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
- BRZSet, Blood Transfusion2Product Code
- BWJLocator, Acupuncture Point2Product Code
- CAKMicrofilter, Blood Transfusion2Product Code
- DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)2Product Code
- FMFSyringe, Piston2Product Code
- FMGStopcock, I.V. Set2Product Code
- FMINeedle, Hypodermic, Single Lumen2Product Code
- FMSBed, Pediatric Open Hospital2Product Code
- FMTWarmer, Infant Radiant2Product Code
- FMZIncubator, Neonatal2Product Code
- FNGLift, Patient, Ac-Powered2Product Code
- FNJBed, Manual1Product Code
- FNKBed, Hydraulic, Adjustable Hospital1Product Code
- FNLBed, Ac-Powered Adjustable Hospital2Product Code
- FNMMattress, Air Flotation, Alternating Pressure2Product Code
- FNNNipple, Lambs Feeding1Product Code
- FODDevice, Occlusion, Umbilical1Product Code
- FOHMattress, Water, Temperature Regulated1Product Code
- FOKPad, Neonatal Eye1Product Code
- FOSCatheter, Umbilical Artery2Product Code
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days2Product Code
- FPASet, Administration, Intravascular2Product Code
- FPBFilter, Infusion Line2Product Code
- FPKTubing, Fluid Delivery2Product Code
- FPLIncubator, Neonatal Transport2Product Code
- FQHLavage, Jet2Product Code
- FQJSupport, Scrotal, Therapeutic1Product Code
- FQKBinder, Perineal1Product Code
- FQLStocking, Medical Support (For General Medical Purposes)1Product Code
- FQMBandage, Elastic1Product Code
- FRFCleaner, Air, Medical Recirculating2Product Code
- K251872Biomoneta Avata Rx2Cleared 510(K)
- K242102CerroZone Mini2Cleared 510(K)
- K240696Airdog X8 Air Purifier (KJ800F-X8)2Cleared 510(K)
- K223835MA-40, MA-1122Cleared 510(K)
- K222416RIA Safeguard2Cleared 510(K)
- K211507Airdog X5 Recirculating Air Cleaner (model KJ300F-X5)2Cleared 510(K)
- K220990Qorda QD12Cleared 510(K)
- K220298CerroZone Mobile2Cleared 510(K)
- K200321Novaerus NV10502Cleared 510(K)
- K130702AIRSONETT AIR-42Cleared 510(K)
- K112728HEPAIRX VENTILATING AIR PURIFIER2Cleared 510(K)
- K081062AIRSONNETT AIRSHOWER AIR 32Cleared 510(K)
- K072185AIRISTAR AIR PURIFICATION SYSTEM, MODEL 500 & 10002Cleared 510(K)
- K070722PLASMAIR, MODEL T20062Cleared 510(K)
- K023693MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-1002Cleared 510(K)
- K012549ADVANCED AIR PURIFICATION SYSTEM; HEPA AIR CLEANING SYSTEM2Cleared 510(K)
- K010616DEFENDER ROOM AIR CLEANER, MODEL RAC-4000A2Cleared 510(K)
- K002692DEFENDER ROOM AIR CLEANER, MODEL RAC-3000A2Cleared 510(K)
- K984116HEPA-CARE AIR CLEANER AMERICAN AIR FILTER AIR FILTRATION SYSTEM MODELS HC800F, HFS800F, HC800C/ HFS800C, HC400C/HFS400C2Cleared 510(K)
- K981841BREATHE EASY, MODELS AD AND CD2Cleared 510(K)
- K974682MICROCON 800M, MICROCON 400M, MICROCON EXC, MICROCON EX, MICROCON WALLMAP2Cleared 510(K)
- K960966HEPA-TYPE AIR CLEANER MODEL 2586 AND TRUE HEPA AIR CLEANER MODELS 2587 AND 25882Cleared 510(K)
- K953536SLANT/FIN HEPA CLEAR2Cleared 510(K)
- K944305FRIEDRICH ELECTRONIC AIR CLEANER2Cleared 510(K)
- K930521AIR CLEANERS WITH HEPA FILTRATION2Cleared 510(K)
- K942434BIONAIRE CLEAR AIR AIR PURIFIER & IONIZER2Cleared 510(K)
- K945161NORELCO CLEAN AIR SYSTEM CAS9502Cleared 510(K)
- K944927NORELCO CLEAN AIR SYSTEM CAS9002Cleared 510(K)
- K943238NORELCO CLEAN AIR SYSTEM2Cleared 510(K)
- K942683BIONAIRE HEPA AIR PURIFIERS /SH-1240, 1260, 1840, 1860, CH-35502Cleared 510(K)
- K942512PA3002Cleared 510(K)
- K942686NORELCO CLEAN AIR SYSTEM MODEL CAM6652Cleared 510(K)
- K940573HEPA AIR CLEANER2Cleared 510(K)
- K925055POLLENEX HEPA AIR CLEANERS2Cleared 510(K)
