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
- 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
- K240761Arisure® Closed Male Luer with Spike Adapter (YM060)2Cleared 510(K)
- K243985Rio™ Drug Reconstitution Transfer Device2Cleared 510(K)
- K243486SmartSiteTM Vented Vial Access Device2Cleared 510(K)
- K241976nextaro® va, 15mm, 5µm2Cleared 510(K)
- K233287Vent Vial Adapter2Cleared 510(K)
- K232987FlowArt Valve for Vial Access2Cleared 510(K)
- K240940Vial2Bag Advanced® 20mm Admixture Device2Cleared 510(K)
- K233284Vial Adapter with Filter2Cleared 510(K)
- K240748nextaro® v, 20/202Cleared 510(K)
- K233021BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device2Cleared 510(K)
- K231071Mix2Vial® Transfer Device2Cleared 510(K)
- K232875Vial Adapter 20mm2Cleared 510(K)
- K230988Vial2Bag Advanced® 13mm Admixture Device2Cleared 510(K)
- K232055Vial Adapter2Cleared 510(K)
- K230464MixJect® Transfer Device2Cleared 510(K)
- K222718Vial Adapter2Cleared 510(K)
- K221406Vented Vial Transfer Pin2Cleared 510(K)
- K213513Vented Vial Adapter 20mm2Cleared 510(K)
- K212525Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices2Cleared 510(K)
- K220856Vial Adapter Ø13mm2Cleared 510(K)
- K212445freeflex+ Transfer Adapter2Cleared 510(K)
- K212530IVX Fluid Transfer Set2Cleared 510(K)
- K202732SOL-CARE IV Bag Safety Connector2Cleared 510(K)
- K203674B Dispensing Line2Cleared 510(K)
- K200893ProntoPump Sterile Tube Set2Cleared 510(K)
- K201469Mini Spike Plus 6/8R2Cleared 510(K)
- K201415Vial2Bag Advanced 20mm Admixture Device2Cleared 510(K)
- K192154Rio Vial-to-Bag Drug Reconstitution Device2Cleared 510(K)
- K182819Decanting Device2Cleared 510(K)
- K190816Vial Adapter Ø20 mm , Vial Adapter Ø13 mm2Cleared 510(K)
- K190149Vial Adapter Ø20 mm2Cleared 510(K)
- K183187nextaro Transfer System, nextaro va2Cleared 510(K)
- K173577Guarded Luer Connector2Cleared 510(K)
- K162216GRI-FILL PERISTALTIC SET2Cleared 510(K)
- K171796Vial Adapter 15mm2Cleared 510(K)
- K172884Arisure Closed Vial Adapter2Cleared 510(K)
- K172631Arisure Dry Spike2Cleared 510(K)
- K170095Vial2Bag Direct Connect2Cleared 510(K)
- K161800OnSite-IV2Cleared 510(K)
- K160503Vented Vial Adapter Transfer Device - 13mm2Cleared 510(K)
- K151423APEX Compounding System Transfer Set2Cleared 510(K)
- K152441KIRO Set2Cleared 510(K)
- K150787Universal Spike2Cleared 510(K)
- K151963SmartSite Vented Vial Access Device2Cleared 510(K)
- K142600VIAL-MATE Adaptor2Cleared 510(K)
- K140730VIAL2BAG DIRECT CONNECT2Cleared 510(K)
- K140442MEDSOURCE SELECTABLE IV SET2Cleared 510(K)
- K140402MEDSOURCE IV ADMINISTRATION SET 72 MEDSOURCE IV ADMINISTRATION SET, NEEDLELESS MALE ADAPTER, MEDSOURCE IV EXTENSION SET2Cleared 510(K)
- K133097E-Z LINK2Cleared 510(K)
- K133602ADD-VANTAGE ADDAPTOR2Cleared 510(K)
- K131646DISPOSABLE INFUSION SET2Cleared 510(K)
- K132863SMARTSITE VIALSHIELD2Cleared 510(K)
- K130179MP VIAL ADAPTER 13MM2Cleared 510(K)
