510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K782093Substantially Equivalent

Detector Pad

Halperin Institute, Ltd. the, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K782093 is the FDA 510(k) clearance record for DETECTOR PAD, a class II device, cleared for Halperin Institute, Ltd. The on under FDA product code KPN (Alarm, Conditioned Response Enuresis). FDA records list one 510(k) clearance for Halperin Institute, Ltd. The. As of , FDA records show no recalls naming K782093.

Clearance record

Decision date
Received
(69 days to decision)
Product code
KPN Alarm, Conditioned Response Enuresis
Regulation
21 CFR 876.2040
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Halperin Institute, Ltd. The 803 N. Front St. Suite 3, Mchenry IL
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