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
- K081718EXPRESS CHEST DRAIN2Cleared 510(K)
- K062302MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM2Cleared 510(K)
- K043582OCEAN CHEST DRAIN2Cleared 510(K)
- K984496ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN2Cleared 510(K)
- K962856PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR2Cleared 510(K)
- K961287ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM2Cleared 510(K)
- K962168MUCUS SPECIMEN TRAP2Cleared 510(K)
- K950677ATRIUM DRY SUCTION CONTROL WATER SEAL CHEST DRAIN2Cleared 510(K)
- K941818PM9000 VAC TRAP2Cleared 510(K)
- K932327THORA-KLEX 350 ML PEDIATRIC CHEST DRAINAGE SYSTEM2Cleared 510(K)
- K912704ATRIUM 2000 CHEST DRAIN2Cleared 510(K)
- K905768PLEUR-EVAC CHEST DRAINAGE SYSTEMS2Cleared 510(K)
- K897125ATRIUM 2000, CHEST DRAIN2Cleared 510(K)
- K896697PLEUR-EVAC(R) A-6020--INFANT SINGLE USE CHEST DRAI2Cleared 510(K)
- K896127THORA-KLEX CHEST DRAINAGE UNIT2Cleared 510(K)
- K892915PLEUR-EVAC A-8002--ADULT/PEDIATRIC DUAL COLLECTION2Cleared 510(K)
- K882468ELIMINATOR AIR FILTER2Cleared 510(K)
- K882223PLEUR-EVAC-A-7000--ADULT/PEDI CHEST DRAINAGE SYST2Cleared 510(K)
- K881149MUCUS TRAP OR SUCTION TRAP2Cleared 510(K)
- K863561URESIL THORACIC VENT2Cleared 510(K)
- K861025T-VAC PLEURAL DRAINAGE UNIT, 7800 SERIES2Cleared 510(K)
- K855074FILTERED VACUUM SAFETY TRAP BOTTLE2Cleared 510(K)
- K854359LM2000A SURGICAL SUCTION MONITOR2Cleared 510(K)
- K860023COMPACT 2000 WATER SEAL CHEST DRAINAGE UNIT2Cleared 510(K)
- K854634BARD PARKER THORACIC VENT2Cleared 510(K)
- K844853NIFA NON INVASIVE FLUTTER ASSEMBLY2Cleared 510(K)
- K851244GRECO-HARVEY SURFACTANT BONDED CATH FOR ANESTHESIO2Cleared 510(K)
- K851892COMPACT 20002Cleared 510(K)
- K851316ABCO SUCTION CANISTER2Cleared 510(K)
- K844942PLURA-GARD CHEST DRAINAGE SYSTEM2Cleared 510(K)
- K830671THORAX-KLEX CHEST DRAINAGE UNIT2Cleared 510(K)
- K812746THORACIC DRAINAGE SET #55-DB2-G2Cleared 510(K)
- K812224PLEURAL DRAINAGE SYSTEM #PDS-43002Cleared 510(K)
- K812139VACUUM SUCTION FILTER2Cleared 510(K)
- K811437MODIFIED THORACENTESIS CATHETER2Cleared 510(K)
- K811955CALIBRATED BREATHING SYSTEM COLLECTION2Cleared 510(K)
- K811192VAC-RITE SUNCTION COLLECTION2Cleared 510(K)
- K810574SUCTION COLLECTION BOTTLE, DISPOSABLE2Cleared 510(K)
- K810892ELECTRO-SUCTION UNIT2Cleared 510(K)
- K802174ARGYLE SUCTION CANISTER W/DISP. LINER2Cleared 510(K)
- K801221THORA-DRAIN III PLASTIC DRAINAGE SYSTEM2Cleared 510(K)
- K800861SNYDER HEMOVAC CHEST DRAINAGE SOLUTION2Cleared 510(K)
- K791254CONPHAR SILICONE DRAINS-STERILE2Cleared 510(K)
- K790379SEP-T-VAC SUCTION CANNISTER W/ TUBING2Cleared 510(K)
- K781279SUCTION CANISTER2Cleared 510(K)
- K781234TUBES, LUKENS, TOMAS2Cleared 510(K)
- K770649VAC-RITE2Cleared 510(K)
- K761202AQUA-SEAL2Cleared 510(K)
- 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
PLEURAL DRAINAGE SYSTEM #PDS-4300
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K812224
- 510(k) Type
- Traditional
- Applicant
- BENTLEY LABORATORIES, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/9/1981
- Days to Decision
- 30 days