# K080816: Visual Footcare Technologies Tempstat

- Pathway: 510(k) (Traditional)
- Applicant: Visual Footcare Technologies, LLC
- Decided: Jun 24, 2008 after 92 days
- Product code: OIZ (Foot Examination Tool For Inflammatory Changes)
- Device class: 1
- Regulation: 21 CFR 890.5050
- 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 K760293 (1976). 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)
- K760293: Mirror, Extend-a-, BK-6235, Fred Sammons, Inc. (1976) Summary page 1.
- (no number) LCR-Hallcrest FeverScan Forehead Strip Thermometer: named in the summary without a submission number

## Most influential descendants
- K150557: Podimetrics Remote Temperature Monitoring System (2015), 0 descendants of its own

## Indications for use
TempStat is a daily activity assist device that is intended to assist a patient to visualize the image and condition of the soles of their feet in connection with a daily self-examination for signs of inflammation on the sole of the foot. TempStat will assist the patient in determining when they should contact their healthcare provider for further diagnosis and treatment regarding any skin changes seen by a mirror and/or highlighted by the liquid crystal foot pads. TempStat is intended to be used as an adjunct to, and not in replacement of, periodic foot care and examinations conducted by a health care professional and used under the direction of a health care professional and does not diagnose any specific disease state.

Source page: https://510kreport.com/device/K080816
Methodology: https://510kreport.com/methodology