Anesthesiology
Review Panel
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- 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
- 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
- K253222Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)2Cleared 510(K)
- K252637Community Containers (Flap and Daisy)2Cleared 510(K)
- K251874PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)2Cleared 510(K)
- K231484PureWay 1.4 Quart Sharps Collector2Cleared 510(K)
- K222906Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA14212Cleared 510(K)
- K222905Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container, MA1212), Maxcon Sharps Container (5.4 QT Sharps Container, MA1213), Maxcon Sharps Container (7 Liter Sharps Container, MA1324)2Cleared 510(K)
- K213274Qlicksmart BladeFlask UNIVERSAL2Cleared 510(K)
- K211890Promisemed Sharps container2Cleared 510(K)
- K211464Nitta M&T Safety Box2Cleared 510(K)
- K203305Tiger Reusable Sharps Container2Cleared 510(K)
- K201523Sharps container2Cleared 510(K)
- K190240Tiger Sharps Containers2Cleared 510(K)
- K182235OnSite Waste Sharps Container2Cleared 510(K)
- K180984Maxcon Sharps Container2Cleared 510(K)
- K180983Maxcon Two Gallon Chemotherapy Container2Cleared 510(K)
- K172719HealthBeacon HB2 Sharps Bin2Cleared 510(K)
- K170513MAUSER PG II Sharps Container2Cleared 510(K)
- K153274Med-Tainer Single Deposit Container2Cleared 510(K)
- K153363Red2Green Reusable Sharps Container2Cleared 510(K)
- K161180Oak Ridge Products Sharps Containers2Cleared 510(K)
- K152340NAR Sharps Shuttle; NAR Sharps Shuttle Pack of six2Cleared 510(K)
- K143693MEDLINE SHARPS CONTAINERS2Cleared 510(K)
- K151249PUREWAY SHARPS COLLECTOR 1.2 GALLON, PUREWAY SHARPS COLLECTOR 2 GALLON, PUREWAY SHARPS COLLECTOR 3 GALLON2Cleared 510(K)
- K150333MedSource Sharps Dart2Cleared 510(K)
- K140285B TRAVELSAVVY SHARPS CONTAINER2Cleared 510(K)
- K141759OAK RIDGE PRODUCTS MULTI-PURPOSE SHARPS CONTAINERS2Cleared 510(K)
- K132476SHARPS CONTAINER2Cleared 510(K)
- K131708BWCSH-1 SHARPS CONTAINER2Cleared 510(K)
- K132767MEDLINE SHARPS CONTAINER2Cleared 510(K)
- K132792ECOSHIP DISPOSABLE SHARPS CONTAINER, ECOSHIP DISPOSABLE SHARPS CONTAINER2Cleared 510(K)
- K132007STERICYCLE SHARPS MANAGEMENT SERVICE REUSABLE SHARPS CONTAINER, 2 GALLON, RED, STERICYCLE SHARPS MANAGEMENT SERVICES REU2Cleared 510(K)
- K133031SHARPSOLOGY 22Cleared 510(K)
- K123807SHARPSCAN2Cleared 510(K)
- K131087SHARPSTANK REUSABLE SHARPS CONTAINER2Cleared 510(K)
- K130281OAK RIDGE PRODUCTS SHARP CONTAINER2Cleared 510(K)
- K111085SHARPS TANK REUSABLE SHARPS CONTAINER2Cleared 510(K)
- K112774BD RECYKLEEN SHARPS COLLECTORS2Cleared 510(K)
- K110262SHARPS CONTAINER2Cleared 510(K)
- K101567SHARPS CONTAINER2Cleared 510(K)
- K091736SHARPSMART DISPOSABLE SHARPS CONTAINER, MODEL S22Cleared 510(K)
- K091690SHARP CHUTE2Cleared 510(K)
- K090157ISOLYSER HOME SHARPS MANAGEMENT (HSM), MODEL 800M; ISOLY SHARPS MANAGEMENT SYSTEM (SMS), MODELS 2400M, 4000M, 10000M, 5.2Cleared 510(K)
- K083511ENVIRO SHARP SOLUTIONS 32Cleared 510(K)
- K083129SHARPS COMPLIANCE CONTAINER2Cleared 510(K)
- K082042GONGDONG DISPOSABLE SHARP CONTAINER2Cleared 510(K)
- K081821D.A.R.T. PRO KIT (D.A.R.T. PRO HANDLE AND X-TRACTOR TIP)2Cleared 510(K)
- K073577SHARPS TRANSPORT TUBE, MODEL 500352Cleared 510(K)
- K081449ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINER2Cleared 510(K)
- K071517AP MEDICAL SHARPS CONTAINERS 0,6-12 LT.2Cleared 510(K)
- K072667SHARPS AWAY DISPOSABLE CONTAINER2Cleared 510(K)
- K070577ON THE GO SHARPS2Cleared 510(K)
- K063722SEKURIT SHARPS COLLECTION CONTAINER2Cleared 510(K)
- K063666SHARPS CONTAINER, MODEL 039-4132Cleared 510(K)
- K060037FITPACK2Cleared 510(K)
