DeviceClearance

Product code BTR— Anesthesiology

ENDOTRACHEAL TUBE

Classification name
Tube, Tracheal (W/Wo Connector)
Device class
Class 2
Regulation
21 CFR 868.5730
Advisory panel
Anesthesiology
Total cleared
242
First cleared
Most recent

Market context for product code BTR

FDA has cleared 242 devices under product code BTR between 1976 and 2026, filed by 125 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code BTR

Adverse events under product code BTR

product code BTR
Death
92
Injury
1,263
Malfunction
7,475
Other
2
Total
8,832

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code BTR

1–100 of 242

Data sourced from openFDA. This site is unofficial and independent of the FDA.