510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K934369Substantially Equivalent

Dri Sleeper

Abbott Medical, Mississauga, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K934369 is the FDA 510(k) clearance record for DRI SLEEPER, a class II device, cleared for Laborie Medical Technologies, Ltd. on under FDA product code KPN (Alarm, Conditioned Response Enuresis). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K934369.

Clearance record

Decision date
Received
(78 days to decision)
Product code
KPN Alarm, Conditioned Response Enuresis
Regulation
21 CFR 876.2040
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Laborie Medical Technologies, Ltd. 6415 Northwest Dr., Unit 11, Mississauga, CA
510(k) summary
Statement
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KPN, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260