# K142469: 2D Mercy TAPE & 3D Mercy TAPE

- Pathway: 510(k) (Traditional)
- Applicant: Children'S Mercy Hospital
- Decided: May 1, 2015 after 240 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: 1 generation back to K790089 (1979). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K790089: Tape Measure, Pfizer, Inc. (1979) Summary page 4.

## Most influential descendants
- K191174: Mercy babyTAPE (2019), 0 descendants of its own

## Indications for use
The Mercy TAPE device (2D and 3D models) is intended 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 Mercy 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). The Mercy TAPE device may be less reliable for use in children with known or apparent limb deformities, or abnormal body proportions caused by conditions such as edema or severe malnutrition.

Source page: https://510kreport.com/device/K142469
Methodology: https://510kreport.com/methodology