Product code BTR: 510(k) clearances and predicates
Product code BTR covers Tenax® Laser Resistant Endotracheal Tube. FDA lists 242 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
242 clearances on file under product code BTR. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 7 |
| 2026 so far | 2 |
Recent clearances
Newest BTR clearances in the FDA index, with applicant and decision date:
- K251794, Tenax® Laser Resistant Endotracheal Tube, applicant Bryan Medical, Inc., decided 2026-09-03. FDA record
- K253437, Spiro-VISTA, applicant Spiro Robotics, decided 2026-06-12. FDA record
- K250173, 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), applicant Covidien, LLC, decided 2025-10-06. FDA record
- K243785, 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, applicant Covidien, LLC, decided 2025-09-25. FDA record
- K243579, AeroJet Ventilation Catheter, applicant Pipeline Medical Products, LLC, decided 2025-08-13. FDA record
- K251499, Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS), applicant William Cook Europe Aps, decided 2025-06-11. FDA record
- K250243, ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U), applicant Flexicare Medical Limited., decided 2025-05-20. FDA record
- K242495, LMA Fastrach ETT SU, applicant Teleflex Medical, decided 2025-04-29. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Spiro-VISTA, 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). Watch new BTR clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code BTR?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent BTR clearances include Tenax® Laser Resistant Endotracheal Tube.
How many 510(k) clearances use product code BTR?
242 at the time this page was generated, from openFDA records.
How do I find a predicate device under BTR?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new BTR clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.