510(k) · Cleared
ClearedDrivewire 35 Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rapid Medical Ltd. · MOF Guide, Wire, Catheter, Neurovasculature
Cleared on Jul 17, 2026 as substantially equivalent to K233791 (Rapid-Medical, Ltd., 2024) after a 214-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- Jul 17, 2026
- Review
- 214 days
- Class
- Class II
- Product code
- MOF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K002212 (2000). No later device cites it as a predicate yet.
- Root · 6 generations backK002212 Mirage Hydrophilic Guidewire, Model 103-0608Micro Therapeutics, Inc. · 2000
- 5 generations backK032146 PVS 1300 Synchro 0.014 & PVS 1600 Synchro 0.010 Guide WiresPrecision Vascular Systems, Inc. · 2003 · Recalled
- 4 generations backK173235 Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire…Scientia Vascular, LLC · 2018
- 3 generations backK183608 Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18…Scientia Vascular, LLC · 2019
- 2 generations backK192783 Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24…Scientia Vascular, LLC · 2019
- 1 generation backK233791 Drivewire 24 GuidewireRapid-Medical, Ltd. · 2024
- This deviceK254006 Drivewire 35 GuidewireRapid Medical Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K002212 | Mirage Hydrophilic Guidewire, Model 103-0608 | Micro Therapeutics, Inc. | 2000 | — |
| −5 | K032146 | PVS 1300 Synchro 0.014 & PVS 1600 Synchro 0.010 Guide Wires | Precision Vascular Systems, Inc. | 2003 | 1 |
| −4 | K173235 | Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm… | Scientia Vascular, LLC | 2018 | — |
| −3 | K183608 | Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm… | Scientia Vascular, LLC | 2019 | — |
| −2 | K192783 | Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm… | Scientia Vascular, LLC | 2019 | — |
| −1 | K233791 | Drivewire 24 Guidewire | Rapid-Medical, Ltd. | 2024 | — |
| 0 (this device) | K254006 | Drivewire 35 Guidewire | Rapid Medical Ltd. | 2026 | — |
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 MOF? 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 MOF device
- #1 K253168 0.014” Willow Guidewirescore 17.9 · 6 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 |
|---|---|---|---|
| * | K233791 | Drivewire 24 GuidewireSummary page 5…, DQX Device Class: II Classification Panel: Neurology, Cardiovascular Legally Marketed Predicate Device Predicate Device: Drivewire 24 Guidewire (K233791) Reference Device Reference Device: Aristotle Colossus Guidewire (K222437) Indications for Use Statement The Drivewire… | 2024 |
| † | K222437 | Aristotle Colossus Guidewire | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 26 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 6 ancestors has a recall of any class.
How does its category compare?
All MOF devicesMOF Guide, Wire, Catheter, Neurovasculature: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · MOF
11so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · MOF
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MOF
No recall names MOF since 2007.
Adverse event reports per year · MOF
135in 2025
MAUDE reports naming product code MOF, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 3 | 133 | 0 | 5 |
| 2016 | 4 | 61 | 0 | 3 |
| 2017 | 1 | — | 0 | 15 |
| 2018 | 2 | — | 0 | 11 |
| 2019 | 4 | 58 | 0 | 12 |
| 2020 | 4 | 36 | 0 | 18 |
| 2021 | 0 | — | 0 | 39 |
| 2022 | 1 | — | 0 | 92 |
| 2023 | 4 | 199 | 0 | 91 |
| 2024 | 2 | — | 0 | 95 |
| 2025 | 5 | 172 | 0 | 135 |
| 2026 | 11 | 192 | 0 | — |
What is it indicated for?
The Drivewire 35 Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The Drivewire 35 Guidewire is intended to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in the coronary arteries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254006 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254006: Drivewire 35 Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254006
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026