Cleared Traditional

K231209 - Rejoyn (FDA 510(k) Clearance)

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

K231209 · Otsuka America Pharmaceutical, Inc. · Neurology device
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Mar 2024
Decision
338d
Days
Class 2
Risk

K231209 is an FDA 510(k) clearance for the Rejoyn. Classified as Computerized Behavioral Therapy Device For Depressive Disorders. (product code SAP), Class II - Special Controls.

Submitted by Otsuka America Pharmaceutical, Inc. (Rockville, US). The FDA issued a Cleared decision on March 30, 2024 after a review of 338 days - an unusually long review period, suggesting complex equivalence evaluation.

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. 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 Otsuka America Pharmaceutical, Inc. devices

Submission Details

510(k) Number K231209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2023
Decision Date March 30, 2024
Days to Decision 338 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
190d slower than avg
Panel avg: 148d · This submission: 338d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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