510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K233872Substantially Equivalent

Daylight

Big Health Inc, San Francisco CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K233872 is the FDA 510(k) clearance record for Daylight, a class II device, cleared for Big Health, Inc. on under FDA product code SCP (Computerized Behavioral Therapy Device For Anxiety Disorders). FDA's definition for product code SCP reads: "Computerized behavioral therapy device for psychiatric disorders". FDA records list 2 510(k) clearances for Big Health, Inc., from to . As of , FDA records show no recalls naming K233872.

Clearance record

Decision date
Received
(267 days to decision)
Product code
SCP Computerized Behavioral Therapy Device For Anxiety Disorders
Regulation
21 CFR 882.5801
Device class
Class II
Review panel
Neurology
Applicant
Big Health, Inc. 461 Bush St., San Francisco CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SCP

Trailing 12 months

FDA records hold no clearances under product code SCP in the trailing twelve months.

FDA records show no clearances under product code SCP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code SCP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260