FDA 510(k)

Cala kIQ Plus

K-Number: K253587 · 2026-03-17

Decision Date2026-03-17

Product CodeQBC

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Cala kIQ Plus is the device name listed in this FDA 510(k) record. The listed applicant is Cala Health, Inc.. It received FDA 510(k) clearance on 2026-03-17 under 510(k) 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. The listed applicant is Cala Health, Inc.. The 510(k) number is K253587.

When did Cala kIQ Plus receive FDA 510(k) clearance?

Cala kIQ Plus received FDA 510(k) clearance on 2026-03-17, under 510(k) number K253587.

Who is the listed applicant for Cala kIQ Plus?

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

What is the FDA product code for Cala kIQ Plus?

The FDA product code for Cala kIQ Plus is QBC.

Other records listing Cala Health, Inc. 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.

K243848Cala kIQ K242259Cala kIQ K222237Cala kIQ K203288Cala Trio K182706External upper limb tremor stimulator

Related Devices (Code: QBC)

K251517Encora X1Encora, Inc.K250096Felix NeuroAI SystemFasikl Incorporated K243848Cala kIQCala Health, Inc.K242259Cala kIQCala Health, Inc.K222237Cala kIQCala Health, Inc.K203288Cala TrioCala Health, Inc.

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.