Hemotag Analysis Software (HAS) (K252736): 510(k) cleared for Aventusoft, LLC
Hemotag Analysis Software (HAS) (K252736): 510(k) cleared for Aventusoft, LLC (Florida): 510(k) cleared for Aventusoft, LLC. Its amount of 419 is top-decile (99th percentile of 414 records). Dated 14 days ago, it is in the active follow-up window. Score 67/100. 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: 419 · 99th percentile of 414 FDAPulse records · 3.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 15 related FL FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K252736 |
| Device | Hemotag Analysis Software (HAS) |
| Applicant | Aventusoft, LLC |
| Specialty / panel | Cardiovascular |
| Product code | DQD |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2025-08-28 |
| Decision date | 2026-10-21 |
| Review time (days) | 419 |
| Third-party review | No |
| Applicant location | Boca Raton, FL, US |
| amount percentile | 99th of 414 (median 138, 3.0x median) |
| Peer records CSV (16 FL records) | 🔒 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: 2026-10-21
- 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: Hemotag Analysis Software (HAS) (K252736): 510(k) cleared for Aventusoft, LLC and 16 Florida peers
- Florida FDAPulse records like this one: 16
- Hemotag Analysis Software (HAS) (K252736): 510(k) cleared for Aventusoft, LLC's amount: 99th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Florida peer: $3,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
67 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 419-day review suggests additional-information requests: a firm likely to value regulatory help next time.
- Posted 14 days ago.
What is the FDAPulse record for Hemotag Analysis Software (HAS) (K252736): 510(k) cleared for Aventusoft, LLC in Florida?
Hemotag Analysis Software (HAS) (K252736) by Aventusoft, LLC was cleared on 2026-10-21 after 419 days of review.
How does Hemotag Analysis Software (HAS) (K252736): 510(k) cleared for Aventusoft, LLC compare to other Florida FDAPulse records?
This is a top-decile record: its amount of 419 is 3.0x the median of 138 across 414 records. It is fresh: dated 14 days ago, inside the window where early outreach matters most.
Hemotag Analysis Software (HAS) (K252736) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| 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 |
| eClinics (K260075) | NY | 2026-10-07 |
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Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Cardiovascular devices
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