- K132040VIAL CONNECTOR 13MM CLOSED COLLAR2Cleared 510(K)
- K120384PROTECTOR, INJECTOR, CONNECTOR2Cleared 510(K)
- K122265VIALOK SINGLE VIAL ACCESS DEVICE VENTED2Cleared 510(K)
- K120424MEDSOURCE IV ADMINSTRATION SET2Cleared 510(K)
- K120150DUAL SPIKE TRANSFER DEVICE2Cleared 510(K)
- K121182VIALOK NON-VENTED2Cleared 510(K)
- K111577MEDLINE VIAL DECANTER2Cleared 510(K)
- K110023INFUSION ADAPTER C1002Cleared 510(K)
- K102590FLEBOSET DOUBLE2Cleared 510(K)
- K101940EQUASHIELD SYSTEM PROTECTIVE PLUS2Cleared 510(K)
- K101309EXELINT ALUMINUM HUB BLUNT NEEDLES2Cleared 510(K)
- K10064020 MMVIAL FLUID TRANSFER ADAPTER, MODEL 7E25002Cleared 510(K)
- K090917SURECONNECT CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM2Cleared 510(K)
- K093182SET GRI-FILL 3.02Cleared 510(K)
- K092782INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJECTOR LUER LOCK, N35C, CONNECTOR LUER LOCK, MODEL C35,2Cleared 510(K)
- K092246NIPRO NEEDLELESS TRANSFER DEVICE, MODELS: M285503 AND M2855052Cleared 510(K)
- K092318BAXJECT II HI-FLOW NEEDLELESS TRANSFER DEVICE2Cleared 510(K)
- K091389EQUALSHIELD LUER LOCK CONNECTOR PAIR2Cleared 510(K)
- K083851INVIROBLUNT CANNULA WITH AND WITHOUT EZ WINGS, MODELS 120522 AND 1200222Cleared 510(K)
- K090905ADDEASE 20MM BINARY CONNECTOR WITH 17 GA. NEEDLE2Cleared 510(K)
- K090634PHASEAL PROTECTOR P14, P21, P28 AND P502Cleared 510(K)
- K083152EQUASHIELD SYSTEM2Cleared 510(K)
- K080976NEXUS I.V. FLUID TRANSFER DEVICE2Cleared 510(K)
- K082752QUICKPIN2Cleared 510(K)
- K080174PHLEBOTOMY BAG WITH VALVE & 17G X 1, MODEL CM-PH17X1B, CM-PH17X1C2Cleared 510(K)
- K070584SMART-ROD2Cleared 510(K)
- K072759VIAL2BAG2Cleared 510(K)
- K072511SWABABLE VIAL ADAPTER 13MM, SWABABLE VIAL ADAPTER 20MM2Cleared 510(K)
- K071741TEVADAPTOR, CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM2Cleared 510(K)
- K062482VENTED VIAL ADAPTER TRANSFER DEVICE2Cleared 510(K)
- K060866PHASEAL - CLOSED SYSTEM FOR THE PREPARATION AND ADMINISTRATION OF PARENTERAL DRUGS2Cleared 510(K)
- K052790SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD2Cleared 510(K)
- K051669TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM2Cleared 510(K)
- K050339SET GRI-FILL 3.0-1 WAY, 2 WAYS, MULTIPLE2Cleared 510(K)
- K043304Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-012Cleared 510(K)
- K041222PINNACLE TPN MANAGEMENT SYSTEM TRANSFER SET2Cleared 510(K)
- K042410BAXJECT II2Cleared 510(K)
- K041691CLIP 'N'JECT RECONSTITUTION SYSTEM (CLIP 'N'JECT2Cleared 510(K)
- K041232GETTIG UNIVERSAL VIAL ACCESS PIN2Cleared 510(K)
- K041564Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-012Cleared 510(K)
- K040634ROBERTSITE VIAL ADAPTER, MODEL 2457000212Cleared 510(K)
- K040456FLEBOSET MULTIPLE2Cleared 510(K)
- K033682SET GRI-FILL 2.0-1 WAY; 2.0-2 WAYS; LUER CONNECTION TUBE2Cleared 510(K)
- K031861MIX2VIAL TRANSFER DEVICE2Cleared 510(K)
- K024239CHEMO DISPENSING PIN, MODEL 124952Cleared 510(K)
- K023539STERI-SPOUTS; BAG-SPOUT, VIAL-SPOUT, TRANSFER MIXER; RAPIDFLOW, VIALFLOW, TRANSFLOW2Cleared 510(K)
