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
- 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
- FLGCleaner, Ultrasonic, Medical Instrument1Product Code
- FLHWasher Of Body Waste Receptacles1Product Code
- FLICabinet, Ethylene-Oxide Gas Aerator2Product Code
- BRTRestraint, Patient, Conductive1Product Code
- BYYTube, Aspirating, Flexible, Connecting2Product Code
- BYZTrap, Sterile Specimen2Product Code
- CBCBottle, Collection And Trap, Breathing System (Uncalibrated)2Product Code
- CBDBottle, Collection, Breathing System (Calibrated)2Product Code
- FLESterilizer, Steam2Product Code
- FLFSterilizer, Ethylene-Oxide Gas2Product Code
- FMADepressor, Tongue, Non-Surgical1Product Code
- FMCPatient Examination Glove1Product Code
- FMEGown, Examination1Product Code
- FMLChair, Blood Donor1Product Code
- FMPProtector, Skin Pressure1Product Code
- FMQRestraint, Protective1Product Code
- FMRDevice, Transfer, Patient, Manual1Product Code
- FMWCover, Mattress (Medical Purposes)1Product Code
- FNPUrinal1Product Code
- FNSRing Cutter1Product Code
- FNYBasin, Emesis1Product Code
- FOABoard, Cardiopulmonary1Product Code
- FOBBedpan1Product Code
- FOXStand, Infusion1Product Code
- FPFBottle, Hot/Cold Water1Product Code
- FPOStretcher, Wheeled2Product Code
- FPPStretcher, Hand-Carried1Product Code
- FPSBoard, Bed1Product Code
- FRAPurifier, Air, Ultraviolet, Medical2Product Code
- FRGWrap, Sterilization2Product Code
- FRJChair, Geriatric1Product Code
- FRKChair, Examination And Treatment1Product Code
- FRZDevice, Patient Transfer, Powered2Product Code
- GAZTubing, Noninvasive2Product Code
- GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered2Product Code
- JOKScissors, Medical, Disposable1Product Code
- JOLCatheter And Tip, Suction2Product Code
- K051370STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F80142Cleared 510(K)
- K000266PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION2Cleared 510(K)
- K000265PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION2Cleared 510(K)
- K003402WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION2Cleared 510(K)
- K994321STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP2Cleared 510(K)
- K974758HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE2Cleared 510(K)
- K974759HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE2Cleared 510(K)
- K974397STERILE SALINE FOR CATHETER CARE2Cleared 510(K)
- K973734STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION2Cleared 510(K)
- K972372GERM TRAPPER SUCTION TUBE HOLDER2Cleared 510(K)
- K960216CPR SUCTION CATHETER KIT2Cleared 510(K)
- K954442STERILE ISOTONIC SALINE & STERILE WATER2Cleared 510(K)
- K950201ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER2Cleared 510(K)
- K951524THORACENTESIS CATHETER2Cleared 510(K)
- K945728CATCO THORACIC CATHETER2Cleared 510(K)
- K943661STERILE PHYSIOLOGICAL SALINE/STERILE WATER2Cleared 510(K)
- K943773STERILE WATER2Cleared 510(K)
- K943834STERILE .9% SODIUM CHLORIDE SOLUTION2Cleared 510(K)
- K943836PRE-FILLED 10CC INFLATION SYRINGE W/STERILE WATER2Cleared 510(K)
- K943832STERILE .9% SODIUM CHLORIDE FOR IRRATION2Cleared 510(K)
- K943831PRE-FILLED 30CC INFLATION SYRINGE W/STERILE WATER2Cleared 510(K)
- K943830PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTION2Cleared 510(K)
- K943829PRE-FILLED SYSRINGE W/STERILE WATER2Cleared 510(K)
- K943828STERILE WATER FOR IRRIGATION2Cleared 510(K)
- K932138SALINE FOR IRRIGATION2Cleared 510(K)
