CAS-One IR (K261225): 510(k) cleared for Cascination AG
CAS-One IR (K261225): 510(k) cleared for Cascination AG: 510(k) cleared for Cascination AG. Its amount of 167 is above the median of 138 (60th percentile). Dated 36 days ago, it serves as a historical benchmark. Score 48/100. 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: 167 · 60th percentile of 414 FDAPulse records · 1.2x the median
Free preview: all 14 published fields of this record are shown below. Locked: 6 related CH FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261225 |
| Device | CAS-One IR |
| Applicant | Cascination AG |
| Specialty / panel | Radiology |
| Product code | JAK |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-04-15 |
| Decision date | 2026-09-29 |
| Review time (days) | 167 |
| Third-party review | No |
| Applicant location | Bern, CH |
| amount percentile | 60th of 414 (median 138, 1.2x median) |
| Peer records CSV (7 CH 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: 2026-09-29
- 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: CAS-One IR (K261225): 510(k) cleared for Cascination AG and 7 CH peers
- CH FDAPulse records like this one: 7
- CAS-One IR (K261225): 510(k) cleared for Cascination AG's amount: 60th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every CH peer: $1,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
48 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 167-day review, longer than typical.
- Posted 36 days ago.
What is the FDAPulse record for CAS-One IR (K261225): 510(k) cleared for Cascination AG?
CAS-One IR (K261225) by Cascination AG was cleared on 2026-09-29 after 167 days of review.
How does CAS-One IR (K261225): 510(k) cleared for Cascination AG compare to other FDAPulse records?
Its amount of 167 sits in the upper half (60th percentile) of 414 records; the median is 138. It is 36 days old, still within a typical 45-day follow-up window.
CAS-One IR (K261225) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| CAS-One IR (K261225) | CH | 2026-09-29 |
| VenusCT (K260510) | CA | 2026-10-19 |
| AVIEW Aorta Metrics (K260391) | KR | 2026-10-16 |
| Vista AI Scan (K260092) | CA | 2026-10-07 |
Related records
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- Single-Use EBUS Balloon (K261616): 510(k) cleared for Micro-Tech (Nanjing) Co., Ltd.
Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Radiology devices
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