Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K251666Substantially Equivalent

SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900

STERIS Corporation, Mentor OH / Traditional, Substantially Equivalent

K251666 is the FDA 510(k) clearance record for SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, a class II device, cleared for STERIS Corporation on under FDA product code MED (Sterilant, Medical Devices). FDA records list 227 510(k) clearances for STERIS Corporation, from to . As of , FDA records show no recalls naming K251666.

Clearance record

Decision date
Received
(313 days to decision)
Product code
MED Sterilant, Medical Devices
Regulation
21 CFR 880.6885
Device class
Class II
Review panel
General Hospital
Applicant
STERIS Corporation 5960 Heisley Rd., Mentor OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MED

Trailing 12 months
1 clearance under product code MED in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MED, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260