S.I.N. Instruments Kits (K262084): 510(k) cleared for S.I.N. Implant System Ltda
S.I.N. Instruments Kits (K262084): 510(k) cleared for S.I.N. Implant System Ltda: 510(k) cleared for S.I.N. Implant System Ltda. Its amount of 122 is below the median of 138 (45th percentile). Dated 13 days ago, it is in the active follow-up window. Score 42/100. 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: 122 · 45th percentile of 414 FDAPulse records · 0.9x the median
Free preview: all 14 published fields of this record are shown below. Locked: 0 related BR FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262084 |
| Device | S.I.N. Instruments Kits |
| Applicant | S.I.N. Implant System Ltda |
| Specialty / panel | General Hospital |
| Product code | KCT |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-06-22 |
| Decision date | 2026-10-22 |
| Review time (days) | 122 |
| Third-party review | No |
| Applicant location | São Paulo, BR |
| amount percentile | 45th of 414 (median 138, 0.9x 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: 2026-10-22
- 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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42 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 122-day review: this device is a strong predicate for similar products.
- Posted 13 days ago.
What is the FDAPulse record for S.I.N. Instruments Kits (K262084): 510(k) cleared for S.I.N. Implant System Ltda?
S.I.N. Instruments Kits (K262084) by S.I.N. Implant System Ltda was cleared on 2026-10-22 after 122 days of review.
How does S.I.N. Instruments Kits (K262084): 510(k) cleared for S.I.N. Implant System Ltda compare to other FDAPulse records?
Its amount of 122 is below the median (45th percentile); smaller records often move faster and face less competition. It is fresh: dated 13 days ago, inside the window where early outreach matters most.
S.I.N. Instruments Kits (K262084) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| S.I.N. Instruments Kits (K262084) | BR | 2026-10-22 |
| 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 |
Compare S.I.N. Instruments Kits (K262084) vs Sterilization Cassette (CASS-1) (K262042) →
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Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: General Hospital devices
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