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
- K042454STRYKER CASSETTE PUMP2Cleared 510(K)
- K992126CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM2Cleared 510(K)
- K972074SUCTION INSTRUMENTATION2Cleared 510(K)
- K971022CHASE SUCKER2Cleared 510(K)
- K964127MEDI-VAC FLEXI-CLEAR SUCTION HANDLE2Cleared 510(K)
- K964519CURITY THORACENTESIS TRAY2Cleared 510(K)
- K963648STRYKER SUCTION REGULATOR2Cleared 510(K)
- K962920RENTON SUCTION DEVICE U.S. PATENT*4,767,4042Cleared 510(K)
- K961880MEDCARE SUCTION CONNECTING TUBING2Cleared 510(K)
- K960223CPR YANKAUER2Cleared 510(K)
- K954869MEDCARE YANKAUER SUCTION DEVICE2Cleared 510(K)
- K954726STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION)2Cleared 510(K)
- K952219SUCTION TIP CLEANER CUP2Cleared 510(K)
- K951119NEZHAT-DORSEY SPECIMEN CONTAINER SYSTEM2Cleared 510(K)
- K950464SSCOR/BOARD ..3 MODEL 23000 PRE-ASSEMBLED SUCTION SYSTEM FOR PATIENT TRANSPORT VEHICLES2Cleared 510(K)
- K931548INAMED DEVELOPMENT ASPIRATION TIP2Cleared 510(K)
- K924570OEM MULTI-VAC POWERED SUCTION PUMP2Cleared 510(K)
- K920912THE MEDIC TM2Cleared 510(K)
- K924337PLEUR-EVAC(R) ADULT/PEDI DUAL COLL CHEST DRAIN SYS2Cleared 510(K)
- K924577MEDIVAC2Cleared 510(K)
- K911238TAHOE SUCTION IRRIGATOR2Cleared 510(K)
- K920248MODEL SLASE 210 HOLMIUM LASER SYSTEM2Cleared 510(K)
- K914601SUCTION CONNECTING TUBING2Cleared 510(K)
- K912753XOMED-TREACE POSITROL FOOTPEDAL SUCTION CONTROL2Cleared 510(K)
- K910377COOPERSURGICAL MODEL 6080 SMOKE EVACUATOR SYSTEM2Cleared 510(K)
- K910218LAPAROMED CHOLANGIOGRAM VACUUM DEVICE2Cleared 510(K)
- K905448THORA-KLEX CHEST DRAINAGE UNIT2Cleared 510(K)
- K895859CONTAIN(TM)2Cleared 510(K)
- K896134ACUFLO, VACUUM-POWERED BODY FLUID SUCTION APPARA.2Cleared 510(K)
- K901937CODMAN SUCTION PATTIE2Cleared 510(K)
- K902089EQUI-GUARD (ASPIRATOR FILTER)2Cleared 510(K)
- K896804MANIFOLD2Cleared 510(K)
- K896562STOPCOCK2Cleared 510(K)
- K896563TUBING CONNECTORS2Cleared 510(K)
- K896558YANKAUER SUCTION TUBE-RIGID TYPE2Cleared 510(K)
- K896557YANKAUER SUCTION TUBE-FLEXIBLE TYPE2Cleared 510(K)
- K896556UNIVERSAL POOLE SUCTION TUBE2Cleared 510(K)
- K894695VACUSAFE DISP. VACUUM - EXTRACTION SYSTEM2Cleared 510(K)
- K895039STERILE SALINE - FOR SUCTION CATHETER LUBRICATION2Cleared 510(K)
- K893649MECONIUM ASPIRATOR2Cleared 510(K)
- K893741RECEPTAL (R) SAF-GARD(TM) SUCTION LINER2Cleared 510(K)
- K892549SUCTION TUBES: HOUSE, BARON2Cleared 510(K)
- K890129PLEUR-EVAC(R) A-8020--INFANT CHEST DRAINAGE SYSTEM2Cleared 510(K)
- K890431PLEUR-EVAC(R) A-8000--ADULT/PEDIATRIC CHEST DRAIN2Cleared 510(K)
- K885208RECEPTAL SAF-GARD(TM) SYSTEM2Cleared 510(K)
- K885334VAC-RITE2Cleared 510(K)
