510(k) · Cleared
ClearedMicro Therapeutics Infusion Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro Therapeutics, Inc. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Oct 14, 1994 after a 242-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 42 later devices descend from it.
- Decided
- Oct 14, 1994
- Review
- 242 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 0
42 later devices descend from it, 1 citing it directly.
- This deviceK940634 Micro Therapeutics Infusion CatheterMicro Therapeutics, Inc. · 1994
- Descendant · cites it directly · 41 of its ownK964868 2.9F Cragg-Mcnamara Valved Infusion CatheterMicro Therapeutics, Inc. · 1997
- Descendant · 2 generations on · 39 of its ownK041629 Lysus Infusion SystemEkos Corp. · 2004
- Descendant · 3 generations on · 38 of its ownK042456 Lysus Infusion SystemEkos Corp. · 2004 · Recalled
- Descendant · 4 generations on · 35 of its ownK051319 Lysus Infusion SystemEkos Corp. · 2005
- Descendant · 5 generations on · 34 of its ownK052071 Lysus Infusion SystemEkos Corp. · 2005
Showing 5 of 42 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 42 · See all- K9648682.9F Cragg-Mcnamara Valved Infusion CatheterMicro Therapeutics, Inc. · 1997 · cites it directly41descendants
- K041629Lysus Infusion SystemEkos Corp. · 2004 · 2 generations on39descendants
- K042456Lysus Infusion SystemEkos Corp. · 2004 · 3 generations on38descendants
- K051319Lysus Infusion SystemEkos Corp. · 2005 · 4 generations on35descendants
- K052071Lysus Infusion SystemEkos Corp. · 2005 · 5 generations on34descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K940634 | Micro Therapeutics Infusion Catheter | Micro Therapeutics, Inc. | 1994 | — |
| +1 | K964868 | 2.9F Cragg-Mcnamara Valved Infusion Catheter | Micro Therapeutics, Inc. | 1997 | — |
| +2 | K041629 | Lysus Infusion System | Ekos Corp. | 2004 | — |
| +3 | K042456 | Lysus Infusion System | Ekos Corp. | 2004 | 3 |
| +4 | K051319 | Lysus Infusion System | Ekos Corp. | 2005 | — |
| +5 | K052071 | Lysus Infusion System | Ekos Corp. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 1 | 0 |
| 2026 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FOZ? 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 FOZ device
- #1 K243403 BD Nexiva™ Closed IV Catheter Systemscore 14.8 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (42)
See all 421 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K964868 | 2.9F Cragg-Mcnamara Valved Infusion Catheter | 1997 | 41 |
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, K964868 (Micro Therapeutics, Inc., 1997) has gone furthest, with 41 descendants of its own.
How does its category compare?
All FOZ devicesFOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FOZ
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FOZ
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FOZ
4in 2023
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · FOZ
5,110in 2025
MAUDE reports naming product code FOZ, 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 | 6 | 159 | 16 | 374 |
| 2008 | 9 | 103 | 0 | 422 |
| 2009 | 9 | 30 | 23 | 508 |
| 2010 | 3 | 28 | 115 | 370 |
| 2011 | 6 | 132 | 0 | 786 |
| 2012 | 13 | 122 | 0 | 560 |
| 2013 | 4 | 104 | 2 | 640 |
| 2014 | 9 | 99 | 4 | 815 |
| 2015 | 10 | 107 | 0 | 729 |
| 2016 | 9 | 63 | 3 (1) | 925 |
| 2017 | 9 | 51 | 22 | 1,966 |
| 2018 | 1 | — | 4 | 3,305 |
| 2019 | 8 | 140 | 3 | 4,365 |
| 2020 | 10 | 191 | 3 | 3,797 |
| 2021 | 4 | 242 | 1 | 4,674 |
| 2022 | 8 | 183 | 4 (2) | 4,133 |
| 2023 | 9 | 129 | 4 (2) | 4,430 |
| 2024 | 6 | 190 | 0 | 4,772 |
| 2025 | 11 | 91 | 0 | 5,110 |
| 2026 | 7 | 203 | 2 | — |
https://510kreport.com/device/K940634 · printed Nov 6, 2026
Cite this page
510(k) Report. “K940634: Micro Therapeutics Infusion Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K940634
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026