510(k) · Cleared
ClearedNmi Coaxial Microintroducer Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Navilyst Medical, Inc. · DRE Dilator, Vessel, For Percutaneous Catheterization
Cleared on Apr 1, 2013 as substantially equivalent to K974640 (Boston Scientific Corp, 1998) after a 144-day review. Its family tree reaches back 1 generation to 1998. 2 later devices descend from it.
- Decided
- Apr 1, 2013
- Review
- 144 days
- Class
- Class II
- Product code
- DRE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K974640 (1998). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK974640 Coaxial Dilator SetBoston Scientific Corp · 1998 · Recalled
- This deviceK123445 Nmi Coaxial Microintroducer SetNavilyst Medical, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK151076 MicroTaper Needle Introducer SetSummit Access, LLC · 2015
- Descendant · cites it directly · 0 of its ownK132713 Nmi Coaxial Microintroducer SetNavilyst Medical, Inc. · 2013 · Recalled
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 | K974640 | Coaxial Dilator Set | Boston Scientific Corp | 1998 | 1 |
| 0 (this device) | K123445 | Nmi Coaxial Microintroducer Set | Navilyst Medical, Inc. | 2013 | — |
| +1 | K151076 | MicroTaper Needle Introducer Set | Summit Access, LLC | 2015 | — |
| +1 | K132713 | Nmi Coaxial Microintroducer Set | Navilyst Medical, Inc. | 2013 | 15 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 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 DRE? 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 DRE device
- #1 K261310 FlexTract Deflectable-Rotational Dilator…score 12.0 · 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? (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 |
|---|---|---|---|
| * | K974640 | Coaxial Dilator SetSummary page 1…edicate Device(s) Predicate Name: VaxcelTM Mini-Stick Coaxial Dilator Set Predicate 510(k): K974640 E. Device Description NMI Coaxial Microintroducer Sets are offered with a 21 gauge needle (4 CM or 7 CM length with… | 1998 |
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 DRE devicesDRE Dilator, Vessel, For Percutaneous Catheterization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · DRE
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRE
31in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRE
1in 2016
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DRE
356in 2025
MAUDE reports naming product code DRE, 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 | 160 | 0 | 81 |
| 2008 | 2 | — | 0 | 38 |
| 2009 | 2 | — | 2 | 69 |
| 2010 | 1 | — | 2 | 73 |
| 2011 | 1 | — | 1 | 90 |
| 2012 | 1 | — | 0 | 132 |
| 2013 | 4 | 111 | 0 | 120 |
| 2014 | 6 | 72 | 0 | 82 |
| 2015 | 4 | 30 | 1 | 82 |
| 2016 | 3 | 90 | 1 | 84 |
| 2017 | 4 | 108 | 0 | 101 |
| 2018 | 2 | — | 0 | 126 |
| 2019 | 3 | 68 | 0 | 144 |
| 2020 | 3 | 30 | 0 | 120 |
| 2021 | 1 | — | 0 | 115 |
| 2022 | 3 | 261 | 0 | 136 |
| 2023 | 2 | — | 0 | 386 |
| 2024 | 1 | — | 0 | 325 |
| 2025 | 3 | 31 | 0 | 356 |
| 2026 | 1 | — | 1 (1) | — |
What is it indicated for?
The NMI Coaxial Microintroducer Set is used for the percutaneous introduction of a guidewire into the vascular system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123445 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123445: Nmi Coaxial Microintroducer Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123445
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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