510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K895346Substantially Equivalent

Dr. Dry

Intellitech, La Jolla CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895346 is the FDA 510(k) clearance record for DR. DRY, a class II device, cleared for Intellitech on under FDA product code KPN (Alarm, Conditioned Response Enuresis). FDA records list one 510(k) clearance for Intellitech. As of , FDA records show no recalls naming K895346.

Clearance record

Decision date
Received
(53 days to decision)
Product code
KPN Alarm, Conditioned Response Enuresis
Regulation
21 CFR 876.2040
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Intellitech 5403 Candlelight Dr., La Jolla CA
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