DeviceClearance

Product code LIX— Cardiovascular

POCKETCPR

Classification name
Aid, Cardiopulmonary Resuscitation
Device class
Class 2
Regulation
21 CFR 870.5210
Advisory panel
Cardiovascular
Total cleared
17
First cleared
Most recent

FDA classification definition

“CPR Aid device WITH feedback (visual, audio or both) on one or more CPR parameters (e.g., rate, depth, ventilation ratio, etc.), and contains software. Provides real-time feedback on CPR performance. Feedback can be audio, visual or both. Device contains software”

— U.S. Food and Drug Administration, device classification record for product code LIX under 21 CFR 870.5210, via openFDA

Market context for product code LIX

FDA has cleared 17 devices under product code LIX between 1984 and 2021, filed by 15 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

Top applicants under product code LIX

Adverse events under product code LIX

product code LIX
Other
2
Total
2

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 LIX

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