FDA 510(k)

iOS CamAPS FX

K-Number: K261896 · 2026-09-16

Decision Date2026-09-16

Product CodeQJI

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

iOS CamAPS FX is the device name listed in this FDA 510(k) record. The listed applicant is CamDiab. It received FDA 510(k) clearance on 2026-09-16 under 510(k) number K261896. The device is classified under product code QJI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iOS CamAPS FX?

iOS CamAPS FX is a medical device that received FDA 510(k) clearance on 2026-09-16. The listed applicant is CamDiab. The 510(k) number is K261896.

When did iOS CamAPS FX receive FDA 510(k) clearance?

iOS CamAPS FX received FDA 510(k) clearance on 2026-09-16, under 510(k) number K261896.

Who is the listed applicant for iOS CamAPS FX?

The FDA 510(k) record lists CamDiab as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iOS CamAPS FX?

The FDA product code for iOS CamAPS FX is QJI.

Other records listing CamDiab as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232603CamAPS FX

Related Devices (Code: QJI)

K262763iLet Dosing Decision SoftwareBeta Bionics, Inc.K261962SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic MiniMed K261461Omnipod 6 algorithmInsulet Corporation K260429Control-IQ+ technologyTandem Diabetes Care, Inc.K253701SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic Minimed K253585SmartGuard technology; Predictive Low Glucose technologyMedtronic Minimed, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.