DeviceClearance

Product code PMK— Cardiovascular

LIFE PULSE RESUSCITATION TIMER

Classification name
Cpr Aid Device Without Feedback
Device class
Class 1
Regulation
21 CFR 870.5210
Advisory panel
Cardiovascular
Total cleared
2
First cleared
Most recent

FDA classification definition

“A device that performs a simple function such as proper hand placement and/or simple prompting for rate and/or timing of compressions/breathing for the professionally trained rescuer, but offers no feedback related to the quality of the CPR being provided. These devices are intended for use by persons professionally trained in CPR to assure proper use and the delivery of optimal CPR to the victim.”

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

Market context for product code PMK

FDA has cleared 2 devices under product code PMK, all in 1994, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code PMK

Recent clearances under product code PMK

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