510(k) · Cleared
Recalled · Class II · 2014Merit 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 Dec 30, 2008 as substantially equivalent to K973645 (Boston Scientific Corp, 1997) after a 113-day review. Its family tree reaches back 1 generation to 1997. 7 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 30, 2008
- Review
- 113 days
- Class
- Class II
- Product code
- KRA
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K973645 (1997). 7 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK973645 Renegade Fiber Braided MicrocatheterBoston Scientific Corp · 1997 · Recalled
- This deviceK082613 Merit MicrocatheterMerit Medical Systems, Inc. · 2008
- Descendant · cites it directly · 4 of its ownK161921 SwiftNINJA MicrocatheterMerit Medical Systems, Inc. · 2016
- Descendant · 2 generations on · 2 of its ownK190126 Bendit2.7 Steerable MicrocatheterBend IT Technologies, Ltd. · 2019
- Descendant · 3 generations on · 1 of its ownK200582 Bendit2.7 Steerable MicrocatheterBend IT Technologies, Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK172081 Maestro MicrocatheterMerit Medical Systems, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 0 of its ownK230636 Maestro MicrocatheterMerit Medical System, Inc. · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K161921SwiftNINJA MicrocatheterMerit Medical Systems, Inc. · 2016 · cites it directly4descendants
- K190126Bendit2.7 Steerable MicrocatheterBend IT Technologies, Ltd. · 2019 · 2 generations on2descendants
- K200582Bendit2.7 Steerable MicrocatheterBend IT Technologies, Ltd. · 2020 · 3 generations on1descendant
- K172081Maestro MicrocatheterMerit Medical Systems, Inc. · 2017 · cites it directly1descendant
- K230636Maestro MicrocatheterMerit Medical System, Inc. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K973645 | Renegade Fiber Braided Microcatheter | Boston Scientific Corp | 1997 | 2 |
| 0 (this device) | K082613 | Merit Microcatheter | Merit Medical Systems, Inc. | 2008 | — |
| +1 | K161921 | SwiftNINJA Microcatheter | Merit Medical Systems, Inc. | 2016 | — |
| +2 | K190126 | Bendit2.7 Steerable Microcatheter | Bend IT Technologies, Ltd. | 2019 | — |
| +3 | K200582 | Bendit2.7 Steerable Microcatheter | Bend IT Technologies, Ltd. | 2020 | — |
| +1 | K172081 | Maestro Microcatheter | Merit Medical Systems, Inc. | 2017 | 1 |
| +2 | K230636 | Maestro Microcatheter | Merit Medical System, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K973645 | Renegade Fiber Braided MicrocatheterSummary page 1…Hydro Pass TM Hydrophilic Coating Predicate Classification Name: Continuous Flush Catheter Device Premarket Notification:K973645 Manufacturer: Boston Scientific Corporation Class II Classification 21 CFR § 870.1… | 1997 |
What descends from it? (7)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 26, 2014 | Class II | Z-0162-2015 | Mixed-up of materials/components | These microcatheters were packaged with a 2.8 F distal tip, rather than the labeled 2.4 F. |
| Dec 6, 2013 | Class II | Z-0614-2014 | Packaging process control | Merit Medical Systems, Inc. is conducting a recall for 3 lots of Maestro Microcatheters with a graphic discrepancy on the carton/box label end panel. The catheter graphic on the front of the carton box (correct) and the graphic on the end… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K161921 (Merit Medical Systems, Inc., 2016) has gone furthest, with 4 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. 2008, 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 Merit 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 as stated in the FDA summary.
https://510kreport.com/device/K082613 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082613: Merit Microcatheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082613
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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