DeviceClearance

Product code DRM— Cardiovascular

PNEUPAC RESUSCITATOR INSTANT ACTION SET

Classification name
Compressor, Cardiac, External
Device class
Class 2
Regulation
21 CFR 870.5200
Advisory panel
Cardiovascular
Total cleared
45
First cleared
Most recent

Market context for product code DRM

FDA has cleared 45 devices under product code DRM between 1976 and 2023, filed by 24 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 DRM

Adverse events under product code DRM

product code DRM
Death
82
Injury
126
Malfunction
4,539
Total
4,747

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 DRM

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