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 Jun 10, 2022 as substantially equivalent to K161402 (Mercator Medsystems, Inc., 2016) after a 228-day review. Its family tree reaches back 5 generations to 1991. 1 later device descends from it.
- Decided
- Jun 10, 2022
- Review
- 228 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K913517 (1991). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK913517 Isolate Infusion Cathetr SystemLake Region Mfg., Inc. · 1991
- 4 generations backK040139 Endobionics Microsyringe (Usyringe) Infusion CatheterEndobionics, Inc. · 2004
- 3 generations backK062752 Mercator Microsyringe II Infusion CatheterMercator Medsystems, Inc. · 2006
- 2 generations backK140637 Peregrine System Infusion CatheterAblative Solutions, Inc. · 2014
- 1 generation backK161402 Bullfrog Micro-Infusion DeviceMercator Medsystems, Inc. · 2016
- This deviceK213442 Extroducer Infusion Catheter SystemSmartWise Sweden AB · 2022
- Descendant · cites it directly · 0 of its ownK254051 Extroducer Infusion Catheter SystemSmartWise Sweden AB · 2026
Most influential descendants
Showing 1 of 1 · See all- K254051Extroducer Infusion Catheter SystemSmartWise Sweden AB · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K913517 | Isolate Infusion Cathetr System | Lake Region Mfg., Inc. | 1991 | — |
| −4 | K040139 | Endobionics Microsyringe (Usyringe) Infusion Catheter | Endobionics, Inc. | 2004 | — |
| −3 | K062752 | Mercator Microsyringe II Infusion Catheter | Mercator Medsystems, Inc. | 2006 | — |
| −2 | K140637 | Peregrine System Infusion Catheter | Ablative Solutions, Inc. | 2014 | — |
| −1 | K161402 | Bullfrog Micro-Infusion Device | Mercator Medsystems, Inc. | 2016 | — |
| 0 (this device) | K213442 | Extroducer Infusion Catheter System | SmartWise Sweden AB | 2022 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 |
|---|---|---|---|
| * | K161402 | Bullfrog Micro-Infusion DeviceSummary page 4…Regulation name: Continuous flush catheter Product code: KRA Class: II 1.1 Predicate Device: Bullfrog® Micro-Infusion Device, manufactured by Mercator MedSystems, Inc. (K161402) 2 Device description The Extroducer™ Infusion Catheter System is a minimally invasive device for administering diagnostic or… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K254051 | Extroducer Infusion Catheter System | 2026 | 0 |
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 31 years and passes through 5 companies; a new generation was cleared every 5.8 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K254051 (SmartWise Sweden AB, 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K161402.
How does its category compare?
All KRA devicesKRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 perivascular area of the peripheral vasculature. The Extroducer Infusion Catheter System is also intended for the infusion of diagnostic and therapeutic solutions intraluminally.
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/K213442 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213442: 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/K213442
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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