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
- K250168Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer2Cleared 510(K)
- K250164Cassette Autoclave (ACA5)2Cleared 510(K)
- K243994Steam Sterilizer (2545D)2Cleared 510(K)
- K243801FRONT-LINE Field Sterilizer (FL135)2Cleared 510(K)
- K233026Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer2Cleared 510(K)
- K233504Lexa MINI (RIS-303, RIS-305)2Cleared 510(K)
- K233132PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)2Cleared 510(K)
- K232658T-Top 10 & T-Top T-Top 112Cleared 510(K)
- K232485AMSCO 600 Steam Sterilizer2Cleared 510(K)
- K231489Sturdy Autoclave Super Microm2Cleared 510(K)
- K223858Lexa MINI (RIS-303, RIS-305)2Cleared 510(K)
- K221474PRIMUS Healthcare Sterilizer (Model PSS11-HC)2Cleared 510(K)
- K213545Steelco VS Series Steam Sterilizers, models 262839, 262851, 2628692Cleared 510(K)
- K222608Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS2Cleared 510(K)
- K220102MOST-T Autoclave2Cleared 510(K)
- K221227Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 661202Cleared 510(K)
- K213758Lexa PLUS RIS-3112Cleared 510(K)
- K220736Consolidated HC Steam Sterilizer2Cleared 510(K)
- K214120GSS610N21 Series Steam Sterilizer2Cleared 510(K)
- K214057STATIM 6000B Vacuum Autoclave2Cleared 510(K)
- K213457Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL1352Cleared 510(K)
- K213991Enbio S2Cleared 510(K)
- K213080T-Edge 10, T-Edge 112Cleared 510(K)
- K210279Enbio S2Cleared 510(K)
- K212424AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers2Cleared 510(K)
- K211500AMSCO 600 Medium Steam Sterilizer2Cleared 510(K)
- K210326Bravo G4 Chamber Autoclave2Cleared 510(K)
- K201927Getinge GSS610N Series Steam Sterilizer2Cleared 510(K)
- K203061Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200),Evolution Automated Loading and Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-600 and HC-1500),Evolution Automated Loading and Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-800 and HC-1000),Evolution Automated Loading and Unloading System (ALUS)2Cleared 510(K)
- K192910STATClave G4 Chamber Autoclave2Cleared 510(K)
- K181993STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R)2Cleared 510(K)
- K191896Belimed Steam Sterilizer MST-H TOP 50002Cleared 510(K)
- K190062STATCLAVE G4 Chamber Autoclave2Cleared 510(K)
- K181456Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves2Cleared 510(K)
- K183410AMSCO 600 Steam Sterilizer2Cleared 510(K)
- K180272Saniclave 2502Cleared 510(K)
- K172825MN-1112Cleared 510(K)
- K173481Amsco Evolution Medium Steam Sterilizer2Cleared 510(K)
- K170304Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers2Cleared 510(K)
- K173493Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-30002Cleared 510(K)
- K173490Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000)2Cleared 510(K)
- K173485Amsco Evolution Medium Steam Sterilizer2Cleared 510(K)
- K172159Getinge GSS67N Series Steam Sterilizer2Cleared 510(K)
- K163337Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer2Cleared 510(K)
- K170228Belimed Steam Sterilizer MST-H TOP 50002Cleared 510(K)
