510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K130951Substantially Equivalent

Sim

Simavita Pty Limited, Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K130951 is the FDA 510(k) clearance record for SIM, a class II device, cleared for Simavita Pty Limited on under FDA product code KPN (Alarm, Conditioned Response Enuresis). FDA records list one 510(k) clearance for Simavita Pty Limited. As of , FDA records show no recalls naming K130951.

Clearance record

Decision date
Received
(139 days to decision)
Product code
KPN Alarm, Conditioned Response Enuresis
Regulation
21 CFR 876.2040
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Simavita Pty Limited 555 13th St., NW, Washington DC
510(k) summary
Summary PDF
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