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
K
23
3713
Pilling Tracheostomy Tubes
2
Cleared 510(K)
K
19
2511
Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mm
2
Cleared 510(K)
K
17
3384
BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube
2
Cleared 510(K)
K
12
0079
PRIMED TRACHEOSTOMY TUBES (MULTIPLE)
2
Cleared 510(K)
K
10
1721
WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA
2
Cleared 510(K)
K
10
0950
VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE
2
Cleared 510(K)
K
10
0480
ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH
2
Cleared 510(K)
K
10
0283
VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC
2
Cleared 510(K)
K
08
3031
PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT
2
Cleared 510(K)
K
07
3702
PHONERIS INNER CANNULAE WITH PHONERIS AERO-FLEX VENTILATOR CIRCUIT CONNECTOR
2
Cleared 510(K)
K
06
2104
TALKING TRACH
2
Cleared 510(K)
K
06
0945
PORTEX PERCUTANEOUS TRACHEOSTOMY KIT
2
Cleared 510(K)
K
05
1587
TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470
2
Cleared 510(K)
K
05
0379
CS MEDICAL ADULT TTCF CATHETER
2
Cleared 510(K)
K
04
2684
WELL LEAD TRACHEOSTOMY TUBE
2
Cleared 510(K)
K
03
1553
SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES
2
Cleared 510(K)
K
03
0570
BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE
2
Cleared 510(K)
K
03
0381
PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA
2
Cleared 510(K)
K
02
1764
RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED
2
Cleared 510(K)
K
98
3000
CRICOTHYROTOMY TUBE
2
Cleared 510(K)
K
98
1080
SCOOP 1
2
Cleared 510(K)
K
95
5461
TRANSTRACHEAL CATHETER (ACC. RAVUSSIN).
2
Cleared 510(K)
K
96
0205
CPR TRACHEOTOMY CARE TRAY
2
Cleared 510(K)
K
96
2240
MOORE TRACHEOSTOMY TUBE
2
Cleared 510(K)
K
95
3559
LARKEL DEVICE WITH ATTACHMENTS A-H(MODIFICATION)
2
Cleared 510(K)
K
95
2416
TRACHEOSTOMY CARE KIT
2
Cleared 510(K)
K
94
5407
SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT
2
Cleared 510(K)
K
94
5406
SSV PHONATE(TM) SHILEY SPEAKING VALVE
2
Cleared 510(K)
K
94
1470
TRACHEOSTOMY CARE KIT
2
Cleared 510(K)
K
92
4193
TRACHEOSTOMY CARE SET W/ HYDRO PEROX(AHC-20-54685)
2
Cleared 510(K)
K
92
4191
TRACHEOSTOMY CARE SET WITH GLOVES AND EXTRA TOWEL
2
Cleared 510(K)
K
92
4195
TRACHEOSTOMY CARE SET W/FORCEPS & GAUZE TRACH DRES
2
Cleared 510(K)
K
92
4194
TRACHEOSTOMY CARE SET W/EXTRA TOWEL(AHC-20-54686)
2
Cleared 510(K)
K
92
3834
TRACHEOSTOMY CARE SET WITH GLOVES
2
Cleared 510(K)
K
92
5249
CMI STOMA COVERS
2
Cleared 510(K)
K
92
2749
LOW PROFILE TRACHEOSTOMY TUBE
2
Cleared 510(K)
K
92
1281
TRACHEOSTOMY CARE KIT
2
Cleared 510(K)
K
92
0281
TRACHEOSTOMY CARE KIT, STERILE, DISPOSABLE
2
Cleared 510(K)
K
92
0604
BIVONA TRACHEAL T-TUBE STENT
2
Cleared 510(K)
K
91
4743
EMERGENCY PERCUTANEOUS CRICOTHYROIDOTOMY KIT,MODIF
2
Cleared 510(K)
K
91
2124
TRACHEOSTOMY TUBE AND CUFF
2
Cleared 510(K)
K
91
2469
BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBE
2
Cleared 510(K)
K
90
3730
D.I.C. TRACHEOSTOMY TUBES & LARYNGECTOMY TUBES
2
Cleared 510(K)
K
90
1920
PRIME CARE NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE
2
Cleared 510(K)
K
90
2281
MODIFIED SCOOP TRANSTRACHEAL CATHETERS
2
Cleared 510(K)
K
90
1078
SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN 0.9% SALINE
2
Cleared 510(K)
K
90
1079
SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN STER. WATER
2
Cleared 510(K)
K
90
0548
SHILEY PHONATION VALVE
2
Cleared 510(K)
K
89
4096
STAT-TRACH(TM) VENTILATION CATHETER
2
Cleared 510(K)
K
89
6798
TRACHEOSTOMY TRAY
2
Cleared 510(K)
K
89
5162
TRAUMAFUSE TRACH SHIELD
2
Cleared 510(K)
K
89
5130
HEIMLICH MICRO TRACH
2
Cleared 510(K)
K
89
3866
HOOD PEDIATRIC TRACHEOSTOMY TUBE
2
Cleared 510(K)
K
88
5139
MODIFIED ADULT CRICOTHYROIDOTOMY KIT
2
Cleared 510(K)
K
89
0342
AIRWAYS (GUEDEL, BERMAN & NASOPHARYNGEAL TYPES)
2
Cleared 510(K)
K
88
4730
SHILEY PERC TRACHEOSTOMY SYSTEM
2
Cleared 510(K)
K
88
4015
PREMIER DECANNULATION STOPPER
2
Cleared 510(K)
K
88
4427
FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY CONNECT.
