MLR — Sterilizer, Chemical Class II

FDA Device Classification

Classification Details

Product Code
MLR
Device Class
Class II
Regulation Number
880.6860
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250802advanced sterilization productsSTERRAD® 100NX Sterilizer with ALLClear™ Technology (10104)April 14, 2025
K231893lowtem coLOWTEM Crystal 120September 18, 2024
K234082advanced sterilization productsSTERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104);July 5, 2024
K233762ideate medicalSteroScope® Sterilization Technology SystemJune 27, 2024
K233065sterisV-PRO maX 2 Low Temperature Sterilization SystemOctober 20, 2023
K223476steris corporationV-PRO maX 2 Low Temperature Sterilization SystemAugust 7, 2023
K231169plasmapp coSTERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINKMay 25, 2023
K223015plasmapp coSTERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassetteMay 9, 2023
K220345plasmapp coSTERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STEApril 14, 2023
K222093sterisV-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature SterSeptember 9, 2022
K220404advanced sterilization productsSTERRAD NX with ALLClear TechnologyMay 16, 2022
K212200plasmapp coSTERLINKTM FPS-15s Plus Sterilizer with STERLOADTM CassetteOctober 22, 2021
K212174advanced sterilization productsSTERRAD 100NX Sterilizer with ALLClear TechnologyOctober 9, 2021
K190005sterilucentSterilucent HC 80TT Hydrogen Peroxide SterilizerSeptember 13, 2019
K190917steris corporationV-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature SterilMay 9, 2019
K190103steris corporationV-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature SterApril 5, 2019
K182568steris corporationV-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature SterilizJanuary 3, 2019
K172754steris corporationV-PRO maX 2 Low Temperature Sterilization SystemFebruary 9, 2018
K172319steris corporationAMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low TempeJanuary 18, 2018
K162413steris corporationAMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low TempeMarch 31, 2017