ClearanceBrief
Panels › Anesthesiology › Product code BTR · Class 2

Tube, Tracheal (W/Wo Connector)

Regulation 868.5730

2510(k)s in 12 months (242 all time)
1recalls in 12 months (227 all time)
203recalls that name a 510(k)
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Top companies in BTR

Company510(k)sRecalls
Teleflex Incorporated1127
Teleflex Medical248
Smiths Medical017
Smiths Medical Asd, Inc.210
Sheridan Catheter Corp.110
Mallinckrodt Critical Care100
Rusch, Inc.100
Bivona Medical Technologies80
Covidien61
Polamedco, Inc.70
DateFirm and productCodeLinked 510(k)
Sep 15, 2026WELL LEAD MEDICAL CO. LTD
SunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25
Open, Classified		 BTRK042683
Mar 12, 2025Smiths Medical ASD, Inc.
Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127
Open, Classified		 BTRK790312
May 28, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline Sub-G Endotracheal Tube with Subglottic Suctioning: (1) REF DYNJ18860, Polyurethane Cuff 6.0 mm ID; (2) REF DYNJ18865, Polyurethane Cuff 6.5 mm ID; (3) REF DYNJ18870, Polyurethane Cuff 7.0 mm
Open, Classified		 BTRK110269
Jun 29, 2023TELEFLEX LLC
Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150055
Open, Classified		 BTRK780900
Jun 29, 2023TELEFLEX LLC
Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150040
Open, Classified		 BTRK780900
Jun 29, 2023TELEFLEX LLC
Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150035
Open, Classified		 BTRK780900
Jun 29, 2023TELEFLEX LLC
Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150030
Open, Classified		 BTRK780900
Jun 29, 2023TELEFLEX LLC
Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150025
Open, Classified		 BTRK780900
Jun 29, 2023TELEFLEX LLC
Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150020
Open, Classified		 BTRK780900
Jun 29, 2023TELEFLEX LLC
RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480045
Open, Classified		 BTRK961837
Jun 29, 2023TELEFLEX LLC
RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480040
Open, Classified		 BTRK993786
Jun 29, 2023TELEFLEX LLC
RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480035
Open, Classified		 BTRK780900
Jun 29, 2023TELEFLEX LLC
RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480030
Open, Classified		 BTRK993786
Jun 29, 2023TELEFLEX LLC
RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480025
Open, Classified		 BTRK993786
Jun 29, 2023TELEFLEX LLC
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082100
Open, Classified		 BTRK961837
Jun 29, 2023TELEFLEX LLC
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082095
Open, Classified		 BTRK961837
Jun 29, 2023TELEFLEX LLC
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082090
Open, Classified		 BTRK961837
Jun 29, 2023TELEFLEX LLC
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082085
Open, Classified		 BTRK961837
Jun 29, 2023TELEFLEX LLC
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082080
Open, Classified		 BTRK961837
Jun 29, 2023TELEFLEX LLC
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082075
Open, Classified		 BTRK961837
Jun 29, 2023TELEFLEX LLC
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082070
Open, Classified		 BTRK961837
Jun 29, 2023TELEFLEX LLC
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082065
Open, Classified		 BTRK961837
Jun 29, 2023TELEFLEX LLC
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082060
Open, Classified		 BTRK961837
Jun 29, 2023TELEFLEX LLC
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082055
Open, Classified		 BTRK961837
Jun 29, 2023TELEFLEX LLC
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082050
Open, Classified		 BTRK961837
Jun 29, 2023TELEFLEX LLC
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080100
Open, Classified		 BTRK961837
Jun 29, 2023TELEFLEX LLC
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080095
Open, Classified		 BTRK961837
Jun 29, 2023TELEFLEX LLC
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080090
Open, Classified		 BTRK961837
Jun 29, 2023TELEFLEX LLC
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080085
Open, Classified		 BTRK961837
Jun 29, 2023TELEFLEX LLC
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080080
Open, Classified		 BTRK961837
Jun 29, 2023TELEFLEX LLC
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080075
Open, Classified		 BTRK961837
Jun 29, 2023TELEFLEX LLC
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080070
Open, Classified		 BTRK961837
Jun 29, 2023TELEFLEX LLC
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080065
Open, Classified		 BTRK961837
Jun 29, 2023TELEFLEX LLC
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080060
Open, Classified		 BTRK961837
Jun 29, 2023TELEFLEX LLC
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080055
Open, Classified		 BTRK961837
Jun 29, 2023TELEFLEX LLC
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080050
Open, Classified		 BTRK961837
Jun 29, 2023TELEFLEX LLC
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781080
Open, Classified		 BTRK931164
Jun 29, 2023TELEFLEX LLC
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781075
Open, Classified		 BTRK931164
Jun 29, 2023TELEFLEX LLC
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781070
Open, Classified		 BTRK931164
Jun 29, 2023TELEFLEX LLC
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781065
Open, Classified		 BTRK931164
Jun 29, 2023TELEFLEX LLC
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781060
Open, Classified		 BTRK931164
Jun 29, 2023TELEFLEX LLC
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781055
Open, Classified		 BTRK931164
Jun 29, 2023TELEFLEX LLC
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781050
Open, Classified		 BTRK931164
Jun 29, 2023TELEFLEX LLC
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781045
Open, Classified		 BTRK931164
Jun 29, 2023TELEFLEX LLC
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781040
Open, Classified		 BTRK931164
Jun 29, 2023TELEFLEX LLC
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781035
Open, Classified		 BTRK931164
Jun 29, 2023TELEFLEX LLC
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780090
Open, Classified		 BTRK931163
Jun 29, 2023TELEFLEX LLC
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780085
Open, Classified		 BTRK931163
Jun 29, 2023TELEFLEX LLC
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780080
Open, Classified		 BTRK931163
Jun 29, 2023TELEFLEX LLC
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780075
Open, Classified		 BTRK931163

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