510(k) · Cleared
ClearedDBLG2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diabeloop · QJI Interoperable Automated Glycemic Controller
Cleared on Dec 19, 2025 as substantially equivalent to K203689 (Tidepool Project, 2023) after a 249-day review. Its family tree reaches back 3 generations to 2019.
- Decided
- Dec 19, 2025
- Review
- 249 days
- Class
- Class II
- Product code
- QJI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN190034 (2019). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K203689 | Tidepool LoopSummary page 6… Predicate Device Device Name: Tidepool Loop Manufacturer: Tidepool Premarket Notification #: K203689 Device Classification Name: Interoperable Automated Glycemic Controller (iAGC) Device Classification:… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K203689.
How does its category compare?
All QJI devicesQJI Interoperable Automated Glycemic Controller: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
DBLG2, a mobile application with algorithm technology, is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) insulin infusion pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also deliver correction boluses when glucose values are predicted to exceed a predefined threshold. To do this, the DBLG2…
Read the full statement (115 words)
DBLG2, a mobile application with algorithm technology, is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) insulin infusion pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also deliver correction boluses when glucose values are predicted to exceed a predefined threshold. To do this, the DBLG2 software takes into account the patient's profile, glycemia (current and predicted), announced meals and physical activities.
DBLG2 is intended for the management of type 1 diabetes mellitus in persons 12 years of age and greater.
DBLG2 is intended for single patient use.
DBLG2 is Rx - For Prescription Use Only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K251152 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251152: DBLG2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251152
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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