Cala kIQ Plus
K-Number: K253587 · 2026-03-17
ApplicantCala Health, Inc.
Decision Date2026-03-17
Product CodeQBC
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Cala kIQ Plus is a medical device manufactured by Cala Health, Inc.. It received FDA 510(k) clearance on 2026-03-17 under approval number K253587. The device is classified under product code QBC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Cala kIQ Plus?
Cala kIQ Plus is a medical device that received FDA 510(k) clearance on 2026-03-17. It is manufactured by Cala Health, Inc.. The 510(k) number is K253587.
When was Cala kIQ Plus approved by the FDA?
Cala kIQ Plus received FDA 510(k) clearance on 2026-03-17, under approval number K253587.
What company makes Cala kIQ Plus?
Cala kIQ Plus is manufactured by Cala Health, Inc..
What is the FDA product code for Cala kIQ Plus?
The FDA product code for Cala kIQ Plus is QBC.
Other Devices by Cala Health, Inc.
Related Devices (Code: QBC)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.