# K261896: iOS CamAPS FX

- Pathway: 510(k) (Traditional)
- Applicant: CamDiab
- Decided: Sep 16, 2026 after 100 days
- Product code: QJI (Interoperable Automated Glycemic Controller)
- Device class: 2
- Regulation: 21 CFR 862.1356
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K232603 (2024). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232603: CamAPS FX, Camdiab, Ltd. (2024) Summary page 7.

## Indications for use
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.

Source page: https://510kreport.com/device/K261896
Methodology: https://510kreport.com/methodology