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)
Top companies in BTR
| Company | 510(k)s | Recalls |
|---|---|---|
| Teleflex Incorporated | 1 | 127 |
| Teleflex Medical | 2 | 48 |
| Smiths Medical | 0 | 17 |
| Smiths Medical Asd, Inc. | 2 | 10 |
| Sheridan Catheter Corp. | 11 | 0 |
| Mallinckrodt Critical Care | 10 | 0 |
| Rusch, Inc. | 10 | 0 |
| Bivona Medical Technologies | 8 | 0 |
| Covidien | 6 | 1 |
| Polamedco, Inc. | 7 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 29, 2023 | TELEFLEX LLC Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504585 Open, Classified |
BTR | K961837 |
| Jun 29, 2023 | TELEFLEX LLC Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504580 Open, Classified |
BTR | K961837 |
| Jun 29, 2023 | TELEFLEX LLC Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504575 Open, Classified |
BTR | K961837 |
| Jun 29, 2023 | TELEFLEX LLC Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504570 Open, Classified |
BTR | K961837 |
| Jun 29, 2023 | TELEFLEX LLC Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504565 Open, Classified |
BTR | K961837 |
| Jun 29, 2023 | TELEFLEX LLC Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504560 Open, Classified |
BTR | K961837 |
| Jun 29, 2023 | TELEFLEX LLC Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504555 Open, Classified |
BTR | K961837 |
| Jun 29, 2023 | TELEFLEX LLC Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504550 Open, Classified |
BTR | K961837 |
| Jun 29, 2023 | TELEFLEX LLC Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170155 Open, Classified |
BTR | K780900 |
| Jun 29, 2023 | TELEFLEX LLC Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170150 Open, Classified |
BTR | K780900 |
| Jun 29, 2023 | TELEFLEX LLC Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170145 Open, Classified |
BTR | K780900 |
| Jun 29, 2023 | TELEFLEX LLC Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170140 Open, Classified |
BTR | K780900 |
| Jun 29, 2023 | TELEFLEX LLC Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170135 Open, Classified |
BTR | K780900 |
| Jun 29, 2023 | TELEFLEX LLC Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170130 Open, Classified |
BTR | K780900 |
| Jun 29, 2023 | TELEFLEX LLC Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170125 Open, Classified |
BTR | K780900 |
| Jun 29, 2023 | TELEFLEX LLC Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170120 Open, Classified |
BTR | K780900 |
| Jun 29, 2023 | TELEFLEX LLC Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170095 Open, Classified |
BTR | K780900 |
| Jun 29, 2023 | TELEFLEX LLC Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170090 Open, Classified |
BTR | K780900 |
| Jun 29, 2023 | TELEFLEX LLC Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170085 Open, Classified |
BTR | K780900 |
| Jun 29, 2023 | TELEFLEX LLC Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170080 Open, Classified |
BTR | K780900 |
| Jun 29, 2023 | TELEFLEX LLC Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170075 Open, Classified |
BTR | K780900 |
| Jun 29, 2023 | TELEFLEX LLC Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170070 Open, Classified |
BTR | K780900 |
| Jun 29, 2023 | TELEFLEX LLC Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170065 Open, Classified |
BTR | K780900 |
| Jun 29, 2023 | TELEFLEX LLC Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170060 Open, Classified |
BTR | K780900 |
| Jun 29, 2023 | TELEFLEX LLC Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170055 Open, Classified |
BTR | K780900 |
| Jun 29, 2023 | TELEFLEX LLC Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170050 Open, Classified |
BTR | K780900 |
| Apr 1, 2023 | Covidien COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D.
The Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed are indicated for
airway management by oral/nasal intubation of the trac Open, Classified |
BTR | K871204 |
| Jan 23, 2023 | TELEFLEX LLC Endotracheal Tube labeled as the following:
a. Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff;
b. Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff;
c Open, Classified |
BTR | None listed |
| Jan 23, 2023 | TELEFLEX LLC Endotracheal Tube labeled as the following:
a. Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal;
b. Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff;
c. RUSC Open, Classified |
BTR | K961837 |
| Jan 23, 2023 | TELEFLEX LLC Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal.
