510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K091022Substantially Equivalent

Modification to Resert Xl Hld High Level Disinfectant

STERIS Corporation, Mentor OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091022 is the FDA 510(k) clearance record for MODIFICATION TO RESERT XL HLD HIGH LEVEL DISINFECTANT, 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 K091022.

Clearance record

Decision date
Received
(368 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 Regulatory Affairs/Corporate, Mentor OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MED

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