510(k) · Cleared
ClearedExtroducer Infusion Catheter System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
SmartWise Sweden AB · KRA Catheter, Continuous Flush
Cleared on Sep 11, 2026 as substantially equivalent to K213442 (SmartWise Sweden AB, 2022) after a 268-day review. Its family tree reaches back 6 generations to 1991.
- Decided
- Sep 11, 2026
- Review
- 268 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K913517 (1991). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK913517 Isolate Infusion Cathetr SystemLake Region Mfg., Inc. · 1991
- 5 generations backK040139 Endobionics Microsyringe (Usyringe) Infusion CatheterEndobionics, Inc. · 2004
- 4 generations backK062752 Mercator Microsyringe II Infusion CatheterMercator Medsystems, Inc. · 2006
- 3 generations backK140637 Peregrine System Infusion CatheterAblative Solutions, Inc. · 2014
- 2 generations backK161402 Bullfrog Micro-Infusion DeviceMercator Medsystems, Inc. · 2016
- 1 generation backK213442 Extroducer Infusion Catheter SystemSmartWise Sweden AB · 2022
- This deviceK254051 Extroducer Infusion Catheter SystemSmartWise Sweden AB · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K913517 | Isolate Infusion Cathetr System | Lake Region Mfg., Inc. | 1991 | — |
| −5 | K040139 | Endobionics Microsyringe (Usyringe) Infusion Catheter | Endobionics, Inc. | 2004 | — |
| −4 | K062752 | Mercator Microsyringe II Infusion Catheter | Mercator Medsystems, Inc. | 2006 | — |
| −3 | K140637 | Peregrine System Infusion Catheter | Ablative Solutions, Inc. | 2014 | — |
| −2 | K161402 | Bullfrog Micro-Infusion Device | Mercator Medsystems, Inc. | 2016 | — |
| −1 | K213442 | Extroducer Infusion Catheter System | SmartWise Sweden AB | 2022 | — |
| 0 (this device) | K254051 | Extroducer Infusion Catheter System | SmartWise Sweden AB | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 2016 | 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 14.4 · 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 |
|---|---|---|---|
| * | K213442 | Extroducer Infusion Catheter SystemSummary page 5…us flush catheter Product code: KRA Class: II Submission number: K254051 1.1 Predicate Device Extroducer Infusion Catheter System, manufactured by SmartWise Sweden AB, (K213442) 2 Device Description The Extroducer® Infusion Catheter System is a minimally invasive device for administering diagnostic or… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 35 years and passes through 5 companies; a new generation was cleared every 5.8 years on median.
- None of the 9 ancestors has a recall.
How does its category compare?
All KRA devicesKRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Extroducer® Infusion Catheter System is intended for infusion of diagnostic or therapeutic solutions into the extravascular area of the peripheral vasculature or intraluminally. The Extroducer® Infusion Catheter System is not intended for use in the coronary or neurovasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254051 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254051: Extroducer Infusion Catheter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254051
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026