510(k) · Cleared

Cleared

Podimetrics Remote Temperature Monitoring System

K150557510(k) TraditionalCleared Oct 8, 2015218-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

Podimetrics,Inc. · OIZ Foot Examination Tool For Inflammatory Changes

Cleared on Oct 8, 2015 as substantially equivalent to K080816 (Visual Footcare Technologies, LLC, 2008) after a 218-day review. Its family tree reaches back 2 generations to 1976.

Decided: Oct 8, 2015
Review: 218 days
Class: Class I
Product code: OIZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K760293 (1976). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK760293 Mirror, Extend-a-, BK-6235Fred Sammons, Inc. · 1976
1 generation backK080816 Visual Footcare Technologies TempstatVisual Footcare Technologies, LLC · 2008
This deviceK150557 Podimetrics Remote Temperature Monitoring SystemPodimetrics,Inc. · 2015

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K760293	Mirror, Extend-a-, BK-6235	Fred Sammons, Inc.	1976	—
−1	K080816	Visual Footcare Technologies Tempstat	Visual Footcare Technologies, LLC	2008	—
0 (this device)	K150557	Podimetrics Remote Temperature Monitoring System	Podimetrics,Inc.	2015	—

FIG. 1 — Lineage of K150557, 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? (1)

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
*	K080816	Visual Footcare Technologies Tempstat Summary page 4 …y Activity Assist Device, (Product Code OIZ, 21 CFR 890.5050) Device Classification: Class I 8.3 Predicate Device Visual Footcare Technologies TempStat™ (K080816, Product Code OIZ) 8.4 Indications for Use The Podimetrics Remote Temperature Monitoring System™ (RTM System™) is intende…	Visual Footcare Technologies, LLC	2008	—

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 39 years and passes through 3 companies; a new generation was cleared every 31.8 years on median.
None of the 2 ancestors has a recall.

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. 2015, 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 (123 words)

The Podimetrics Remote Temperature Monitoring System™ (RTM System™) is intended to be used by a patient in conjunction with a healthcare professional or caretaker for periodic evaluation of the temperature over the soles of the feet for signs of inflammation. It will provide information indicating when the patient and healthcare provider should communicate for further evaluation and treatment regarding any persistent localized inflammation observed on the feet via the electronic sensing system and remote visualization of its data. The Podimetrics RTM System™ is intended to be used under the direction of a healthcare professional as an adjunct to, and not in replacement of, self-examination and periodic foot care and examination conducted by a healthcare professional and does not diagnose any specific disease state.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K150557 · printed Nov 6, 2026

Cite this page

510(k) Report. “K150557: Podimetrics Remote Temperature Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150557

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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