# THERMEO® I MSI (K260031): 510(k) cleared for Pro3Dure Medical GmbH

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

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260031 |
| Device | THERMEO® I MSI |
| Applicant | Pro3Dure Medical GmbH |
| Specialty / panel | Other |
| Product code | MQC |
| Device class | U |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-01-06 |
| Decision date | 2026-09-29 |
| Review time (days) | 266 |
| Third-party review | No |
| Applicant location | Iserlohn, DE |

## Why this score
- A long 266-day review suggests additional-information requests: a firm likely to value regulatory help next time.
- Posted 37 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=K260031). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.