medical, Inc. | 2015 | — |
| +2 | K162565 | VIA 17 Microcatheter | Sequent Medical, Inc. | 2017 | — |
| +2 | K192135 | VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter… | MicroVention, Inc. | 2019 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 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 KRA? 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 KRA device
- #1 K253509 TriSalus TriNav Advance Infusion Systemscore 14.5 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K993672 | Rebar Micro Catheter, Models 105-5080, 105-5086Summary page 1…h of Device: Classification of KRA, Class 11 Device: Predicate Micro Therapeutics, Inc. d/b/a ev3 Neurovascular, Rebar® Device: Micro Catheter, K993672 Cordis Neurovascular, Inc., PROWLER@ SELECT® Plus Infusion Catheter, K021591 Device… | 2000 |
| * | K021591 | Prowler Select (10, 14, and Plus) Infusion Catheters with and Without Pre-Shaped TipsSummary page 1…ascular, Rebar® Device: Micro Catheter, K993672 Cordis Neurovascular, Inc., PROWLER@ SELECT® Plus Infusion Catheter, K021591 Device The OrionTM Micro Catheter is a .021 inch size delivery Description: catheter. The construction consi… | 2002 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150894 | VIA 21 Microcatheter | 2015 | 2 |
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 17 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K150894 (Sequent Medical, Inc., 2015) has gone furthest, with 2 descendants of its own.
- 7 other devices also cite its predicate K993672.
How does its category compare?
All KRA devicesKRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · KRA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KRA
63in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRA
41so far in 2026, the most since 2007
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · KRA
980in 2025
MAUDE reports naming product code KRA, 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 | 5 | 44 | 2 | 118 |
| 2008 | 7 | 144 | 6 | 117 |
| 2009 | 5 | 69 | 8 | 187 |
| 2010 | 2 | — | 26 | 355 |
| 2011 | 2 | — | 3 | 239 |
| 2012 | 3 | 29 | 3 | 217 |
| 2013 | 3 | 126 | 2 | 209 |
| 2014 | 4 | 61 | 3 (2) | 276 |
| 2015 | 0 | — | 1 | 339 |
| 2016 | 8 | 122 | 3 (1) | 418 |
| 2017 | 4 | 166 | 0 | 538 |
| 2018 | 4 | 178 | 0 | 434 |
| 2019 | 4 | 133 | 4 (4) | 418 |
| 2020 | 6 | 29 | 1 | 381 |
| 2021 | 6 | 108 | 0 | 440 |
| 2022 | 6 | 228 | 0 | 543 |
| 2023 | 7 | 63 | 2 | 829 |
| 2024 | 0 | — | 0 | 942 |
| 2025 | 1 | — | 0 | 980 |
| 2026 | 5 | 268 | 41 | — |
What is it indicated for?
The Orion TM Micro Catheter device is intended for the controlled selective infusion of physician-specified therapeutics agents or contrast media into the vasculature of the peripheral and neuro anatomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113289 · printed Nov 3, 2026
Cite this page
510(k) Report. “K113289: Orion Micro Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K113289
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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