510(k) · Cleared
ClearediOS CamAPS FX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CamDiab · QJI Interoperable Automated Glycemic Controller
Cleared on Sep 16, 2026 as substantially equivalent to K232603 (Camdiab, Ltd., 2024) after a 100-day review. Its family tree reaches back 1 generation to 2024.
- Decided
- Sep 16, 2026
- Review
- 100 days
- Class
- Class II
- Product code
- QJI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K232603 (2024). No later device cites it as a predicate yet.
- Root · 1 generation backK232603 CamAPS FXCamdiab, Ltd. · 2024
- This deviceK261896 iOS CamAPS FXCamDiab · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K232603 | CamAPS FX | Camdiab, Ltd. | 2024 | — |
| 0 (this device) | K261896 | iOS CamAPS FX | CamDiab | 2026 | — |
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 |
|---|---|---|---|
| * | K232603 | CamAPS FXSummary page 7…e cleared for use in the US market. Version 5 Submission K261896 510(k) Summary Table 1: Comparison of CamAPS FX (iOS) with CamAPS FX (Android) (K232603). CamAPS FX iOS CamAPS FX Android Justification for… | 2024 |
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?
- Its one ancestor has no recall.
How does its category compare?
All QJI devicesQJI Interoperable Automated Glycemic Controller: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
CamAPS FX is a mobile app intended for managing glucose levels in people with type 1 diabetes, aged 2 years and over, using a hybrid closed loop approach (automated basal insulin delivery with manual bolusing for meals). Additional age and other restrictions may apply depending on the chosen continuous glucose monitor and insulin pump.
CamAPS FX requires an insulin pump and a continuous glucose monitor (CGM) to fulfill its intended use. The list of supported insulin pumps and CGMs is provided in this User Manual.
CamAPS FX is indicated for use in pregnancy complicated by type 1 diabetes provided that linked continuous glucose monitoring system is approved for use in pregnancy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261896 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261896: iOS CamAPS FX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261896
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026