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Panels › Anesthesiology › Product code BTO · Class 2

Tube, Tracheostomy (W/Wo Connector)

Regulation 868.5800

1510(k)s in 12 months (129 all time)
1recalls in 12 months (73 all time)
69recalls that name a 510(k)
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Top companies in BTO

DateFirm and productCodeLinked 510(k)
Jul 2, 2026Covidien LLC
Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes that include the Covidien Shiley Disposable Decannulation Plug are: Product Number / UDI-DI code 4DCF
Open, Classified
BTOK843730
Sep 11, 2024Smiths Medical ASD Inc.
smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BLUselect tracheostomy tubes, labeled as follows: 1) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator
Open, Classified
BTOK173384
Sep 11, 2024Smiths Medical ASD Inc.
smiths medical portex BLUgriggs Percutaneous Dilation Procedural Trays with BLUselect tracheotomy tubes, labeled as follows: 1) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 8.0mm
Open, Classified
BTOK173384
Sep 11, 2024Smiths Medical ASD Inc.
smiths medical portex BLUselect, tracheostomy tube, labeled as follows: 1) BLUSELECT 6.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/060CZ; 2) BLUSELECT 7.0, CUFFED, NON-FEN, 10/BX, Item Number 10
Open, Classified
BTOK173384
K173912
Aug 23, 2024Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN025; b) 3.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , P
Open, Classified
BTOK912469
Aug 23, 2024Smiths Medical ASD Inc.
a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Numb
Open, Classified
BTOK912469
Aug 23, 2024Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V NECK, Product Code/List Number/Item Code 67PFS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS
Open, Classified
BTOK912469
Aug 23, 2024Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS40; b) PEDIATRIC TRACHEOSTOMY
Open, Classified
BTOK912469
Aug 23, 2024Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP40; b) PEDIATRIC TRACHEOSTOMY TUBE 4
Open, Classified
BTOK912469
Aug 23, 2024Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P025; b) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P03
Open, Classified
BTOK912469
Aug 23, 2024Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS25; b) NEONATAL TRACHEOSTOMY TUBE
Open, Classified
BTOK912469
Aug 23, 2024Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP25; b) NEONATAL TRACHEOSTOMY TUBE 3.0mm TTS
Open, Classified
BTOK912469
Aug 23, 2024Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: TTS NEONATAL TRACHY TUBE 4.0MMTIGHT TO SHAFT CUFF , Product Code/List Number/Item Code 67N040
Open, Classified
BTOK912469
Aug 23, 2024Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N025; b) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N0
Open, Classified
BTOK912469
Aug 23, 2024Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN025; 3.0MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Cod
Open, Classified
BTOK912469
Aug 23, 2024Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM AIRE-CUF , Product Code/List Number/Item Code 65P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM AIRE-CUF , Product Code
Open, Classified
BTOK912469
Aug 23, 2024Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N025; b) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 6
Open, Classified
BTOK912469
Aug 23, 2024Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN025; b) 3.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product C
Open, Classified
BTOK912469
Aug 23, 2024Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND PEDIATRIC STANDARD S
Open, Classified
BTOK912469
Aug 23, 2024Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM PEDIATRIC UNCUFFED FLEXTEND PLUS TRACHEOSTOMY TUBE WITH NEONATE STRAIGHT NECKSTRAP, Product Code/List Number/Item Code 60PFSS25
Open, Classified
BTOK912469
Aug 23, 2024Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS25; b) PAED. TRACHEOSTOMY TUBE 3.0MM STANDARD
Open, Classified
BTOK912469
Aug 23, 2024Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS40; b) 4.5MM FLEXTEND PEDIATRIC PLUS STRAIGHT
Open, Classified
BTOK912469
Aug 23, 2024Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 6.0MM FLEXTEND PEDIATRIC PLUS VEE TRACH TUBE , Product Code/List Number/Item Code 60PFP60
Open, Classified
BTOK912469
Aug 23, 2024Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP40; b) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Pro
Open, Classified
BTOK912469
Aug 23, 2024Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List Number/Item Code 60P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM UNCUFFED , Product Code
Open, Classified
BTOK912469
Aug 23, 2024Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS30; b) 3.5MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product
