510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN200029Unknown

Parallel

Mahana Therapeutics, Inc., San Francisco CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN200029 is the FDA 510(k) clearance record for Parallel, a class II device, cleared for Mahana Therapeutics, Inc. on under FDA product code QMY (Computerized Behavioral Therapy Device For Treating Symptoms). FDA's definition for product code QMY reads: "A computerized behavioral therapy device for treating symptoms of gastrointestinal conditions is a prescription device intended to provide a computerized version of condition-specific therapy as an adjunct to standard of care treatments to...". FDA records list 2 510(k) clearances for Mahana Therapeutics, Inc., from to . As of , FDA records show no recalls naming DEN200029.

Clearance record

Decision date
Received
(209 days to decision)
Product code
QMY Computerized Behavioral Therapy Device For Treating Symptoms
Regulation
21 CFR 876.5960
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Mahana Therapeutics, Inc. 230 California St., San Francisco CA
Third party review
No

Clearances, product code QMY

Trailing 12 months

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

FDA records show no clearances under product code QMY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QMY, 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