# K232603: CamAPS FX

- Pathway: 510(k) (Traditional)
- Applicant: Camdiab, Ltd.
- Decided: May 23, 2024 after 269 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K261896: iOS CamAPS FX (2026), 0 descendants of its own

## 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 fulfil its intended use. The list of supported insulin pumps and CGMs is provided in the User Manual. CamAPS FX is indicated for use in pregnancy complicated by type 1 diabetes provided that the linked continuous glucose monitoring system is suitable for use in pregnancy.

Source page: https://510kreport.com/device/K232603
Methodology: https://510kreport.com/methodology