- K161848Family of Steam sterilizers B17 B22 Series2Cleared 510(K)
- K151597Family of Steam Sterilizers B 28 series2Cleared 510(K)
- K141879BELIMED STEAM STERILIZER MST-H2Cleared 510(K)
- K140736STERISAFE HP TABLE-TOP STEAM STERILIZER2Cleared 510(K)
- K143311Pre-vacuum Tabletop Autoclave2Cleared 510(K)
- K141009FORT DEFIANCE AUTOMATED STEAM STERILIZER2Cleared 510(K)
- K132439SAKURA STEAM STERILIZER ASSR; -AO12, -A012W, -AO12P,-AO12PW / SKYTRON INTEGRITY 270;STEAM STERILIZER,VP STEAM STERILIZER2Cleared 510(K)
- K130172BELIMED STEAM STERILIZER MST-V2Cleared 510(K)
- K122978SANICLAVE 102, MODEL RS-SC-1022Cleared 510(K)
- K122625GETINGE 800HC- SERIES STEAM STERILIZER2Cleared 510(K)
- K122774SAKURA STEAM STERILIZAER MODEL ASSV-AH06; SAKURA STEAM STERILIZER MODEL ASSV-AH06E; SKYTRON INTEGRITY 175; SKYTRON INTEG2Cleared 510(K)
- K122071GETINGE 400HC-E / SERIES STEAM STERILIZER2Cleared 510(K)
- K112872STATIM 2000 G4 CASSETTE2Cleared 510(K)
- K120441GETINGE 700HC-E SERIES STEAM STERILIZER2Cleared 510(K)
- K120149SKYRON INTEGRITY 215 STEAM STERILIZER SKYTRON INTEGRITY 215 SG STEAM STERILIZER SAKURA STEAM STERILIZER ASSV-AB09 SAKURA2Cleared 510(K)
- K112403AMSCO CHIMERON MEDIUM STEAM STERLILZER2Cleared 510(K)
- K112811SANICLAVE 2002Cleared 510(K)
- K112055AMSCO CHIMERON MEDIUM STEAM STERILIZER2Cleared 510(K)
- K111736TUTTNAUER EZ PLUS SERIES ELECTRONIC TABLETOP AUTOCLAVES2Cleared 510(K)
- K111223AMSCO CHIMERON SMALL STEAM STERILIZER2Cleared 510(K)
- K103504GETINGE 400HC/500HC SERIES STEAM STERILIZER2Cleared 510(K)
- K103841BELIMED STEAM STERILIZER MST-V2Cleared 510(K)
- K100622BELIMED STEAM STERILIZER, MODEL MST-V 3-3-62Cleared 510(K)
- K093333PRIMUS STEAM STERILIZER PSS8-AA (16X16X26 MULTI FUNCTIONAL STERILIZER), LAB/LO STERILIZER,PRIMUS STEAM STERILIZER PSS82Cleared 510(K)
- K092490AMSCO EVOLUTION SERIES STEAM STERILIZER, MODEL: HC-2000 AND HC-30002Cleared 510(K)
- K090339BELIMED STEAM STERILIZER TOP 5000, SERIES 8, MODELS: 6-0-12 VS1 AND VS22Cleared 510(K)
- K091731AMSCO EVOLUTION MEDIUM STEAM STERILIZER2Cleared 510(K)
- K090783TUTTNAUER ELARA-11 PRE-VACUUM TABLETOP AUTOCLAVE2Cleared 510(K)
- K090670MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER2Cleared 510(K)
- K091136AMSCO EVOLUTION MEDIUM STEAM STERILIZER, MODEL HC-900 AND HC-12002Cleared 510(K)
- K082817PRIMUS STEAM STERILIZER, MODELS PSS5-G-1 AND PSS5-M2Cleared 510(K)
- K090265BRAVO AUTOCLAVE, MODELS 17, 17V AND 21V2Cleared 510(K)
- K082435AMSCO EVOLUTION MEDIUM STEAM STERILIZER2Cleared 510(K)
- K072466STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-7021012Cleared 510(K)
- K072087BELIMED STEAM STERILIZER MODEL TOP 5000 SERIES 242Cleared 510(K)
- K063681TECNO-GAZ ANDROMEDA VACUUM CS AUTOCLAVE2Cleared 510(K)
- K070657GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZER2Cleared 510(K)
- K063711TUTTNAUER PREVACUUM STEAM HEATED AUTOCLAVE, MODELS 6990 SP-1A, 66120 SP-1A, 69150 SP-2A, 69120 L USA SP-2A, 69180 SP-2HA2Cleared 510(K)
- K050263MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU2Cleared 510(K)
- K052532IMAX 9.5 STERILIZERS2Cleared 510(K)
