510(k) Report

FDA product code · Clinical toxicology

Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types

OIWClass II21 CFR 862.3100510(k) required4 decisions since 20080 recalls

4 FDA decisions since 2008. No recall names this code. The most-cited predicate is K120489, named by 1 later device.

This test is intended to measure the degree of similarity between the RNA expression pattern in a patient?s fresh-frozen tumor and the RNA expression patterns in a database of tumor samples for some common malignant tumor types that were diagnosed according to then current clinical and pathological practice. The test result is intended for use in the context of the patient?s clinical history and other diagnostic…

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, clinical toxicology panel

Twenty years of OIW 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 · OIW

1in 2018

2008: 12010: 12012: 12018: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OIW

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

Recalls per year · OIW

No recall names OIW since 2007.

Adverse event reports per year · OIW

No MAUDE report names OIW since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20081—00
20090—00
20101—00
20110—00
20121—00
20130—00
20140—00
20150—00
20160—00
20170—00
20181—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — OIW by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OIW? 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 OIW devices cite most?

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

  • K120489Tissue of Origin Test Kit FfpePathwork Diagnostics, Inc. · 20121cites it
  • K092967Pathwork Tissue of Origin Test Kit-Ffpe (Origin Test Kit-FfpePathwork Diagnostics · 20101cites it
  • K080896Pathwork Diagnostics Tissue of Origin TestPathwork Diagnostics, Inc. · 20081cites it

Which OIW devices have the deepest lineage?

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

  • K173839Tissue of Origin Test Kit-FFPECancer Genetics, Inc. · 20185generations
  • K120489Tissue of Origin Test Kit FfpePathwork Diagnostics, Inc. · 20124generations
  • K092967Pathwork Tissue of Origin Test Kit-Ffpe (Origin Test Kit-FfpePathwork Diagnostics · 20103generations
  • K080896Pathwork Diagnostics Tissue of Origin TestPathwork Diagnostics, Inc. · 20082generations

What has FDA decided in OIW lately?

  • K173839Tissue of Origin Test Kit-FFPECancer Genetics, Inc. · 2018
  • K120489Tissue of Origin Test Kit FfpePathwork Diagnostics, Inc. · 2012
  • K092967Pathwork Tissue of Origin Test Kit-Ffpe (Origin Test Kit-FfpePathwork Diagnostics · 2010
  • K080896Pathwork Diagnostics Tissue of Origin TestPathwork Diagnostics, Inc. · 2008

All 4 OIW decisions →

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