510(k) Report

FDA product code · General hospital

Foot Examination Tool For Inflammatory Changes

OIZClass I21 CFR 890.5050510(k) exempt2 decisions since 20080 recalls

FDA lists OIZ as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 890.9 applies, such as a new intended use or a different fundamental technology. 2 FDA decisions since 2008. No recall names this code. The most-cited predicate is K080816, named by 1 later device.

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. The device 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. Intended…

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

FIG. A — Illustration, general hospital panel

Twenty years of OIZ at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · OIZ

1in 2015

2008: 12015: 1
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20081—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20151—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — OIZ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OIZ? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do OIZ devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K080816Visual Footcare Technologies TempstatVisual Footcare Technologies, LLC · 20081cites it

Which OIZ devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K150557Podimetrics Remote Temperature Monitoring SystemPodimetrics,Inc. · 20152generations
  • K080816Visual Footcare Technologies TempstatVisual Footcare Technologies, LLC · 20081generation

What has FDA decided in OIZ lately?

  • K150557Podimetrics Remote Temperature Monitoring SystemPodimetrics,Inc. · 2015
  • K080816Visual Footcare Technologies TempstatVisual Footcare Technologies, LLC · 2008

All 2 OIZ decisions →

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Other codes under 21 CFR 890.5050.

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