DeviceClearance

Product code BTI— Anesthesiology

MEDICAL AIR COMPRESSOR

Classification name
Compressor, Air, Portable
Device class
Class 2
Regulation
21 CFR 868.6250
Advisory panel
Anesthesiology
Total cleared
74
First cleared
Most recent

Market context for product code BTI

FDA has cleared 74 devices under product code BTI between 1977 and 2013, filed by 59 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 BTI

Adverse events under product code BTI

product code BTI
Death
25
Malfunction
1,168
Total
1,193

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 BTI

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