510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K120489Substantially Equivalent

Tissue of Origin Test Kit Ffpe

Pathwork Diagnostics, Inc., Palo Alto CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K120489 is the FDA 510(k) clearance record for TISSUE OF ORIGIN TEST KIT FFPE, a class II device, cleared for Pathwork Diagnostics, Inc. on under FDA product code OIW (Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types). FDA's definition for product code OIW reads: "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...". FDA records list 3 510(k) clearances for Pathwork Diagnostics, Inc., from to . As of , FDA records show no recalls naming K120489.

Clearance record

Decision date
Received
(90 days to decision)
Product code
OIW Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types
Regulation
21 CFR 862.3100
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Pathwork Diagnostics, Inc. 1900 Embarcadero Rd., Palo Alto CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OIW

Trailing 12 months

FDA records hold no clearances under product code OIW in the trailing twelve months.

FDA records show no clearances under product code OIW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OIW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260