FDA Browser
by
Innolitics
Anesthesiology
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—Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Cardiovascular 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
BRW
Protector, Dental
1
Product Code
BSF
Absorber, Carbon-Dioxide
1
Product Code
BSJ
Mask, Gas, Anesthetic
1
Product Code
BSK
Cuff, Tracheal Tube, Inflatable
2
Product Code
BSN
Filter, Conduction, Anesthetic
2
Product Code
BSO
Catheter, Conduction, Anesthetic
2
Product Code
BSP
Needle, Conduction, Anesthetic (W/Wo Introducer)
2
Product Code
BSR
Stylet, Tracheal Tube
1
Product Code
BSZ
Gas-Machine, Anesthesia
2
Product Code
BTB
Hook, Ether
1
Product Code
BTC
Bag, Reservoir
1
Product Code
BTK
Strap, Head, Gas Mask
1
Product Code
BTL
Ventilator, Emergency, Powered (Resuscitator)
2
Product Code
BTM
Ventilator, Emergency, Manual (Resuscitator)
2
Product Code
BTO
Tube, Tracheostomy (W/Wo Connector)
2
Product Code
BTP
Dropper, Ether
1
Product Code
BTQ
Airway, Nasopharyngeal
1
Product Code
BTR
Tube, Tracheal (W/Wo Connector)
2
Product Code
BTS
Tube, Bronchial (W/Wo Connector)
2
Product Code
BTT
Humidifier, Respiratory Gas, (Direct Patient Interface)
2
Product Code
BWB
Forceps, Tube Introduction
1
Product Code
BWC
Needle, Emergency Airway
2
Product Code
BWF
Spirometer, Therapeutic (Incentive)
2
Product Code
BWL
Apparatus, Electronanesthesia
3
Product Code
BYD
Condenser, Heat And Moisture (Artificial Nose)
1
Product Code
BYE
Attachment, Breathing, Positive End Expiratory Pressure
2
Product Code
K
16
0112
Besmed PEEP Valve
2
Cleared 510(K)
K
13
3957
DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE
2
Cleared 510(K)
K
13
3210
B&B BUBBLER
2
Cleared 510(K)
K
12
2610
PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES
2
Cleared 510(K)
K
11
2546
O_TWO CPAP SYSTEM
2
Cleared 510(K)
K
11
0713
WATERPAP VALVE
2
Cleared 510(K)
K
10
3833
NEOPIP PATIENT CIRCUIT WITH PEEP
2
Cleared 510(K)
K
09
2029
VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310
2
Cleared 510(K)
K
09
0710
MERCURY CPAP
2
Cleared 510(K)
K
09
0317
BABI*PLUS BUBBLE PAP VALVE
2
Cleared 510(K)
K
08
1266
MERCURY MEDICAL PEEP VALVE
2
Cleared 510(K)
K
08
0256
PULMODYNE CHF FLOW GENERATOR SYSTEM
2
Cleared 510(K)
K
07
0416
NEOPEEP NEONATAL RESUSCITATION CIRCUIT WITH PEEP
2
Cleared 510(K)
K
05
0918
KOO AMERICAS VALVE PEEP, MODEL KM-809
2
Cleared 510(K)
K
01
3884
BOUSSIGNAC C.P.A.P. DEVICE
2
Cleared 510(K)
K
00
1318
CPAP SYSTEM, MODEL 102001
2
Cleared 510(K)
K
98
2283
WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH
2
Cleared 510(K)
K
98
3920
EMS PEEP VALVES- ADJUSTABLE
2
Cleared 510(K)
K
98
1415
0-20 CM H20 PEEP VALVE
2
Cleared 510(K)
K
96
3347
REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142
2
Cleared 510(K)
K
96
2492
SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM
2
Cleared 510(K)
K
96
1867
PEEP VALVE
2
