Product code MED— General Hospital
SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM
- Classification name
- Sterilant, Medical Devices
- Device class
- Class 2
- Regulation
- 21 CFR 880.6885
- Advisory panel
- General Hospital
- Total cleared
- 64
- First cleared
- Most recent
Market context for product code MED
FDA has cleared devices under product code MED between 1988 and 2026, filed by 30 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2023
- 2022
- 2021
- 2019
- 2018
- 2017
- 2016
- 2014
- 2013
- 2012
- 2010
- 2008
- 2007
- 2006
Top applicants under product code MED
Recent clearances under product code MED
- K251666 — SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700 +1 more
- K232914 — SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500) +2 more
- K230582 — SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
- K222615 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate
- K211607 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate
- K210737 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate
- K192929 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
- K191343 — SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900
- K190104 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System
- K182827 — SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900
- K180342 — SYSTEM 1E Liquid Chemical Sterilant Processing System
- K173256 — System 1 endo Liquid Chemical Sterilant Processing System
- K170956 — SYSTEM 1E Liquid Chemical Sterilant Processing System
- K161683 — SYSTEM 1E Liquid Chemical Sterilant Processing System
- K140703 — OPA 30 SOLUTION
- K131078 — SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM
- K120306 — RAPICIDE OPA-28
- K113520 — SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM
- K113015 — ALDAHOL V HIGH LEVEL DISINFECTANT
- K102462 — SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM
- K101409 — SYSTEM IE LIQUID CHEMICAL CTERILANT PROCESSING SYSTEM
- K091022 — MODIFICATION TO RESERT XL HLD HIGH LEVEL DISINFECTANT
- K090036 — SYSTEM 1.5 STERILE PROCESSING SYSTEM
- K091890 — EXTENDED USE ALDAHOL HIGH LEVEL DISINFECTANT
- K091210 — ACECIDE-C HIGH LEVEL DISINFECTANT AND STERILANT
- K080420 — RESERT XL HLD HIGH LEVEL DISINFECTANT
- K070627 — OPACIDEN SOLUTION
- K063159 — STERILOX LIQUID CHEMICAL STERILANT SYSTEM
- K061356 — POLYURETHANE INFUSION CATHETER, ALPHA CATH, MODEL PAC20, AND POLYURETHANE INFUSION CATHETER, MULTI DRIP, MODEL PMD20-6
- K060618 — CIDEX ACTIVATED DIALDEHYDE SOLUTION
- K041984 — ACECIDE HIGH-LEVEL DISINFECTANT AND STERILANT
- K041360 — ALDAHOL III HIGH-LEVEL DISINFECTANT
- K032959 — CIDEX OPA CONCENTRATE
- K033381 — DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G CONCENTRATE AND DILUENT, AQUARIUS MODEL
- K012889 — BANICIDE LIQUID CHEMICAL STERILANT/HIGH-LEVEL DISINFECTANT
- K030004 — 0.55% ORTH-PHTHALALDEHYDE SOLUTION
- K013280 — STERILOX LIQUID CHEMICAL STERILANT SYSTEM
- K003087 — MODIFICATION TO SPORICIDIN STERILIZING AND DISINFECTING SOLUTION
- K002401 — CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION)
- K993042 — MEDIVATORS 5 MINUTE HIGH-LEVEL DISINFECTANT
- K001381 — CIDEX OPA SOLUTION
- K991487 — CIDEX OPA SOLUTION
- K972708 — ENDO-SPOR PLUS / HYPROCIDE
- K984270 — VAPO-SOLUTION FOR USE IN MDT HARVEY CHEMICLAVE STERILIZERS, MODELS 5000, 5500, AND 6000
- K990703 — SPOROX II STERILIZING & DISINFECTING SOLUTION
- K983194 — SPORICIDIN STERILIZING AND DISINFECTING SOLUTION (SSDS)
- K974188 — CETYLCIDE-G
- K974062 — MEDSCI 3% GLUTARALDEHYDE
- K962959 — PERACIDIN DIALYZER REPROCESSING CONCENTRATE
- K970726 — VAPOCIDE
- K961289 — VAPOPHENE
- K970230 — SPOROX
- K960513 — PERACT 20 LIQUID STERILANT
- K914749 — WAVICIDE(R) -01
- K932922 — PROCIDE 14 N.S., OMNICIDE/LIQUID & PLUS LIQ ACTIVATOR
- K930284 — METRICIDE
- K931052 — METRICIDE 28
- K931592 — METRICIDE PLUS 30 LIQUID CHEMICAL GERMICIDE
- K932047 — WAVICIDE MONITOR STRIPS
- K924334 — CIDEX FORMULA 7* LONG-LIFE ACTIVATED DIALDEHYDE
- K932740 — HOMEPUMP NSF
- K915170 — PYMAH COLD STERILOG GLUTARALDEHYDE MONITOR
- K913943 — SERIM DISINTEK REAGENT STRIPS
- K875280 — STERIS SYSTEM 1 PROCESSOR AND 20 STERILANT
Data sourced from openFDA. This site is unofficial and independent of the FDA.