- K943833STERILE WATER FOR IRRATION2Cleared 510(K)
- K931509GERITREX STERILE SALINE SOLUTION FOR IRRIGATION2Cleared 510(K)
- K933762STB YANKAUER SUCKER/NOZZLE2Cleared 510(K)
- K942061DISPOSABLE SUCTION PROBE2Cleared 510(K)
- K941232THORA-CATH2Cleared 510(K)
- K933526STERILE WATER2Cleared 510(K)
- K931511GERITREX STERILE WATER FOR IRRIGATION2Cleared 510(K)
- K934382VCI SUCTION/IRRIGATION TUBING SET2Cleared 510(K)
- K932185SURGICAL SUCTION TIP2Cleared 510(K)
- K922714UNIVERSAL IRRIGATION & SUCTION TUBING SET2Cleared 510(K)
- K913896JAIN BLOOD SHIELD2Cleared 510(K)
- K913876ENDOTRACHEAL SUCTIONTUBE2Cleared 510(K)
- K910693PHARMASEAL THORACENTESIS TRAY W/UNIV DRAINAGE SET2Cleared 510(K)
- K910963THOROCENTESIS KIT2Cleared 510(K)
- K904216STERILE WATER SOLUTION CATALOG # 100002Cleared 510(K)
- K903569CURITY THORACENTESIS TRAY2Cleared 510(K)
- K890039KLEEN TEST BASIN SET2Cleared 510(K)
- K893667SUCTION TIP2Cleared 510(K)
- K893527LAPAROSCOPIC SUCTION PROBE2Cleared 510(K)
- K893135GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER2Cleared 510(K)
- K883905ARROW PNEUMOTHORAX KIT, AK-015002Cleared 510(K)
- K872948URESIL THORA-FLO THORACENTESIS PROCEDURE KIT2Cleared 510(K)
- K873563APLICARE STERILE WATER - FOR SUCTION CATHETER ONLY2Cleared 510(K)
- K873464VAN DELLEN CANNULA2Cleared 510(K)
- K873525DEKNATEL TROCAR CATHETER2Cleared 510(K)
- K873517DEKNATEL THORACIC CATHETER2Cleared 510(K)
- K871950VIA-GUARD2Cleared 510(K)
- K870572ARROW-CLARKE(TM) PLEURA-SEAL(TM) THORACENTESIS KIT2Cleared 510(K)
- K864937'EXMOOR' ZOELLNER SUCKER ENDS2Cleared 510(K)
- K860927HD CRYSTALINE SUCTION TIP2Cleared 510(K)
- K852041DEKNATEL THORACIC CATHETER2Cleared 510(K)
- K851979TROCAR CATHETER2Cleared 510(K)
- K851611IMPACT TURBO CATH2Cleared 510(K)
- K851385THORA-CATH TROCAR-TYPE CHEST DRAINAGE TUBE2Cleared 510(K)
- K850240KM PRODUCTS SUCTION TIPS2Cleared 510(K)
- K843469PHARMA-PLAST SUCTION TIP, TYPE ORTHOPAE-2Cleared 510(K)
- K843188WELLS JOHNSON CO. CHAJ-CHIR-SUCTION TIP2Cleared 510(K)
- K840669SUCTION DEVICE-PHARYNEAL DEVICE2Cleared 510(K)
- K840007SURGICAL SUCTION INSTRUMENT-REUSABLE2Cleared 510(K)
- K832880TRACHEOSTOMY CARE TRAYS2Cleared 510(K)
- K832517CUSTOM KWIK SET AND/OR PAK2Cleared 510(K)
- K831999FEMORAL CANAL SUCTION TAMPON2Cleared 510(K)
- K832027ARGYLE YANKAVER SUCTION TUBE W/CONTROL2Cleared 510(K)
- K830942SUCTION CATHETERS2Cleared 510(K)
- K821342METAL BACKED ACETABULAR COMPONENT2Cleared 510(K)
- K820718ARGYLE THORACIC CATHETERS2Cleared 510(K)
- K8204603.5 & 5.5 OZ. SODIUM CHLORIDE SOLUTION2Cleared 510(K)
- K812312STERILE WATER 4OZ.2Cleared 510(K)
- K803206SUCTION PROBE2Cleared 510(K)
- K803187ARGYLE UNIVERSAL POOLE SUCTION TUBE2Cleared 510(K)
- K801134MICROVAC2Cleared 510(K)
- K801127MACROVAC2Cleared 510(K)
- K800635C.C.-PAK2Cleared 510(K)
- K800234ABCO SUCTION CATHETER & KITS W/GLOVE&CUP2Cleared 510(K)
- K791801CONPHAR FINGERTIP SUCTION CONTROL2Cleared 510(K)
- K782027HYSTERECTOMY T DRAIN2Cleared 510(K)
- K770983CATHETER THORACIC, AXIOM2Cleared 510(K)
- K770233STERILE SUCTION CATHETER W/CONTROL2Cleared 510(K)
- K760586SUCTION KIT2Cleared 510(K)
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories2Product Code
- KDPRegulator, Vacuum2Product Code
- KDQBottle, Collection, Vacuum2Product Code
- KIACover, Cast1Product Code
- KMEBedding, Disposable, Medical1Product Code
- KMGPurifier, Water, Ultraviolet, Medical2Product Code
- KMHSterilizer, Dry Heat2Product Code
- KMJLubricant, Patient1Product Code
- KMNChair And Table, Medical1Product Code
- KXFApplicator, Absorbent Tipped, Non-Sterile1Product Code
- KXGApplicator, Absorbent Tipped, Sterile1Product Code
- KYRBag, Ice1Product Code
- KYSInsoles, Medical1Product Code
- KYTLight, Examination, Medical, Battery Powered1Product Code
- KYWContainer, Liquid Medication, Graduated1Product Code
- KYXDispenser, Liquid Medication1Product Code
- KYZSyringe, Irrigating (Non Dental)1Product Code
- KZADevice, Vein Location, Liquid Crystal1Product Code
- KZFDevice, Medical Examination, Ac Powered1Product Code
- KZHIntroducer, Syringe Needle2Product Code
- LBJDevice, Vein Stabilization1Product Code
- LDSDevice, Pasteurization, Hot Water2Product Code
- LRJDisinfectant, Medical Devices1Product Code
- LYYLatex Patient Examination Glove1Product Code
- LYZVinyl Patient Examination Glove1Product Code
- LZAPolymer Patient Examination Glove1Product Code
- LZBFinger Cot1Product Code
- LZCPatient Examination Glove, Specialty1Product Code
- MDZCleaners, Medical Devices2Product Code
- MECDisinfector, Medical Devices2Product Code
- MEDSterilant, Medical Devices2Product Code
- MKBDevice, Germicidal, Ultraviolet2Product Code
- MLRSterilizer, Chemical2Product Code
- MMSLubricant, Vaginal, Patient1Product Code
- MTVSharps Needle Destruction Device2Product Code
- NRVImplantable Radio Frequency Transponder System2Product Code
- NZDStretcher, Patient Restraint1Product Code
- NZHMedication Management System, Remote2Product Code
- NZJRespirator, N95, For Use By The General Public In Public Health Medical Emergencies2Product Code
- OHYPill Crusher/Cutter1Product Code
- OIGPowder-Free Guayle Rubber Examination Glove1Product Code
- PEQAccessories To Examination Light1Product Code
- OPCPowder-Free Polychloroprene Patient Examination Glove1Product Code
- OPHRadiation Attenuating Medical Glove1Product Code
- OPIAntimicrobial Medical Glove1Product Code
- OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs1Product Code
- ORWN95 Respirator With Antimicrobial/Antiviral Agent For Use By The General Public In Public Health Medical Emergencies2Product Code
- OSZAntimicrobial Keyboard2Product Code
- OUGMedical Device Data System1Product Code
- OVYLiquid Chemical Processing System2Product Code
- OYSPatient Bed With Canopy/Restraints1Product Code
- PADChest Drainage Kit2Product Code
- PECSterilizer Automated Loading System2Product Code
- PJJTwo Or More Sterilant Sterilizer2Product Code
- PWMAdmission Kit (Patient Utensil)1Product Code
- PYQRfid Chip For Dental Appliance2Product Code
- PWPBlood Borne Pathogen Response Kit1Product Code
- PWSChemotherapy Administration Kit1Product Code
- PWTChemotherapy Spill Clean-Up Kit1Product Code
- PWUClean-Up Kit1Product Code
- PWVDelivery Room Apparel Kit1Product Code
- PWZMid-Stream Collection Kit1Product Code
- PXAOral Administration Set1Product Code
- PXCPersonal Protection Kit1Product Code
- PXDPrep Kit1Product Code
- PXFSitz Bath Kit1Product Code
- PXGSpill Kit1Product Code
- PXMVomitus Clean-Up Kit1Product Code
- QDOFentanyl And Other Opioid Protection Glove1Product Code
- QTVMattress And Bed Deck Cover (Medical Purposes)1Product Code
- 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
STERILE ISOTONIC SALINE & STERILE WATER
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K954442
- 510(k) Type
- Traditional
- Applicant
- MEDCARE CUSTOM PACKAGING, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/21/1995
- Days to Decision
- 87 days
- Submission Type
- Summary