DeviceClearance

Product code BTT— Anesthesiology

HEATED RESPIRATORY HUMIDIFIER

Classification name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Device class
Class 2
Regulation
21 CFR 868.5450
Advisory panel
Anesthesiology
Total cleared
222
First cleared
Most recent

Market context for product code BTT

FDA has cleared 222 devices under product code BTT between 1976 and 2026, filed by 100 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 BTT

Adverse events under product code BTT

product code BTT
Death
60
Injury
152
Malfunction
7,232
Other
2
Total
7,446

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 BTT

1–100 of 222

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