FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart C—General Hospital and Personal Use Monitoring Devices
CFR Sub-Part
Subpart D—Pathology Instrumentation and Accessories
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—General Hospital and Personal Use Miscellaneous Devices
CFR Sub-Part
FLG
Cleaner, Ultrasonic, Medical Instrument
1
Product Code
FLH
Washer Of Body Waste Receptacles
1
Product Code
FLI
Cabinet, Ethylene-Oxide Gas Aerator
2
Product Code
BRT
Restraint, Patient, Conductive
1
Product Code
BYY
Tube, Aspirating, Flexible, Connecting
2
Product Code
BYZ
Trap, Sterile Specimen
2
Product Code
CBC
Bottle, Collection And Trap, Breathing System (Uncalibrated)
2
Product Code
CBD
Bottle, Collection, Breathing System (Calibrated)
2
Product Code
FLE
Sterilizer, Steam
2
Product Code
FLF
Sterilizer, Ethylene-Oxide Gas
2
Product Code
FMA
Depressor, Tongue, Non-Surgical
1
Product Code
FMC
Patient Examination Glove
1
Product Code
FME
Gown, Examination
1
Product Code
FML
Chair, Blood Donor
1
Product Code
FMP
Protector, Skin Pressure
1
Product Code
FMQ
Restraint, Protective
1
Product Code
FMR
Device, Transfer, Patient, Manual
1
Product Code
FMW
Cover, Mattress (Medical Purposes)
1
Product Code
FNP
Urinal
1
Product Code
FNS
Ring Cutter
1
Product Code
FNY
Basin, Emesis
1
Product Code
FOA
Board, Cardiopulmonary
1
Product Code
FOB
Bedpan
1
Product Code
FOX
Stand, Infusion
1
Product Code
FPF
Bottle, Hot/Cold Water
1
Product Code
FPO
Stretcher, Wheeled
2
Product Code
FPP
Stretcher, Hand-Carried
1
Product Code
FPS
Board, Bed
1
Product Code
FRA
Purifier, Air, Ultraviolet, Medical
2
Product Code
FRG
Wrap, Sterilization
2
Product Code
FRJ
Chair, Geriatric
1
Product Code
FRK
Chair, Examination And Treatment
1
Product Code
FRZ
Device, Patient Transfer, Powered
2
Product Code
GAZ
Tubing, Noninvasive
2
Product Code
GCX
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
2
Product Code
JOK
Scissors, Medical, Disposable
1
Product Code
JOL
Catheter And Tip, Suction
2
Product Code
KCT
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
2
Product Code
KDP
Regulator, Vacuum
2
Product Code
KDQ
Bottle, Collection, Vacuum
2
Product Code
K
08
1718
EXPRESS CHEST DRAIN
2
Cleared 510(K)
K
06
2302
MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM
2
Cleared 510(K)
K
04
3582
OCEAN CHEST DRAIN
2
Cleared 510(K)
K
98
4496
ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN
2
Cleared 510(K)
K
96
2856
PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR
2
Cleared 510(K)
K
96
1287
ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM
2
Cleared 510(K)
K
96
2168
MUCUS SPECIMEN TRAP
2
Cleared 510(K)
K
95
0677
ATRIUM DRY SUCTION CONTROL WATER SEAL CHEST DRAIN
2
Cleared 510(K)
K
94
1818
PM9000 VAC TRAP
2
Cleared 510(K)
K
93
2327
THORA-KLEX 350 ML PEDIATRIC CHEST DRAINAGE SYSTEM
2
Cleared 510(K)
K
91
2704
ATRIUM 2000 CHEST DRAIN
2
Cleared 510(K)
K
90
5768
PLEUR-EVAC CHEST DRAINAGE SYSTEMS
2
Cleared 510(K)
K
89
7125
ATRIUM 2000, CHEST DRAIN
2
Cleared 510(K)
K
89
6697
PLEUR-EVAC(R) A-6020--INFANT SINGLE USE CHEST DRAI
2