- K884103REMOTE VACUUM BOOSTER SYSTEM, 7600 SERIES2Cleared 510(K)
- K881252PLEUR-EVAC(R) A6000 ADULT/PEDIATRIC CHEST DRAINAGE2Cleared 510(K)
- K874505CONTAIN(TM)2Cleared 510(K)
- K870874CSPI SPECIMEN TRAP (NON-STERILE)2Cleared 510(K)
- K880704CERULLO SUCTION REGULATOR2Cleared 510(K)
- K873489EMERSON DISPOS THORACIC DRAINAGE SET - 551-80002Cleared 510(K)
- K861261OHMEDA POSI-PULSE SUCTION UNIT2Cleared 510(K)
- K853095BOEHRINGER LABORATORIES SUCTION INTERMITTOR2Cleared 510(K)
- K851384MEDICAL/SURGICAL SUCTION SYSTEM2Cleared 510(K)
- K844881RICO RS4-XP EMERGENCY MEDICAL ASPIRATOR2Cleared 510(K)
- K844882RICO RS-6X EMERGENCY MEDICAL ASPIRATOR2Cleared 510(K)
- K833674ACCURATE MEASUREMENT DEVICE KG-AMD2Cleared 510(K)
- K833673ACCURATE MEASUREMENT DEVICE EZ-AMD2Cleared 510(K)
- K831116INVAC W/VARIOUS MODELS2Cleared 510(K)
- K831939TALL FLOOR STAND TFS-012Cleared 510(K)
- K823037PLEUR-EVAC A-4005 SYSTEM2Cleared 510(K)
- K822311DISPOSABLE COLLECTION BOTTLE W/TUBING2Cleared 510(K)
- K822005SPECIMEN COLLECTORS2Cleared 510(K)
- K821841MEDIGAS SUCTION/DRAINAGE EQUIPMENT2Cleared 510(K)
- K821160PNEUMO DRAIN T.M. RECORDER #PD-8002Cleared 510(K)
- K821023THORACIC DRAINAGE SYSTEM2Cleared 510(K)
- K820765PLEURAL DRAINAGE RESERVOIR2Cleared 510(K)
- K820424IMPACT, MODEL 3102Cleared 510(K)
- K820337IMPACT, MODEL 3032Cleared 510(K)
- K813394DS-7 CLOSED WOUND SUCTION DRAIN SYSTEM2Cleared 510(K)
- K813319ASPIRATOR VENTURI SYSTEM MODEL 55-JV2Cleared 510(K)
- K813029VALVED SURGICAL ASPIRATORS2Cleared 510(K)
- K813066ARGYLE YANKAUER SUCTION TUBE2Cleared 510(K)
- K812845SURGICAL SUCTION INSTRUMENTS-DISPOS.2Cleared 510(K)
- K802440ARGYLE COMPACT CHEST DRAINAGE SYS.2Cleared 510(K)
- K801979ARGYLE COMPACT CHEST DRAINAGE SYSTEM2Cleared 510(K)
- K801942OHIO THORACIC COLLECTION UNIT2Cleared 510(K)
- K790055TUBING, DYNACOR UNIVERSAL2Cleared 510(K)
- K781988SUCTION APPARATUS, POWERED BY COMP. AIR2Cleared 510(K)
- K771737SUCTION CANISTER2Cleared 510(K)
- K760814HEPARINIZED PENROSE TUBING2Cleared 510(K)
- K760813HEPARINIZED SARATOGA SUMP DRAIN2Cleared 510(K)
- K760812HEPARINIZED WOUND SUCTION TUBING2Cleared 510(K)
- K760333JAR, COLLECTOR FOR SUCTION SYSTEMS2Cleared 510(K)
- K760217SUCTION INSTRUMENT, MACBICK DIS. FRAZ.2Cleared 510(K)
- K760216SUCTION INSTRUMENT, MACBICK POOLE TIP2Cleared 510(K)
- JOKScissors, Medical, Disposable1Product Code
- JOLCatheter And Tip, Suction2Product Code
- 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
MANIFOLD
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K896804
- 510(k) Type
- Traditional
- Applicant
- WESTMARK, STERILE PACKING SYSTEMS, INC. (SPS)
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/8/1990
- Days to Decision
- 69 days