Cleared Traditional

K233872 - Daylight (FDA 510(k) Clearance)

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

K233872 · Big Health, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2024
Decision
267d
Days
Class 2
Risk

K233872 is an FDA 510(k) clearance for the Daylight. Classified as Computerized Behavioral Therapy Device For Anxiety Disorders (product code SCP), Class II - Special Controls.

Submitted by Big Health, Inc. (San Francisco, US). The FDA issued a Cleared decision on August 30, 2024 after a review of 267 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 Big Health, Inc. devices

Submission Details

510(k) Number K233872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2023
Decision Date August 30, 2024
Days to Decision 267 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
119d slower than avg
Panel avg: 148d · This submission: 267d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code SCP Computerized Behavioral Therapy Device For Anxiety Disorders
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5801
Definition Computerized Behavioral Therapy Device For Psychiatric Disorders
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
NCT05748652 Completed Interventional Industry-sponsored

Generalized Anxiety Therapy Effectiveness

Clinical Effectiveness of Digital CBT for the Treatment of Generalized Anxiety Disorder: A Randomized Controlled Trial

351
Patients (actual)
1
Site
Treatment
Purpose
Double blind
Masking
Condition studied Generalized Anxiety Disorder
Study design Parallel
Eligibility All sexes · 22 Years+
Sponsor Big Health Inc. (industry)
Started 2023-03-06 → Primary completion 2023-11-15 → Completed 2024-02-28
Primary outcome
Generalized Anxiety Disorder Questionnaire (GAD-7)
Secondary outcome
Generalized Anxiety Disorder Questionnaire (GAD-7)
Study completed - no results published. This trial concluded in 2024 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov