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3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) (K261992): 510(k) cleared for Solventum US, LLC vs S.I.N. Instruments Kits (K262084): 510(k) cleared for S.I.N. Implant System Ltda: FDAPulse comparison
S.I.N. Instruments Kits (K262084): 510(k) cleared for S.I.N. Implant System Ltda's review days of 122 is 1.2x 3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) (K261992): 510(k) cleared for Solventum US, LLC's 102 (45th percentile). 3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) (K261992): 510(k) cleared for Solventum US, LLC is dated 2026-09-25; S.I.N. Instruments Kits (K262084): 510(k) cleared for S.I.N. Implant System Ltda 2026-10-22.
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Both records plus every comparable record, with all columns and source links · Card, Apple Pay, Google Pay or Link via Stripe
How does 3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) (K261992): 510(k) cleared for Solventum US, LLC compare to S.I.N. Instruments Kits (K262084): 510(k) cleared for S.I.N. Implant System Ltda?
| Field | 3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) (K261992): 510(k) cleared for Solventum US, LLC | S.I.N. Instruments Kits (K262084): 510(k) cleared for S.I.N. Implant System Ltda |
|---|---|---|
| Record | 510(k) clearance | 510(k) clearance |
| 510(k) number | K261992 | K262084 |
| Device | 3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) | S.I.N. Instruments Kits |
| Applicant | Solventum US, LLC | S.I.N. Implant System Ltda |
| Specialty / panel | General Hospital | General Hospital |
| Product code | JOJ | KCT |
| Device class | 2 | 2 |
| Clearance type | Traditional | Traditional |
| Decision | Substantially Equivalent | Substantially Equivalent |
| Received | 2026-06-15 | 2026-06-22 |
| Decision date | 2026-09-25 | 2026-10-22 |
| Review time (days) | 102 | 122 |
| Third-party review | No | No |
| Applicant location | San Antonio, TX, US | São Paulo, BR |
| amount percentile | 36th | 45th |
| Predicate Speed & CAPA Advisory Opportunity Score | 36/100 | 42/100 |
| Peer rank and all 500 records (CSV) | 🔒 Click to unlock → | |
| Official source URLs for every peer record | 🔒 Click to unlock → | |
Official records: 3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) (K261992): 510(k) cleared for Solventum US, LLC · S.I.N. Instruments Kits (K262084): 510(k) cleared for S.I.N. Implant System Ltda
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