HipStudio Analysis (K262442): 510(k) cleared for Replasia BV
HipStudio Analysis (K262442): 510(k) cleared for Replasia BV: 510(k) cleared for Replasia BV. Its amount of 68 is below the median of 138 (19th percentile). Dated 44 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: 68 · 19th percentile of 414 FDAPulse records · 0.5x the median
Free preview: all 14 published fields of this record are shown below. Locked: 4 related BE FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262442 |
| Device | HipStudio Analysis |
| Applicant | Replasia BV |
| Specialty / panel | Radiology |
| Product code | LLZ |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-07-16 |
| Decision date | 2026-09-22 |
| Review time (days) | 68 |
| Third-party review | No |
| Applicant location | Leuven, BE |
| amount percentile | 19th of 414 (median 138, 0.5x 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: 2026-09-22
- Data refreshed: 2026-11-04
- 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: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: HipStudio Analysis (K262442): 510(k) cleared for Replasia BV and 5 BE peers
- BE FDAPulse records like this one: 5
- HipStudio Analysis (K262442): 510(k) cleared for Replasia BV's amount: 19th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every BE peer: $1,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
36 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 68-day review: this device is a strong predicate for similar products.
- Posted 44 days ago.
What is the FDAPulse record for HipStudio Analysis (K262442): 510(k) cleared for Replasia BV?
HipStudio Analysis (K262442) by Replasia BV was cleared on 2026-09-22 after 68 days of review.
How does HipStudio Analysis (K262442): 510(k) cleared for Replasia BV compare to other FDAPulse records?
Its amount of 68 is below the median (19th percentile); smaller records often move faster and face less competition. It is 44 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.
HipStudio Analysis (K262442) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| HipStudio Analysis (K262442) | BE | 2026-09-22 |
| VenusCT (K260510) | CA | 2026-10-19 |
| AVIEW Aorta Metrics (K260391) | KR | 2026-10-16 |
| Vista AI Scan (K260092) | CA | 2026-10-07 |
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