Cleared 510(K)
K
95
5047
WESTMED CIRCULARIE PEP DEVICES
2
Cleared 510(K)
K
95
3511
KENDALL SHERIDAN CPAP SYSTEM
2
Cleared 510(K)
K
95
3485
SIMS CPAP SYSTEM
2
Cleared 510(K)
K
95
0397
SYSTEM 22 VALVE
2
Cleared 510(K)
K
94
2246
PURITAN-BENNETT NASAL CPAP MASK
2
Cleared 510(K)
K
93
2799
SINGLE USE MANUAL RESUSCITATOR PEEP VALVE
2
Cleared 510(K)
K
92
3976
AMBU SINGLE PATIENT USE PEEP VALVE
2
Cleared 510(K)
K
92
3618
PEEP VALVE
2
Cleared 510(K)
K
92
2178
COMPANION 318 NASAL CPAP SYSTEM -- MODIFICATION
2
Cleared 510(K)
K
91
2578
20CM/H20 PEEP VALVE
2
Cleared 510(K)
K
91
2240
CPAP SYSTEM AND BRONCHO-CATH W/CPAP SYSTEM
2
Cleared 510(K)
K
90
4874
ADJUSTABLE PEEP VALVE
2
Cleared 510(K)
K
90
3764
COMPANION 318 NASAL CPAP SYSTEM
2
Cleared 510(K)
K
90
3125
PURITAN BENNETT SINGLE PATIENT USE PEEP VALVE
2
Cleared 510(K)
K
90
2062
PEEP VALVE
2
Cleared 510(K)
K
90
1728
ONE-LUNG CPAP DEVICE
2
Cleared 510(K)
K
90
0113
RESPIRONICS' REMSTAR(TM) SLEEPEASY
2
Cleared 510(K)
K
90
0164
AIRWAY DELIVERY & MANAGEMENT (ADAM) NASAL VENTILA.
2
Cleared 510(K)
K
89
4779
LIFECARE NASAL MASK KIT CAT. NO. 06-800
2
Cleared 510(K)
K
89
5360
C.P.A.P. VALVE AND C.P.P.A. KIT
2
Cleared 510(K)
K
89
4424
DEVILBISS MODEL 7351 SERIES
2
Cleared 510(K)
K
89
4690
CPAP MASK
2
Cleared 510(K)
K
89
3388
DEVILBISS MODEL 7351D REVITALIZER CPAP SYSTEM
2
Cleared 510(K)
K
89
1540
EDENTEC MODEL 2860 PRESSURE METER
2
Cleared 510(K)
K
88
3825
MODIFIED SANDERS BI-PAPEASY
2
Cleared 510(K)
K
88
2219
P.E.E.P. VALVE
2
Cleared 510(K)
K
88
1833
NASAL CPAP SYSTEM
2
Cleared 510(K)
K
88
2292
SULLIVAN NASAL CPAP SYSTEM
2
Cleared 510(K)
K
88
1614
MODIFIED OHMEDA PEEP VALVE (FOR GMS ABSORBER)
2
Cleared 510(K)
K
88
0161
ACKRAD PEDIATRIC C.P.A.P. SYSTEM
2
Cleared 510(K)
K
87
5073
BREATHE-FREE
2
Cleared 510(K)
K
87
4479
MC/CPAP MANIFOLD
2
Cleared 510(K)
K
87
3170
ARIES
2
Cleared 510(K)
K
87
1693
SLEEP APNEA NASAL CPAP SYSTEM
2
Cleared 510(K)
K
87
2202
ADJUSTABLE PEEP VALVE
2
Cleared 510(K)
K
87
1523
RESPIRONICS SANDERS BIPAPEASY
2
Cleared 510(K)
K
86
1758
CUSHION-FLEX TM NASAL CPAP MASK FOR SLEEP APNEA
2
Cleared 510(K)
K
86
0848
VITAL FLOW NASAL CPAP SYSTEM
2
Cleared 510(K)
K
86
1104
VARIABLE HIGH FLOW DOWNS CPAP GENERATOR
2
Cleared 510(K)
K
85
4822
LDS PEEP VALVE
2
Cleared 510(K)
K
85
4458
CUSHION-FLEX TM-CPAP FACE MASK
2
Cleared 510(K)
K
85
1396
SANDER'S MASKCPAP BY RESPIRONICS
2
Cleared 510(K)
K
85
1194
AMBU CPAP SYSTEM
2
Cleared 510(K)
K
84
3889
RESPIRONICS SLEEPEASY NASAL CPAP SYS
2
Cleared 510(K)
K
84
3835
OHMEDA PEEP VALVE FOR GMS ABSORBER
2
Cleared 510(K)
K
83
4085
DRAGER PEEP SYSTEM D
2
Cleared 510(K)
K
83
1503
DOWNS ADJUSTABLE FLOW GENERATOR
2
Cleared 510(K)
K
83
1301
PEEP SYSTEM D
2
Cleared 510(K)
K
83
0395
PEEPER
2
Cleared 510(K)
K
82
0404
PEEP VALVE
2
Cleared 510(K)
K
80
2943
POSITIVE END EXPIRATORY PRESSURE VALVE
2
Cleared 510(K)
K
80
2707
DRAGER PEEP CONTROL SYSTEM
2