2
Cleared 510(K)
K
88
2430
HOOD TRACHEAL STOMA BUTTON
2
Cleared 510(K)
K
88
0614
SHILEY DISP. CANNULA CUFFLESS TRACEOSTOMY TUBE
2
Cleared 510(K)
K
88
0317
PREFILLED SODIUM CHLORIDE SOLUTION FOR IRRIGA. USP
2
Cleared 510(K)
K
88
0316
PREFILLED WATER FOR IRRIGATION USP
2
Cleared 510(K)
K
87
4450
SCHACHNER-OVIL RAPITRAC PERCUTAN. TRACHEOSTOMY KIT
2
Cleared 510(K)
K
88
0247
MODIFIED SHILEY LOW PRESSURE CUFFED TRACHEO. TUBES
2
Cleared 510(K)
K
87
4742
QUICKTRACH
2
Cleared 510(K)
K
87
3499
TODD MEDICAL/SKILLED CARE PRODUCTS
2
Cleared 510(K)
K
87
2486
LARKEL DEVICE W/ATTACHMENTS A-H
2
Cleared 510(K)
K
87
1199
MODIFIED PERTRACH DISP. PEDIATRIC PERCUT. TRACHEO.
2
Cleared 510(K)
K
87
0181
JOHNSON INTRATRACHEAL OXYGEN CATHETER SET
2
Cleared 510(K)
K
86
5061
SHILEY DISPOS CANNULA FENES LP CUFFED TRACHE TUBE
2
Cleared 510(K)
K
86
2436
TRANS- CIRCOTHYROTOMY DEVICE (ACC. RAVUSSIN)
2
Cleared 510(K)
K
86
2909
RE-TRAKE WEISS EMERGENCY AIRWAY & THORACIC SYSTEM
2
Cleared 510(K)
K
86
2167
MINI-TRACH KIT
2
Cleared 510(K)
K
86
2267
FOME-CUF AND AIRE CUF TRACHEOSTOMY TUBES
2
Cleared 510(K)
K
86
1645
MICRO-TRACHEOSTOMY CARE KIT
2
Cleared 510(K)
K
85
3051
TRACHEAL TUBES
2
Cleared 510(K)
K
85
5130
TRACHEOSTOMY CARE KIT
2
Cleared 510(K)
K
85
4252
TRANSTRACHEAL SYSTEM-SCOOP-INSERTION TRAY-CATHETER
2
Cleared 510(K)
K
86
0176
LARYNGECTOMY TUBE, CUFFED
2
Cleared 510(K)
K
85
3511
THE HOOD LIFE SAVER
2
Cleared 510(K)
K
85
3419
CLEANING KIT CARE & CLEANING OF TRACHEAL T-TUBE
2
Cleared 510(K)
K
85
2413
LGT TUBE
2
Cleared 510(K)
K
85
2272
BIVONA TRACHEOSTOMA VALVE II
2
Cleared 510(K)
K
85
1016
PASSY-MUIR TRACH VALVE
2
Cleared 510(K)
K
85
1462
BFW VOICE GENERATOR
2
Cleared 510(K)
K
85
0456
TRACHEOSTOMY CARE KIT
2
Cleared 510(K)
K
85
0446
TRACHEOSTOMY CARE KIT
2
Cleared 510(K)
K
85
0445
TRACHEOSTOMY CARE TRAY
2
Cleared 510(K)
K
84
3785
WISSS PEDIATRIC TRACH- TUBE W/OBTURATOR
2
Cleared 510(K)
K
84
3730
SHILEY DISPOS. DECANNULATION PLUG W/SW/
2
Cleared 510(K)
K
84
3729
SHILEY DISPOS. CANNULA FENESTRATED LOW
2
Cleared 510(K)
K
82
2440
PERCUTANEOUS CRICOTHYROIDOTOMY
2
Cleared 510(K)
K
83
2466
TRACHEAL TUBE 16 GAUGE-1.65MM-
2
Cleared 510(K)
K
84
2415
ALL-HANDS TRACHEOSTOMY CARE SET 0101
2
Cleared 510(K)
K
84
1266
MONTGOMERY TRACHEAL T-TUBE
2
Cleared 510(K)
K
84
0925
PEDIA-TRAKE CRICOTHYROTOMY KIT
2
Cleared 510(K)
K
84
1546
COMMUNI-TRACH TUBE
2
Cleared 510(K)
K
83
3832
3-DAY BIOINDICATOR RELEASE FOR RESPIR
2
Cleared 510(K)
K
84
0539
DISPOS. LOW PRESS. CUFFED TRACHEOSTOMY
2
Cleared 510(K)
K
83
4179
H.R. JAKOBI SURG. INSTRUMENTS #9 48
2
Cleared 510(K)
K
83
2498
PERCUTANEOUS TRACHEOSTOMY DEVICE
2
Cleared 510(K)
K
83
1720
ARGYLE SILICONE TRACHESTOMY TUBE W/LOW
2
Cleared 510(K)
K
83
1511
TRACHEOSTOMY TUBE
2
Cleared 510(K)
K
83
0509
EMERGENCY TRACHEOSTOMY & CRICOTHYROIDO-
2
Cleared 510(K)
K
82
3291
COMMUNITRACH TUBE
2
Cleared 510(K)
K
82
2811
