Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- FLGCleaner, Ultrasonic, Medical Instrument1Product Code
- FLHWasher Of Body Waste Receptacles1Product Code
- FLICabinet, Ethylene-Oxide Gas Aerator2Product Code
- BRTRestraint, Patient, Conductive1Product Code
- BYYTube, Aspirating, Flexible, Connecting2Product Code
- BYZTrap, Sterile Specimen2Product Code
- CBCBottle, Collection And Trap, Breathing System (Uncalibrated)2Product Code
- CBDBottle, Collection, Breathing System (Calibrated)2Product Code
- FLESterilizer, Steam2Product Code
- FLFSterilizer, Ethylene-Oxide Gas2Product Code
- FMADepressor, Tongue, Non-Surgical1Product Code
- FMCPatient Examination Glove1Product Code
- FMEGown, Examination1Product Code
- FMLChair, Blood Donor1Product Code
- FMPProtector, Skin Pressure1Product Code
- FMQRestraint, Protective1Product Code
- FMRDevice, Transfer, Patient, Manual1Product Code
- FMWCover, Mattress (Medical Purposes)1Product Code
- FNPUrinal1Product Code
- FNSRing Cutter1Product Code
- FNYBasin, Emesis1Product Code
- FOABoard, Cardiopulmonary1Product Code
- FOBBedpan1Product Code
- FOXStand, Infusion1Product Code
- FPFBottle, Hot/Cold Water1Product Code
- FPOStretcher, Wheeled2Product Code
- FPPStretcher, Hand-Carried1Product Code
- FPSBoard, Bed1Product Code
- FRAPurifier, Air, Ultraviolet, Medical2Product Code
- FRGWrap, Sterilization2Product Code
- FRJChair, Geriatric1Product Code
- FRKChair, Examination And Treatment1Product Code
- FRZDevice, Patient Transfer, Powered2Product Code
- GAZTubing, Noninvasive2Product Code
- GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered2Product Code
- JOKScissors, Medical, Disposable1Product Code
- JOLCatheter And Tip, Suction2Product Code
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories2Product Code
- KDPRegulator, Vacuum2Product Code
- KDQBottle, Collection, Vacuum2Product Code
- KIACover, Cast1Product Code
- KMEBedding, Disposable, Medical1Product Code
- KMGPurifier, Water, Ultraviolet, Medical2Product Code
- KMHSterilizer, Dry Heat2Product Code
- KMJLubricant, Patient1Product Code
- KMNChair And Table, Medical1Product Code
- KXFApplicator, Absorbent Tipped, Non-Sterile1Product Code
- KXGApplicator, Absorbent Tipped, Sterile1Product Code
- KYRBag, Ice1Product Code
- KYSInsoles, Medical1Product Code
- KYTLight, Examination, Medical, Battery Powered1Product Code
- KYWContainer, Liquid Medication, Graduated1Product Code
- KYXDispenser, Liquid Medication1Product Code
- KYZSyringe, Irrigating (Non Dental)1Product Code
- KZADevice, Vein Location, Liquid Crystal1Product Code
- KZFDevice, Medical Examination, Ac Powered1Product Code
- KZHIntroducer, Syringe Needle2Product Code
- LBJDevice, Vein Stabilization1Product Code
- LDSDevice, Pasteurization, Hot Water2Product Code
- LRJDisinfectant, Medical Devices1Product Code
- LYYLatex Patient Examination Glove1Product Code
- LYZVinyl Patient Examination Glove1Product Code
- LZAPolymer Patient Examination Glove1Product Code
- LZBFinger Cot1Product Code
- LZCPatient Examination Glove, Specialty1Product Code
- MDZCleaners, Medical Devices2Product Code
- MECDisinfector, Medical Devices2Product Code
- MEDSterilant, Medical Devices2Product Code
- K232914SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900)2Cleared 510(K)
