# K191174: Mercy babyTAPE

- Pathway: 510(k) (Traditional)
- Applicant: Children'S Mercy Hospital
- Decided: Oct 10, 2019 after 162 days
- Product code: PIR (Mercy Tape 2d And 3d Models)
- Device class: 1
- Regulation: 21 CFR 878.4800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K790089 (1979). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142469: 2D Mercy TAPE & 3D Mercy TAPE, Children'S Mercy Hospital (2015) Summary page 4.

## Indications for use
The Mercy babyTAPE device is intended for use by health care professionals to estimate the body weight of infants between the ages of 0 days (birth) and 90 days, using circumferential measurements from specific anatomical landmarks made with the Mercy babyTAPE device for head and chest circumference. Head: place the Mercy babyTAPE across the frontal bones, slightly above eyebrows and ears, over the occipital prominence, perpendicular to the long axis of the face. Chest: place the Mercy babyTAPE around the upper torso, passing under the axilla and by the xyphoid process at the level of the nipple. Measure at end-exhalation.

Source page: https://510kreport.com/device/K191174
Methodology: https://510kreport.com/methodology