Product code PIR— General, Plastic Surgery

“The Mercy TAPE device (2D and 3D models) is intended for use by health care professionals to estimate the body weight of pediatric patients between the ages of 2 months and 16 years, using linear measurements from specific anatomical landmarks made with the TAPE device for humeral length (HL, for the 2D model) or half-humeral length (HHL, for the 3D model) and the mid-upper arm circumference (MUAC).”

FDA has cleared 2 devices under product code PIR between 2015 and 2019, 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.

• 20191 clearance
• 20151 clearance

• Children'S Mercy Hospital2 clearances

• K191174 — Mercy babyTAPEChildren'S Mercy Hospital·2019-10-10
• K142469 — 2D Mercy TAPE & 3D Mercy TAPEChildren'S Mercy Hospital·2015-05-01