510(k) · Cleared
ClearedAristotle Colossus Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scientia Vascular, Inc. · MOF Guide, Wire, Catheter, Neurovasculature
Cleared on Jan 26, 2023 as substantially equivalent to K192783 (Scientia Vascular, LLC, 2019) after a 167-day review. Its family tree reaches back 5 generations to 2000. 5 later devices descend from it.
- Decided
- Jan 26, 2023
- Review
- 167 days
- Class
- Class II
- Product code
- MOF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K002212 (2000). 5 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK002212 Mirage Hydrophilic Guidewire, Model 103-0608Micro Therapeutics, Inc. · 2000
- 4 generations backK032146 PVS 1300 Synchro 0.014 & PVS 1600 Synchro 0.010 Guide WiresPrecision Vascular Systems, Inc. · 2003 · Recalled
- 3 generations backK173235 Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire…Scientia Vascular, LLC · 2018
- 2 generations backK183608 Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18…Scientia Vascular, LLC · 2019
- 1 generation backK192783 Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24…Scientia Vascular, LLC · 2019
- This deviceK222437 Aristotle Colossus GuidewireScientia Vascular, Inc. · 2023
- Descendant · cites it directly · 2 of its ownK243938 Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24…Scientia Vascular, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK254181 Aristotle 65 MacrowireScientia Vascular · 2026
- Descendant · cites it directly · 0 of its ownK260751 35 Helix GuidewirePiraeus Medical, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK260223 Aristotle Mini GuidewireScientia Vascular, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK252317 Zenith Micro GuidewireSuzhou Zenith Vascular SciTech Limited · 2026
Most influential descendants
Showing 5 of 5 · See all- K243938Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14…Scientia Vascular, Inc. · 2025 · cites it directly2descendants
- K254181Aristotle 65 MacrowireScientia Vascular · 2026 · cites it directly0descendants
- K26075135 Helix GuidewirePiraeus Medical, Inc. · 2026 · cites it directly0descendants
- K260223Aristotle Mini GuidewireScientia Vascular, Inc. · 2026 · 2 generations on0descendants
- K252317Zenith Micro GuidewireSuzhou Zenith Vascular SciTech Limited · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K002212 | Mirage Hydrophilic Guidewire, Model 103-0608 | Micro Therapeutics, Inc. | 2000 | — |
| −4 | K032146 | PVS 1300 Synchro 0.014 & PVS 1600 Synchro 0.010 Guide Wires | Precision Vascular Systems, Inc. | 2003 | 1 |
| −3 | K173235 | Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm… | Scientia Vascular, LLC | 2018 | — |
| −2 | K183608 | Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm… | Scientia Vascular, LLC | 2019 | — |
| −1 | K192783 | Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm… | Scientia Vascular, LLC | 2019 | — |
| 0 (this device) | K222437 | Aristotle Colossus Guidewire | Scientia Vascular, Inc. | 2023 | — |
| +1 | K243938 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom… | Scientia Vascular, Inc. | 2025 | — |
| +1 | K254181 | Aristotle 65 Macrowire | Scientia Vascular | 2026 | — |
| +1 | K260751 | 35 Helix Guidewire | Piraeus Medical, Inc. | 2026 | — |
| +2 | K260223 | Aristotle Mini Guidewire | Scientia Vascular, Inc. | 2026 | — |
| +2 | K252317 | Zenith Micro Guidewire | Suzhou Zenith Vascular SciTech Limited | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 4 | 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 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 |
|---|---|---|---|
| * | K192783 | Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard…Summary page 4…Review Panel: Neurology Device Class: Class II device per 21 CFR 870.1330 Predicate Device: Aristotle 24 Guidewire (K192783) Reference Device: ASAHI Neurovascular Guide Wire ASAHI CHIKAI Black 18 (K141751)… | 2019 |
| † | K141751 | Asahi Neurovascular Guide Wire Asahi Chikai 008, Asahi Neurovascular Guide Wire Asahi… | 2015 |
What descends from it? (5)
3 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?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K243938 (Scientia Vascular, Inc., 2025) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K192783.
How does its category compare?
All MOF devicesMOF Guide, Wire, Catheter, Neurovasculature: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Aristotle Colossus Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K222437 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222437: Aristotle Colossus Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222437
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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