Cleared Traditional

K253587 - Cala kIQ Plus (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence.

K253587 · Cala Health, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2026
Decision
120d
Days
Class 2
Risk

K253587 is an FDA 510(k) clearance for the Cala kIQ Plus. 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 March 17, 2026 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5897 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cala Health, Inc. devices

Submission Details

510(k) Number K253587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2025
Decision Date March 17, 2026
Days to Decision 120 days
Submission Type Traditional
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
28d faster than avg
Panel avg: 148d · This submission: 120d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Neurology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT03597100 Completed Interventional Industry-sponsored

Prospective Study for Symptomatic Relief of ET With Cala Therapy

Prospective Study for Symptomatic Relief of Essential Tremor With Cala Therapy

263
Patients (actual)
32
Sites
Treatment
Purpose
Open label
Masking
Condition studied Essential Tremor
Study design Single group
Eligibility All sexes · 22 Years+
Sponsor Cala Health, Inc. (industry)
Started 2018-12-14 → Primary completion 2019-05-29
Primary outcome
TRG (Tremor Research Group) Essential Tremor Rating Assessment Scale (TETRAS) Subset Score
Secondary outcome
Kinematic Measurements, as Collected With the Device During Postural Holds, Change From Pre-stimulation to Post-stimulation Across Sessions
View full study on ClinicalTrials.gov