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
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
K
08
3702
TRACH-ASSIST
1
Cleared 510(K)
K
95
4383
SURELOC CIRCUIT CONNECTOR
1
Cleared 510(K)
K
95
4197
DISPOSABLE FLEX TUBE
1
Cleared 510(K)
K
95
3786
UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONS
1
Cleared 510(K)
K
95
2824
NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR
1
Cleared 510(K)
K
95
1345
DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLING
1
Cleared 510(K)
K
94
4532
PRIMA, INC. VENTILATOR HOSES
1
Cleared 510(K)
K
94
4534
PRIMA, INC. CONNECTORS AND AIRWAY EXTENSIONS
1
Cleared 510(K)
K
94
4535
PRIMA, INC. GAS SAMPLING LINES AND CONNECTORS
1
Cleared 510(K)
K
94
2392
AIRWAY CONNECTOR WITH FLEX TUBE
1
Cleared 510(K)
K
94
1026
THAYER MASK TO MOUTHPIECE ADAPTER/CONNECTOR
1
Cleared 510(K)
K
94
0793
DOUBLE TRACH SWIVEL CONNECTOR
1
Cleared 510(K)
K
94
0544
DOUBLE TRACH SEIVEL CONNECTOR
1
Cleared 510(K)
K
93
5821
DOUBLE TRACH SWIVEL CONNECTOR
1
Cleared 510(K)
K
93
1800
MAG CONNECTORS AND AIRWAY EXTENSIONS
1
Cleared 510(K)
K
93
1345
CONNECTORS AND AIRWAY EXTENSIONS
1
Cleared 510(K)
K
93
1216
CONNECTORS AND AIRWAY EXTENSIONS
1
Cleared 510(K)
K
93
1036
CONNECTORS AND AIRWAY EXTENSIONS
1
Cleared 510(K)
K
93
1038
CONNECTORS AND AIRWAY EXTENSIONS
1
Cleared 510(K)
K
92
5263
MERIDIAN MEDICAL SYSTEMS CONNECTORS & AIRWAY EXT
1
Cleared 510(K)
K
92
2537
DURALIFE
1
Cleared 510(K)
K
92
4225
OXYGEN SWIVEL ADAPTER (PLASTIC)
1
Cleared 510(K)
K
92
1512
ENTENDED LINE ACCESSORIES & CONNECTORS
1
Cleared 510(K)
K
92
1511
CATHETER MOUNTS -- MODIFICATION
1
Cleared 510(K)
K
91
3726
DURALIFE(TM)
1
Cleared 510(K)
K
91
3216
TRACH T ADAPTER
1
Cleared 510(K)
K
91
2652
FLEX-ELBOW
1
Cleared 510(K)
K
91
1425
ACCESSORIES & CONNECTORS, 22MM-15MM-8.5MM
1
Cleared 510(K)
K
91
1421
CATHETER MOUNTS
1
Cleared 510(K)
K
91
1294
ULTRASET CATHETER
1
Cleared 510(K)
K
89
5549
M.D.I. ADAPTER
1
Cleared 510(K)
K
89
5014
BAXTER BAFFLED TEE ADAPTER
1
Cleared 510(K)
K
89
4969
AEROVENT
1
Cleared 510(K)
K
89
5388
SHILEY ELBOW 15MM SWIVEL CONNECTOR
1
Cleared 510(K)
K
89
5144
INTERTECH METERED DOSE ELBOW
1
Cleared 510(K)
K
88
4374
E.T. PUFFER
1
Cleared 510(K)
K
88
1849
BODAI M.D.D. ADAPTOR(TM)
1
Cleared 510(K)
K
88
2203
NEOTECH UNIVERSAL ADAPTER
1
Cleared 510(K)
K
88
1230
FLEX TUBE
1
Cleared 510(K)
K
87
3696
BODAI NEO2-SAFE(TM)
1
Cleared 510(K)
K
88
0434
MEDICOMP STRAIGHT SWIVEL ADAPTOR
1
Cleared 510(K)
K
87
3974
TILSON TRACH GUARD
