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)
Top companies in BTO
| Company | 510(k)s | Recalls |
|---|---|---|
| Smiths Medical Asd, Inc. | 1 | 55 |
| Shiley, Inc. | 13 | 0 |
| Bivona Medical Technologies | 6 | 0 |
| Nellcor Puritan Bennett Inc. (dba Covidien Ltd) | 0 | 6 |
| American Healthcare Corp. | 5 | 0 |
| Frederic J. Toye, M.D. | 5 | 0 |
| Hood Laboratories | 4 | 0 |
| Portex , Ltd. | 3 | 1 |
| Arcadia Medical Corporation | 1 | 2 |
| Boston Medical Products, Inc. | 3 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 2, 2026 | Covidien 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 |
BTO | K843730 |
| Sep 11, 2024 | Smiths 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 |
BTO | K173384 |
| Sep 11, 2024 | Smiths 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 |
BTO | K173384 |
| Sep 11, 2024 | Smiths 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 |
BTO | K173384 K173912 |
| Aug 23, 2024 | Smiths 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 |
BTO | K912469 |
| Aug 23, 2024 | Smiths 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 |
BTO | K912469 |
| Aug 23, 2024 | Smiths 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 |
BTO | K912469 |
| Aug 23, 2024 | Smiths 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 |
BTO | K912469 |
| Aug 23, 2024 | Smiths 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 |
BTO | K912469 |
| Aug 23, 2024 | Smiths 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 |
BTO | K912469 |
| Aug 23, 2024 | Smiths 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 |
BTO | K912469 |
| Aug 23, 2024 | Smiths 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 |
BTO | K912469 |
| Aug 23, 2024 | Smiths 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 |
BTO | K912469 |
| Aug 23, 2024 | Smiths 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 |
BTO | K912469 |
| Aug 23, 2024 | Smiths 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 |
BTO | K912469 |
| Aug 23, 2024 | Smiths 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 |
BTO | K912469 |
| Aug 23, 2024 | Smiths 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 |
BTO | K912469 |
| Aug 23, 2024 | Smiths 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 |
BTO | K912469 |
| Aug 23, 2024 | Smiths 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 |
BTO | K912469 |
| Aug 23, 2024 | Smiths 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 |
BTO | K912469 |
| Aug 23, 2024 | Smiths 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 |
BTO | K912469 |
| Aug 23, 2024 | Smiths 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 |
BTO | K912469 |
| Aug 23, 2024 | Smiths 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 |
BTO | K912469 |
| Aug 23, 2024 | Smiths 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 |
BTO | K912469 |
| Aug 23, 2024 | Smiths 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 |
BTO | K912469 |
| Aug 23, 2024 | Smiths 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 |
BTO | K912469 |
| Aug 23, 2024 | Smiths 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 |
BTO | K912469 |
| Aug 23, 2024 | Smiths 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 |
BTO | K912469 |
| Aug 23, 2024 | Smiths 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 |
BTO | K912469 |
| Aug 23, 2024 | Smiths Medical ASD Inc. PORTEX Bivona Tracheostomy Silicone Tube, labeled as:
a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60N025 Open, Classified |
BTO | K912469 |
| Aug 23, 2024 | Smiths 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 |
BTO | K912469 |
| Aug 23, 2024 | Smiths 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 |
BTO | K912469 |
| Feb 16, 2024 | Cardinal Health 200, LLC TRACH KIT W/HYDROGEN & SALI Open, Classified |
BTO | K761190 |
| Feb 11, 2019 | Smiths 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 |
BTO | K030381 |
| Apr 2, 2018 | Smiths Medical ASD Inc. Bivona Tracheostomy Tube Tracheostomy Tubes Terminated |
BTO | None listed |
| Mar 24, 2016 | Ambu 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 |
BTO | None listed |
| Sep 23, 2015 | Instrumentation Industries Inc Ventilator Tubing Terminated |
BTO | None listed |
| Jul 8, 2013 | Bryan Medical Inc Tracoe Mini 3.0mm Tube, for pediatric use.
Pediatric tracheostomy tube used to provide safe airway access. Terminated |
BTO | K893866 |
| May 21, 2012 | Arcadia 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 |
BTO | K031553 |
| Jan 19, 2012 | Smiths 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 |
BTO | K912469 |
| Jan 19, 2012 | Smiths Medical ASD, Inc. Bivona Uncuffed Neonatal Tracheostomy Tube Sizes 2.5 - 4.0 (With a V-Shaped Neck Flange) Terminated |
BTO | K912469 |
| Jan 19, 2012 | Smiths 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 |
BTO | K912469 |
| Jan 19, 2012 | Smiths 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 |
BTO | K912469 |
| Jan 19, 2012 | Smiths 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 |
BTO | K912469 |
| Jan 19, 2012 | Smiths 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 |
BTO | K912469 |
| Jan 19, 2012 | Smiths 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 |
BTO | K912469 |
| Jan 19, 2012 | Smiths 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 |
BTO | K912469 |
| Jan 19, 2012 | Smiths 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 |
BTO | K912469 |
| Jan 19, 2012 | Smiths 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 |
BTO | K912469 |
| Jan 19, 2012 | Smiths 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 |
BTO | K912469 |
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