# Mint ACE Pump (K260001): 510(k) cleared for Beta Bionics, Inc.

**Predicate Speed & CAPA Advisory Opportunity Score:** 55/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260001 |
| Device | Mint ACE Pump |
| Applicant | Beta Bionics, Inc. |
| Specialty / panel | Clinical Chemistry |
| Product code | QFG |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-01-02 |
| Decision date | 2026-09-11 |
| Review time (days) | 252 |
| Third-party review | No |
| Applicant location | Irvine, CA, US |

## Why this score
- A long 252-day review suggests additional-information requests: a firm likely to value regulatory help next time.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260001). 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.