CONTAINERS OF STERILE WATER OS SALINE
2
Cleared 510(K)
K
82
2295
SURGI TEK'S DISPOS. INNER CANNULA FOR
2
Cleared 510(K)
K
82
0099
TRACH TAPE
2
Cleared 510(K)
K
81
1447
SHILEY DISPOSABLE CANNULA TRACH. TUBE
2
Cleared 510(K)
K
81
1033
SHILEY LOW PRESSURE THIN-CUFFED TRACH
2
Cleared 510(K)
K
81
0978
MONTGOMERY SILICONE TRACHEAL T-TUBE
2
Cleared 510(K)
K
81
0575
MARTIN TRACH-SECURE
2
Cleared 510(K)
K
81
0436
TRACHEOSTOMA VENT
2
Cleared 510(K)
K
81
0321
REINFORCED TRACHEOSTOMY TUBE SET(TENTAT)
2
Cleared 510(K)
K
81
0106
SHILEY SINGLE CANNULA TRACHEOSTOMY TUBE
2
Cleared 510(K)
K
80
2916
MONTG. TRACHEAL CANNULA
2
Cleared 510(K)
K
80
1379
CUFFED TRACHEA TUBE FOR USE W/PERTRACH
2
Cleared 510(K)
K
80
1931
MARTIN TRACH-SECURE
2
Cleared 510(K)
K
79
2069
TRACHEOSTOMY CARE KIT
2
Cleared 510(K)
K
79
0930
TRACHE FITTING M-307
2
Cleared 510(K)
K
79
1044
TRACHEOSTOMY TUBES, SHORT AND LONG TERM
2
Cleared 510(K)
K
79
0437
TRACH CARE KIT
2
Cleared 510(K)
K
78
1729
TRACHEOTOMY TUBES
2
Cleared 510(K)
K
77
2138
ENDOTRACHEAL TUBE
2
Cleared 510(K)
K
77
0218
SHILEY PEDIATRIC MURPHY ENDOTRACH. TUBE
2
Cleared 510(K)
K
76
1258
DOVER LOW PRESSURE TRACHEAL TUBE
2
Cleared 510(K)
K
76
1190
TRACHEOSTOMY CARE KIT
2
Cleared 510(K)
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
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
/
BTO
/
K832466
View Source
TRACHEAL TUBE 16 GAUGE-1.65MM-
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K832466
510(k) Type
Traditional
Applicant
ERIE MEDICAL
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/19/1984
Days to Decision
421 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)
K
23
3713
Pilling Tracheostomy Tubes
K
19
2511
Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mm
K
17
3384
BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube
K
12
0079
PRIMED TRACHEOSTOMY TUBES (MULTIPLE)
K
10
1721
WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA
K
10
0950
VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE
K
10
0480
ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH
K
10
0283
VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC
K
08
3031
PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT
K
07
3702
PHONERIS INNER CANNULAE WITH PHONERIS AERO-FLEX VENTILATOR CIRCUIT CONNECTOR
K
06
2104
TALKING TRACH
K
06
0945
PORTEX PERCUTANEOUS TRACHEOSTOMY KIT
K
05
1587
TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470
K
05
0379
CS MEDICAL ADULT TTCF CATHETER
K
04
2684
WELL LEAD TRACHEOSTOMY TUBE
K
03
1553
SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES
K
03
0570
BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE
K
03
0381
PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA
K
02
1764
RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED
K
98
3000
CRICOTHYROTOMY TUBE
K
98
1080
SCOOP 1
K
95
5461
TRANSTRACHEAL CATHETER (ACC. RAVUSSIN).
