# K251255: LymphaTech Mobile 3D Measuring Tool

- Pathway: 510(k) (Traditional)
- Applicant: Lymphatech, Inc.
- Decided: Jul 22, 2025 after 90 days
- Product code: SFG (Camera, Surgical, Measurement)
- Device class: 1
- Regulation: 21 CFR 878.4160
- 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 K070426 (2007). 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)
- K131596: Wound Measuring & Monitoring Device, Woundvision, LLC (2013) Summary page 5.

## Indications for use
The LymphaTech Mobile 3D Measuring Tool is a software application that uses input from the Structure Sensor, an off-the-shelf long-wave infrared camera, to measure the diameter, surface area, volume, and perimeter/circumference of a part of the body. The 3D Measuring Tool is non-contact with respect to the patient and provides an adjunctive tool to help a qualified health care professional measure and record body part data. The device uses input from the Structure Sensor camera to accurately capture and construct a 3D model of a patient’s anatomy. It is intended for trained and qualified healthcare professionals, who are trained in its use. The 3D Measuring Tool is to be used on a patient population that includes non-pregnant female or male adults. The 3D Measuring Tool is intended to be used in any environment where health care is provided by a qualified health care professional. The 3D Measuring Tool does not provide a diagnosis or therapy.

Source page: https://510kreport.com/device/K251255
Methodology: https://510kreport.com/methodology