Cleared Special

K243848 - Cala kIQ (FDA 510(k) Clearance)

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K243848 · Cala Health, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2025
Decision
31d
Days
Class 2
Risk

K243848 is an FDA 510(k) clearance for the Cala kIQ. Classified as External Upper Limb Tremor Stimulator (product code QBC), Class II - Special Controls.

Submitted by Cala Health, Inc. (San Mateo, US). The FDA issued a Cleared decision on January 16, 2025 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5897 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cala Health, Inc. devices

Submission Details

510(k) Number K243848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2024
Decision Date January 16, 2025
Days to Decision 31 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 148d · This submission: 31d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code QBC External Upper Limb Tremor Stimulator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5897
Definition An External Upper Limb Tremor Stimulator Is A Prescription Device Which Is Placed Externally On The Upper Limb And Designed To Aid In Tremor Symptom Relief Of The Upper Limb.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Consultant

Gardner Law Pllc
Amanda Johnston

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - QBC External Upper Limb Tremor Stimulator

All 8
Devices cleared under the same product code (QBC) and FDA review panel - the closest regulatory comparables to K243848.
Cala kIQ Plus
K253587 · Cala Health, Inc. · Mar 2026
Encora X1
K251517 · Encora, Inc. · Feb 2026
Felix NeuroAI System
K250096 · Fasikl Incorporated · Jul 2025
Cala kIQ
K242259 · Cala Health, Inc. · Nov 2024
Cala kIQ
K222237 · Cala Health, Inc. · Nov 2022
Cala Trio
K203288 · Cala Health, Inc. · Oct 2021