510(k) clearance
Mint ACE Pump
- 510(k) number
- K263422
- Applicant
- Beta Bionics, Inc.
- Decision date
- Oct 21, 2026
- Date received
- Sep 25, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- QFG
- Device type
- Alternate Controller Enabled Insulin Infusion Pump
- Device class
- Class II
- Regulation
- 21 CFR 880.5730
- Advisory committee
- Clinical Chemistry
- Statement or summary
- Summary
- Third party
- N
- Location
- Irvine, CA, US