510(k) · Cleared
ClearedMicrocatheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Navilyst Medical, Inc. · DQO Catheter, Intravascular, Diagnostic
Cleared on Aug 19, 2011 as substantially equivalent to K000177 (Boston Scientific Corp, 2000) and 1 other predicate after a 25-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it.
- Decided
- Aug 19, 2011
- Review
- 25 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K000177 (2000). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK000177 Renegade HI-Flo MicrocatheterBoston Scientific Corp · 2000 · Recalled
- This deviceK112124 MicrocatheterNavilyst Medical, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK121954 Nmi MicrocatheterNavilyst Medical, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK113638 Nmi 2.8 MicrocatheterNavilyst Medical, Inc. · 2012
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 | K000177 | Renegade HI-Flo Microcatheter | Boston Scientific Corp | 2000 | 5 |
| 0 (this device) | K112124 | Microcatheter | Navilyst Medical, Inc. | 2011 | — |
| +1 | K121954 | Nmi Microcatheter | Navilyst Medical, Inc. | 2012 | — |
| +1 | K113638 | Nmi 2.8 Microcatheter | Navilyst Medical, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 DQO? 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 DQO device
- #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K000177 | Renegade HI-Flo MicrocatheterSummary page 1…vice(s) Trade Name/S 10(k) Notification: Boston Scientific Renegade Hi-Flo Microcatheter K000 177 Boston Scientific Renegade STC Microcatheter… | 2000 |
| * | K023681 | Renegade STC 18 Microcatheter Our reading of the summary gave K023861, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Boston Scientific Renegade STC Microcatheter”. | 2002 |
What descends from it? (2)
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)
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 DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · DQO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQO
148in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQO
1in 2023
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · DQO
656in 2025
MAUDE reports naming product code DQO, 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 | 8 | 106 | 14 | 564 |
| 2008 | 3 | 80 | 4 | 726 |
| 2009 | 8 | 58 | 7 | 933 |
| 2010 | 7 | 137 | 11 | 556 |
| 2011 | 6 | 74 | 7 | 625 |
| 2012 | 15 | 94 | 2 | 532 |
| 2013 | 2 | — | 1 | 753 |
| 2014 | 3 | 109 | 0 | 601 |
| 2015 | 10 | 209 | 1 (1) | 628 |
| 2016 | 4 | 89 | 2 (1) | 614 |
| 2017 | 10 | 176 | 1 | 873 |
| 2018 | 10 | 234 | 2 | 777 |
| 2019 | 6 | 113 | 71 | 386 |
| 2020 | 3 | 30 | 4 (4) | 312 |
| 2021 | 1 | — | 0 | 338 |
| 2022 | 4 | 181 | 1 | 379 |
| 2023 | 4 | 73 | 1 (1) | 391 |
| 2024 | 4 | 148 | 0 | 511 |
| 2025 | 2 | — | 0 | 656 |
| 2026 | 3 | 85 | 24 (4) | — |
What is it indicated for?
The NMI Microcatheter is intended for use in small vessels and superselective anatomy during diagnostic and interventional procedures in the peripheral vasculature. Upon access of the desired region, the microcatheter can be used for the controlled and selective infusion of diagnostic, therapeutic and embolic materials. All products must be used in accordance with the original manufacturer's instructions for use. The catheter is not intended for use in coronary or neuro- vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112124 · printed Nov 3, 2026
Cite this page
510(k) Report. “K112124: Microcatheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K112124
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