510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K834311Substantially Equivalent

Night Trainer

Maddak, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K834311 is the FDA 510(k) clearance record for NIGHT TRAINER, a class II device, cleared for Maddak, Inc. on under FDA product code KPN (Alarm, Conditioned Response Enuresis). FDA records list 51 510(k) clearances for Maddak, Inc., from to . As of , FDA records show no recalls naming K834311.

Clearance record

Decision date
Received
(126 days to decision)
Product code
KPN Alarm, Conditioned Response Enuresis
Regulation
21 CFR 876.2040
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Maddak, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code KPN

Trailing 12 months

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

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