Cleared 510(K)
K
80
2070
VITAL SIGNS PEEP VALVE
2
Cleared 510(K)
K
80
0755
BOEHRINGER LABS AMBULATORY PEEP VALVE
2
Cleared 510(K)
K
78
2152
VALVE, AMBU PEEP
2
Cleared 510(K)
K
78
1332
PEEP/CPAP VALVE
2
Cleared 510(K)
K
77
0766
REGULATOR, PRESSURE, EXPIRATORY
2
Cleared 510(K)
K
76
0230
VALVE, PEEP
2
Cleared 510(K)
BYF
Mask, Oxygen, Low Concentration, Venturi
1
Product Code
BYG
Mask, Oxygen
1
Product Code
BYH
Drain, Tee (Water Trap)
1
Product Code
BYI
Percussor, Powered-Electric
2
Product Code
BYJ
Unit, Liquid-Oxygen, Portable
2
Product Code
BYK
Tent, Oxygen, Electrically Powered
2
Product Code
BYL
Tent, Oxygen
1
Product Code
BYN
Chair, Posture, For Cardiac And Pulmonary Treatment
1
Product Code
BYO
Bottle, Blow
1
Product Code
BYP
Mouthpiece, Breathing
1
Product Code
BYT
Ventilator, External Body, Negative Pressure, Adult (Cuirass)
2
Product Code
BYW
Device, Rebreathing
1
Product Code
BYX
Tubing, Pressure And Accessories
1
Product Code
BZA
Connector, Airway (Extension)
1
Product Code
BZB
Catheter, Nasal, Oxygen
1
Product Code
BZD
Ventilator, Non-Continuous (Respirator)
2
Product Code
BZE
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
2
Product Code
BZO
Set, Tubing And Support, Ventilator (W Harness)
1
Product Code
BZR
Mixer, Breathing Gases, Anesthesia Inhalation
2
Product Code
CAD
Vaporizer, Anesthesia, Non-Heated
2
Product Code
CAE
Airway, Oropharyngeal, Anesthesiology
1
Product Code
CAF
Nebulizer (Direct Patient Interface)
2
Product Code
CAG
Circulator, Breathing-Circuit
2
Product Code
CAI
Circuit, Breathing (W Connector, Adaptor, Y Piece)
1
Product Code
CAL
Laryngoscope, Non-Rigid
1
Product Code
CAO
Airway, Esophageal (Obturator)
2
Product Code
CAT
Cannula, Nasal, Oxygen
1
Product Code
CAW
Generator, Oxygen, Portable
2
Product Code
CAZ
Anesthesia Conduction Kit
2
Product Code
CBF
Chamber, Hyperbaric
2
Product Code
CBG
Spreader, Cuff
1
Product Code
CBH
Device, Fixation, Tracheal Tube
1
Product Code
CBI
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
2
Product Code
CBK
Ventilator, Continuous, Facility Use
2
Product Code
CBL
Absorbent, Carbon-Dioxide
1
Product Code
CBN
Apparatus, Gas-Scavenging
2
Product Code
CBO
Attachment, Intermittent Mandatory Ventilation (Imv)
2
Product Code
CBP
Valve, Non-Rebreathing
2
Product Code
MOD
Accessory To Continuous Ventilator (Respirator)
2
Product Code
CCO
Bed, Rocking, Breathing Assist
2
Product Code
CCQ
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
1
Product Code
CCT
Applicator (Laryngo-Tracheal), Topical Anesthesia
2
Product Code
CCW
Laryngoscope, Rigid
1
Product Code
EPE
Brush, Cleaning, Tracheal Tube
1
Product Code
FNC
Tent, Pediatric Aerosol
2
Product Code
FOG
Hood, Oxygen, Infant
1
Product Code
JAY
Support, Breathing Tube
1
Product Code
JOH
Tube Tracheostomy And Tube Cuff
2
Product Code
KFZ
Humidifier, Non-Direct Patient Interface (Home-Use)
