# K131596: Wound Measuring & Monitoring Device

- Pathway: 510(k) (Traditional)
- Applicant: Woundvision, LLC
- Decided: Dec 11, 2013 after 191 days
- Product code: FXN (Tape, Camera, Surgical)
- 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: 1 generation back to K070426 (2007). 1 ancestor in all.
4 later devices descend from it; 4 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070426: Silhouette, Model 1000.01, Aranz Medical Limited (2007) Summary page 1.

## Most influential descendants
- K251678: Swift Ray 1 (2026), 0 descendants of its own
- K251255: LymphaTech Mobile 3D Measuring Tool (2025), 0 descendants of its own
- K230734: Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009) (2023), 0 descendants of its own
- K190074: Presero 3D Scanning System (2019), 0 descendants of its own

## Indications for use
The Scout is a combination digital camera and long-wave infrared camera. The digital camera is indicated for the use of capturing visual images to measure the diameter, surface area, and perimeter of a part of the body or two body surfaces. The long-wave infrared camera is indicated for the use of capturing thermal images to measure the thermal intensity data of a part of the body or two body surfaces. Both components of the Scout are non-contact with respect to the patient and provide an adjunctive tool to help a trained and qualified health care professional measure and record external wound and body surface data. Intended for qualified healthcare professionals who are trained in its use, the Scout is a non-invasive and non-radiating device. The Scout is to be used on a patient population that includes non-pregnant female or male patients 18 years of age or older. The Scout is intended to be used in hospital, acute and sub-acute care settings, long term care, surgery, health care practitioner facilities, outpatient, home healthcare, or in any environment where health care is provided by a qualified health care professional. The Scout does not provide a diagnosis or therapy.

Source page: https://510kreport.com/device/K131596
Methodology: https://510kreport.com/methodology