510(k) · Cleared
ClearedMMS Guide Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro Medical Solutions, Inc. · KRA Catheter, Continuous Flush
Cleared on Mar 9, 2016 as substantially equivalent to K111490 (Ev3, Inc., 2011) after a 176-day review. Its family tree reaches back 1 generation to 2011. 2 later devices descend from it.
- Decided
- Mar 9, 2016
- Review
- 176 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K111490 (2011). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK111490 Marksman Catheter, *Refers to Different Catheter Working Lenghts…Ev3, Inc. · 2011
- This deviceK152625 MMS Guide CatheterMicro Medical Solutions, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK163231 Chameleon PTA Balloon CatheterAv Medical Technologies, Ltd. · 2017 · Recalled
- Descendant · 2 generations on · 0 of its ownK170635 Chameleon PTA Balloon CatheterAv Medical Technologies, Ltd. · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K111490 | Marksman Catheter, *Refers to Different Catheter Working Lenghts, Distal… | Ev3, Inc. | 2011 | — |
| 0 (this device) | K152625 | MMS Guide Catheter | Micro Medical Solutions, Inc. | 2016 | — |
| +1 | K163231 | Chameleon PTA Balloon Catheter | Av Medical Technologies, Ltd. | 2017 | 2 |
| +2 | K170635 | Chameleon PTA Balloon Catheter | Av Medical Technologies, Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 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 |
|---|---|---|---|
| * | K111490 | Marksman Catheter, *Refers to Different Catheter Working Lenghts, Distal Single Coiled…Summary page 5…870.1210 Device Classification: Class II Product Code: KRA Predicate Devices: Marksman Catheter (K111490) Contact Greg Mathison VP Regulatory, Clinical & Quality… | 2011 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163231 | Chameleon PTA Balloon Catheter | 2017 | 1 |
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?
How does its category compare?
All KRA devicesKRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 MMS Guide Catheter is intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152625 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152625: MMS Guide Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152625
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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