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
- K233277Filter Needle for Single Use2Cleared 510(K)
- K143583Cathivex ¿GV filter units2Cleared 510(K)
- K113227NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER2Cleared 510(K)
- K021293ARTERIA BLOOD FILTER2Cleared 510(K)
- K993379PALL SUPOR AEF FILTER2Cleared 510(K)
- K9746610.2 U BACTERIAL FILTER2Cleared 510(K)
- K964283AUTOPRIME2Cleared 510(K)
- K954331PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER)2Cleared 510(K)
- K933523I.V. FILTER SET2Cleared 510(K)
- K94162840 MICRON BLOOD TRANSFUSION FILTER2Cleared 510(K)
- K9426251.2 MICRON AIR ELIMINATING FILTER2Cleared 510(K)
- K943127PHARMASSURE LARGE VOLUME TRANSFER FILTERS2Cleared 510(K)
- K9425322 MICRON AIR ELIMINATING FILTER2Cleared 510(K)
- K941684IVEX-2 EXTENSION SET WITH Y-INJECTION SITE2Cleared 510(K)
- K942275VIAL VENT FILTER2Cleared 510(K)
- K940980CHARGED SUPOR(R) FILTER EXTENSION SET2Cleared 510(K)
- K933869EXTENSION SET WITH 0.22 MICRON 96 HOUR FILTER2Cleared 510(K)
- K9402931.2 MICRON FINAL FILTER WITH EXTENSION TUBE2Cleared 510(K)
- K933294MIS CLEAN-SET FLUSHING UNIT AND ACCESSORIES2Cleared 510(K)
- K9356410.2. MICRON FILTER SETS AND 1.2 MICRON FILTER SETS2Cleared 510(K)
- K932301FENWAL(R) 40/150 MICRON DUAL SCREEN FILTER2Cleared 510(K)
- K931441FENWAL 40 MICRON TRANSFUSION FILTER2Cleared 510(K)
- K920736IVEX-HP96 EXTENDED LIFE FILTER SET2Cleared 510(K)
- K913308IVEX-TPN EXTENSION FILTER SET2Cleared 510(K)
- K912848I.V. FILTER EXTENSION SET2Cleared 510(K)
- K905794PALL 3N1 FILTER2Cleared 510(K)
- K911451I.V. EXTENDER SET2Cleared 510(K)
- K896333CMS IV FILTERS2Cleared 510(K)
- K8962921.2 MICRON FILTER WITH IV SET2Cleared 510(K)
- K894954.22 & 1.2 MICRON IV FILTERS2Cleared 510(K)
- K880605LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER2Cleared 510(K)
- K880026CHURCHILL 0.22 MICRON LIQUID COMPACT FILTER SETS2Cleared 510(K)
- K880025CHURCHILL 0.22 MICRON LIQUID FILTER SETS2Cleared 510(K)
- K880027CHURCHILL 1.2 MICRON LIQUID FILTER SET2Cleared 510(K)
- K872634CUTTER PUREFLO PLUS IV FILTER2Cleared 510(K)
- K865029CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER2Cleared 510(K)
- K864113CLYDE (TM) FILTRATION SYSTEM2Cleared 510(K)
- K861644CRITIKON 48-HOUR AIR ELIMINATING FILTER2Cleared 510(K)
- K860372FAST FLOW XX (AQUEOUS SOLUTION FILTER)2Cleared 510(K)
- K860803IV FILTER EXTENSION SET2Cleared 510(K)
- K860746AUTO SYRINGE MICRO VOL EXT SET W/AIR VENT FILTER2Cleared 510(K)
- K855065PREVENT 0.2 MICRON IV FILTER W/VENT & EXTENSION SE2Cleared 510(K)
- K854172I.V. WATCH2Cleared 510(K)
- K852996DYNA GARD SYRINGE FILTER2Cleared 510(K)
- K851818SARTORIUS MINI SART FH 165922Cleared 510(K)
- K851817SARTORIUS MINI-SART FH 165552Cleared 510(K)
- K851816SARTORIUS MINISART FH 165342Cleared 510(K)
- K852030PEDIATRIC IV WATCH2Cleared 510(K)
- K852029I.V. WATCH2Cleared 510(K)