- K060337BELIMED STEAM STERILIZER TOP 5000, MODEL 5-5-92Cleared 510(K)
- K041833CONSOLIDATED SR AND SSE MC-SERIES STEAM STERILIZER2Cleared 510(K)
- K032192PRE-VACUUM AUTOCLAVE WITH STEAM GENERATOR AND VERTICAL SLIDING DOOR, MODELS 4472 EP-1V AND 5596 EP-1V2Cleared 510(K)
- K033538BELIMED STEAM STERILIZER TOP 5000, SERIES 4 - 82Cleared 510(K)
- K024133CLS-2000 UNIT2Cleared 510(K)
- K031259MODEL 833HC VACUUM/GRAVITY STEAM STERILIZER2Cleared 510(K)
- K030789AMSCO CENTURY STEAM STERILIZER2Cleared 510(K)
- K023348MIDMARK M9 ULTRACLAVE STEAM STERILIZER2Cleared 510(K)
- K022816W & H LISA STEAM STERILIZER2Cleared 510(K)
- K021064QUANTIM 16 AUTOCLAVE2Cleared 510(K)
- K021504TUTTNAUER EHS SERIES TABLE-TOP AUTOCLAVE, MODEL 25402Cleared 510(K)
- K021223BELIMED STEAM STERILIZER, MODEL TOP 50002Cleared 510(K)
- K020747AMSCO CENTURY MEDIUM STERILIZER 26 X 262Cleared 510(K)
- K020590MODEL 733HC GRAVITY/VACUUM STEAM STERILIZER2Cleared 510(K)
- K014174HARVEY PV DRY STERILIZER, MODEL # ST127325; ST127320; ST127320-332Cleared 510(K)
- K012573CASTLE 400HC/500HC SERIES STEAM STERILIZER, MODELS 422HC, 433HC, 522HC, AND 533HC2Cleared 510(K)
- K010865AMSCO CENTURY MEDIUM STERILIZER, MODEL CENTURY2Cleared 510(K)
- K003470EHS SERIES TABLE TOP AUTOCLAVE, MODELS 2540 AND 38702Cleared 510(K)
- K993856TUTTNAUER ELECTRONIC AUTOCLAVE, MODELS E, EA, EK, EKA, EP2Cleared 510(K)
- K003441CASTLE MODEL 233HC STEAM STERILIZER2Cleared 510(K)
- K000077STERIS AMSCO MILLENNIUM STEAM STERILIZER2Cleared 510(K)
- K994314CASTLE SERIES 100HC STEAM STERILIZERS2Cleared 510(K)
- K992744MIDMARK M4*9 EASYCLAVE STEAM STERILIZER2Cleared 510(K)
- K991575PRIMUS STEAM STERILIZERS2Cleared 510(K)
- K990189MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER2Cleared 510(K)
- K982332STERIS TEN SIXTEEN STEAM STERILIZER2Cleared 510(K)
- K983679STATIM 5000 CASSETTE AUTOCLAVE2Cleared 510(K)
- K964332EAGLE CENTURY STEAM STERILIZER2Cleared 510(K)
- K980014THE SYSTEM 2S STEAM STERILIZER2Cleared 510(K)
- K962903PRESTIGE MEDICAL SERIES 2100 CLINICAL AUTOCLAVE2Cleared 510(K)
- K973225CASTLE SERIES 200 STEAM STERILIZER (POWERCLAVE)2Cleared 510(K)
- K970907CASTLE SERIES 100 STEAM STERILIZERS (STRAIGHTLINE)2Cleared 510(K)
- K962282TUTTNAUER PREVACUUM TABLE AUTOCLAVE2Cleared 510(K)
- K973550TUTTNAUER TABLE-TOP AUTOCLAVE2Cleared 510(K)
- K954142STERRADD STERILIZATION SYSTEM2Cleared 510(K)
- K962755STRYKER ENCORE STERILIZER2Cleared 510(K)
- K945117DELTA2Cleared 510(K)
- K953938STERILEMAX2Cleared 510(K)
- K962179STAT IM 5000 CASSETTE AUTOCLAVE2Cleared 510(K)
- K944036STERIMASTER AUTOCLAVE2Cleared 510(K)
- K954736ACCESS (POWERCLAVE)2Cleared 510(K)
- K961230EASTERCLAVE2Cleared 510(K)
- K951557EASTERCLAVE2Cleared 510(K)
- K951273BUXTON BUILT STERILIZER, BUXTON BUILT RECONDITIONED STERILIZER2Cleared 510(K)
- K942989OCR II & OCM II2Cleared 510(K)
- K950341BARNARD & ASSOCIATES REMANUFACTURED GENERAL PURPOSE, VACUUM OR LABORATORY STERILIZER2Cleared 510(K)
- K936181MIDMARK M-11 ULTRACLAVE STEAM STERILIZER2Cleared 510(K)
- K926185PRIMUS PSS SERIES STERILIZERS2Cleared 510(K)
- K924596SES-2012 AUTOMATIC STEAM STERILIZER2Cleared 510(K)