1
Product Code
KGB
Mask, Oxygen, Non-Rebreathing
1
Product Code
KHA
Mask, Scavenging
1
Product Code
LNZ
Changer, Tube, Endotracheal
2
Product Code
MIA
Needle, Spinal, Short Term
2
Product Code
MNS
Ventilator, Continuous, Non-Life-Supporting
2
Product Code
MNT
Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
2
Product Code
MRN
Apparatus, Nitric Oxide Delivery
2
Product Code
MRO
Apparatus, Nitric Oxide, Backup Delivery
2
Product Code
MZT
Device, Heimlich Maneuver Assist
2
Product Code
NFB
Conserver, Oxygen
2
Product Code
NHJ
Device, Positive Pressure Breathing, Intermittent
2
Product Code
NHK
Resuscitator, Manual, Non Self-Inflating
2
Product Code
NMA
Tube, Tracheal, Reprocessed
2
Product Code
NMC
Mask, Ventilator, Non-Continuous, Reprocessed
2
Product Code
NMR
Needle, Spinal, Short Term, Reprocessed
2
Product Code
NNH
Needle, Conduction, Anesthesia, Reprocessed
2
Product Code
NOU
Continuous, Ventilator, Home Use
2
Product Code
NQY
Ventilator, Continuous, Minimal Ventilatory Support, Home Use
2
Product Code
NVO
Spacer, Direct Patient Interface
2
Product Code
NVP
Holding Chambers, Direct Patient Interface
2
Product Code
NXA
Tracheotomy Care Kit
2
Product Code
OBN
Humidifier, Respiratory, Mask (Direct Patient Interface)
2
Product Code
OFQ
Anesthesia Kit
2
Product Code
OFT
Spinal Epidural Anesthesia Kit
2
Product Code
OFU
Spinal Anesthesia Kit
2
Product Code
OFV
Regional Anesthesia Kit
2
Product Code
OGA
Brachial Plexus Anesthesia Kit
2
Product Code
OGB
Caudal Anesthesia Kit
2
Product Code
OGC
Continuous Brachial Plexus Block Tray
2
Product Code
OGD
Custom Anesthesia Tray
2
Product Code
OGE
Epidural Anesthesia Kit
2
Product Code
OGF
Glossopharyngeal Anesthesia Kit
2
Product Code
OGG
Humidifier Nebulizer Kit
2
Product Code
OGH
Laryngoscope Kit
1
Product Code
OGI
Nasal Endotracheal Tube Holder Kit
1
Product Code
OGJ
Nerve Block Tray
2
Product Code
OGL
Oxygen Administration Kit
2
Product Code
OLF
Medevac Use Oxygen Generator
2
Product Code
ONZ
Mechanical Ventilator
2
Product Code
OQU
Airway Monitoring System
2
Product Code
PHS
Oral Airway Assist
1
Product Code
PMB
External Airway
2
Product Code
QAV
High Flow/High Velocity Humidified Oxygen Delivery Device
2
Product Code
QBY
Positive Airway Pressure System
2
Product Code
QCX
Retrograde Intubation Set
2
Product Code
OZR
Intraoral Pressure Gradient Device
2
Product Code
QFB
Isocapnic Ventilation Device
2
Product Code
Subpart G—Miscellaneous
CFR Sub-Part
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
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 16 August 2024 at 11:05 pm
AN
/
subpart-f—therapeutic-devices
/
BYE
/
K820404
View Source
PEEP VALVE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K820404
510(k) Type
Traditional
Applicant
VITAL SIGNS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/1/1982
Days to Decision
17 days
FDA Browser