- K230582SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P69002Cleared 510(K)
- K222615SYSTEM 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 Concentrate2Cleared 510(K)
- K211607SYSTEM 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 Concentrate2Cleared 510(K)
- K210737SYSTEM 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 Concentrate2Cleared 510(K)
- K192929SYSTEM 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 P69002Cleared 510(K)
- K191343SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P69002Cleared 510(K)
- K190104SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System2Cleared 510(K)
- K182827SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 69002Cleared 510(K)
- K180342SYSTEM 1E Liquid Chemical Sterilant Processing System2Cleared 510(K)
- K173256System 1 endo Liquid Chemical Sterilant Processing System2Cleared 510(K)
- K170956SYSTEM 1E Liquid Chemical Sterilant Processing System2Cleared 510(K)
- K161683SYSTEM 1E Liquid Chemical Sterilant Processing System2Cleared 510(K)
- K140703OPA 30 SOLUTION2Cleared 510(K)
- K131078SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM2Cleared 510(K)
- K120306RAPICIDE OPA-282Cleared 510(K)
- K113520SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM2Cleared 510(K)
- K113015ALDAHOL V HIGH LEVEL DISINFECTANT2Cleared 510(K)
- K102462SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM2Cleared 510(K)
- K101409SYSTEM IE LIQUID CHEMICAL CTERILANT PROCESSING SYSTEM2Cleared 510(K)
- K091022MODIFICATION TO RESERT XL HLD HIGH LEVEL DISINFECTANT2Cleared 510(K)
- K090036SYSTEM 1.5 STERILE PROCESSING SYSTEM2Cleared 510(K)
- K091890EXTENDED USE ALDAHOL HIGH LEVEL DISINFECTANT2Cleared 510(K)
- K091210ACECIDE-C HIGH LEVEL DISINFECTANT AND STERILANT2Cleared 510(K)
- K080420RESERT XL HLD HIGH LEVEL DISINFECTANT2Cleared 510(K)
- K070627OPACIDEN SOLUTION2Cleared 510(K)
- K063159STERILOX LIQUID CHEMICAL STERILANT SYSTEM2Cleared 510(K)
- K061356POLYURETHANE INFUSION CATHETER, ALPHA CATH, MODEL PAC20, AND POLYURETHANE INFUSION CATHETER, MULTI DRIP, MODEL PMD20-62Cleared 510(K)
- K060618CIDEX ACTIVATED DIALDEHYDE SOLUTION2Cleared 510(K)
- K041984ACECIDE HIGH-LEVEL DISINFECTANT AND STERILANT2Cleared 510(K)
- K041360ALDAHOL III HIGH-LEVEL DISINFECTANT2Cleared 510(K)
- K032959CIDEX OPA CONCENTRATE2Cleared 510(K)
- K033381DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G CONCENTRATE AND DILUENT, AQUARIUS MODEL2Cleared 510(K)
- K012889BANICIDE LIQUID CHEMICAL STERILANT/HIGH-LEVEL DISINFECTANT2Cleared 510(K)
- K0300040.55% ORTH-PHTHALALDEHYDE SOLUTION2Cleared 510(K)
- K013280STERILOX LIQUID CHEMICAL STERILANT SYSTEM2Cleared 510(K)
- K003087MODIFICATION TO SPORICIDIN STERILIZING AND DISINFECTING SOLUTION2Cleared 510(K)
- K002401CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION)2Cleared 510(K)
- K993042MEDIVATORS 5 MINUTE HIGH-LEVEL DISINFECTANT2Cleared 510(K)
- K001381CIDEX OPA SOLUTION2Cleared 510(K)
- K991487CIDEX OPA SOLUTION2Cleared 510(K)
- K972708ENDO-SPOR PLUS / HYPROCIDE2Cleared 510(K)
- K984270VAPO-SOLUTION FOR USE IN MDT HARVEY CHEMICLAVE STERILIZERS, MODELS 5000, 5500, AND 60002Cleared 510(K)
- K990703SPOROX II STERILIZING & DISINFECTING SOLUTION2Cleared 510(K)
- K983194SPORICIDIN STERILIZING AND DISINFECTING SOLUTION (SSDS)2Cleared 510(K)
