# Yumizen H550 (K260781): 510(k) cleared for HORIBA ABX SAS

**Predicate Speed & CAPA Advisory Opportunity Score:** 42/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260781 |
| Device | Yumizen H550 |
| Applicant | HORIBA ABX SAS |
| Specialty / panel | Other |
| Product code | GKZ |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-03-10 |
| Decision date | 2026-09-14 |
| Review time (days) | 188 |
| Third-party review | No |
| Applicant location | Montpellier, FR |

## Why this score
- 188-day review, longer than typical.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260781). 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.