Cleared 510(K)
K
89
6127
THORA-KLEX CHEST DRAINAGE UNIT
2
Cleared 510(K)
K
89
2915
PLEUR-EVAC A-8002--ADULT/PEDIATRIC DUAL COLLECTION
2
Cleared 510(K)
K
88
2468
ELIMINATOR AIR FILTER
2
Cleared 510(K)
K
88
2223
PLEUR-EVAC-A-7000--ADULT/PEDI CHEST DRAINAGE SYST
2
Cleared 510(K)
K
88
1149
MUCUS TRAP OR SUCTION TRAP
2
Cleared 510(K)
K
86
3561
URESIL THORACIC VENT
2
Cleared 510(K)
K
86
1025
T-VAC PLEURAL DRAINAGE UNIT, 7800 SERIES
2
Cleared 510(K)
K
85
5074
FILTERED VACUUM SAFETY TRAP BOTTLE
2
Cleared 510(K)
K
85
4359
LM2000A SURGICAL SUCTION MONITOR
2
Cleared 510(K)
K
86
0023
COMPACT 2000 WATER SEAL CHEST DRAINAGE UNIT
2
Cleared 510(K)
K
85
4634
BARD PARKER THORACIC VENT
2
Cleared 510(K)
K
84
4853
NIFA NON INVASIVE FLUTTER ASSEMBLY
2
Cleared 510(K)
K
85
1244
GRECO-HARVEY SURFACTANT BONDED CATH FOR ANESTHESIO
2
Cleared 510(K)
K
85
1892
COMPACT 2000
2
Cleared 510(K)
K
85
1316
ABCO SUCTION CANISTER
2
Cleared 510(K)
K
84
4942
PLURA-GARD CHEST DRAINAGE SYSTEM
2
Cleared 510(K)
K
83
0671
THORAX-KLEX CHEST DRAINAGE UNIT
2
Cleared 510(K)
K
81
2746
THORACIC DRAINAGE SET #55-DB2-G
2
Cleared 510(K)
K
81
2224
PLEURAL DRAINAGE SYSTEM #PDS-4300
2
Cleared 510(K)
K
81
2139
VACUUM SUCTION FILTER
2
Cleared 510(K)
K
81
1437
MODIFIED THORACENTESIS CATHETER
2
Cleared 510(K)
K
81
1955
CALIBRATED BREATHING SYSTEM COLLECTION
2
Cleared 510(K)
K
81
1192
VAC-RITE SUNCTION COLLECTION
2
Cleared 510(K)
K
81
0574
SUCTION COLLECTION BOTTLE, DISPOSABLE
2
Cleared 510(K)
K
81
0892
ELECTRO-SUCTION UNIT
2
Cleared 510(K)
K
80
2174
ARGYLE SUCTION CANISTER W/DISP. LINER
2
Cleared 510(K)
K
80
1221
THORA-DRAIN III PLASTIC DRAINAGE SYSTEM
2
Cleared 510(K)
K
80
0861
SNYDER HEMOVAC CHEST DRAINAGE SOLUTION
2
Cleared 510(K)
K
79
1254
CONPHAR SILICONE DRAINS-STERILE
2
Cleared 510(K)
K
79
0379
SEP-T-VAC SUCTION CANNISTER W/ TUBING
2
Cleared 510(K)
K
78
1279
SUCTION CANISTER
2
Cleared 510(K)
K
78
1234
TUBES, LUKENS, TOMAS
2
Cleared 510(K)
K
77
0649
VAC-RITE
2
Cleared 510(K)
K
76
1202
AQUA-SEAL
2
Cleared 510(K)
KIA
Cover, Cast
1
Product Code
KME
Bedding, Disposable, Medical
1
Product Code
KMG
Purifier, Water, Ultraviolet, Medical
2
Product Code
KMH
Sterilizer, Dry Heat
2
Product Code
KMJ
Lubricant, Patient
1
Product Code
KMN
Chair And Table, Medical
1
Product Code
KXF
Applicator, Absorbent Tipped, Non-Sterile
1
Product Code
KXG
Applicator, Absorbent Tipped, Sterile
1
Product Code
KYR
Bag, Ice
1
Product Code
KYS
Insoles, Medical
1
Product Code
KYT
Light, Examination, Medical, Battery Powered
1
Product Code
KYW
Container, Liquid Medication, Graduated
1
Product Code
KYX
Dispenser, Liquid Medication
1
Product Code
KYZ
Syringe, Irrigating (Non Dental)
1
Product Code
KZA
Device, Vein Location, Liquid Crystal
1
Product Code
KZF
Device, Medical Examination, Ac Powered
1
Product Code
KZH
Introducer, Syringe Needle
2
Product Code
LBJ
Device, Vein Stabilization
1
Product Code
LDS
Device, Pasteurization, Hot Water
2
Product Code
LRJ
Disinfectant, Medical Devices
1
Product Code
LYY
Latex Patient Examination Glove
1
Product Code
LYZ
Vinyl Patient Examination Glove
1
Product Code
