Tri Stage Venous Cannulae (K262052): 510(k) cleared for Sorin Group Italia S.R.L.
Tri Stage Venous Cannulae (K262052): 510(k) cleared for Sorin Group Italia S.R.L.: 510(k) cleared for Sorin Group Italia S.R.L. Its amount of 102 is below the median of 138 (36th percentile). Dated 38 days ago, it serves as a historical benchmark. Score 36/100. As of 2026-11-04, 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: 102 · 36th percentile of 414 FDAPulse records · 0.7x 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 | K262052 |
| Device | Tri Stage Venous Cannulae |
| Applicant | Sorin Group Italia S.R.L. |
| Specialty / panel | Cardiovascular |
| Product code | DWF |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-06-18 |
| Decision date | 2026-09-28 |
| Review time (days) | 102 |
| Third-party review | No |
| Applicant location | Mirandola, IT |
| amount percentile | 36th of 414 (median 138, 0.7x median) |
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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: 2026-09-28
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FDAPulse records (IT first): Vessel Closure Device (VCD177213P) (K260677) · Digistat Care (K261287) · HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5 · Plenity-V (MC0979 / GS110) (K261783) · Dual Stage Venous Cannulae (K263092) · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: Tri Stage Venous Cannulae (K262052): 510(k) cleared for Sorin Group Italia S.R.L. and 6 IT peers
- IT FDAPulse records like this one: 6
- Tri Stage Venous Cannulae (K262052): 510(k) cleared for Sorin Group Italia S.R.L.'s amount: 36th 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)
36 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 102-day review: this device is a strong predicate for similar products.
- Posted 38 days ago.
What is the FDAPulse record for Tri Stage Venous Cannulae (K262052): 510(k) cleared for Sorin Group Italia S.R.L.?
Tri Stage Venous Cannulae (K262052) by Sorin Group Italia S.R.L. was cleared on 2026-09-28 after 102 days of review.
How does Tri Stage Venous Cannulae (K262052): 510(k) cleared for Sorin Group Italia S.R.L. compare to other FDAPulse records?
Its amount of 102 is below the median (36th percentile); smaller records often move faster and face less competition. It is 38 days old, still within a typical 45-day follow-up window. Its Predicate Speed & CAPA Advisory Opportunity Score of 36/100 is modest; treat it as background rather than a priority.
Tri Stage Venous Cannulae (K262052) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Tri Stage Venous Cannulae (K262052) | IT | 2026-09-28 |
| TriSalus TriNav Advance Infusion System (K253509) | CO | 2026-09-21 |
| Hemotag Analysis Software (HAS) (K252736) | FL | 2026-10-21 |
| Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168) | TX | 2026-10-16 |
Related records
- TriSalus TriNav Advance Infusion System (K253509): 510(k) cleared for Trisalus Life Sciences
- Hemotag Analysis Software (HAS) (K252736): 510(k) cleared for Aventusoft, LLC
- 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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- DistaSense(TM) (v1) (K254058): 510(k) cleared for Life Detection Technologies
- S-Patch CardioAI (K254255): 510(k) cleared for Wellysis Corp.
- Tempus ECG-MR (K254297): 510(k) cleared for Tempus AI, Inc.
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Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Cardiovascular devices
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