by
Innolitics
Anesthesiology
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—Monitoring Devices
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
Subpart F—Cardiovascular Therapeutic Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
BRW
Protector, Dental
BSF
Absorber, Carbon-Dioxide
BSJ
Mask, Gas, Anesthetic
BSK
Cuff, Tracheal Tube, Inflatable
BSN
Filter, Conduction, Anesthetic
BSO
Catheter, Conduction, Anesthetic
BSP
Needle, Conduction, Anesthetic (W/Wo Introducer)
BSR
Stylet, Tracheal Tube
BSZ
Gas-Machine, Anesthesia
BTB
Hook, Ether
BTC
Bag, Reservoir
BTK
Strap, Head, Gas Mask
BTL
Ventilator, Emergency, Powered (Resuscitator)
BTM
Ventilator, Emergency, Manual (Resuscitator)
BTO
Tube, Tracheostomy (W/Wo Connector)
BTP
Dropper, Ether
BTQ
Airway, Nasopharyngeal
BTR
Tube, Tracheal (W/Wo Connector)
BTS
Tube, Bronchial (W/Wo Connector)
BTT
Humidifier, Respiratory Gas, (Direct Patient Interface)
BWB
Forceps, Tube Introduction
BWC
Needle, Emergency Airway
BWF
Spirometer, Therapeutic (Incentive)
BWL
Apparatus, Electronanesthesia
BYD
Condenser, Heat And Moisture (Artificial Nose)
BYE
Attachment, Breathing, Positive End Expiratory Pressure
K
16
0112
Besmed PEEP Valve
K
13
3957
DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE
K
13
3210
B&B BUBBLER
K
12
2610
PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES
K
11
2546
O_TWO CPAP SYSTEM
K
11
0713
WATERPAP VALVE
K
10
3833
NEOPIP PATIENT CIRCUIT WITH PEEP
K
09
2029
VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310
K
09
0710
MERCURY CPAP
K
09
0317
BABI*PLUS BUBBLE PAP VALVE
K
08
1266
MERCURY MEDICAL PEEP VALVE
K
08
0256
PULMODYNE CHF FLOW GENERATOR SYSTEM
K
07
0416
NEOPEEP NEONATAL RESUSCITATION CIRCUIT WITH PEEP
K
05
0918
KOO AMERICAS VALVE PEEP, MODEL KM-809
K
01
3884
BOUSSIGNAC C.P.A.P. DEVICE
K
00
1318
CPAP SYSTEM, MODEL 102001
K
98
2283
WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH
K
98
3920
EMS PEEP VALVES- ADJUSTABLE
K
98
1415
0-20 CM H20 PEEP VALVE
K
96
3347
REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142
K
96
2492
SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM
K
96
1867
PEEP VALVE
K
95
5047
WESTMED CIRCULARIE PEP DEVICES
K
95
3511
KENDALL SHERIDAN CPAP SYSTEM
K
95
3485
SIMS CPAP SYSTEM
K
95
0397
SYSTEM 22 VALVE
K
94
2246
PURITAN-BENNETT NASAL CPAP MASK
K
93
2799
SINGLE USE MANUAL RESUSCITATOR PEEP VALVE
K
92
3976
AMBU SINGLE PATIENT USE PEEP VALVE
K
92
3618
PEEP VALVE
K
92
2178
COMPANION 318 NASAL CPAP SYSTEM -- MODIFICATION
K
91
2578
20CM/H20 PEEP VALVE
K
91
2240
CPAP SYSTEM AND BRONCHO-CATH W/CPAP SYSTEM
K
90
4874
ADJUSTABLE PEEP VALVE
K
90
3764
COMPANION 318 NASAL CPAP SYSTEM
K
90
3125
PURITAN BENNETT SINGLE PATIENT USE PEEP VALVE
K
90
2062
PEEP VALVE
K
90
1728
ONE-LUNG CPAP DEVICE
K
90
0113
RESPIRONICS' REMSTAR(TM) SLEEPEASY
K
90
0164
AIRWAY DELIVERY & MANAGEMENT (ADAM) NASAL VENTILA.