- K850826POSIDYNE SOLUTION CONTAINER FILTER, RECORDER #962Cleared 510(K)
- K850825AEF POSIDYNE I.V. FILTER/AIR ELIMINATOR2Cleared 510(K)
- K84239948 HOUR SET CHANGES2Cleared 510(K)
- K842075CRITIKON I.V. FILTER2Cleared 510(K)
- K841280SOLOPAK BRAND FILTER NEEDLE W/5 MICRO2Cleared 510(K)
- K834376FILTRARE TM ALLVENT TM2Cleared 510(K)
- K834381POSIDYNE I.V. FILTER/AIR ELIMINATOR2Cleared 510(K)
- K840248IV-FILTER2Cleared 510(K)
- K833684IVEX-INT2Cleared 510(K)
- K832952MILLIPORE IVEX INT FILTER UNIT2Cleared 510(K)
- K831882POSIDYNE SOLUTION CONTAINER FILTER2Cleared 510(K)
- K831668CONTINU-FLO SOLUTION ADMINISTRATION2Cleared 510(K)
- K831350IVFLO-HP & IVFIL-HP FILTER2Cleared 510(K)
- K831315TRILEX2Cleared 510(K)
- K823690IVFLO-HP & IVFIL-HP2Cleared 510(K)
- K821013IVEX-HP PEDIATRIC EXTENSION SET-SL2Cleared 510(K)
- K813454I.V. FILTER-PREVENT2Cleared 510(K)
- K813446IV FILTERSET 0.22 MICROMETER2Cleared 510(K)
- K813445IV FILTERSET 5 MICROMETER2Cleared 510(K)
- K813001FIBRI-FILTER 202Cleared 510(K)
- K812457HIFLO-HP2Cleared 510(K)
- K811773BACTAGARD2Cleared 510(K)
- K810113TERFUSION FINAL FILTER SET2Cleared 510(K)
- K802765ACRODISC FILTER ASSEMBLY2Cleared 510(K)
- K801602DESERET I.V. FILTER2Cleared 510(K)
- K801614MODEL 40-30-2 AIR ELIMINATING FILTER SET2Cleared 510(K)
- K801605BIMECO FILTERED EXTENSION SET2Cleared 510(K)
- K801343B-D FILTER NEEDLE2Cleared 510(K)
- K792510MICROBAR MONITORING LINE FILTER2Cleared 510(K)
- K791822BIOGUARD INFUSION LINE FILTER2Cleared 510(K)
- K792021LARGE VOLUME 5 MICRON CONICAL FILTER2Cleared 510(K)
- K791809BLOOD TRANSFUSION MICROFILTER2Cleared 510(K)
- K790879ULTIPOR SOLUTION CONTAINER FILTER2Cleared 510(K)
- K790471JELCO* DISC FILTER-0.2 MICRON2Cleared 510(K)
- K790314FLUID ADMINISTRATION SETS, 15 MICRON2Cleared 510(K)
- K781815HEMO-NATE SYRINGE BLOOD FILTER2Cleared 510(K)
- K772312FILTERSET W/Y-INJECTION SITE, 0.22Cleared 510(K)
- K7719725UM FILTERSET WITH Y-INJECTION SITE2Cleared 510(K)
- K771536AIR VENT FILTER NEEDLE, 0.452Cleared 510(K)
- K771862TRANSFUSION BLOOD FILTER2Cleared 510(K)
- K771827INTRAVENOUS FILTER W/FLASH BULB2Cleared 510(K)
- K771826INTRAVENOUS FILTER W/AUTO AIR VENT2Cleared 510(K)
- K771594PRIMARY PIGGYBACK VENOSET W/ FILTER2Cleared 510(K)
- K771430BLOOD FILTER, W/SET2Cleared 510(K)
- K771498CONTINU-FLO Y-TYPE SOLUTION ADMIN. SET2Cleared 510(K)
- K770843IV PUMP FILTERSET, UNIVERSAL2Cleared 510(K)
- K770703FILTER UNIT, SINGLE USE2Cleared 510(K)
- K7701820.22/UM FILTERSET W/Y-INJECTION SITE2Cleared 510(K)
- K770183O.22/UM FILTERSET W/FLASHBACK2Cleared 510(K)
- 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
- 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
48 HOUR SET CHANGES
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K842399
- 510(k) Type
- Traditional
- Applicant
- TRI-MED, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/9/1984
- Days to Decision
- 112 days