# MOWANA™ Auto Duo (K261266): 510(k) cleared for PENTAMASTER MEDIQ SDN BHD

**Predicate Speed & CAPA Advisory Opportunity Score:** 47/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261266 |
| Device | MOWANA™ Auto Duo |
| Applicant | PENTAMASTER MEDIQ SDN BHD |
| Specialty / panel | General Hospital |
| Product code | FMI |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-04-16 |
| Decision date | 2026-09-17 |
| Review time (days) | 154 |
| Third-party review | Yes |
| Applicant location | Simpang Ampat, MY |

## Why this score
- 154-day review, longer than typical.
- Reviewed through the third-party program.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261266). 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.