K
96
0205
CPR TRACHEOTOMY CARE TRAY
K
96
2240
MOORE TRACHEOSTOMY TUBE
K
95
3559
LARKEL DEVICE WITH ATTACHMENTS A-H(MODIFICATION)
K
95
2416
TRACHEOSTOMY CARE KIT
K
94
5407
SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT
K
94
5406
SSV PHONATE(TM) SHILEY SPEAKING VALVE
K
94
1470
TRACHEOSTOMY CARE KIT
K
92
4193
TRACHEOSTOMY CARE SET W/ HYDRO PEROX(AHC-20-54685)
K
92
4191
TRACHEOSTOMY CARE SET WITH GLOVES AND EXTRA TOWEL
K
92
4195
TRACHEOSTOMY CARE SET W/FORCEPS & GAUZE TRACH DRES
K
92
4194
TRACHEOSTOMY CARE SET W/EXTRA TOWEL(AHC-20-54686)
K
92
3834
TRACHEOSTOMY CARE SET WITH GLOVES
K
92
5249
CMI STOMA COVERS
K
92
2749
LOW PROFILE TRACHEOSTOMY TUBE
K
92
1281
TRACHEOSTOMY CARE KIT
K
92
0281
TRACHEOSTOMY CARE KIT, STERILE, DISPOSABLE
K
92
0604
BIVONA TRACHEAL T-TUBE STENT
K
91
4743
EMERGENCY PERCUTANEOUS CRICOTHYROIDOTOMY KIT,MODIF
K
91
2124
TRACHEOSTOMY TUBE AND CUFF
K
91
2469
BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBE
K
90
3730
D.I.C. TRACHEOSTOMY TUBES & LARYNGECTOMY TUBES
K
90
1920
PRIME CARE NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE
K
90
2281
MODIFIED SCOOP TRANSTRACHEAL CATHETERS
K
90
1078
SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN 0.9% SALINE
K
90
1079
SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN STER. WATER
K
90
0548
SHILEY PHONATION VALVE
K
89
4096
STAT-TRACH(TM) VENTILATION CATHETER
K
89
6798
TRACHEOSTOMY TRAY
K
89
5162
TRAUMAFUSE TRACH SHIELD
K
89
5130
HEIMLICH MICRO TRACH
K
89
3866
HOOD PEDIATRIC TRACHEOSTOMY TUBE
K
88
5139
MODIFIED ADULT CRICOTHYROIDOTOMY KIT
K
89
0342
AIRWAYS (GUEDEL, BERMAN & NASOPHARYNGEAL TYPES)
K
88
4730
SHILEY PERC TRACHEOSTOMY SYSTEM
K
88
4015
PREMIER DECANNULATION STOPPER
K
88
4427
FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY CONNECT.
K
88
2430
HOOD TRACHEAL STOMA BUTTON
K
88
0614
SHILEY DISP. CANNULA CUFFLESS TRACEOSTOMY TUBE
K
88
0317
PREFILLED SODIUM CHLORIDE SOLUTION FOR IRRIGA. USP
K
88
0316
PREFILLED WATER FOR IRRIGATION USP
K
87
4450
SCHACHNER-OVIL RAPITRAC PERCUTAN. TRACHEOSTOMY KIT
K
88
0247
MODIFIED SHILEY LOW PRESSURE CUFFED TRACHEO. TUBES
K
87
4742
QUICKTRACH
K
87
3499
TODD MEDICAL/SKILLED CARE PRODUCTS
K
87
2486
LARKEL DEVICE W/ATTACHMENTS A-H
K
87
1199
MODIFIED PERTRACH DISP. PEDIATRIC PERCUT. TRACHEO.
