510(k) · Cleared
ClearedTitan Micro Catheter, Model 105-5074-153; HD Injector, Model 103-0305
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro Therapeutics, Inc. · DYB Introducer, Catheter
Cleared on Sep 13, 2002 as substantially equivalent to K993672 (Micro Therapeutics, Inc., 2000) and 1 other predicate after an 86-day review. Its family tree reaches back 2 generations to 1998. 5 later devices descend from it.
- Decided
- Sep 13, 2002
- Review
- 86 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K974473 (1998). 3 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK974473 Easy Rider Micro CatheterMicro Therapeutics, Inc. · 1998
- 1 generation backK993672 Rebar Micro Catheter, Models 105-5080, 105-5086Micro Therapeutics, Inc. · 2000
- This deviceK022003 Titan Micro Catheter, Model 105-5074-153; HD Injector, Model 103-0305Micro Therapeutics, Inc. · 2002
- Descendant · cites it directly · 4 of its ownK024122 Nautica Micro Catheter, Model 105-5094-153Micro Therapeutics, Inc. · 2003
- Descendant · 2 generations on · 3 of its ownK093750 Echelon Micro Catheter, Marathon Micro Catheter, Nautica Micro…Ev3, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 1 of its ownK210114 Rebar Micro CatheterMicro Therapeuatics, Inc. D/B/A Ev3 Neurovascular · 2021
- Descendant · 4 generations on · 0 of its ownK243534 Micro CatheterSuzhou Zenith Vascular SciTech Limited · 2025
- Descendant · 3 generations on · 0 of its ownK202318 Marathon Flow Directed Micro CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2020
Most influential descendants
Showing 5 of 5 · See all- K024122Nautica Micro Catheter, Model 105-5094-153Micro Therapeutics, Inc. · 2003 · cites it directly4descendants
- K093750Echelon Micro Catheter, Marathon Micro Catheter, Nautica Micro Catheter Ultraflow HPC…Ev3, Inc. · 2009 · 2 generations on3descendants
- K210114Rebar Micro CatheterMicro Therapeuatics, Inc. D/B/A Ev3 Neurovascular · 2021 · 3 generations on1descendant
- K243534Micro CatheterSuzhou Zenith Vascular SciTech Limited · 2025 · 4 generations on0descendants
- K202318Marathon Flow Directed Micro CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K974473 | Easy Rider Micro Catheter | Micro Therapeutics, Inc. | 1998 | — |
| −1 | K993672 | Rebar Micro Catheter, Models 105-5080, 105-5086 | Micro Therapeutics, Inc. | 2000 | — |
| 0 (this device) | K022003 | Titan Micro Catheter, Model 105-5074-153; HD Injector, Model 103-0305 | Micro Therapeutics, Inc. | 2002 | — |
| +1 | K024122 | Nautica Micro Catheter, Model 105-5094-153 | Micro Therapeutics, Inc. | 2003 | — |
| +2 | K093750 | Echelon Micro Catheter, Marathon Micro Catheter, Nautica Micro Catheter… | Ev3, Inc. | 2009 | 2 |
| +3 | K210114 | Rebar Micro Catheter | Micro Therapeuatics, Inc. D/B/A Ev3 Neurovascular | 2021 | — |
| +4 | K243534 | Micro Catheter | Suzhou Zenith Vascular SciTech Limited | 2025 | — |
| +3 | K202318 | Marathon Flow Directed Micro Catheter | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2009 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 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 DYB? 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 DYB device
- #1 K251051 AuST Steerable Sheathscore 18.0 · 10 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 1Micro Therapeutics, Inc. Traditional 510(k) (modifications to K993672 and KO1 1535) TitanTMMicro Catheter and MTI HD Injector Syringe / y o 2 1 0 0.3 June 18,2002… | 2000 |
| * | K011535 | Cadence Precision Injector, Model 103-0304 | 2001 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K024122 | Nautica Micro Catheter, Model 105-5094-153 | 2003 | 4 |
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 4 years and passes through 1 company; a new generation was cleared every 2.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K024122 (Micro Therapeutics, Inc., 2003) has gone furthest, with 4 descendants of its own.
- 7 other devices also cite its predicate K993672.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DYB
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DYB
63in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DYB
3in 2025
Class I (48 since 2007) Class II/III not classified
Adverse event reports per year · DYB
4,539in 2025
MAUDE reports naming product code DYB, 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 | 12 | 95 | 15 | 316 |
| 2008 | 17 | 37 | 9 | 423 |
| 2009 | 14 | 52 | 25 | 399 |
| 2010 | 18 | 123 | 18 | 445 |
| 2011 | 17 | 100 | 4 | 628 |
| 2012 | 22 | 128 | 3 | 898 |
| 2013 | 26 | 118 | 5 (1) | 743 |
| 2014 | 30 | 122 | 2 | 780 |
| 2015 | 17 | 129 | 2 (1) | 913 |
| 2016 | 19 | 95 | 45 (3) | 1,234 |
| 2017 | 24 | 70 | 22 (1) | 1,672 |
| 2018 | 19 | 156 | 1 | 1,903 |
| 2019 | 18 | 47 | 2 | 2,450 |
| 2020 | 9 | 49 | 21 (21) | 2,465 |
| 2021 | 12 | 78 | 6 | 2,835 |
| 2022 | 13 | 143 | 2 | 4,084 |
| 2023 | 15 | 55 | 10 | 3,775 |
| 2024 | 18 | 56 | 2 | 3,931 |
| 2025 | 16 | 63 | 3 | 4,539 |
| 2026 | 17 | 59 | 23 (21) | — |
What is it indicated for?
The Titan Micro Catheter is intended for the controlled selective infusion of physician-specified therapeutic agents or contrast media into the vasculature of the peripheral and neuro anatomy.
The MTI HD Injector is intended for the infusion of physician-specified fluids with the MTI Titan Micro Catheter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022003 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022003: Titan Micro Catheter, Model 105-5074-153; HD Injector, Model 103-0305.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022003
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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