iLet Dosing Decision Software— 510(k) K262763
Substantially EquivalentBeta Bionics, Inc.
FDA 510(k) clearance K262763 for iLet Dosing Decision Software, Substantially Equivalent on 2026-09-11. Applicant: Beta Bionics, Inc.. Device class: 2.
Summary
iLet Dosing Decision Software from Beta Bionics is filed under QJI, interoperable automated glycemic controllers. The code covers devices that automatically calculate drug doses from inputs such as glucose and command a connected infusion pump to deliver them.
Class II, 21 CFR 862.1356. The Clinical Chemistry panel reviewed it as a Traditional 510(k).
Beta Bionics filed from Irvine, California. Review took 38 days (August 4 to September 11, 2026). It cleared the same day as the company's Mint ACE Pump (K260001), which went through a 252-day review.
Clearance details
- Applicant
- Beta Bionics, Inc.
- Product code
- Product code QJI
- Device class
- Class 2
- Regulation
- 21 CFR 862.1356
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code QJI
view allMore clearances from Beta Bionics, Inc.
view allAdverse events under product code QJI
product code QJI- Other
- 3
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.