DeviceClearance

Product code MNT— Anesthesiology

STELLAR 150

Classification name
Sv70 Ventilator
Device class
Class 2
Regulation
21 CFR 868.5895
Advisory panel
Anesthesiology
Total cleared
25
First cleared
Most recent

Market context for product code MNT

FDA has cleared 25 devices under product code MNT between 1996 and 2026, filed by 14 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 MNT

Adverse events under product code MNT

product code MNT
Death
118
Injury
324
Malfunction
25,451
Other
2
Total
25,895

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 MNT

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