FDAPulse / report
HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305) (K261438): 510(k) cleared for Eurosets S.R.L
HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305) (K261438): 510(k) cleared for Eurosets S.R.L: 510(k) cleared for Eurosets S.R.L. Its amount of 137 is above the median of 138 (50th percentile). Dated 51 days ago, it serves as a historical benchmark. Score 30/100. 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: 137 · 50th percentile of 414 FDAPulse records · 1.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 5 related IT FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261438 |
| Device | HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305) |
| Applicant | Eurosets S.R.L |
| Specialty / panel | Cardiovascular |
| Product code | DTZ |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-04-30 |
| Decision date | 2026-09-14 |
| Review time (days) | 137 |
| Third-party review | No |
| Applicant location | Medolla, IT |
| amount percentile | 50th of 414 (median 138, 1.0x median) |
| Peer records CSV (6 IT 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: 2026-09-14
- Data refreshed: 2026-11-03
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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: HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305) (K261438): 510(k) cleared for Eurosets S.R.L and 6 IT peers
- IT FDAPulse records like this one: 6
- HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305) (K261438): 510(k) cleared for Eurosets S.R.L's amount: 50th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every IT peer: $1,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
30 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 137-day review: this device is a strong predicate for similar products.
What is the FDAPulse record for HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305) (K261438): 510(k) cleared for Eurosets S.R.L?
HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305) (K261438) by Eurosets S.R.L was cleared on 2026-09-14 after 137 days of review.
How does HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305) (K261438): 510(k) cleared for Eurosets S.R.L compare to other FDAPulse records?
Its amount of 137 sits in the upper half (50th percentile) of 414 records; the median is 138. It is 51 days old; check the official source for later updates before acting. Its Predicate Speed & CAPA Advisory Opportunity Score of 30/100 is modest; treat it as background rather than a priority.
HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305) (K261438) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305) (K261438) | IT | 2026-09-14 |
| 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 |
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Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Cardiovascular devices
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