510(k) · Cleared
ClearedTidepool Loop
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tidepool Project · QJI Interoperable Automated Glycemic Controller
Cleared on Jan 23, 2023 as substantially equivalent to K200467 (Tandem Diabetes Care, Inc., 2020) after a 767-day review. Its family tree reaches back 2 generations to 2019. 2 later devices descend from it.
- Decided
- Jan 23, 2023
- Review
- 767 days
- Class
- Class II
- Product code
- QJI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN190034 (2019). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backDEN190034 Control-IQ TechnologyTandem Diabetes Care, Inc. · 2019
- 1 generation backK200467 Control-IQ TechnologyTandem Diabetes Care, Inc. · 2020
- This deviceK203689 Tidepool LoopTidepool Project · 2023
- Descendant · cites it directly · 0 of its ownK251152 DBLG2Diabeloop · 2025
- Descendant · cites it directly · 0 of its ownK234055 DEKA LoopDeka Research and Development · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN190034 | Control-IQ Technology | Tandem Diabetes Care, Inc. | 2019 | — |
| −1 | K200467 | Control-IQ Technology | Tandem Diabetes Care, Inc. | 2020 | — |
| 0 (this device) | K203689 | Tidepool Loop | Tidepool Project | 2023 | — |
| +1 | K251152 | DBLG2 | Diabeloop | 2025 | — |
| +1 | K234055 | DEKA Loop | Deka Research and Development | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K200467 | Control-IQ TechnologySummary page 5…I. Predicate Device Information Device Name Control – IQ Technology Manufacturer: Tandem Diabetes Care, Inc. Premarket Notification #: K200467 Classification Name: Interoperable Automated Glycemic Controller (iAGC) Classification: Class II, 21 CFR 862… | 2020 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K251152 (Diabeloop, 2025) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K200467.
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?
Tidepool Loop, 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 recommend, and with the user’s confirmation, control the delivery of correction boluses when glucose values are…
Read the full statement (107 words)
Tidepool Loop, 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 recommend, and with the user’s confirmation, control the delivery of correction boluses when glucose values are predicted to exceed user configurable thresholds.
Tidepool Loop is intended for the management of type 1 diabetes mellitus in persons six years of age and greater.
Tidepool Loop is intended for single patient use.
Tidepool Loop is Rx - For Prescription Use Only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203689 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203689: Tidepool Loop.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203689
Report an extraction error
Are you the manufacturer?
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