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
- K131517MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING2Cleared 510(K)
- K063114DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES2Cleared 510(K)
- K063239LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 175262Cleared 510(K)
- K052431MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S12Cleared 510(K)
- K041178EMPOWER TRANSFER SET, (CAT. NO. 7725)2Cleared 510(K)
- K031808MEDRAD SWABBABLE VALVE TRANSFER SET2Cleared 510(K)
- K022431MEDRAD TRANSFER SET2Cleared 510(K)
- K965208POLYFIN EXTENSION SET, MODELS 126 AND 1282Cleared 510(K)
- K953864SILCLEAR TUBING (MODIFICATION)2Cleared 510(K)
- K950508SYSMEX SF-30002Cleared 510(K)
- K952243EXTENSION SET/I.V. SET2Cleared 510(K)
- K95266360 MICRO VOLUME EXTENSION SET W/.22 MICRON FILTER, 21 EXTENSION SET W/1.2 MIVTON GILYRT, INJ. SITE, CLAMP2Cleared 510(K)
- K950861RECONSTITUTION ACCESSOREIS2Cleared 510(K)
- K933524EXTENTION SET2Cleared 510(K)
- K950200IVID2Cleared 510(K)
- K943992SILCLEAR TUBING2Cleared 510(K)
- K943206VARIOUS TUBING2Cleared 510(K)
- K945184INTRAVASCULAR ADMINISTRATION SET2Cleared 510(K)
- K941214LIFESHIELD EXTENSION SET2Cleared 510(K)
- K935642EVANS MEDICAL EXTENSION SETS2Cleared 510(K)
- K921450NON-INVASIVE TUBING2Cleared 510(K)
- K923972OPHTHALMIC FLUID DISTRIBUTION SETS2Cleared 510(K)
- K915560LO-PROFILE EXTENSION SET2Cleared 510(K)
- K912103LIFESHIELD EXTENSION SET2Cleared 510(K)
- K910906CENTURION KLEEN-NEEDLE SYSTEM I.V. EXTENSION SETS2Cleared 510(K)
- K891009INTRAVASCULAR ADMINISTRATION SET MODEL 600402Cleared 510(K)
- K891005INTRAVASCULAR ADMINI. SET MODELS 60030 & 600502Cleared 510(K)
- K883718MERIT HI-FLEX(TM)2Cleared 510(K)
- K884156HYPERBARIC INTRAVENOUS INFUSION EXTENSION SET2Cleared 510(K)
- K884370CMS IV EXTENSION SETS2Cleared 510(K)
- K875186IV EXTENSION SET2Cleared 510(K)
- K873465VAN DELLEN BACTERIA FILTER2Cleared 510(K)
- K873852INFUSION MANIFOLD2Cleared 510(K)
- K874360PLASTIC TUBING CONNECTOR2Cleared 510(K)
- K871085EXTENSION TUBE PUMP SET2Cleared 510(K)
- K871540SWIVEL CONNECTORS #014452/#014453/#014459-1202Cleared 510(K)
- K870416LP EXTENSION SETS2Cleared 510(K)
- K870912T-CONNECTORS 014500/014501/014502/014503-1202Cleared 510(K)
- K870326VARIOUS LUER AND TUBING FITTINGS2Cleared 510(K)
- K864692EXTENSION SETS2Cleared 510(K)
- K864395LOW VOLUME EXTENSION SET2Cleared 510(K)
- K861626CHURCHILL EXTENSION TUBE2Cleared 510(K)
- K854629CHURCHILL-H EXTENSION TUBE2Cleared 510(K)
- K834164SPINAL NEEDLES & ACCESSORY2Cleared 510(K)
- K833659IV EXTENSION SET2Cleared 510(K)
- K833076C-FLEX MEDICAL GRADE TUBING2Cleared 510(K)
- K832758RED COLOR-TINTED TUBING2Cleared 510(K)
- K820527ANESTHESIA EXTENSION TUBES2Cleared 510(K)
- K812981FLUVEN SETS (EXT-1, EXT-2, EXT-3, EXT-4)2Cleared 510(K)
- K811847SEA MEDICAL PRODUCTS LO-VOL2Cleared 510(K)
- K810005SAFEED EXTENSION TUBES2Cleared 510(K)
- K800879CLEAR PLASTIC CONNECTING TUBES2Cleared 510(K)
- K800877ANESTHESIA EXTENSION TUBES2Cleared 510(K)
- K800825EXTENSION SET QUEST CODE #30002Cleared 510(K)
- K781087MEDICAL GRADE SILICONE ELASTOMER TUBING2Cleared 510(K)
- K780673CENTRAL CATHETER KIT2Cleared 510(K)
- K780396NASAL GASTRIC TUBE RETAINER2Cleared 510(K)
- K772119TIME WATCH2Cleared 510(K)
- K771269BLOOD COLLECTION SET TYPE H2Cleared 510(K)
- K771387MONITORING LINES & FLUID ADMIN.2Cleared 510(K)
- K770945POUCH, TYVEK-POLYMYLON2Cleared 510(K)
- K770596CONNECTORS2Cleared 510(K)
- K770174LUER-LOCK EXTENSION SET2Cleared 510(K)
- K770108TUBE HOLDING DEVICE2Cleared 510(K)
- 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
RECONSTITUTION ACCESSOREIS
- Page Type
- Cleared 510(K)
- 510(k) Number
- K950861
- 510(k) Type
- Traditional
- Applicant
- ORGANON, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/26/1995
- Days to Decision
- 88 days
- Submission Type
- Summary