Not Cleared Direct

DEN170028 - Cala ONE (FDA 510(k) Clearance)

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

DEN170028 · Cala Health, Inc. · Neurology device
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Apr 2018
Decision
344d
Days
Class 2
Risk

DEN170028 is an FDA 510(k) submission (not cleared) for the Cala ONE. 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 Not Cleared (DENG) decision on April 26, 2018 after a review of 344 days.

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 requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 344 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Cala Health, Inc. devices

Submission Details

510(k) Number DEN170028 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received May 17, 2017
Decision Date April 26, 2018
Days to Decision 344 days
Submission Type Direct
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
196d slower than avg
Panel avg: 148d · This submission: 344d
Pathway characteristics

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
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