DeviceClearance

Product code BTO— Anesthesiology

TRACHEOSTOMY CARE KIT

Classification name
Tube, Tracheostomy (W/Wo Connector)
Device class
Class 2
Regulation
21 CFR 868.5800
Advisory panel
Anesthesiology
Total cleared
129
First cleared
Most recent

Market context for product code BTO

FDA has cleared 129 devices under product code BTO between 1976 and 2026, filed by 77 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 BTO

Adverse events under product code BTO

product code BTO
Death
14
Injury
328
Malfunction
1,851
Total
2,193

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 BTO

1–100 of 129

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