510(k) · Cleared
Cleared2.9F Cragg-Mcnamara Valved Infusion 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 May 20, 1997 as substantially equivalent to K940634 (Micro Therapeutics, Inc., 1994) after a 167-day review. Its family tree reaches back 1 generation to 1994. 41 later devices descend from it.
- Decided
- May 20, 1997
- Review
- 167 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K940634 (1994). 41 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK940634 Micro Therapeutics Infusion CatheterMicro Therapeutics, Inc. · 1994
- This deviceK964868 2.9F Cragg-Mcnamara Valved Infusion CatheterMicro Therapeutics, Inc. · 1997
- Descendant · cites it directly · 39 of its ownK041629 Lysus Infusion SystemEkos Corp. · 2004
- Descendant · 2 generations on · 38 of its ownK042456 Lysus Infusion SystemEkos Corp. · 2004 · Recalled
- Descendant · 3 generations on · 35 of its ownK051319 Lysus Infusion SystemEkos Corp. · 2005
- Descendant · 4 generations on · 34 of its ownK052071 Lysus Infusion SystemEkos Corp. · 2005
- Descendant · 5 generations on · 27 of its ownK060422 Lysus Infusion SystemEkos Corp. · 2006 · Recalled
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 41 · See all- K041629Lysus Infusion SystemEkos Corp. · 2004 · cites it directly39descendants
- K042456Lysus Infusion SystemEkos Corp. · 2004 · 2 generations on38descendants
- K051319Lysus Infusion SystemEkos Corp. · 2005 · 3 generations on35descendants
- K052071Lysus Infusion SystemEkos Corp. · 2005 · 4 generations on34descendants
- K060422Lysus Infusion SystemEkos Corp. · 2006 · 5 generations on27descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K940634 | Micro Therapeutics Infusion Catheter | Micro Therapeutics, Inc. | 1994 | — |
| 0 (this device) | K964868 | 2.9F Cragg-Mcnamara Valved Infusion Catheter | Micro Therapeutics, Inc. | 1997 | — |
| +1 | K041629 | Lysus Infusion System | Ekos Corp. | 2004 | — |
| +2 | K042456 | Lysus Infusion System | Ekos Corp. | 2004 | 3 |
| +3 | K051319 | Lysus Infusion System | Ekos Corp. | 2005 | — |
| +4 | K052071 | Lysus Infusion System | Ekos Corp. | 2005 | — |
| +5 | K060422 | Lysus Infusion System | Ekos Corp. | 2006 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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 14.4 · 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? (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 |
|---|---|---|---|
| * | K940634 | Micro Therapeutics Infusion CatheterSummary page 1…utics, Inc. 1062-F Calle Negocio San Clemente, CA 92673 Contact Linda D'Abate Clinical and Regulatory Affairs Predicate Devices Micro Therapeutics Infusion Catheters (K940634, October 14, 1994) Device Description The 2.9F Cragg-McNamara™ Valved Infusion Catheter is a single lumen plastic catheter suit… | 1994 |
What descends from it? (41)
See all 412 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has no recall.
- Of its descendants, K041629 (Ekos Corp., 2004) has gone furthest, with 39 descendants of its own.
How does its category compare?
All KRA devicesKRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 2.9F Cragg-McNamara™ Valved Infusion Catheter is intended to be used for the controlled selective infusion of physician specified pharmacological agents and radiopaque contrast media into the general vasculature. It is not intended for coronary, neurological, pediatric or neonatal use.
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/K964868 · printed Nov 5, 2026
Cite this page
510(k) Report. “K964868: 2.9F Cragg-Mcnamara Valved Infusion Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K964868
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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