510(k) · Cleared
ClearedSelective Infusion II Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Cardiovascular Systems, Inc. · KRA Catheter, Continuous Flush
Cleared on May 24, 1993 after a 580-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 10 later devices descend from it.
- Decided
- May 24, 1993
- Review
- 580 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 2 citing it directly.
- This deviceK914751 Selective Infusion II CatheterAdvanced Cardiovascular Systems, Inc. · 1993
- Descendant · cites it directly · 9 of its ownK040139 Endobionics Microsyringe (Usyringe) Infusion CatheterEndobionics, Inc. · 2004
- Descendant · cites it directly · 8 of its ownK062752 Mercator Microsyringe II Infusion CatheterMercator Medsystems, Inc. · 2006
- Descendant · 2 generations on · 6 of its ownK140637 Peregrine System Infusion CatheterAblative Solutions, Inc. · 2014
- Descendant · 2 generations on · 5 of its ownK153501 Bullfrog Micro-Infusion DeviceMercator Medsystems, Inc. · 2016
- Descendant · 2 generations on · 4 of its ownK161402 Bullfrog Micro-Infusion DeviceMercator Medsystems, Inc. · 2016
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K040139Endobionics Microsyringe (Usyringe) Infusion CatheterEndobionics, Inc. · 2004 · cites it directly9descendants
- K062752Mercator Microsyringe II Infusion CatheterMercator Medsystems, Inc. · 2006 · cites it directly8descendants
- K140637Peregrine System Infusion CatheterAblative Solutions, Inc. · 2014 · 2 generations on6descendants
- K153501Bullfrog Micro-Infusion DeviceMercator Medsystems, Inc. · 2016 · 2 generations on5descendants
- K161402Bullfrog Micro-Infusion DeviceMercator Medsystems, Inc. · 2016 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K914751 | Selective Infusion II Catheter | Advanced Cardiovascular Systems, Inc. | 1993 | — |
| +1 | K040139 | Endobionics Microsyringe (Usyringe) Infusion Catheter | Endobionics, Inc. | 2004 | — |
| +1 | K062752 | Mercator Microsyringe II Infusion Catheter | Mercator Medsystems, Inc. | 2006 | — |
| +2 | K140637 | Peregrine System Infusion Catheter | Ablative Solutions, Inc. | 2014 | — |
| +2 | K153501 | Bullfrog Micro-Infusion Device | Mercator Medsystems, Inc. | 2016 | — |
| +2 | K161402 | Bullfrog Micro-Infusion Device | Mercator Medsystems, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2026 | 1 | 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 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (10)
2 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?
- Of its descendants, K040139 (Endobionics, Inc., 2004) has gone furthest, with 9 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 | — |
https://510kreport.com/device/K914751 · printed Nov 6, 2026
Cite this page
510(k) Report. “K914751: Selective Infusion II Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K914751
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026