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
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories2Product Code
- KDPRegulator, Vacuum2Product Code
- KDQBottle, Collection, Vacuum2Product Code
- KIACover, Cast1Product Code
- KMEBedding, Disposable, Medical1Product Code
- K042145READY-HEAT BLANKET1Cleared 510(K)
- K944953OREX MEDICAL BEDDING1Cleared 510(K)
- K933636DISPOSE-A-SHEET1Cleared 510(K)
- K932539DOCTOR DOWN --RESCUE WRAP1Cleared 510(K)
- K922143AMERICAN BURN SHEET1Cleared 510(K)
- K915303FOIL BABY BUNTING1Cleared 510(K)
- K912257CHEM-SLEEVE B1Cleared 510(K)
- K911948MEDI GUARD PILLOWCASE1Cleared 510(K)
- K911953MEDI GUARD SHEETS/UNDERLAYS1Cleared 510(K)
- K911952MEDI GUARD UNDERPAD1Cleared 510(K)
- K911950MEDI GUARD DRAPES1Cleared 510(K)
- K905003BIO-GUARD SHAVE PREP TRAY1Cleared 510(K)
- K904274RECEIVING BLANKET1Cleared 510(K)
- K901509TRAUMA SLEEVE1Cleared 510(K)
- K901629CHEM-SLEEVE1Cleared 510(K)
- K900643FLUID SOAKERSHIELD1Cleared 510(K)
- K896043MATTRESS COVER FOR MEDICAL PURPOSES1Cleared 510(K)
- K891986MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE1Cleared 510(K)
- K894170DEVON DISPOSABLE HEAD POSITIONER COVER1Cleared 510(K)
- K884380BED SHEET, PILLOW CASE1Cleared 510(K)
- K882332HEADREST, PATIENT COMFORT1Cleared 510(K)
- K881969DRY COMFORT DISPOSABLE UNDERPAD1Cleared 510(K)
- K881859DRIPRIDE DISPOSABLE UNDERPAD1Cleared 510(K)
- K871725DRIPRIDE DISPOSABLE UNDERPADS1Cleared 510(K)
- K870925PAD, BED LINEN PROTECTIVE1Cleared 510(K)
- K870522DEPEND UNDERPAD1Cleared 510(K)
- K864158THERMAPAD1Cleared 510(K)
- K863179KIMLON DISPOSABLE BLANKET1Cleared 510(K)
- K862348SINGLE-USE PATIENT UNDERPAD1Cleared 510(K)
- K860066REFLECTIVE BLANKET1Cleared 510(K)
- K853970ALPHA CHUCK1Cleared 510(K)
- K853880ATTENDS DISPOS. UNDERPAD1Cleared 510(K)
- K850067MEDICAL, DISPOSABLE BEDDING1Cleared 510(K)
- K850811PAD, PRE-OPERATIVE PREPARATION1Cleared 510(K)
- K850544SHAVE PREP TRAY1Cleared 510(K)
- K844196WET SKIN SCRUB TRAY STERILE WET SKIN SCRUB KIT1Cleared 510(K)
- K842989SHAVE PREP KITS1Cleared 510(K)
- K843038DISPOSABLE PATIENT BLANKET1Cleared 510(K)
- K843402MOLINEA UNDERPADS1Cleared 510(K)
- K842335PILLOW W/STAPHCHEK TICKING1Cleared 510(K)
- K842336DISPOSABLE PILLOW1Cleared 510(K)
- K832487DRAW SHEET, ANTI-MICROBIAL1Cleared 510(K)
- K832486PILLOW COVER, ANTI-MICROBIAL1Cleared 510(K)
- K822650SUPER DONUT1Cleared 510(K)
- K821835BARRIER BURN SHEET1Cleared 510(K)
- K8205823M THINSULATE DISPOSABLE HOSPITAL BED1Cleared 510(K)
- K813519NON-ABSORBENT TOWELS1Cleared 510(K)
- K813263PATIENT UNDERPAD1Cleared 510(K)
- K812079DISPOSABLE PILLOW1Cleared 510(K)
- K811232DISPOSABLE UNDERPADS1Cleared 510(K)
- K810264DISPOSABLE PILLOW1Cleared 510(K)
- K802998PATIENT CARE DISPOSABLE INFANT SHIRTS1Cleared 510(K)
- K802730FLUFF UNDERPAD TYPE UP10021Cleared 510(K)
- K802740FLUFF UNDERPAD TYPE UP10011Cleared 510(K)
- K792626STERILIZATION PROCESS/BABY BLANKET1Cleared 510(K)
- K790411AUTO TRAUMA KIT1Cleared 510(K)
- K790659INFANT SCALE DISPOSABLE LINER1Cleared 510(K)
- K790283PILLOW, CARTER ARM ELEVATION1Cleared 510(K)
- K782001ROSEALAE1Cleared 510(K)
- K781796BEDDING, DISPOSABLE HOSPITAL1Cleared 510(K)
- K781354PILLOWS- SINGLE PATIENT USE1Cleared 510(K)
- K781227TOWELS, SHEETS, PILLOWCASES1Cleared 510(K)
- K770486SHEET KIT, STRETCHER, DISPOSABLE1Cleared 510(K)
- K761109TERRYCLOTH BIBS1Cleared 510(K)
- K761108PLASTIC DISPOSABLE BIB1Cleared 510(K)
- 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
SUPER DONUT
- Page Type
- Cleared 510(K)
- 510(k) Number
- K822650
- 510(k) Type
- Traditional
- Applicant
- ALIMED, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/30/1982
- Days to Decision
- 28 days