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 is the algorithm behind Beta Bionics' iLet bionic pancreas, cleared as a standalone component. Product code QJI covers interoperable automated glycemic controllers: software that reads CGM data and decides insulin doses for a compatible pump.
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 just 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. The algorithm on its own evidently needed far less back-and-forth than the new pump did.
Clearance details
- Applicant
- Beta Bionics, Inc.
- Product code
- 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.