510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864448Substantially Equivalent

The Biosonics Continence Control System Ccs(tm)

Biosonics, Inc., Philadelphia PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864448 is the FDA 510(k) clearance record for THE BIOSONICS CONTINENCE CONTROL SYSTEM CCS(TM), a class II device, cleared for Biosonics, Inc. on under FDA product code KPN (Alarm, Conditioned Response Enuresis). FDA records list 3 510(k) clearances for Biosonics, Inc., from to . As of , FDA records show no recalls naming K864448.

Clearance record

Decision date
Received
(86 days to decision)
Product code
KPN Alarm, Conditioned Response Enuresis
Regulation
21 CFR 876.2040
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Biosonics, Inc. 1500 Walnut St., Philadelphia PA
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