LZA
Polymer Patient Examination Glove
1
Product Code
LZB
Finger Cot
1
Product Code
LZC
Patient Examination Glove, Specialty
1
Product Code
MDZ
Cleaners, Medical Devices
2
Product Code
MEC
Disinfector, Medical Devices
2
Product Code
MED
Sterilant, Medical Devices
2
Product Code
MKB
Device, Germicidal, Ultraviolet
2
Product Code
MLR
Sterilizer, Chemical
2
Product Code
MMS
Lubricant, Vaginal, Patient
1
Product Code
MTV
Sharps Needle Destruction Device
2
Product Code
NRV
Implantable Radio Frequency Transponder System
2
Product Code
NZD
Stretcher, Patient Restraint
1
Product Code
NZH
Medication Management System, Remote
2
Product Code
NZJ
Respirator, N95, For Use By The General Public In Public Health Medical Emergencies
2
Product Code
OHY
Pill Crusher/Cutter
1
Product Code
OIG
Powder-Free Guayle Rubber Examination Glove
1
Product Code
PEQ
Accessories To Examination Light
1
Product Code
OPC
Powder-Free Polychloroprene Patient Examination Glove
1
Product Code
OPH
Radiation Attenuating Medical Glove
1
Product Code
OPI
Antimicrobial Medical Glove
1
Product Code
OPJ
Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
1
Product Code
ORW
N95 Respirator With Antimicrobial/Antiviral Agent For Use By The General Public In Public Health Medical Emergencies
2
Product Code
OSZ
Antimicrobial Keyboard
2
Product Code
OUG
Medical Device Data System
1
Product Code
OVY
Liquid Chemical Processing System
2
Product Code
OYS
Patient Bed With Canopy/Restraints
1
Product Code
PAD
Chest Drainage Kit
2
Product Code
PEC
Sterilizer Automated Loading System
2
Product Code
PJJ
Two Or More Sterilant Sterilizer
2
Product Code
PWM
Admission Kit (Patient Utensil)
1
Product Code
PYQ
Rfid Chip For Dental Appliance
2
Product Code
PWP
Blood Borne Pathogen Response Kit
1
Product Code
PWS
Chemotherapy Administration Kit
1
Product Code
PWT
Chemotherapy Spill Clean-Up Kit
1
Product Code
PWU
Clean-Up Kit
1
Product Code
PWV
Delivery Room Apparel Kit
1
Product Code
PWZ
Mid-Stream Collection Kit
1
Product Code
PXA
Oral Administration Set
1
Product Code
PXC
Personal Protection Kit
1
Product Code
PXD
Prep Kit
1
Product Code
PXF
Sitz Bath Kit
1
Product Code
PXG
Spill Kit
1
Product Code
PXM
Vomitus Clean-Up Kit
1
Product Code
QDO
Fentanyl And Other Opioid Protection Glove
1
Product Code
QTV
Mattress And Bed Deck Cover (Medical Purposes)
1
Product Code
Subpart G—Miscellaneous Devices
CFR Sub-Part
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 23 May 2025 at 11:06 pm
HO
/
subpart-g—general-hospital-and-personal-use-miscellaneous-devices
/
KDQ
/
K863561
View Source
URESIL THORACIC VENT
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K863561
510(k) Type
Traditional
Applicant
URESIL CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/23/1986
Days to Decision
11 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—General Hospital and Personal Use Monitoring Devices
Subpart D—Pathology Instrumentation and Accessories
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—General Hospital and Personal Use Miscellaneous Devices
FLG