K
89
4779
LIFECARE NASAL MASK KIT CAT. NO. 06-800
K
89
5360
C.P.A.P. VALVE AND C.P.P.A. KIT
K
89
4424
DEVILBISS MODEL 7351 SERIES
K
89
4690
CPAP MASK
K
89
3388
DEVILBISS MODEL 7351D REVITALIZER CPAP SYSTEM
K
89
1540
EDENTEC MODEL 2860 PRESSURE METER
K
88
3825
MODIFIED SANDERS BI-PAPEASY
K
88
2219
P.E.E.P. VALVE
K
88
1833
NASAL CPAP SYSTEM
K
88
2292
SULLIVAN NASAL CPAP SYSTEM
K
88
1614
MODIFIED OHMEDA PEEP VALVE (FOR GMS ABSORBER)
K
88
0161
ACKRAD PEDIATRIC C.P.A.P. SYSTEM
K
87
5073
BREATHE-FREE
K
87
4479
MC/CPAP MANIFOLD
K
87
3170
ARIES
K
87
1693
SLEEP APNEA NASAL CPAP SYSTEM
K
87
2202
ADJUSTABLE PEEP VALVE
K
87
1523
RESPIRONICS SANDERS BIPAPEASY
K
86
1758
CUSHION-FLEX TM NASAL CPAP MASK FOR SLEEP APNEA
K
86
0848
VITAL FLOW NASAL CPAP SYSTEM
K
86
1104
VARIABLE HIGH FLOW DOWNS CPAP GENERATOR
K
85
4822
LDS PEEP VALVE
K
85
4458
CUSHION-FLEX TM-CPAP FACE MASK
K
85
1396
SANDER'S MASKCPAP BY RESPIRONICS
K
85
1194
AMBU CPAP SYSTEM
K
84
3889
RESPIRONICS SLEEPEASY NASAL CPAP SYS
K
84
3835
OHMEDA PEEP VALVE FOR GMS ABSORBER
K
83
4085
DRAGER PEEP SYSTEM D
K
83
1503
DOWNS ADJUSTABLE FLOW GENERATOR
K
83
1301
PEEP SYSTEM D
K
83
0395
PEEPER
K
82
0404
PEEP VALVE
K
80
2943
POSITIVE END EXPIRATORY PRESSURE VALVE
K
80
2707
DRAGER PEEP CONTROL SYSTEM
K
80
2070
VITAL SIGNS PEEP VALVE
K
80
0755
BOEHRINGER LABS AMBULATORY PEEP VALVE
K
78
2152
VALVE, AMBU PEEP
K
78
1332
PEEP/CPAP VALVE
K
77
0766
REGULATOR, PRESSURE, EXPIRATORY
K
76
0230
VALVE, PEEP
BYF
Mask, Oxygen, Low Concentration, Venturi
BYG
Mask, Oxygen
BYH
Drain, Tee (Water Trap)
BYI
Percussor, Powered-Electric
BYJ
Unit, Liquid-Oxygen, Portable
BYK
Tent, Oxygen, Electrically Powered
BYL
Tent, Oxygen
BYN
Chair, Posture, For Cardiac And Pulmonary Treatment
BYO
Bottle, Blow
BYP
Mouthpiece, Breathing
BYT
Ventilator, External Body, Negative Pressure, Adult (Cuirass)
BYW
Device, Rebreathing
BYX
Tubing, Pressure And Accessories
BZA
Connector, Airway (Extension)
BZB
Catheter, Nasal, Oxygen
BZD
Ventilator, Non-Continuous (Respirator)
BZE
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
BZO
Set, Tubing And Support, Ventilator (W Harness)
BZR
Mixer, Breathing Gases, Anesthesia Inhalation
CAD
Vaporizer, Anesthesia, Non-Heated
CAE
Airway, Oropharyngeal, Anesthesiology
CAF
Nebulizer (Direct Patient Interface)
CAG
Circulator, Breathing-Circuit
CAI
Circuit, Breathing (W Connector, Adaptor, Y Piece)
CAL
Laryngoscope, Non-Rigid
CAO
Airway, Esophageal (Obturator)
CAT
Cannula, Nasal, Oxygen
CAW
Generator, Oxygen, Portable
CAZ
Anesthesia Conduction Kit
CBF
Chamber, Hyperbaric
CBG
Spreader, Cuff
CBH
Device, Fixation, Tracheal Tube
CBI
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
