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
K934585Substantially Equivalent

Pro-Flo System with Infra-Red Remote Control

Lafayette Pharmaceuticals, Inc., Lafayette IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K934585 is the FDA 510(k) clearance record for PRO-FLO SYSTEM WITH INFRA-RED REMOTE CONTROL, a class I device, cleared for Lafayette Pharmaceuticals, Inc. on under FDA product code FCD (Barium Enema Kit). FDA's definition for product code FCD reads: "This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the...". FDA records list one 510(k) clearance for Lafayette Pharmaceuticals, Inc. As of , FDA records show no recalls naming K934585.

Clearance record

Decision date
Received
(41 days to decision)
Product code
FCD Barium Enema Kit
Regulation
21 CFR 876.5210
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Lafayette Pharmaceuticals, Inc. 522 N. Earl Ave., Lafayette IN
510(k) summary
Summary
Third party review
No

Clearances, product code FCD

Trailing 12 months

FDA records hold no clearances under product code FCD in the trailing twelve months.

FDA records show no clearances under product code FCD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FCD, 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