- K925566HOLMES AIR PURIFIER MODELS HAP-240 & HAP-3002Cleared 510(K)
- K930860HEPA 2500 AIR CLEANER2Cleared 510(K)
- K930420HUNTER AIR CLEANERS MODEL NOS. 30100/30250/303002Cleared 510(K)
- K884472AIR-ELECTRONIC AIR CLEANER (FILTER)2Cleared 510(K)
- K872359ENVIRACAIRE MODEL EV-12Cleared 510(K)
- K862432HEPACRON PUREAIR-ZONE SYSTEM2Cleared 510(K)
- K861299HYGIENIC AIR PURIFYING DEVICE2Cleared 510(K)
- K854817INSTAPURE2Cleared 510(K)
- K851358MODEL BION 2/TYPE 90 ROOM IONIZER2Cleared 510(K)
- K851094MODEL BION 1/TYPE 1084T CAR IONIZER2Cleared 510(K)
- K843435LABMASTER & CRSI 6002Cleared 510(K)
- K842973HAYFEVER HELMET2Cleared 510(K)
- K831067BREATHING ZONE2Cleared 510(K)
- K812320AIR ALIVE2Cleared 510(K)
- K813258ULTIMATE-AIRE2Cleared 510(K)
- K812656DOTRICH ELECTRONIC AIR CLEANER #C500AM2Cleared 510(K)
- K760921AIR PURIFIER2Cleared 510(K)
- K760879ROOM AIR PURIFIER (TEX-DYN)2Cleared 510(K)
- K760481FILTER, PARTICULATE ARRESTING2Cleared 510(K)
- FRLFiber, Medical, Absorbent1Product Code
- FRNPump, Infusion2Product Code
- FRPHolder, Infant Position1Product Code
- FRRChamber, Reverse Isolation, Patient Care2Product Code
- FSALift, Patient, Non-Ac-Powered1Product Code
- FSDBinder, Abdominal1Product Code
- HEFBinder, Breast1Product Code
- HFSShield, Nipple1Product Code
- IKYMattress, Flotation Therapy, Non-Powered1Product Code
- KMKDevice, Intravascular Catheter Securement1Product Code
- KMOBinder, Elastic1Product Code
- KPEContainer, I.V.2Product Code
- KYPSnake Bite Suction Kit1Product Code
- KYQKit, Chemical Snake-Bite3Product Code
- KZDInfusor, Pressure, For I.V. Bags1Product Code
- KZEInjector, Fluid, Non-Electrically Powered2Product Code
- LBIUnit, Neonatal Phototherapy2Product Code
- LDRController, Infusion, Intravascular, Electronic2Product Code
- LGMChamber, Patient Isolation2Product Code
- LGNChamber, Patient Transport Isolation2Product Code
- LGZWarmer, Thermal, Infusion Fluid2Product Code
- LHFWarmer, Microwave, Infusion Fluid2Product Code
- LHISet, I.V. Fluid Transfer2Product Code
- LJLDetectors And Removers, Lice, (Including Combs)1Product Code
- LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days2Product Code
- LJTPort & Catheter, Implanted, Subcutaneous, Intravascular2Product Code
- LLIBed, Therapeutic, Ac-Powered, Adjustable Home-Use2Product Code
- LLKLegging, Compression, Non-Inflatable2Product Code
- LZHPump, Infusion, Enteral2Product Code
- MDRBinder, Medical, Therapeutic1Product Code
- MEAPump, Infusion, Pca2Product Code
- MEBPump, Infusion, Elastomeric2Product Code
- MEGSyringe, Antistick2Product Code
- MHCNeedle, Interosseous2Product Code
- MHDPump, Infusion, Gallstone Dissolution2Product Code
- MJFCheck Valve, Retrograde Flow (In-Line)2Product Code
- MMKContainer, Sharps2Product Code
- MQXNeedle, Acupuncture, Single Use2Product Code
- MRZAccessories, Pump, Infusion2Product Code
- MZRTopical Approximation System1Product Code
- NEPSystem/Device, Pharmacy Compounding2Product Code
- NGTSaline, Vascular Access Flush2Product Code
- NKKNeedle, Hypodermic, Single Lumen, Reprocessed2Product Code
- NKNSyringe, Piston, Reprocessed2Product Code
- NRWStimulator, Intramuscular, Automatic2Product Code
- NSCInjector, Pen2Product Code
- NTCNursing Pad, Hydrogel1Product Code
- NTXNursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)1Product Code
- NXHNursing Pad, Cohesive Gel1Product Code
- NZGBassinet, Hospital2Product Code
- NZWHeparin, Vascular Access Flush2Product Code
- NZXWater, Vascular Access Flush2Product Code
- OBKPort, Protector/Cushion2Product Code
