CuratOR EX2742 (K262397): 510(k) cleared for Eizo Corporation
CuratOR EX2742 (K262397): 510(k) cleared for Eizo Corporation: 510(k) cleared for Eizo Corporation. Its amount of 59 is below the median of 138 (16th percentile). Dated 54 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: 59 · 16th percentile of 414 FDAPulse records · 0.4x the median
Free preview: all 14 published fields of this record are shown below. Locked: 9 related JP FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262397 |
| Device | CuratOR EX2742 |
| Applicant | Eizo Corporation |
| Specialty / panel | Gastroenterology, Urology |
| Product code | GCJ |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-07-14 |
| Decision date | 2026-09-11 |
| Review time (days) | 59 |
| Third-party review | No |
| Applicant location | Hakusan, Ishikawa, JP |
| amount percentile | 16th of 414 (median 138, 0.4x median) |
| Peer records CSV (10 JP 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: 2026-09-11
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
Top FDAPulse records (JP first): Lilium one (USM330) (K260605) · SCENARIA View Phase 6.0 (K261229) · APERTO Lucent MRI System (K261283) · KOWA FM-600 (K261255) · DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece ( · 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: CuratOR EX2742 (K262397): 510(k) cleared for Eizo Corporation and 10 JP peers
- JP FDAPulse records like this one: 10
- CuratOR EX2742 (K262397): 510(k) cleared for Eizo Corporation's amount: 16th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every JP peer: $2,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
30 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 59-day review: this device is a strong predicate for similar products.
What is the FDAPulse record for CuratOR EX2742 (K262397): 510(k) cleared for Eizo Corporation?
CuratOR EX2742 (K262397) by Eizo Corporation was cleared on 2026-09-11 after 59 days of review.
How does CuratOR EX2742 (K262397): 510(k) cleared for Eizo Corporation compare to other FDAPulse records?
Its amount of 59 is below the median (16th percentile); smaller records often move faster and face less competition. It is 54 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.
CuratOR EX2742 (K262397) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| CuratOR EX2742 (K262397) | JP | 2026-09-11 |
| CapsoView (CVV); CapsoCloud (CLD) (K254230) | CA | 2026-09-25 |
| Drainage Catheter (K254179) | CN | 2026-09-18 |
| colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) (K253481) | DE | 2026-09-14 |
Related records
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- Drainage Catheter (K254179): 510(k) cleared for Canyon Medical, Inc.
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Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Gastroenterology & Urology devices
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