1
Cleared 510(K)
K
87
1737
CK 7000 SERIES 5 IN 1 CONNECTOR AND Y-CONNECTOR
1
Cleared 510(K)
K
86
4896
MEDICOMP INHALANT MASK ELBOW
1
Cleared 510(K)
K
86
5046
SALTER LABS MODEL #4005 GAS SAMPLING TEE AND LINE
1
Cleared 510(K)
K
86
2435
DOUBLE LUMEN E T ADAPTOR
1
Cleared 510(K)
K
86
3318
AEROSOL-T
1
Cleared 510(K)
K
86
2433
UNI-JET CONNECTOR
1
Cleared 510(K)
K
86
0838
INSPIRON DOUBLE SWIVEL TRACH ADAPTER
1
Cleared 510(K)
K
86
0650
90 DEGREE ELBOW & STRAIGHT CONNECTOR
1
Cleared 510(K)
K
86
1056
STRAIGHT ADAPT W/TEMP SENSING PORT/CLOSURE PLUG
1
Cleared 510(K)
K
86
0885
STRAIGHT CONNECTORS, 15MM, 30MM & 19MM
1
Cleared 510(K)
K
86
0882
DISPOSABLE CATHETER
1
Cleared 510(K)
K
86
0878
BRITISH BREATHING CIRCUIT SYSTEM
1
Cleared 510(K)
K
86
0888
CONNECTORS/VALVE INSERT
1
Cleared 510(K)
K
86
0881
CATHETER MOUNTS & ELBOWS (VARIOUS TYPES)
1
Cleared 510(K)
K
86
0886
STRAIGHT CONNECTORS, 22MM
1
Cleared 510(K)
K
86
0887
T-PIECES CONNECTORS
1
Cleared 510(K)
K
86
0352
SPACELABS AIRWAY ADAPTER SET SERIES, NO. 369014
1
Cleared 510(K)
K
85
3828
FLS MED. PROD. RACINE TYPE ADAPTOR
1
Cleared 510(K)
K
85
0964
DOUBLE-SWIVEL CONNECTOR
1
Cleared 510(K)
K
85
0625
ARGYLE 15MM SWIVEL CONNECTOR
1
Cleared 510(K)
K
84
4656
OHMEDA DOUBLE SWIVEL ADAPTER
1
Cleared 510(K)
K
84
0015
SWIVEL ADAPTOR W/ALARM PORT
1
Cleared 510(K)
K
83
3373
BODIA BRONCH-SAF DOUBLE SWIVEL
1
Cleared 510(K)
K
83
3372
BODIA TRACH-SAF DOUBLE SWIVEL
1
Cleared 510(K)
K
81
3383
DISPOSABLE TRACH SWIVEL CONNECTOR
1
Cleared 510(K)
K
81
2977
RESPIRATORY CARE MONITOR
1
Cleared 510(K)
K
81
2067
INSPIRATORY FORCE PRESSURE ADAPTOR
1
Cleared 510(K)
K
81
2000
PEDIATRIC DOUBLE SWIVEL CONNECTOR
1
Cleared 510(K)
K
81
1922
45DEGREES SWIVEL ELBOW
1
Cleared 510(K)
K
81
1890
DISPOSABLE TRACH T OXYGENATOR
1
Cleared 510(K)
K
81
1708
UNIVERSAL ADAPTER SYSTEM-U/ADAPIT
1
Cleared 510(K)
K
81
0621
DISPOSABLE 22MM. FLEXIBLE ADAPTOR
1
Cleared 510(K)
K
81
0620
DISPOSABLE ELBOW ADAPTOR
1
Cleared 510(K)
K
81
0361
CONNECTOR ADAPTERS
1
Cleared 510(K)
K
80
2663
BLOW-BY-SET-UP CONNECTOR-AIRWAY
1
Cleared 510(K)
K
79
1538
DISPOSABLE AEROSOL T
1
Cleared 510(K)
K
79
1539
DISPOSABLE 22MM ADAPTOR
1
Cleared 510(K)
K
79
1532
SURELOC EXTERNAL CONNECTOR
1
Cleared 510(K)
K
79
0888
TRACH T WITH ONE-WAY VALVES
1
Cleared 510(K)
K
79
0887
TEE ADAPTER
1
Cleared 510(K)
K
79
0156
TRACH T W/DRAINAGE BAG
1
Cleared 510(K)
K
79
0157
TRACH T ADAPTER
1
Cleared 510(K)
K
79
0155
VENTILATOR ELBOW W/SUCTION PORT
1
Cleared 510(K)
