Pathology— FDA advisory panel PA
339 FDA 510(k) clearances across 73 product codes since 1976.
By Andrew Weston — Installation Systems Engineer
Pathology is a small panel by clearance count but a disproportionately interesting one right now. Historically it held laboratory infrastructure — tissue processors, stainers, cryostats, and immunohistochemistry reagent systems. The modern story is digital: whole-slide imaging scanners, digital pathology viewing platforms, and the first algorithmic analysis tools for tissue images all clear through this panel, and that family of software clearances is young enough that most of its predicate chains are only a few links deep.
For anyone tracking clinical AI beyond radiology, this is the panel to watch: pathology's digitization is roughly a decade behind radiology's PACS transition, which makes today's filings here look structurally like early imaging-informatics clearances did — platform clearances first, analysis algorithms following. The panel's small historical volume means individual clearances carry more signal than they would in a crowded panel.
Clearances per year
last 10 years- 2026
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
Top product codes in the Pathology panel
all codes- FMH — TRI-TECH URINE SPECIMEN KIT
- PSY — NanoZoomer S540MD Slide Scanner System
- KPA — PROFIBLOT
- PPM — TOMTEC GRAM STAINER DECOLORIZER
- KEM — XYLENE
- IFP — CONSED FECAL CONCENTRATION SYSTEM
- QKQ — INFINITT DPS
- KDT — BIOSURE SPECIMEN COLLECTION CONTAINER
- IEO — MICROWAVE AUTOMATED TISSUE PROCESSOR
- KEO — TISSUE EMBEDDING MEDIUM
- IBJ — VIDEO ANALYZER 4000
- PZM — CellDx-Tissue
- LDZ — ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTION
- KEW — THE CEN-SLIDE(TM) CENTRIFUGE TUBE
- KDX — DECALCIFYING SOLUTION
Recent clearances in the Pathology panel
all clearances- K260964 — NanoZoomer S540MD Slide Scanner System
- K251952 — Virasight
- K253606 — NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system
- K260235 — CellDx-Tissue
- K254115 — ArteraAI Breast
- K243449 — INFINITT DPS
- K252762 — HALO AP Dx
- K241868 — xR IVD
- K250003 — GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)
- DEN240068 — ArteraAI Prostate
Data sourced from openFDA. This site is unofficial and independent of the FDA.