- K974188CETYLCIDE-G2Cleared 510(K)
- K974062MEDSCI 3% GLUTARALDEHYDE2Cleared 510(K)
- K962959PERACIDIN DIALYZER REPROCESSING CONCENTRATE2Cleared 510(K)
- K970726VAPOCIDE2Cleared 510(K)
- K961289VAPOPHENE2Cleared 510(K)
- K970230SPOROX2Cleared 510(K)
- K960513PERACT 20 LIQUID STERILANT2Cleared 510(K)
- K914749WAVICIDE(R) -012Cleared 510(K)
- K932922PROCIDE 14 N.S., OMNICIDE/LIQUID & PLUS LIQ ACTIVATOR2Cleared 510(K)
- K931592METRICIDE PLUS 30 LIQUID CHEMICAL GERMICIDE2Cleared 510(K)
- K931052METRICIDE 282Cleared 510(K)
- K930284METRICIDE2Cleared 510(K)
- K932047WAVICIDE MONITOR STRIPS2Cleared 510(K)
- K924334CIDEX FORMULA 7* LONG-LIFE ACTIVATED DIALDEHYDE2Cleared 510(K)
- K932740HOMEPUMP NSF2Cleared 510(K)
- K915170PYMAH COLD STERILOG GLUTARALDEHYDE MONITOR2Cleared 510(K)
- K913943SERIM DISINTEK REAGENT STRIPS2Cleared 510(K)
- K875280STERIS SYSTEM 1 PROCESSOR AND 20 STERILANT2Cleared 510(K)
- MKBDevice, Germicidal, Ultraviolet2Product Code
- MLRSterilizer, Chemical2Product Code
- MMSLubricant, Vaginal, Patient1Product Code
- MTVSharps Needle Destruction Device2Product Code
- NRVImplantable Radio Frequency Transponder System2Product Code
- NZDStretcher, Patient Restraint1Product Code
- NZHMedication Management System, Remote2Product Code
- NZJRespirator, N95, For Use By The General Public In Public Health Medical Emergencies2Product Code
- OHYPill Crusher/Cutter1Product Code
- OIGPowder-Free Guayle Rubber Examination Glove1Product Code
- PEQAccessories To Examination Light1Product Code
- OPCPowder-Free Polychloroprene Patient Examination Glove1Product Code
- OPHRadiation Attenuating Medical Glove1Product Code
- OPIAntimicrobial Medical Glove1Product Code
- OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs1Product Code
- ORWN95 Respirator With Antimicrobial/Antiviral Agent For Use By The General Public In Public Health Medical Emergencies2Product Code
- OSZAntimicrobial Keyboard2Product Code
- OUGMedical Device Data System1Product Code
- OVYLiquid Chemical Processing System2Product Code
- OYSPatient Bed With Canopy/Restraints1Product Code
- PADChest Drainage Kit2Product Code
- PECSterilizer Automated Loading System2Product Code
- PJJTwo Or More Sterilant Sterilizer2Product Code
- PWMAdmission Kit (Patient Utensil)1Product Code
- PYQRfid Chip For Dental Appliance2Product Code
- PWPBlood Borne Pathogen Response Kit1Product Code
- PWSChemotherapy Administration Kit1Product Code
- PWTChemotherapy Spill Clean-Up Kit1Product Code
- PWUClean-Up Kit1Product Code
- PWVDelivery Room Apparel Kit1Product Code
- PWZMid-Stream Collection Kit1Product Code
- PXAOral Administration Set1Product Code
- PXCPersonal Protection Kit1Product Code
- PXDPrep Kit1Product Code
- PXFSitz Bath Kit1Product Code
- PXGSpill Kit1Product Code
- PXMVomitus Clean-Up Kit1Product Code
- QDOFentanyl And Other Opioid Protection Glove1Product Code
- QTVMattress And Bed Deck Cover (Medical Purposes)1Product Code
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION)
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K002401
- 510(k) Type
- Special
- Applicant
- ADVANCED STERILIZATION PRODUCTS
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/29/2000
- Days to Decision
- 22 days
- Submission Type
- Summary