- K023747PHASEAL2Cleared 510(K)
- K022523RAPID-FILL TUBESET, MODEL 900052Cleared 510(K)
- K012189ANGELTOUCH VENTED IV ADMINISTRATION SET2Cleared 510(K)
- K013523CISTEM FLUID TRANSFER DEVICE, MODEL 7S2012 AND 7S20132Cleared 510(K)
- K013087SINGLE DOSE DISPENSING PIN, MODEL 22012Cleared 510(K)
- K010703INTER-VIAL2Cleared 510(K)
- K010623RECONSTITUTION KIT & VIAL CONNECTOR2Cleared 510(K)
- K002705EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 24002Cleared 510(K)
- K003730CHEMO-AIDE DISPENSING PIN2Cleared 510(K)
- K001831NEEDLELESS TRANSFER DEVICE2Cleared 510(K)
- K001368PROTECTOR 21, PROTECTOR 50, PROTECTOR 14, INJECTOR LUER LOCK, INFUSION ADAPTER2Cleared 510(K)
- K001293MODIFICATION TO MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PRE-ATTACHED NEEDLE2Cleared 510(K)
- K994323KAWASUMI LABORATORIES PHILEBOTOMY SET2Cleared 510(K)
- K000367SECURMIX2Cleared 510(K)
- K990711CODAN CHEMOSPIKE2Cleared 510(K)
- K983794CHEMO MINI SPIKE PLUS2Cleared 510(K)
- K980587IV DECANTER-FLEXIBLE2Cleared 510(K)
- K980381PHASEAL, CLOSED SYSTEM FORHANDLING OF PARENTERAL DRUGS, ADDITIONAL ADMINISTRATION DEVICES. C80 INFUSION ADAPTER, A10 PRO2Cleared 510(K)
- K974431CHEMO-SPIKE II RECONSTITUTION DEVICE2Cleared 510(K)
- K974198TAKY-SPIKE PLUS2Cleared 510(K)
- K973654VIAL-MATE RECONSTITUTION DEVICE (2B8071)2Cleared 510(K)
- K961008AUTOMIX 3+3/AS COMPOUNDER SYSTEM2Cleared 510(K)
- K972134BAG DECANTER2Cleared 510(K)
- K972117MSI BOTTLEFLOW, TRANSFLOW, VIALFLOW2Cleared 510(K)
- K955622AUTOMIX PLUS, 3+3, MICROMIX COMPOUNDING SYSTEM;2Cleared 510(K)
- K970789SAFE-CONNECT VIAL DISPENSING SPIKE2Cleared 510(K)
- K964989CDC VIAL AND BAG ACCESS PIN (CDC-P-1/P-2/P-3/P-4/P-5)2Cleared 510(K)
- K970359COMBIPROT EMERGENCY ENFUSION DEVICE2Cleared 510(K)
- K963012BIOJECT NEEDLE-FREE VIAL ADAPTER (13MM)2Cleared 510(K)
- K963583MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PREATTACHED NEEDLE2Cleared 510(K)
- K960466IVEX-2 EXTENSION SET WITH Y-INJECTION SITE (MODIFICATION)2Cleared 510(K)
- K960921CODAN MEDLON BC110 VIAL ADAPTER CODAN SPIKE2Cleared 510(K)
- K955398FORMULATION PREPARATION DEVICE2Cleared 510(K)
- K955594SAFELINE I.V. BAG ACCESS DEVICE2Cleared 510(K)
- K955595SAFELINE MULTIDOSE VIAL ADAPTER2Cleared 510(K)
- K955896MACROBORE TUBING - CDC-F-1 THROUGH CDC-F-112Cleared 510(K)
- K950305QTMICRO(TM) SYSTEM2Cleared 510(K)
- K943095IV TRANSFER SPIKE2Cleared 510(K)
- K943181DISPENSING PIN WITH ONE-WAY VALVE2Cleared 510(K)
- K935532TRANSFER SET2Cleared 510(K)
- K935274DIPRIVAN LUER CONNECTOR2Cleared 510(K)
- K926071ONCO-VIAL ADAPTER2Cleared 510(K)
- K932462VENTED NEEDLE2Cleared 510(K)
- K923782TRANSFER SET2Cleared 510(K)
- K923966SYRINGE ADAPTOR2Cleared 510(K)
- K924064INTERLINK UNIVERSAL VIAL ADAPTER2Cleared 510(K)
- K925401IV FLUID TRANSFER PIN2Cleared 510(K)
- K920015QUICKTEST SYSTEM2Cleared 510(K)
- K921031EDGE MEDICAL DISPENSING PIN2Cleared 510(K)
