510(k) · Cleared
ClearedWallaby 017 Micro Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wallaby Medical · KRA Catheter, Continuous Flush
Cleared on Apr 25, 2023 as substantially equivalent to K214025 (Medos International SARL, 2022) after a 203-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Apr 25, 2023
- Review
- 203 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K945904 (1995). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK945904 Scimed (R) Venture (TM) II Infusion CatheterScimed Peripheral Interventions · 1995
- 4 generations backK972518 Transit/Rapidtransit/Speedster/Prowler Infusion CatheterCordis Neurovascular, Inc. · 1997
- 3 generations backK020680 Prowler Select 10 and 14 Infusion Catheters with and Without…Cordis Neurovascular, Inc. · 2002
- 2 generations backK021591 Prowler Select (10, 14, and Plus) Infusion Catheters with and…Cordis Neurovascular, Inc. · 2002 · Recalled
- 1 generation backK214025 PROWLER SELECT LP ES Microcatheter; PROWLER XS MicrocatheterMedos International SARL · 2022
- This deviceK223139 Wallaby 017 Micro CatheterWallaby Medical · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K945904 | Scimed (R) Venture (TM) II Infusion Catheter | Scimed Peripheral Interventions | 1995 | — |
| −4 | K972518 | Transit/Rapidtransit/Speedster/Prowler Infusion Catheter | Cordis Neurovascular, Inc. | 1997 | — |
| −3 | K020680 | Prowler Select 10 and 14 Infusion Catheters with and Without Pre-Shaped Tips | Cordis Neurovascular, Inc. | 2002 | — |
| −2 | K021591 | Prowler Select (10, 14, and Plus) Infusion Catheters with and Without… | Cordis Neurovascular, Inc. | 2002 | 2 |
| −1 | K214025 | PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter | Medos International SARL | 2022 | — |
| 0 (this device) | K223139 | Wallaby 017 Micro Catheter | Wallaby Medical | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 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 14.5 · 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 |
|---|---|---|---|
| * | K214025 | PROWLER SELECT LP ES Microcatheter; PROWLER XS MicrocatheterSummary page 4…P, DQY Classification Name: Class II, KRA (21 CFR 870.1210), QJP and DQY (21 CFR 870.1250) Predicate Device: PROWLER SELECT LP ES Microcatheter (K214025) Reference Device: Tip-Shape Echelon Micro Catheter (K042187) a. Device Description The Wal… | 2022 |
| † | K042187 | Echelon 10,45 Tip Shape Micro Catheter Echelon 10,90 Tip Shape Micro Catheter, Echelon… | 2004 |
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 28 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 9 ancestors have a recall of any class.
How does its category compare?
All KRA devicesKRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Wallaby 017 Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic devices such as embolization materials and of diagnostic materials such as contrast media as well as delivery of embolic coils.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223139 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223139: Wallaby 017 Micro Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223139
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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