510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K231209Substantially Equivalent

Rejoyn

Otsuka America Pharmaceutical, Inc, Rockville MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K231209 is the FDA 510(k) clearance record for Rejoyn, a class II device, cleared for Otsuka America Pharmaceutical, Inc. on under FDA product code SAP (Computerized Behavioral Therapy Device For Depressive Disorders.). FDA's definition for product code SAP reads: "The device is intended to provide computerized behavioral therapy to treat depressive disorders". FDA records list 3 510(k) clearances for Otsuka America Pharmaceutical, Inc., from to . As of , FDA records show no recalls naming K231209.

Clearance record

Decision date
Received
(338 days to decision)
Product code
SAP Computerized Behavioral Therapy Device For Depressive Disorders.
Regulation
21 CFR 882.5801
Device class
Class II
Review panel
Neurology
Applicant
Otsuka America Pharmaceutical, Inc. 2440 Research Blvd., Rockville MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SAP

Trailing 12 months
1 clearance under product code SAP in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SAP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260