K
79
0149
MASK INTULATION ADAPTOR
1
Cleared 510(K)
K
79
0148
CUFF CONNECTOR
1
Cleared 510(K)
K
78
1759
RESCAL
1
Cleared 510(K)
K
78
1395
DISPOSABLE AEROSOL T BRIGGS ADAPTOR
1
Cleared 510(K)
K
77
0630
ADAPTER, UNIVERSAL, BE 105-6
1
Cleared 510(K)
K
77
0634
ADAPTER BE 105-101 & 125-101
1
Cleared 510(K)
K
77
0585
AEROSOL T ADAPTER, #752
1
Cleared 510(K)
K
77
0587
VENTILATOR ADAPTOR, #751
1
Cleared 510(K)
K
77
0052
VITAL-LOK TRACHEAL SWIVEL COUPLING
1
Cleared 510(K)
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
/
BZA
/
K913216
View Source
TRACH T ADAPTER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K913216
510(k) Type
Traditional
Applicant
SPECIALTY PACKAGING PRODUCS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/15/1992
Days to Decision
180 days
Submission Type
Summary
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
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)
K
08
3702
TRACH-ASSIST
K
95
4383
SURELOC CIRCUIT CONNECTOR
K
95
4197
DISPOSABLE FLEX TUBE
K
95
3786
UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONS
K
95
2824
NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR
K
95
1345
DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLING
K
94
4532
PRIMA, INC. VENTILATOR HOSES
K
94
4534
PRIMA, INC. CONNECTORS AND AIRWAY EXTENSIONS
K
94
4535
PRIMA, INC. GAS SAMPLING LINES AND CONNECTORS
K
94
2392
AIRWAY CONNECTOR WITH FLEX TUBE
K
94
1026
THAYER MASK TO MOUTHPIECE ADAPTER/CONNECTOR
K
94
0793
DOUBLE TRACH SWIVEL CONNECTOR
K
94
0544
DOUBLE TRACH SEIVEL CONNECTOR
K
93
5821
DOUBLE TRACH SWIVEL CONNECTOR
K
93
1800
MAG CONNECTORS AND AIRWAY EXTENSIONS
K
93
1345
CONNECTORS AND AIRWAY EXTENSIONS
K
93
1216
CONNECTORS AND AIRWAY EXTENSIONS
K
93
1036
CONNECTORS AND AIRWAY EXTENSIONS
K
93
1038
CONNECTORS AND AIRWAY EXTENSIONS
K
92
5263
MERIDIAN MEDICAL SYSTEMS CONNECTORS & AIRWAY EXT
K
92
2537
DURALIFE
K
92
4225
OXYGEN SWIVEL ADAPTER (PLASTIC)
K
92
1512
ENTENDED LINE ACCESSORIES & CONNECTORS
K
92
1511
CATHETER MOUNTS -- MODIFICATION
K
91
3726
DURALIFE(TM)
K
91
3216
TRACH T ADAPTER
K
91
2652
FLEX-ELBOW
K
91
1425
ACCESSORIES & CONNECTORS, 22MM-15MM-8.5MM
K
91
1421
CATHETER MOUNTS
K
91
1294
ULTRASET CATHETER
K
89
5549
M.D.I. ADAPTER
K
89
5014
BAXTER BAFFLED TEE ADAPTER
K
89
4969
AEROVENT
K
89
5388
SHILEY ELBOW 15MM SWIVEL CONNECTOR
K
89
5144
INTERTECH METERED DOSE ELBOW
K
88
4374
E.T. PUFFER
K
88
1849
BODAI M.D.D. ADAPTOR(TM)
K
88
2203
NEOTECH UNIVERSAL ADAPTER
K
88
1230
FLEX TUBE