CBK
Ventilator, Continuous, Facility Use
CBL
Absorbent, Carbon-Dioxide
CBN
Apparatus, Gas-Scavenging
CBO
Attachment, Intermittent Mandatory Ventilation (Imv)
CBP
Valve, Non-Rebreathing
MOD
Accessory To Continuous Ventilator (Respirator)
CCO
Bed, Rocking, Breathing Assist
CCQ
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
CCT
Applicator (Laryngo-Tracheal), Topical Anesthesia
CCW
Laryngoscope, Rigid
EPE
Brush, Cleaning, Tracheal Tube
FNC
Tent, Pediatric Aerosol
FOG
Hood, Oxygen, Infant
JAY
Support, Breathing Tube
JOH
Tube Tracheostomy And Tube Cuff
KFZ
Humidifier, Non-Direct Patient Interface (Home-Use)
KGB
Mask, Oxygen, Non-Rebreathing
KHA
Mask, Scavenging
LNZ
Changer, Tube, Endotracheal
MIA
Needle, Spinal, Short Term
MNS
Ventilator, Continuous, Non-Life-Supporting
MNT
Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
MRN
Apparatus, Nitric Oxide Delivery
MRO
Apparatus, Nitric Oxide, Backup Delivery
MZT
Device, Heimlich Maneuver Assist
NFB
Conserver, Oxygen
NHJ
Device, Positive Pressure Breathing, Intermittent
NHK
Resuscitator, Manual, Non Self-Inflating
NMA
Tube, Tracheal, Reprocessed
NMC
Mask, Ventilator, Non-Continuous, Reprocessed
NMR
Needle, Spinal, Short Term, Reprocessed
NNH
Needle, Conduction, Anesthesia, Reprocessed
NOU
Continuous, Ventilator, Home Use
NQY
Ventilator, Continuous, Minimal Ventilatory Support, Home Use
NVO
Spacer, Direct Patient Interface
NVP
Holding Chambers, Direct Patient Interface
NXA
Tracheotomy Care Kit
OBN
Humidifier, Respiratory, Mask (Direct Patient Interface)
OFQ
Anesthesia Kit
OFT
Spinal Epidural Anesthesia Kit
OFU
Spinal Anesthesia Kit
OFV
Regional Anesthesia Kit
OGA
Brachial Plexus Anesthesia Kit
OGB
Caudal Anesthesia Kit
OGC
Continuous Brachial Plexus Block Tray
OGD
Custom Anesthesia Tray
OGE
Epidural Anesthesia Kit
OGF
Glossopharyngeal Anesthesia Kit
OGG
Humidifier Nebulizer Kit
OGH
Laryngoscope Kit
OGI
Nasal Endotracheal Tube Holder Kit
OGJ
Nerve Block Tray
OGL
Oxygen Administration Kit
OLF
Medevac Use Oxygen Generator
ONZ
Mechanical Ventilator
OQU
Airway Monitoring System
PHS
Oral Airway Assist
PMB
External Airway
QAV
High Flow/High Velocity Humidified Oxygen Delivery Device
QBY
Positive Airway Pressure System
QCX
Retrograde Intubation Set
OZR
Intraoral Pressure Gradient Device
QFB
Isocapnic Ventilation Device
Subpart G—Miscellaneous
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
AN
/
subpart-f—therapeutic-devices
/
BYE
/
K820404
View Source
PEEP VALVE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K820404
510(k) Type
Traditional
Applicant
VITAL SIGNS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/1/1982
Days to Decision
17 days