Cleaner, Ultrasonic, Medical Instrument
FLH
Washer Of Body Waste Receptacles
FLI
Cabinet, Ethylene-Oxide Gas Aerator
BRT
Restraint, Patient, Conductive
BYY
Tube, Aspirating, Flexible, Connecting
BYZ
Trap, Sterile Specimen
CBC
Bottle, Collection And Trap, Breathing System (Uncalibrated)
CBD
Bottle, Collection, Breathing System (Calibrated)
FLE
Sterilizer, Steam
FLF
Sterilizer, Ethylene-Oxide Gas
FMA
Depressor, Tongue, Non-Surgical
FMC
Patient Examination Glove
FME
Gown, Examination
FML
Chair, Blood Donor
FMP
Protector, Skin Pressure
FMQ
Restraint, Protective
FMR
Device, Transfer, Patient, Manual
FMW
Cover, Mattress (Medical Purposes)
FNP
Urinal
FNS
Ring Cutter
FNY
Basin, Emesis
FOA
Board, Cardiopulmonary
FOB
Bedpan
FOX
Stand, Infusion
FPF
Bottle, Hot/Cold Water
FPO
Stretcher, Wheeled
FPP
Stretcher, Hand-Carried
FPS
Board, Bed
FRA
Purifier, Air, Ultraviolet, Medical
FRG
Wrap, Sterilization
FRJ
Chair, Geriatric
FRK
Chair, Examination And Treatment
FRZ
Device, Patient Transfer, Powered
GAZ
Tubing, Noninvasive
GCX
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
JOK
Scissors, Medical, Disposable
JOL
Catheter And Tip, Suction
KCT
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
KDP
Regulator, Vacuum
KDQ
Bottle, Collection, Vacuum
K
08
1718
EXPRESS CHEST DRAIN
K
06
2302
MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM
K
04
3582
OCEAN CHEST DRAIN
K
98
4496
ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN
K
96
2856
PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR
K
96
1287
ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM
K
96
2168
MUCUS SPECIMEN TRAP
K
95
0677
ATRIUM DRY SUCTION CONTROL WATER SEAL CHEST DRAIN
K
94
1818
PM9000 VAC TRAP
K
93
2327
THORA-KLEX 350 ML PEDIATRIC CHEST DRAINAGE SYSTEM
K
91
2704
ATRIUM 2000 CHEST DRAIN
K
90
5768
PLEUR-EVAC CHEST DRAINAGE SYSTEMS
K
89
7125
ATRIUM 2000, CHEST DRAIN
K
89
6697
PLEUR-EVAC(R) A-6020--INFANT SINGLE USE CHEST DRAI
K
89
6127
THORA-KLEX CHEST DRAINAGE UNIT
K
89
2915
PLEUR-EVAC A-8002--ADULT/PEDIATRIC DUAL COLLECTION
K
88
2468
ELIMINATOR AIR FILTER
K
88
2223
PLEUR-EVAC-A-7000--ADULT/PEDI CHEST DRAINAGE SYST
K
88
1149
MUCUS TRAP OR SUCTION TRAP
K
86
3561
URESIL THORACIC VENT
K
86
1025
T-VAC PLEURAL DRAINAGE UNIT, 7800 SERIES
K
85
5074
FILTERED VACUUM SAFETY TRAP BOTTLE
K
85
4359
LM2000A SURGICAL SUCTION MONITOR
K
86
0023
COMPACT 2000 WATER SEAL CHEST DRAINAGE UNIT
K
85
4634
BARD PARKER THORACIC VENT
K
84
4853
NIFA NON INVASIVE FLUTTER ASSEMBLY
K
85
1244
GRECO-HARVEY SURFACTANT BONDED CATH FOR ANESTHESIO
K
85
1892
COMPACT 2000
K
85
1316
ABCO SUCTION CANISTER
K
84
4942
PLURA-GARD CHEST DRAINAGE SYSTEM
K
83
0671
THORAX-KLEX CHEST DRAINAGE UNIT
K
81
2746
THORACIC DRAINAGE SET #55-DB2-G
K
81
2224
PLEURAL DRAINAGE SYSTEM #PDS-4300
K
81
2139
VACUUM SUCTION FILTER
K
81
1437
MODIFIED THORACENTESIS CATHETER
K
81
1955
CALIBRATED BREATHING SYSTEM COLLECTION
K
81
1192
VAC-RITE SUNCTION COLLECTION
K
81
0574
SUCTION COLLECTION BOTTLE, DISPOSABLE
K
81
0892
ELECTRO-SUCTION UNIT
K
80
2174
ARGYLE SUCTION CANISTER W/DISP. LINER
K
80
1221
THORA-DRAIN III PLASTIC DRAINAGE SYSTEM
