TSK OptiXion (K262516): 510(k) cleared for Tsk Laboratory, Japan
TSK OptiXion (K262516): 510(k) cleared for Tsk Laboratory, Japan: 510(k) cleared for Tsk Laboratory, Japan. Its amount of 77 is below the median of 138 (21st percentile). Dated 29 days ago, it is in the active follow-up window. Score 36/100. 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: 77 · 21th percentile of 414 FDAPulse records · 0.6x 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 | K262516 |
| Device | TSK OptiXion |
| Applicant | Tsk Laboratory, Japan |
| Specialty / panel | General Hospital |
| Product code | QYM |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-07-21 |
| Decision date | 2026-10-06 |
| Review time (days) | 77 |
| Third-party review | No |
| Applicant location | Tochigi-Ken, JP |
| amount percentile | 21th of 414 (median 138, 0.6x 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: 2026-10-06
- Data refreshed: 2026-11-03
- 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: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: TSK OptiXion (K262516): 510(k) cleared for Tsk Laboratory, Japan and 10 JP peers
- JP FDAPulse records like this one: 10
- TSK OptiXion (K262516): 510(k) cleared for Tsk Laboratory, Japan's amount: 21st percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every JP peer: $2,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
36 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 77-day review: this device is a strong predicate for similar products.
- Posted 29 days ago.
What is the FDAPulse record for TSK OptiXion (K262516): 510(k) cleared for Tsk Laboratory, Japan?
TSK OptiXion (K262516) by Tsk Laboratory, Japan was cleared on 2026-10-06 after 77 days of review.
How does TSK OptiXion (K262516): 510(k) cleared for Tsk Laboratory, Japan compare to other FDAPulse records?
Its amount of 77 is below the median (21th percentile); smaller records often move faster and face less competition. It is 29 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.
TSK OptiXion (K262516) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| TSK OptiXion (K262516) | JP | 2026-10-06 |
| Gravity Blood Sets with 200µm Filter (K260261) | PA | 2026-10-22 |
| Endox High Level Disinfectant (K254094) | DE | 2026-10-16 |
| Carecube Negative Pressure Isolation Chamber (1BY) (K260180) | CA | 2026-10-16 |
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