510(k) · Cleared
Recalled · Class II · 2023Maestro Microcatheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merit Medical Systems, Inc. · KRA Catheter, Continuous Flush
Cleared on Aug 4, 2017 as substantially equivalent to K082613 (Merit Medical Systems, Inc., 2008) after a 25-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it. It has been recalled once.
- Decided
- Aug 4, 2017
- Review
- 25 days
- Class
- Class II
- Product code
- KRA
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K973645 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK973645 Renegade Fiber Braided MicrocatheterBoston Scientific Corp · 1997 · Recalled
- 1 generation backK082613 Merit MicrocatheterMerit Medical Systems, Inc. · 2008 · Recalled
- This deviceK172081 Maestro MicrocatheterMerit Medical Systems, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK230636 Maestro MicrocatheterMerit Medical System, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K230636Maestro MicrocatheterMerit Medical System, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K973645 | Renegade Fiber Braided Microcatheter | Boston Scientific Corp | 1997 | 2 |
| −1 | K082613 | Merit Microcatheter | Merit Medical Systems, Inc. | 2008 | 2 |
| 0 (this device) | K172081 | Maestro Microcatheter | Merit Medical Systems, Inc. | 2017 | — |
| +1 | K230636 | Maestro Microcatheter | Merit Medical System, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K082613 | Merit MicrocatheterSummary page 4…Trade Name: Maestro Microcatheter Classification Name: Continuous Flush Catheter Predicate Device Premarket Notification: K082613 Manufacturer: Merit Medical Systems, Inc. This predicate has not been subjec… | 2008 |
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 |
|---|---|---|---|
| K230636 | Maestro Microcatheter | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 6, 2023 | Class II | Z-0627-2024 | Package design/selection | The sterility of microcatheter and infusion system devices cannot be guaranteed. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 11.1 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K230636 (Merit Medical System, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K082613.
How does its category compare?
All KRA devicesKRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the subselective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic or therapeutic materials into vessels. The catheter should not be used in the cerebral vessels.
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/K172081 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172081: Maestro Microcatheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172081
Report an extraction error
Are you the manufacturer?
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