510(k) · Cleared

Cleared

Visual Footcare Technologies Tempstat

K080816510(k) TraditionalCleared Jun 24, 200892-day reviewClass I21 CFR 890.5050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Visual Footcare Technologies, LLC · OIZ Foot Examination Tool For Inflammatory Changes

Cleared on Jun 24, 2008 as substantially equivalent to K760293 (Fred Sammons, Inc., 1976) after a 92-day review. Its family tree reaches back 1 generation to 1976. 1 later device descends from it.

Decided: Jun 24, 2008
Review: 92 days
Class: Class I
Product code: OIZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K760293 (1976). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK760293 Mirror, Extend-a-, BK-6235Fred Sammons, Inc. · 1976
This deviceK080816 Visual Footcare Technologies TempstatVisual Footcare Technologies, LLC · 2008
Descendant · cites it directly · 0 of its ownK150557 Podimetrics Remote Temperature Monitoring SystemPodimetrics,Inc. · 2015

Most influential descendants

Showing 1 of 1 · See all

K150557Podimetrics Remote Temperature Monitoring SystemPodimetrics,Inc. · 2015 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K760293	Mirror, Extend-a-, BK-6235	Fred Sammons, Inc.	1976	—
0 (this device)	K080816	Visual Footcare Technologies Tempstat	Visual Footcare Technologies, LLC	2008	—
+1	K150557	Podimetrics Remote Temperature Monitoring System	Podimetrics,Inc.	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	1	0

FIG. 1 — Lineage of K080816, 1976–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in OIZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K760293	Mirror, Extend-a-, BK-6235 Summary page 1 …aily activity assist device 3. PREDICATE DEVICES * 890.5050 Daily Activity Assist Device Class I (General Controls) * The Fred Sammons Extend-A-Mirror (K760293, Product Code ILW). * 880.2200 Liquid Crystal Forehead Temperature Strip Class II (Special Controls) LCR-Hallcres…	Fred Sammons, Inc.	1976	—
*	—	LCR-Hallcrest FeverScan Forehead Strip Thermometer Named without a submission number			—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K150557	Podimetrics Remote Temperature Monitoring System	Podimetrics,Inc.	2015	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K150557 (Podimetrics,Inc., 2015) has gone furthest, with 0 descendants of its own.

How does its category compare?

All OIZ devices

OIZ Foot Examination Tool For Inflammatory Changes: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · OIZ

1in 2015

2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OIZ

Too few OIZ 510(k)s in any year since 2007 to give a median.

Recalls per year · OIZ

No recall names OIZ since 2007.

Adverse event reports per year · OIZ

No MAUDE report names OIZ since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	1	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	1	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

Read the full statement (121 words)

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K080816 · printed Nov 6, 2026

Cite this page

510(k) Report. “K080816: Visual Footcare Technologies Tempstat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080816

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026