Open, Classified
BTOK912469
Aug 23, 2024Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM UNCUFFED NEONATAL FLEXTEND PLUS TRACHEOSTOMY TUBE W/NEO STRAIGHT STRAP, Product Code/List Number/Item Code 60NFPS25
Open, Classified
BTOK912469
Aug 23, 2024Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP25; b) NEONATAL TRACHEOSTOMY TUBE 3.0FLEXTEND PLUS ,
Open, Classified
BTOK912469
Aug 23, 2024Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N030; b) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N035; c) N
Open, Classified
BTOK912469
Aug 23, 2024Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60N025
Open, Classified
BTOK912469
Aug 23, 2024Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160; b) AIRE-CUF TRACHY TUBE 7.0MM MID-RANGE , Product Code/Li
Open, Classified
BTOK912469
Aug 23, 2024Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CU
Open, Classified
BTOK912469
Feb 16, 2024Cardinal Health 200, LLC
TRACH KIT W/HYDROGEN & SALI
Open, Classified
BTOK761190
Feb 11, 2019Smiths Medical ASD Inc.
Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled in part, Product Usage: The Portex Blue Line Ultra Tracheostomy Tubes are indicated for a
Terminated
BTOK030381
Apr 2, 2018Smiths Medical ASD Inc.
Bivona Tracheostomy Tube Tracheostomy Tubes
Terminated
BTONone listed
Mar 24, 2016Ambu Inc.
Ambu, Aura Gain - Single Use Laryngeal Mask- Sterile for use as an alternative to a face mask for achieving and maintaining control of the airway during routine emergency anesthetic procedures.
Terminated
BTONone listed
Sep 23, 2015Instrumentation Industries Inc
Ventilator Tubing
Terminated
BTONone listed
Jul 8, 2013Bryan Medical Inc
Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide safe airway access.
Terminated
BTOK893866
May 21, 2012Arcadia Medical Corporation
Silicone Cuffed Wire Reinforced Extended Connect Pediatric Perfect Fit Neck Flange Tracheostomy Tube, Size 4.0 mm I.D. Catalog Number 353-040. Intended for use in providing direct tracheal access fo
Terminated
BTOK031553
Jan 19, 2012Smiths Medical ASD, Inc.
Bivona Uncuffed Neonatal Tracheostomy Tube Sizes 2.5 - 4.0 (With a Straight Neck Flange) Product Usage: This tube is intended to provide direct airway access for a tracheostomized patient for up t
Terminated
BTOK912469
Jan 19, 2012Smiths Medical ASD, Inc.
Bivona Uncuffed Neonatal Tracheostomy Tube Sizes 2.5 - 4.0 (With a V-Shaped Neck Flange)
Terminated
BTOK912469
Jan 19, 2012Smiths Medical ASD, Inc.
Bivona Uncuffed Pediatric Tracheostomy Tube Sizes 2.5 - 5.5 (With a Straight Neck Flange) Product Usage: This tube is intended to provide direct airway access for a tracheostomized patient for up to
Terminated
BTOK912469
Jan 19, 2012Smiths Medical ASD, Inc.
Bivona Uncuffed Pediatric Tracheostomy Tube Sizes 2.5 - 5.5 (With a V-Shaped Neck Flange) Product Usage: This tube is intended to provide direct airway access for a tracheostomized patient for up t
Terminated
BTOK912469
Jan 19, 2012Smiths Medical ASD, Inc.
Bivona TTS Cuffed Pediatric Tracheostomy Tube Sizes 2.5 - 5.5 (With a Straight Neck Flange) Product Usage: This tube is intended to provide direct airway access for a tracheostomized patient for up
Terminated
BTOK912469
Jan 19, 2012Smiths Medical ASD, Inc.
Bivona TTS Cuffed Pediatric Tracheostomy Tube Sizes 2.5 - 5.5 (With a V-Shaped Neck Flange) Product Usage: This tube is intended to provide direct airway access for a tracheostomized patient for up
Terminated
BTOK912469
Jan 19, 2012Smiths Medical ASD, Inc.
Bivona Uncuffed Pediatric Flex Tend Plus Extra Length Tracheostomy Tube Sizes 4.0 - 6.0 (With a Straight Neck Flange) Product Usage: This tube is intended to provide direct airway access for a trach
Terminated
BTOK912469
Jan 19, 2012Smiths Medical ASD, Inc.
Bivona Uncuffed Pediatric Flex Tend Plus Extra Length Tracheostomy Tube Sizes 4.0 - 6.0 (With a V-Shaped Neck Flange) Product Usage: This tube is intended to provide direct airway access for a trac
Terminated
BTOK912469
Jan 19, 2012Smiths Medical ASD, Inc.
Bivona Uncuffed Pediatric Flex Tend Plus Standard Tracheostomy Tube Sizes 2.5 - 5.5 (With a Straight Neck Flange) Product Usage: This tube is intended to provide direct airway access for a tracheos
Terminated
BTOK912469
Jan 19, 2012Smiths Medical ASD, Inc.
Bivona Uncuffed Pediatric Flex Tend Plus Standard Tracheostomy Tube Sizes 2.5 - 5.5 (With a V-Shaped Neck Flange) Product Usage: This tube is intended to provide direct airway access for a tracheost
Terminated
BTOK912469
Jan 19, 2012Smiths Medical ASD, Inc.
Bivona Uncuffed Neonatal Flex Tend Plus Tracheostomy Tube Sizes 2.5 - 4.0 (With a Straight Neck Flange) Product Usage: This tube is intended to provide direct airway access for a tracheostomized pa
Terminated
BTOK912469

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