# TumorSight Risk (K260023): 510(k) cleared for SimBioSys, Inc.

**Predicate Speed & CAPA Advisory Opportunity Score:** 61/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260023 |
| Device | TumorSight Risk |
| Applicant | SimBioSys, Inc. |
| Specialty / panel | Other |
| Product code | SHW |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-01-05 |
| Decision date | 2026-09-25 |
| Review time (days) | 263 |
| Third-party review | No |
| Applicant location | Chicago, IL, US |

## Why this score
- A long 263-day review suggests additional-information requests: a firm likely to value regulatory help next time.
- Posted 41 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260023). Last refreshed: 2026-11-04T21:30:53.898Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.