KOWA FM-600 (K261255): 510(k) cleared for Kowa Company, Ltd. Chofu Factory
KOWA FM-600 (K261255): 510(k) cleared for Kowa Company, Ltd. Chofu Factory: 510(k) cleared for Kowa Company, Ltd. Chofu Factory. Its amount of 148 is above the median of 138 (55th percentile). Dated 54 days ago, it serves as a historical benchmark. Score 30/100. 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: 148 · 55th percentile of 414 FDAPulse records · 1.1x 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 | K261255 |
| Device | KOWA FM-600 |
| Applicant | Kowa Company, Ltd. Chofu Factory |
| Specialty / panel | Ophthalmic |
| Product code | MYC |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-04-16 |
| Decision date | 2026-09-11 |
| Review time (days) | 148 |
| Third-party review | No |
| Applicant location | Tokyo, JP |
| amount percentile | 55th of 414 (median 138, 1.1x median) |
| Peer records CSV (10 JP 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: 2026-09-11
- Data refreshed: 2026-11-04
- 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) · DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece ( · TSK OptiXion (K262516) · 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: KOWA FM-600 (K261255): 510(k) cleared for Kowa Company, Ltd. Chofu Factory and 10 JP peers
- JP FDAPulse records like this one: 10
- KOWA FM-600 (K261255): 510(k) cleared for Kowa Company, Ltd. Chofu Factory's amount: 55th 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 148-day review: this device is a strong predicate for similar products.
What is the FDAPulse record for KOWA FM-600 (K261255): 510(k) cleared for Kowa Company, Ltd. Chofu Factory?
KOWA FM-600 (K261255) by Kowa Company, Ltd. Chofu Factory was cleared on 2026-09-11 after 148 days of review.
How does KOWA FM-600 (K261255): 510(k) cleared for Kowa Company, Ltd. Chofu Factory compare to other FDAPulse records?
Its amount of 148 sits in the upper half (55th percentile) of 414 records; the median is 138. 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.
KOWA FM-600 (K261255) vs. top 2 peers
| Organization | Location | Record date |
|---|---|---|
| KOWA FM-600 (K261255) | JP | 2026-09-11 |
| SLIT LAMP SL-D4 (Type | JP | 2026-09-18 |
| Miru 1day UpSide (midafilcon A) (K262495) | JP | 2026-09-17 |
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Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Ophthalmic devices
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