K
80
0861
SNYDER HEMOVAC CHEST DRAINAGE SOLUTION
K
79
1254
CONPHAR SILICONE DRAINS-STERILE
K
79
0379
SEP-T-VAC SUCTION CANNISTER W/ TUBING
K
78
1279
SUCTION CANISTER
K
78
1234
TUBES, LUKENS, TOMAS
K
77
0649
VAC-RITE
K
76
1202
AQUA-SEAL
KIA
Cover, Cast
KME
Bedding, Disposable, Medical
KMG
Purifier, Water, Ultraviolet, Medical
KMH
Sterilizer, Dry Heat
KMJ
Lubricant, Patient
KMN
Chair And Table, Medical
KXF
Applicator, Absorbent Tipped, Non-Sterile
KXG
Applicator, Absorbent Tipped, Sterile
KYR
Bag, Ice
KYS
Insoles, Medical
KYT
Light, Examination, Medical, Battery Powered
KYW
Container, Liquid Medication, Graduated
KYX
Dispenser, Liquid Medication
KYZ
Syringe, Irrigating (Non Dental)
KZA
Device, Vein Location, Liquid Crystal
KZF
Device, Medical Examination, Ac Powered
KZH
Introducer, Syringe Needle
LBJ
Device, Vein Stabilization
LDS
Device, Pasteurization, Hot Water
LRJ
Disinfectant, Medical Devices
LYY
Latex Patient Examination Glove
LYZ
Vinyl Patient Examination Glove
LZA
Polymer Patient Examination Glove
LZB
Finger Cot
LZC
Patient Examination Glove, Specialty
MDZ
Cleaners, Medical Devices
MEC
Disinfector, Medical Devices
MED
Sterilant, Medical Devices
MKB
Device, Germicidal, Ultraviolet
MLR
Sterilizer, Chemical
MMS
Lubricant, Vaginal, Patient
MTV
Sharps Needle Destruction Device
NRV
Implantable Radio Frequency Transponder System
NZD
Stretcher, Patient Restraint
NZH
Medication Management System, Remote
NZJ
Respirator, N95, For Use By The General Public In Public Health Medical Emergencies
OHY
Pill Crusher/Cutter
OIG
Powder-Free Guayle Rubber Examination Glove
PEQ
Accessories To Examination Light
OPC
Powder-Free Polychloroprene Patient Examination Glove
OPH
Radiation Attenuating Medical Glove
OPI
Antimicrobial Medical Glove
OPJ
Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
ORW
N95 Respirator With Antimicrobial/Antiviral Agent For Use By The General Public In Public Health Medical Emergencies
OSZ
Antimicrobial Keyboard
OUG
Medical Device Data System
OVY
Liquid Chemical Processing System
OYS
Patient Bed With Canopy/Restraints
PAD
Chest Drainage Kit
PEC
Sterilizer Automated Loading System
PJJ
Two Or More Sterilant Sterilizer
PWM
Admission Kit (Patient Utensil)
PYQ
Rfid Chip For Dental Appliance
PWP
Blood Borne Pathogen Response Kit
PWS
Chemotherapy Administration Kit
PWT
Chemotherapy Spill Clean-Up Kit
PWU
Clean-Up Kit
PWV
Delivery Room Apparel Kit
PWZ
Mid-Stream Collection Kit
PXA
Oral Administration Set
PXC
Personal Protection Kit
PXD
Prep Kit
PXF
Sitz Bath Kit
PXG
Spill Kit
PXM
Vomitus Clean-Up Kit
QDO
Fentanyl And Other Opioid Protection Glove
QTV
Mattress And Bed Deck Cover (Medical Purposes)
Subpart G—Miscellaneous Devices
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
HO
/
subpart-g—general-hospital-and-personal-use-miscellaneous-devices
/
KDQ
/
K863561
View Source
URESIL THORACIC VENT
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K863561
510(k) Type
Traditional
Applicant
URESIL CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/23/1986
Days to Decision
11 days