- K921365NUTRIMIX MICROCOMPOUNDER2Cleared 510(K)
- K913985TRANSFER-AID(TM)2Cleared 510(K)
- K912771ACACIAS PHARM/PUMP2Cleared 510(K)
- K913804EXCELSIOR SINGLE LEAD DISPENSING SET2Cleared 510(K)
- K902853GRAVITY PLUS CONTROLLER/COMPOUNDER2Cleared 510(K)
- K905116PHARM-ASSIST2Cleared 510(K)
- K910213NUTRIMIX(R) MACRO(TM) TPN COMPOUNDER/MODIFICATION2Cleared 510(K)
- K910793RECONSTITUTION DEVICE2Cleared 510(K)
- K905201TPN FLUID TRANSFER SET2Cleared 510(K)
- K904855ADD-A-VIAL2Cleared 510(K)
- K903159VALVE CONTROLLER FOR MICROMACRO COMPOUNDER2Cleared 510(K)
- K904225KWIKMIX2Cleared 510(K)
- K895922METRICARE EMPTY CONTAINER SYSTEMS2Cleared 510(K)
- K900865ADD-A-VIAL II BINARY CONNECTOR2Cleared 510(K)
- K901063LUER LOCK TRANSFER PIN2Cleared 510(K)
- K902482VITALMIX (SET & BAG)2Cleared 510(K)
- K901404NUTRIMIX MACRO TPN COMPOUNDER2Cleared 510(K)
- K900585TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP2Cleared 510(K)
- K896990PHARMULATOR2Cleared 510(K)
- K890204AUTOMIX COMPOUNDER VENTED SPIKE ADAPTOR2Cleared 510(K)
- K890205AUTOMIX COMPOUNDER Y - ADAPTOR SET2Cleared 510(K)
- K894827AUTOMIX 3+3 COMPOUNDER2Cleared 510(K)
- K884626MODIFIED SLIDING RECONSTITUTION DEVICE2Cleared 510(K)
- K874495ADCOMP 4000 HP SYSTEM2Cleared 510(K)
- K872446MODIFIED INSTAFIL2Cleared 510(K)
- K860610ADCOMP2Cleared 510(K)
- K860703U - STAR (MICRO-STAR)2Cleared 510(K)
- K861434MODIFIED HC-417 BAG TO BAG & HC-418 BOTTLE TO BAG2Cleared 510(K)
- K860595TRANSFER SET2Cleared 510(K)
- K860434CHEMO-VENT2Cleared 510(K)
- K860113DOUBLE-JECT TRANSFER NEEDLE2Cleared 510(K)
- K854556TRANSFER NEEDLE2Cleared 510(K)
- K854008STATLOCK2Cleared 510(K)
- K853830SLIDING RECONSTITUTION DEVICE W/ADMIX VIALEX PLAST2Cleared 510(K)
- K852467VIAL VENT FILTER2Cleared 510(K)
- K853075MEDNOVA SAFETY BAG2Cleared 510(K)
- K853212FLOW EASE(PLASTIC VENTED NEEDLE)2Cleared 510(K)
- K853188TRANSFER DEVICE2Cleared 510(K)
- K852882MAXIFILL TRANSFER SET2Cleared 510(K)
- K850757TANDEM SETS I.V.2Cleared 510(K)
- K850051VERSA-FILL 120 & FILL SET 42-502Cleared 510(K)
- K844904CYTOSAFE NEEDLE2Cleared 510(K)
- K843639ADD-A-VIAL SOLUTION TRANSFER DEVICE2Cleared 510(K)
- K844340TRAVENOL RECONSTITUTION DEVICE W/ADMIX CAP2Cleared 510(K)
- K842345MAXIFILL TRANSFER SET2Cleared 510(K)
- K834500SOLUTION TRANSFER SET2Cleared 510(K)
- K832332VENTED I.V. TRANSFER NEEDLE2Cleared 510(K)
- K832347TWOFER NEEDLE2Cleared 510(K)
- K832312I.V. TRANSFER NEEDLE2Cleared 510(K)
- K830836Q.C. TESTER2Cleared 510(K)
- K830970DOUBLE LUMEN TRANSFER DEVICE2Cleared 510(K)
- K820937ACKRAD FLUID CONNECTING SET2Cleared 510(K)
- K812928VACU-FIL TRANSFER SET2Cleared 510(K)
- 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
Decanting Device
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K182819
- 510(k) Type
- Traditional
- Applicant
- Gcmedica Enterprise Ltd., (WUXI)
- Country
- China
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/2/2019
- Days to Decision
- 424 days
- Submission Type
- Summary