Digistat Care (K261287): 510(k) cleared for Ascom Ums Srl Unipersonale
Digistat Care (K261287): 510(k) cleared for Ascom Ums Srl Unipersonale: 510(k) cleared for Ascom Ums Srl Unipersonale. Its amount of 145 is above the median of 138 (54th percentile). Dated 53 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: 145 · 54th percentile of 414 FDAPulse records · 1.1x 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 | K261287 |
| Device | Digistat Care |
| Applicant | Ascom Ums Srl Unipersonale |
| Specialty / panel | Cardiovascular |
| Product code | MSX |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-04-20 |
| Decision date | 2026-09-12 |
| Review time (days) | 145 |
| Third-party review | No |
| Applicant location | Scandicci (Fi), IT |
| amount percentile | 54th of 414 (median 138, 1.1x 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: 2026-09-12
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
Top FDAPulse records (IT first): Vessel Closure Device (VCD177213P) (K260677) · HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5 · Plenity-V (MC0979 / GS110) (K261783) · Tri Stage Venous Cannulae (K262052) · 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: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: Digistat Care (K261287): 510(k) cleared for Ascom Ums Srl Unipersonale and 6 IT peers
- IT FDAPulse records like this one: 6
- Digistat Care (K261287): 510(k) cleared for Ascom Ums Srl Unipersonale's amount: 54th 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 145-day review: this device is a strong predicate for similar products.
What is the FDAPulse record for Digistat Care (K261287): 510(k) cleared for Ascom Ums Srl Unipersonale?
Digistat Care (K261287) by Ascom Ums Srl Unipersonale was cleared on 2026-09-12 after 145 days of review.
How does Digistat Care (K261287): 510(k) cleared for Ascom Ums Srl Unipersonale compare to other FDAPulse records?
Its amount of 145 sits in the upper half (54th percentile) of 414 records; the median is 138. It is 53 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.
Digistat Care (K261287) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Digistat Care (K261287) | IT | 2026-09-12 |
| 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.
- MyoVista wavECG (DG-200-B15-003) (K260005): 510(k) cleared for HeartSciences, Inc.
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- ECG Analysis Software (AiTiALVSD) (K254302): 510(k) cleared for Medical AI Co., Ltd.
- QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W) (K260250): 510(k) cleared for QT Medical, Inc.
- 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.
- Echo-2 (K254240): 510(k) cleared for Neko Health AB
Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Cardiovascular devices
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