K
87
3696
BODAI NEO2-SAFE(TM)
K
88
0434
MEDICOMP STRAIGHT SWIVEL ADAPTOR
K
87
3974
TILSON TRACH GUARD
K
87
1737
CK 7000 SERIES 5 IN 1 CONNECTOR AND Y-CONNECTOR
K
86
4896
MEDICOMP INHALANT MASK ELBOW
K
86
5046
SALTER LABS MODEL #4005 GAS SAMPLING TEE AND LINE
K
86
2435
DOUBLE LUMEN E T ADAPTOR
K
86
3318
AEROSOL-T
K
86
2433
UNI-JET CONNECTOR
K
86
0838
INSPIRON DOUBLE SWIVEL TRACH ADAPTER
K
86
0650
90 DEGREE ELBOW & STRAIGHT CONNECTOR
K
86
1056
STRAIGHT ADAPT W/TEMP SENSING PORT/CLOSURE PLUG
K
86
0885
STRAIGHT CONNECTORS, 15MM, 30MM & 19MM
K
86
0882
DISPOSABLE CATHETER
K
86
0878
BRITISH BREATHING CIRCUIT SYSTEM
K
86
0888
CONNECTORS/VALVE INSERT
K
86
0881
CATHETER MOUNTS & ELBOWS (VARIOUS TYPES)
K
86
0886
STRAIGHT CONNECTORS, 22MM
K
86
0887
T-PIECES CONNECTORS
K
86
0352
SPACELABS AIRWAY ADAPTER SET SERIES, NO. 369014
K
85
3828
FLS MED. PROD. RACINE TYPE ADAPTOR
K
85
0964
DOUBLE-SWIVEL CONNECTOR
K
85
0625
ARGYLE 15MM SWIVEL CONNECTOR
K
84
4656
OHMEDA DOUBLE SWIVEL ADAPTER
K
84
0015
SWIVEL ADAPTOR W/ALARM PORT
K
83
3373
BODIA BRONCH-SAF DOUBLE SWIVEL
K
83
3372
BODIA TRACH-SAF DOUBLE SWIVEL
K
81
3383
DISPOSABLE TRACH SWIVEL CONNECTOR
K
81
2977
RESPIRATORY CARE MONITOR
K
81
2067
INSPIRATORY FORCE PRESSURE ADAPTOR
K
81
2000
PEDIATRIC DOUBLE SWIVEL CONNECTOR
K
81
1922
45DEGREES SWIVEL ELBOW
K
81
1890
DISPOSABLE TRACH T OXYGENATOR
K
81
1708
UNIVERSAL ADAPTER SYSTEM-U/ADAPIT
K
81
0621
DISPOSABLE 22MM. FLEXIBLE ADAPTOR
K
81
0620
DISPOSABLE ELBOW ADAPTOR
K
81
0361
CONNECTOR ADAPTERS
K
80
2663
BLOW-BY-SET-UP CONNECTOR-AIRWAY
K
79
1538
DISPOSABLE AEROSOL T
K
79
1539
DISPOSABLE 22MM ADAPTOR
K
79
1532
SURELOC EXTERNAL CONNECTOR
K
79
0888
TRACH T WITH ONE-WAY VALVES
K
79
0887
TEE ADAPTER
K
79
0156
TRACH T W/DRAINAGE BAG
K
79
0157
TRACH T ADAPTER
K
79
0155
VENTILATOR ELBOW W/SUCTION PORT
K
79
0149
MASK INTULATION ADAPTOR
K
79
0148
CUFF CONNECTOR
K
78
1759
RESCAL
K
78
1395
DISPOSABLE AEROSOL T BRIGGS ADAPTOR
K
77
0630
ADAPTER, UNIVERSAL, BE 105-6
K
77
0634
ADAPTER BE 105-101 & 125-101
K
77
0585
AEROSOL T ADAPTER, #752
K
77
0587
VENTILATOR ADAPTOR, #751
K
77
0052
VITAL-LOK TRACHEAL SWIVEL COUPLING
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
/
BZA
/
K913216
View Source
TRACH T ADAPTER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K913216
510(k) Type
Traditional
Applicant
SPECIALTY PACKAGING PRODUCS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/15/1992
Days to Decision
180 days
Submission Type
Summary