- K021983ULTI GUARD HOME INSULIN SYRINGE CONTAINER2Cleared 510(K)
- K020664STERISHARP 3-GALLON RSDC, MODEL RSDC3G2Cleared 510(K)
- K001337DANIELS SHARPSMART REUSABLE SHARPS CONTAINER2Cleared 510(K)
- K991612STERISHARP 2.5-GALLON RSDC, MODEL #RSDC2.5G2Cleared 510(K)
- K983367QLICKSMART2Cleared 510(K)
- K982781DEMOLIZER #47 ONE-GALLON POINT OF GENERATION SHARPS CONTAINER2Cleared 510(K)
- K980490SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPS2Cleared 510(K)
- K964387POINT OF USE II SHARPS-A-GATOR2Cleared 510(K)
- K964858BEMIS TWO GALLON CHEMOTHERAPY CONTAINER2Cleared 510(K)
- K955514SHARPS SAFE 1.5 & SHARPS SAFE 2.02Cleared 510(K)
- K960525BEMIS ONE QUART PHLEBOTOMY CONTAINER (PART NUMBER 100)2Cleared 510(K)
- K953797SHARPS DISPOSAL CONTAINERS2Cleared 510(K)
- K950898BIOBOX WITH FUNNEL TOP (SMALL, MEDIUM, LARGE, AND X-LARGE)2Cleared 510(K)
- K950897BIOBOX TRAPTOP (SMALL, MEDIUM, LARGE AND X-LARGE)2Cleared 510(K)
- K950340IGHT AND ELEVEN GALLON SHARPS AND CHEMOTHERAPY CONTAINERS2Cleared 510(K)
- K943659ANCILLARY AND LARGE VOLUME SHARPS DISPOSAL CONTAINERS2Cleared 510(K)
- K943658CHEMOTHERAPY WASTE DISPOSAL CONTAINERS2Cleared 510(K)
- K943660PHLEBOTOMY SHARPS DISPOSAL CONTAINERS2Cleared 510(K)
- K942902SHARPS-TAINER SMALL OPENING W/NEEDLE REMOVER2Cleared 510(K)
- K945197THE SHARPS COLLECTION AND DISPOSAL SYSTEM2Cleared 510(K)
- K943138VACUTAINER BRAND NEEDLE DISPOSAL CONTAINER2Cleared 510(K)
- K941991IN-ROOM AND SHARPSTAR2Cleared 510(K)
- K941665SHARPS DISPOSAL CONTAINER/PHLEBOTOMY2Cleared 510(K)
- K941664SHARP DISPOSAL CONTAINERS WALL SAFE2Cleared 510(K)
- K931664SHARPS DISPOSABLE CONTAINERS2Cleared 510(K)
- K923512OPERATING ROOM NEEDLE COUNTER2Cleared 510(K)
- K921913HYPO-GARD2Cleared 510(K)
- K915067DISPOSABLE NEEDLE COUNTERS & DISPOSABLE SYSTEMS2Cleared 510(K)
- K913446ICAN NEEDLE COUNTERS2Cleared 510(K)
- K911077JAIN SUTURE PACKAGE COUNTER2Cleared 510(K)
- K911076JAIN QUICK COUNT2Cleared 510(K)
- K910516DISPOSAL PAD FOR SHARPS2Cleared 510(K)
- K904148PREVEN-A-STIK2Cleared 510(K)
- K903947QUALTEX NEEDLE COUNTERS2Cleared 510(K)
- K897095DISPOSINEEDLE SHARPS DISPOSAL UNIT2Cleared 510(K)
- K896195NEEDLE SYRINGE DISPOSAL DEVICE2Cleared 510(K)
- K890314PROTECTOR (SURGICAL INSTRUMENT)2Cleared 510(K)
- K884448BLADEMATE2Cleared 510(K)
- K872313NEEDLE & BLADE COUNTER & DISPOSAL UNIT2Cleared 510(K)
- K861319DISPOSABLE NEEDLE COUNTER (20-560)2Cleared 510(K)
- K861317DISPOSABLE NEEDLE COUNTER (20-530)2Cleared 510(K)
- K861316DISPOSABLE NEEDLE COUNTER (20-240)2Cleared 510(K)
- K861307DISPOSABLE NEEDLE COUNTER2Cleared 510(K)
- K844654SHARP COLLECTION SYSTEM-SHARP-A-GATOR2Cleared 510(K)
- K822735SURE-COUNT DISPOSABLE NEEDLE COUNTER2Cleared 510(K)
- K830275NEEDELET HANDLER FOR SHARPS2Cleared 510(K)
- K821394SUTURE-SAFE 40 ADHESIVE NEEDLE COUNTER2Cleared 510(K)
- K811997SHARPS SAFE2Cleared 510(K)
- K810134KEEP-ACCOUNT SHARPS DISPOSAL SYSTEM2Cleared 510(K)
- K810208BLADE SAFE2Cleared 510(K)
- K801259NEEDLE COUNTER-SURE COUNT/100 COUNT2Cleared 510(K)
- K792016DISCARD-A-PAD 40-COUNT SHARPS DISPOSAL2Cleared 510(K)
- K790661PROTECTOR II2Cleared 510(K)
- K790405ANCHOR BRAND COUNT-TAINER2Cleared 510(K)
- K790039COUNTER, DISPOSABLE SURGICAL NEEDLE2Cleared 510(K)
- K781791BOARD, DISPOSABLE CONTROL COUNT2Cleared 510(K)
- K771791NEEDLE COUNTING2Cleared 510(K)
- K771611PROTECTOR2Cleared 510(K)
- 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
D.A.R.T. PRO KIT (D.A.R.T. PRO HANDLE AND X-TRACTOR TIP)
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K081821
- 510(k) Type
- Traditional
- Applicant
- Global Pathogen Solutions, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/2/2008
- Days to Decision
- 67 days
- Submission Type
- Summary