DeviceClearance

Product code BTM— Anesthesiology

MANUAL RESUSCITATOR

Classification name
Ventilator, Emergency, Manual (Resuscitator)
Device class
Class 2
Regulation
21 CFR 868.5915
Advisory panel
Anesthesiology
Total cleared
209
First cleared
Most recent

Market context for product code BTM

FDA has cleared 209 devices under product code BTM between 1976 and 2025, filed by 113 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 BTM

Adverse events under product code BTM

product code BTM
Death
19
Other
2
Total
21

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 BTM

1–100 of 209

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