Aristotle 65 Macrowire (K254181): 510(k) cleared for Scientia Vascular
Aristotle 65 Macrowire (K254181): 510(k) cleared for Scientia Vascular (Utah): 510(k) cleared for Scientia Vascular. Its amount of 267 is above the median of 138 (88th percentile). Dated 49 days ago, it serves as a historical benchmark. Score 55/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 267 · 88th percentile of 414 FDAPulse records · 1.9x the median
Free preview: all 14 published fields of this record are shown below. Locked: 10 related UT FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K254181 |
| Device | Aristotle 65 Macrowire |
| Applicant | Scientia Vascular |
| Specialty / panel | Cardiovascular |
| Product code | MOF |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2025-12-23 |
| Decision date | 2026-09-16 |
| Review time (days) | 267 |
| Third-party review | No |
| Applicant location | West Valley City, UT, US |
| amount percentile | 88th of 414 (median 138, 1.9x median) |
| Peer records CSV (11 UT records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-09-16
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: Aristotle 65 Macrowire (K254181): 510(k) cleared for Scientia Vascular and 11 Utah peers
- Utah FDAPulse records like this one: 11
- Aristotle 65 Macrowire (K254181): 510(k) cleared for Scientia Vascular's amount: 88th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Utah peer: $2,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
55 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 267-day review suggests additional-information requests: a firm likely to value regulatory help next time.
What is the FDAPulse record for Aristotle 65 Macrowire (K254181): 510(k) cleared for Scientia Vascular in Utah?
Aristotle 65 Macrowire (K254181) by Scientia Vascular was cleared on 2026-09-16 after 267 days of review.
How does Aristotle 65 Macrowire (K254181): 510(k) cleared for Scientia Vascular compare to other Utah FDAPulse records?
Its amount of 267 sits in the upper half (88th percentile) of 414 records; the median is 138. It is 49 days old; check the official source for later updates before acting.
Aristotle 65 Macrowire (K254181) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Aristotle 65 Macrowire (K254181) | UT | 2026-09-16 |
| Hemotag Analysis Software (HAS) (K252736) | FL | 2026-10-21 |
| TriSalus TriNav Advance Infusion System (K253509) | CO | 2026-09-21 |
| Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168) | TX | 2026-10-16 |
Related records
- Hemotag Analysis Software (HAS) (K252736): 510(k) cleared for Aventusoft, LLC
- TriSalus TriNav Advance Infusion System (K253509): 510(k) cleared for Trisalus Life Sciences
- Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168): 510(k) cleared for Skycade Med Corporation
- eClinics (K260075): 510(k) cleared for Ceiba Healthcare US, Inc.
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