K
87
0181
JOHNSON INTRATRACHEAL OXYGEN CATHETER SET
K
86
5061
SHILEY DISPOS CANNULA FENES LP CUFFED TRACHE TUBE
K
86
2436
TRANS- CIRCOTHYROTOMY DEVICE (ACC. RAVUSSIN)
K
86
2909
RE-TRAKE WEISS EMERGENCY AIRWAY & THORACIC SYSTEM
K
86
2167
MINI-TRACH KIT
K
86
2267
FOME-CUF AND AIRE CUF TRACHEOSTOMY TUBES
K
86
1645
MICRO-TRACHEOSTOMY CARE KIT
K
85
3051
TRACHEAL TUBES
K
85
5130
TRACHEOSTOMY CARE KIT
K
85
4252
TRANSTRACHEAL SYSTEM-SCOOP-INSERTION TRAY-CATHETER
K
86
0176
LARYNGECTOMY TUBE, CUFFED
K
85
3511
THE HOOD LIFE SAVER
K
85
3419
CLEANING KIT CARE & CLEANING OF TRACHEAL T-TUBE
K
85
2413
LGT TUBE
K
85
2272
BIVONA TRACHEOSTOMA VALVE II
K
85
1016
PASSY-MUIR TRACH VALVE
K
85
1462
BFW VOICE GENERATOR
K
85
0456
TRACHEOSTOMY CARE KIT
K
85
0446
TRACHEOSTOMY CARE KIT
K
85
0445
TRACHEOSTOMY CARE TRAY
K
84
3785
WISSS PEDIATRIC TRACH- TUBE W/OBTURATOR
K
84
3730
SHILEY DISPOS. DECANNULATION PLUG W/SW/
K
84
3729
SHILEY DISPOS. CANNULA FENESTRATED LOW
K
82
2440
PERCUTANEOUS CRICOTHYROIDOTOMY
K
83
2466
TRACHEAL TUBE 16 GAUGE-1.65MM-
K
84
2415
ALL-HANDS TRACHEOSTOMY CARE SET 0101
K
84
1266
MONTGOMERY TRACHEAL T-TUBE
K
84
0925
PEDIA-TRAKE CRICOTHYROTOMY KIT
K
84
1546
COMMUNI-TRACH TUBE
K
83
3832
3-DAY BIOINDICATOR RELEASE FOR RESPIR
K
84
0539
DISPOS. LOW PRESS. CUFFED TRACHEOSTOMY
K
83
4179
H.R. JAKOBI SURG. INSTRUMENTS #9 48
K
83
2498
PERCUTANEOUS TRACHEOSTOMY DEVICE
K
83
1720
ARGYLE SILICONE TRACHESTOMY TUBE W/LOW
K
83
1511
TRACHEOSTOMY TUBE
K
83
0509
EMERGENCY TRACHEOSTOMY & CRICOTHYROIDO-
K
82
3291
COMMUNITRACH TUBE
K
82
2811
CONTAINERS OF STERILE WATER OS SALINE
K
82
2295
SURGI TEK'S DISPOS. INNER CANNULA FOR
K
82
0099
TRACH TAPE
K
81
1447
SHILEY DISPOSABLE CANNULA TRACH. TUBE
K
81
1033
SHILEY LOW PRESSURE THIN-CUFFED TRACH
K
81
0978
MONTGOMERY SILICONE TRACHEAL T-TUBE
K
81
0575
MARTIN TRACH-SECURE
K
81
0436
TRACHEOSTOMA VENT
K
81
0321
REINFORCED TRACHEOSTOMY TUBE SET(TENTAT)
K
81
0106
SHILEY SINGLE CANNULA TRACHEOSTOMY TUBE
K
80
2916
MONTG. TRACHEAL CANNULA
K
80
1379
CUFFED TRACHEA TUBE FOR USE W/PERTRACH
K
80
1931
MARTIN TRACH-SECURE
K
79
2069
TRACHEOSTOMY CARE KIT
K
79
0930
TRACHE FITTING M-307
K
79
1044
TRACHEOSTOMY TUBES, SHORT AND LONG TERM
K
79
0437
TRACH CARE KIT
K
78
1729
TRACHEOTOMY TUBES
K
77
2138
ENDOTRACHEAL TUBE
K
77
0218
SHILEY PEDIATRIC MURPHY ENDOTRACH. TUBE
K
76
1258
DOVER LOW PRESSURE TRACHEAL TUBE
K
76
1190
TRACHEOSTOMY CARE KIT
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)
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
/
BTO
/
K832466
View Source
TRACHEAL TUBE 16 GAUGE-1.65MM-
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K832466
510(k) Type
Traditional
Applicant
ERIE MEDICAL
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/19/1984
Days to Decision
421 days