Cleared Traditional

Somryst (K191716) - FDA 510(k) Clearance

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

K191716 · Pear Therapeutics, Inc. · Neurology device
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Mar 2020
Decision
271d
Days
Class 2
Risk

K191716 is an FDA 510(k) clearance for the Somryst. Classified as Computerized Behavioral Therapy Device For Insomnia (product code QVO), Class II - Special Controls.

Submitted by Pear Therapeutics, Inc. (San Francisco, US). The FDA issued a Cleared decision on March 23, 2020 after a review of 271 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5801 - 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 Pear Therapeutics, Inc. devices

Submission Details

510(k) Number K191716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2019
Decision Date March 23, 2020
Days to Decision 271 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
123d slower than avg
Panel avg: 148d · This submission: 271d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QVO Computerized Behavioral Therapy Device For Insomnia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5801
Definition The Device Is Intended To Provide Cognitive Behavioral Therapy To Treat Insomnia.
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.