Intended for patients requiring endotracheal intubation Open, Classified |
BTR | K780900 |
| Aug 9, 2021 | Smiths Medical ASD Inc. Bivona Uncuffed Wire Endotracheal Tubes, Terminated |
BTR | K792035 |
| Aug 9, 2021 | Smiths Medical ASD Inc. Bivona Aire-Cuf Endotracheal Tube Terminated |
BTR | K792035 |
| Jul 16, 2021 | Teleflex Medical Europe Ltd RUSCH Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF numbers:
a) 112082050
b) 112082055
c) 112082060
d) 112082065
e) 112082070
f) 112082075
g) 112082080
h) 112082085 Terminated |
BTR | K961837 |
| Jul 16, 2021 | Teleflex Medical Europe Ltd RUSCH Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF numbers:
a) 112080050
b) 112080055
c) 112080060
d) 112080065
e) 112080070
f) 112080075
g) 112080080
h) 112080085
i) Terminated |
BTR | K961837 |
| Jul 16, 2021 | Teleflex Medical Europe Ltd RUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers:
a) 504550
b) 504555
c) 504560
d) 504565
e) 504570
f) 504575
g) 504580
f) 504585
g) 504590 Terminated |
BTR | K961837 |
| Jul 16, 2021 | Teleflex Medical Europe Ltd RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers:
a) 170050
b) 170055
c) 170060
d) 170065
e) 170070
f) 170075
g) 170080
h) 170085
i) 170090
j) 170095 Terminated |
BTR | K780900 |
| Nov 26, 2020 | Flexicare Medical Ltd. ProVu Single Use Video Stylet with ET Tube, Part/Size: 038-990-080U/ 8.0, 038-990-075U/ 7.5, 038-990-070U/ 7.0, 038-990-065U/ 6.5
*Note: product list updated per 12/23/2020 letter to customers Terminated |
BTR | K091591 |
| May 29, 2020 | TELEFLEX MEDICAL INC RUSCH LASERTUBE (Rubber), RES 102004, Sizes:
a) I.D. mm 4,0, Product Code 102004-000040
b) I.D. mm 5,0, Product Code 102004-000050
c) I.D. mm 6,0, Product Code 102004-000060
d) I.D. mm 7,0, Product Co Terminated |
BTR | K935842 |
| Sep 9, 2019 | Teleflex Medical Sheridan/HVT Novaplus:
a) 7.0 mm, REF V5-10314
b) 7.5 mm, REF V5-10315
c) 8.0 mm, REF V5-10316
d) 8.5 mm, REF V5-10317
Product Usage:
Tracheal tube/airway management Terminated |
BTR | K822082 |
| Sep 9, 2019 | Teleflex Medical Sheridan/CF Novaplus 7.0 mm, REF V5-10114
Product Usage:
Tracheal tube/airway management Terminated |
BTR | K822082 |
| Sep 9, 2019 | Teleflex Medical Hudson RCI Sheridan/HVT:
a) 5.0 mm, REF 5-10310
b) 5.5 mm, REF 5-10311
c) 6.0 mm, REF 5-10312
d) 6.5 mm, REF 5-10313
e) 7.0 mm, REF 5-10314
f) 7.5 mm, REF 5-10315
g) 8.0 mm, REF 5-10316
h) 8.5 mm, REF Terminated |
BTR | K822082 |
| Sep 9, 2019 | Teleflex Medical Hudson RCI Sheridan Uncuffed:
a) 2.0 mm, REF 5-10404
b) 2.5 mm, REF 5-10405
c) 3.0 mm, REF 5-10406
d) 3.5 mm, REF 5-10407
e) 4.0 mm, REF 5-10408
f) 4.5 mm, REF 5-10409
g) 5.0 mm, REF 5-10410
h) 5.5 Terminated |
BTR | K822082 |
| Sep 9, 2019 | Teleflex Medical Hudson RCI Sheridan Preformed:
a) 3.0 mm, REF 5-22006, REF 5-22106
b) 3.5 mm, REF 5-22007, REF 5-22107
c) 4.0 mm, REF 5-22008, REF 5-22108, REF 5-22208
d) 4.5 mm, REF 5-22009, REF 5-22109, REF 5-22209 Terminated |
BTR | K822082 |
| Sep 9, 2019 | Teleflex Medical Hudson RCI Sheridan EZ-ENDO:
a) 5.0 mm, REF 5-22510
b) 5.5 mm, REF 5-22511
c) 7.0 mm, REF 5-22514
d) 7.5 mm, REF 5-22515
e) 8.0 mm, REF 5-22516
f) 8.5 mm, REF 5-22517
g) 9.0 mm, REF 5-22518
h) 6.0 mm, Terminated |
BTR | K822082 |
| Sep 9, 2019 | Teleflex Medical Hudson RCI Sheridan/CF:
a) 3.0 mm, REF 5-10106, REF 5-10206
b) 3.5 mm, REF 5-10107
c) 4.0 mm, REF 5-10108, REF 5-10208
d) 4.5 mm, REF 5-10109
e) 5.0 mm, REF 5-10110, REF 5-10210
f) 5.5 mm, REF 5-1011 Terminated |
BTR | K822082 |
| Sep 9, 2019 | Teleflex Medical Hudson RCI Sheridan LTS:
a) 4.0 mm, REF 5-11108
b) 5.0 mm, REF 5-11110
c) 6.0 mm, REF 5-11112
Product Usage:
Tracheal tube/airway management Terminated |
BTR | K822082 |
| Jul 30, 2019 | Centurion Medical Products Corporation Sheridan Endotracheal Tube contained inside Centurion kit code TC7855. Terminated |
BTR | K091761 K822082 |
| Jun 19, 2019 | Teleflex Medical Sheridan/HVT:
1) Novaplus 7.0 mm, Product Code V5-10314
2) Novaplus 7.5 mm, Product Code V5-10315
3) Novaplus 8.0 mm, Product Code V5-10316
4) Novaplus 8.5 mm, Product Code V5-10317
Product Usage:
Tr Terminated |
BTR | K822082 |
| Jun 19, 2019 | Teleflex Medical Sheridan/CF Novaplus 7.0 mm, Product Code V5-10114
Product Usage:
Tracheal tube/airway management Terminated |
BTR | K822082 |
| Jun 19, 2019 | Teleflex Medical Hudson RCI Sheridan:
1) HVT 6.0 mm, Product Code 5-10312
2) HVT 6.5 mm, Product Code 5-10313
3) HVT 7.0 mm, Product Code 5-10314
4) HVT 7.5 mm, Product Code 5-10315
5) HVT 8.0 mm, Product Code 5-10316 Terminated |
BTR | K822082 |
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