Cleared Traditional

K203288 - Cala Trio (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K203288 · Cala Health, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2021
Decision
330d
Days
Class 2
Risk

K203288 is an FDA 510(k) clearance for the Cala Trio. Classified as External Upper Limb Tremor Stimulator (product code QBC), Class II - Special Controls.

Submitted by Cala Health, Inc. (Burlingame, US). The FDA issued a Cleared decision on October 5, 2021 after a review of 330 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K203288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2020
Decision Date October 05, 2021
Days to Decision 330 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
182d slower than avg
Panel avg: 148d · This submission: 330d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 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 K203288.
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
K243848 · Cala Health, Inc. · Jan 2025
Cala kIQ
K242259 · Cala Health, Inc. · Nov 2024
Cala kIQ
K222237 · Cala Health, Inc. · Nov 2022