iOS CamAPS FX— 510(k) K261896

Name: FDA 510(k) clearance K261896
Creator: U.S. Food and Drug Administration
Published: 2026-09-16

Substantially Equivalent

CamDiab

FDA 510(k) clearance K261896 for iOS CamAPS FX, Substantially Equivalent on 2026-09-16. Applicant: CamDiab. Device class: 2.

Summary

iOS CamAPS FX is from CamDiab, filed under product code QJI (Interoperable Automated Glycemic Controller). The record has nothing on the product beyond its name and code.

Class II, 21 CFR 862.1356. Clinical Chemistry is both the classification panel and the review panel. It was a Traditional 510(k), decided Substantially Equivalent.

CamDiab filed from London, United Kingdom. The decision came 100 calendar days after receipt (June 8 to September 16, 2026).

Clearance details

Applicant: CamDiab
Product code: Product code QJI
Device class: Class 2
Regulation: 21 CFR 862.1356
Advisory panel: Clinical Chemistry
Date received: 2026-06-08
Decision date: 2026-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: London, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code QJI

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K262763 — iLet Dosing Decision Software2026-09-11
K261962 — SmartGuard Technology; Predictive Low Glucose Technology2026-07-09
K261461 — Omnipod 6 algorithm2026-06-29
K260429 — Control-IQ+ technology2026-04-24
K253701 — SmartGuard Technology; Predictive Low Glucose Technology2026-02-03

Adverse events under product code QJI

product code QJI

Other: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.