FDA product code BTR: Tube, Tracheal (W/Wo Connector)
BTR is the FDA product code for tube, tracheal (w/wo connector). It is a Class II device, regulated under 21 CFR 868.5730 and reviewed by the Anesthesiology panel. FDA has cleared 242 510(k) submissions under BTR, 12 in the last five years, from 125 different applicants. The average 510(k) review took 130 days (median 88); 265 days on average over the last three years. FDA has posted 227 recalls for BTR devices, 130 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Tube, Tracheal (W/Wo Connector) |
| Device class | Class II |
| Regulation | 21 CFR 868.5730 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
510(k) clearances per year for BTR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 356 |
| 2018 | 5 | 249 |
| 2019 | 5 | 227 |
| 2020 | 3 | 240 |
| 2021 | 1 | 30 |
| 2022 | 1 | 428 |
| 2023 | 1 | 331 |
| 2024 | 1 | 234 |
| 2025 | 7 | 210 |
| 2026 | 2 | 351 |
Compare with all 510(k) review times · Search every BTR clearance
Top BTR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sheridan Catheter Corp. | 11 | 1993-05-07 |
| Rusch, Inc. | 10 | 1996-06-27 |
| Mallinckrodt Critical Care | 10 | 1987-11-06 |
| Bivona Medical Technologies | 8 | 1993-10-06 |
| Rusch Intl. | 7 | 2002-12-23 |
120 more applicants have BTR clearances. See the full list in Caduvo.
Most recent BTR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251794 | Bryan Medical, Inc. | Tenax® Laser Resistant Endotracheal Tube | 2026-09-03 | 448 |
| K253437 | Spiro Robotics | Spiro-VISTA | 2026-06-12 | 254 |
| K250173 | Covidien, LLC | Shiley Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley Oral RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (115-XXOR) Shiley Nasal RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (119-XXNR) | 2025-10-06 | 258 |
| K243785 | Covidien, LLC | Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced | 2025-09-25 | 290 |
| K243579 | Pipeline Medical Products, LLC | AeroJet Ventilation Catheter | 2025-08-13 | 267 |
Recalls for BTR devices
227 product recalls in 35 recall events; 130 initiated in the last five years and 130 still open. Most recent: 2026-07-31.
| Year | Recalls |
|---|---|
| 2019 | 22 |
| 2020 | 2 |
| 2021 | 6 |
| 2022 | 3 |
| 2023 | 124 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code BTR?
BTR is the FDA product code for tube, tracheal (w/wo connector). It is a Class II device, regulated under 21 CFR 868.5730 and reviewed by the Anesthesiology panel.
What device class is BTR?
Class II, regulation 21 CFR 868.5730. Typical premarket route: 510(k).
How long does a 510(k) take for product code BTR?
Across 242 cleared submissions the average was 130 days from receipt to decision (median 88).
Which companies have the most BTR clearances?
Sheridan Catheter Corp. (11); Rusch, Inc. (10); Mallinckrodt Critical Care (10); Bivona Medical Technologies (8); Rusch Intl. (7).
Have BTR devices been recalled?
Yes: 227 product recalls across 35 recall events; the most recent began 2026-07-31.
Next steps
- Run an FDA pathway report with predicate devices for product code BTR
- Run a recall and safety report across every BTR manufacturer
- Watch product code BTR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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