- K924955MDT/HARVEY MC-8 AND MC-102Cleared 510(K)
- K920478TUTTNAUER LSI (AUTOMATIC)2Cleared 510(K)
- K921613STERILIZER, SURG INSTR/DRESSING #6530-01-306-95102Cleared 510(K)
- K915054STATIM CASSETT AUTOCLAVE, MODIFICATION2Cleared 510(K)
- K912471EAGLE 3000 SDS2Cleared 510(K)
- K920293DAVIS AND GECK HANDHELD INST. STERILIZATION TRAY2Cleared 510(K)
- K910777MDT/CASTLE MODELS S-8 TABLE TOP STEAM STERILIZER2Cleared 510(K)
- K911206MAXIMA-102Cleared 510(K)
- K910778STEAM VACUUM PULSE STERILIZER SYSTEM (SVPSS)2Cleared 510(K)
- K911322MODEL #M9 ULTRACLAVE STEAM STERILIZER2Cleared 510(K)
- K910789KAVOKLAVE STEAM AUTOCLAVE2Cleared 510(K)
- K910241STATIM CASSETTE AUTOCLAVE2Cleared 510(K)
- K903614HARVARD/LTE LABORATORY STEAM STERILIZER AUTOCLAVE2Cleared 510(K)
- K901147JOSLYN STEAM STERILIZER / STEAM MODERNIZATION KIT2Cleared 510(K)
- K895275MAC LAVE STEAM STERILIZER2Cleared 510(K)
- K903613HARVARD/LTE BENCHTOP STEAM STERILIZER (AUTOCLAVE)2Cleared 510(K)
- K903096RACK-IT (R)2Cleared 510(K)
- K900432MODEL #M8 ELECTRONIC STERILIZER2Cleared 510(K)
- K895638STEAM STERILIZER (AUTOCLAVE), DENTAL2Cleared 510(K)
- K895848PRESSURE STEAM STERILIZERS2Cleared 510(K)
- K893886MITEK STERILIZATION TRAY2Cleared 510(K)
- K890359RESUBMITTED STC SERIES 8600 AUTOCLAVE2Cleared 510(K)
- K885140MULTI-PURPOSE CONTROL SYSTEM2Cleared 510(K)
- K882713REBUILDING STERILIZERS2Cleared 510(K)
- K882465MODEL 172-P AND 172-N ROTARY SPRAY ARM2Cleared 510(K)
- K874644STEAM AUTOCLAVE CONTROL. & DATALOG. BY DATACON2Cleared 510(K)
- K870975MODIFIED CASTLE POWERCLAVE2Cleared 510(K)
- K862495STARCRAFT ELITE AUTOCLAVE2Cleared 510(K)
- K852114ARS ENTERPRISES PRE-VACUUM STEAM STERILIZER 850002Cleared 510(K)
- K852113ARS ENTERPRISES NEW/REMFR'D GP STEAM STERILIZER 812Cleared 510(K)
- K844649ELECTRICALLY HEATED STERILIZER STEAM STERILIZER2Cleared 510(K)
- K850264TUTTNAUER PRE-VACUUM AUTOCLAVE2Cleared 510(K)
- K842631STERELIS SEALING EQUIPMENT2Cleared 510(K)
- K831356STEAM STERILIZER2Cleared 510(K)
- K834152ETHYLENE OXIDE DETECTOR GLD-1-072Cleared 510(K)
- K833837AMERICAN GOLD SERIES AUTOCLAVE2Cleared 510(K)
- K830931PORTABLE AUTOCLAVES2Cleared 510(K)
- K823457NON-PRESSURE AUTOCLAVE FOR STERILIZATION2Cleared 510(K)
- K821591STEAM STERILIZATION EQUIPMENT2Cleared 510(K)
- K801309RITTER STERILIZER2Cleared 510(K)
- K800080STERILIZING CASE CAT. NO. 651992Cleared 510(K)
- K792558CONTAINER SYSTEM2Cleared 510(K)
- K781684STERILIZER, EAGLE 20002Cleared 510(K)
- K771229STERILIZERS, 3100 SERIES TRIM LINE2Cleared 510(K)
- K770682STERILIZER, SERIES 3000, MODIFICATION TO2Cleared 510(K)
- K770536STEAM STERILIZER, 30002Cleared 510(K)
- K770372STERILIZER, STEAM, CASTLE 30002Cleared 510(K)
- K761032CRADLING SYSTEM2Cleared 510(K)
- 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
- 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
PRIMUS Healthcare Sterilizer (Model PSS11-HC)
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K221474
- 510(k) Type
- Abbreviated
- Applicant
- Primus Sterilizer Company, LLC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/10/2023
- Days to Decision
- 266 days
- Submission Type
- Summary