510(k) · Cleared
Recalled · Class II · 2025iLet® Dosing Decision Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beta Bionics, Inc. · QJI Interoperable Automated Glycemic Controller
Cleared on Sep 22, 2023 as substantially equivalent to K220916 (Beta Bionics, Inc., 2023) after a 57-day review. Its family tree reaches back 3 generations to 2019. 1 later device descends from it. It has been recalled once.
- Decided
- Sep 22, 2023
- Review
- 57 days
- Class
- Class II
- Product code
- QJI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN190034 (2019). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backDEN190034 Control-IQ TechnologyTandem Diabetes Care, Inc. · 2019
- 2 generations backK200467 Control-IQ TechnologyTandem Diabetes Care, Inc. · 2020
- 1 generation backK220916 iLet® Dosing Decision SoftwareBeta Bionics, Inc. · 2023
- This deviceK232224 iLet® Dosing Decision SoftwareBeta Bionics, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK262763 iLet Dosing Decision SoftwareBeta Bionics, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K262763iLet Dosing Decision SoftwareBeta Bionics, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN190034 | Control-IQ Technology | Tandem Diabetes Care, Inc. | 2019 | — |
| −2 | K200467 | Control-IQ Technology | Tandem Diabetes Care, Inc. | 2020 | — |
| −1 | K220916 | iLet® Dosing Decision Software | Beta Bionics, Inc. | 2023 | — |
| 0 (this device) | K232224 | iLet® Dosing Decision Software | Beta Bionics, Inc. | 2023 | — |
| +1 | K262763 | iLet Dosing Decision Software | Beta Bionics, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QJI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QJI device
- #1 K253701 SmartGuard Technology; Predictive Low Glucose…score 17.1 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K220916 | iLet® Dosing Decision SoftwareSummary page 4…egulation Number, Device Class and Pro Code: 21CFR 862.1356, Class II, QJI Predicate Device: iLet® Dosing Decision Software (Beta Bionics, Inc., K220916) Purpose of 510(k) Notification: The User Guide and Quick Reference Guide are being updated to expand the indications for use of… | 2023 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K262763 | iLet Dosing Decision Software | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 13, 2025 | Class II | Z-1809-2026 | Software design | it was found that in versions 1.3.7, 1.4.2, and 1.4.3, the Lock Screen and Limited Access Passcode Screen on the iLet graphical user interface (GUI) include certain icons displayed in the status bar that are active, thereby allowing the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 6 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K262763 (Beta Bionics, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QJI devicesQJI Interoperable Automated Glycemic Controller: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QJI
8so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QJI
130in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QJI
No recall names QJI since 2007.
Adverse event reports per year · QJI
3in 2025
MAUDE reports naming product code QJI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 2 | — | 0 | 4 |
| 2023 | 4 | 251 | 0 | 26 |
| 2024 | 4 | 174 | 0 | 15 |
| 2025 | 5 | 130 | 0 | 3 |
| 2026 | 8 | 65 | 0 | — |
What is it indicated for?
The iLet Dosing Decision Software is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps. A self-monitoring of blood glucose (SMBG) meter may also be used for manual input of blood glucose values to continue insulin dosing for a limited period of time when input from the iCGM is temporarily not available. The iLet Dosing Decision Software autonomously determines and commands an…
Read the full statement (145 words)
The iLet Dosing Decision Software is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps. A self-monitoring of blood glucose (SMBG) meter may also be used for manual input of blood glucose values to continue insulin dosing for a limited period of time when input from the iCGM is temporarily not available. The iLet Dosing Decision Software autonomously determines and commands an increase, decrease, maintenance, or suspension of all basal doses of insulin and autonomously determines and commands correction doses of insulin based on input from an iCGM, and it autonomously determines and commands meal doses of insulin based on meal announcements. iLet Dosing Decision Software is intended for the management of type 1 diabetes mellitus in people 6 years of age or older. iLet Dosing Decision Software is intended for single patient use and requires a prescription.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232224 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232224: iLet® Dosing Decision Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232224
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026