- ODIAdministration Set Docking Station2Product Code
- ODYTunneled Catheter Remover2Product Code
- OJAIntravenous Extension Tubing Set2Product Code
- OKCImplanted Subcutaneous Securement Catheter2Product Code
- OKEPort Introducer Kit2Product Code
- OKLIntravascular Administration Set, Automated Air Removal System2Product Code
- OMFPercutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position2Product Code
- ONBClosed Antineoplastic And Hazardous Drug Reconstitution And Transfer System2Product Code
- ONMRadiant Infant Warmer Cabinet2Product Code
- PUKAdministration Set Securement Device1Product Code
- OPPPump, Infusion, Insulin Bolus2Product Code
- OSIBariatric Bed2Product Code
- OUWInfant Positioner, Rx, Use In Highly Monitored Setting1Product Code
- OWLPeripheral Catheter Insertion Kit2Product Code
- PDHBlanket, Neonatal Phototherapy2Product Code
- PEFHeparin Flush In 0.45% Sodium Chloride2Product Code
- PEZCentral Venous Catheter Dressing Change Kit2Product Code
- PHCInfusion Safety Management Software2Product Code
- PKPImmunoglobulin G (Igg) Infusion System2Product Code
- PMSPeripheral Intravenous (Piv) Infiltration Monitor2Product Code
- PNDMidline Catheter2Product Code
- POQBlood Transfusion Kit2Product Code
- PORParenteral Administration Kit2Product Code
- PQHIodinated Contrast Media Transfer Tubing Set2Product Code
- PQXEpinephrine Syringe2Product Code
- PRNPediatric Position Holder1Product Code
- PTDSubcutaneous Implanted Apheresis Port2Product Code
- PTINon-Coring (Huber) Needle2Product Code
- PUNLice Removal Kit Containing A Solution1Product Code
- PURVacuum Syringe2Product Code
- PVZNon-Stainless Steel Needle2Product Code
- PWHAdministrations Sets With Neuraxial Connectors2Product Code
- PWNBaby Care Kit2Product Code
- PWOBlood Administration Kit2Product Code
- PWQBuret Administration Intravenous Kit2Product Code
- PWRCatheter Repair Kit2Product Code
- PWXInsect Sting Emergency Kit1Product Code
- PWYLumbar Puncture Tray (Adult & Pediatric)2Product Code
- PXBPercutaneous Introducer Kit2Product Code
- PXIThoracentesis Tray2Product Code
- PXJUmbilical Catheter Insertion Tray2Product Code
- PXKVascular Access Port Kit2Product Code
- PXLVenipuncture Kit2Product Code
- PYRNeuraxial Administration Set - Intrathecal Delivery2Product Code
- PZWCatheter Access Cover, Tamper-Resistant2Product Code
- QBLPiston Syringe Lever2Product Code
- QDMMidazolam Syringe2Product Code
- QEHPiston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact2Product Code
- QJYInfusion Pump, Drug Specific, Pharmacy-Filled2Product Code
- QLFOn-Body Injector2Product Code
- QLYOphthalmic Syringe2Product Code
- QMTPrep Kit – Vaccine Injection2Product Code
- QNQLow Dead Space Piston Syringe2Product Code
- QNSLow Dead Space Needle, Single Lumen, Hypodermic2Product Code
- QOGInjection Data Capture Device2Product Code
- QOIIntravenous Catheter Force-Activated Separation Device.2Product Code
- QTISaline Vascular Access Flush With Integrated Alcohol Disinfectant Device2Product Code
- QYMOphthalmic Needle2Product Code
- SCLAllergen And Vaccine Delivery Needles2Product Code
- SEFCentral Venous Catheter With Manual Insertion System2Product Code
- 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
- 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
DEFENDER ROOM AIR CLEANER, MODEL RAC-4000A
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K010616
- 510(k) Type
- Special
- Applicant
- Hmi Industries, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/28/2001
- Days to Decision
- 27 days
- Submission Type
- Statement