FDA Review Panel · PA

FDA 510(k) Pathology Devices

FDA 510(k) Pathology Devices - Regulatory Overview

FDA 510(k) pathology devices include instruments used in anatomical and clinical pathology laboratories. The FDA review panel code is PA.

Key categories:

  • Tissue staining systems - automated H&E, IHC and special stain platforms
  • Histology instruments - microtomes, tissue processors and embedding stations
  • Digital pathology - whole slide imaging (WSI) scanners and image analysis software
  • Cytology systems - liquid-based cytology and automated cell screening

Most pathology devices are Class I or Class II under 21 CFR Part 864. Data sourced from FDA 510(k) public files. Updated monthly.

1105
Total
1082
Cleared
212d
Avg (2y)
1976
Since
639 Pathology devices
126–150 of 639
Cleared Mar 23, 1993
ONE DRAM SHELL VIAL, CATALOG #02-281
K930379 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 56d
Cleared Mar 23, 1993
16 X 125 MM TEST TUBE, CATALOG #01-261
K930380 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 56d
Cleared Mar 23, 1993
ONE DRAM SHELL VIAL, CATALOG #02-441
K930381 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 56d
Cleared Mar 23, 1993
ONE DRAMSHELL VIAL, CATALOG #02-421
K930382 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 56d
Cleared Mar 23, 1993
25 CM2, 75 CM2, 150 CM2 FLASK, CATALOG #03-421
K930383 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 56d
Cleared Mar 23, 1993
25 CM2, 75 CM2, 150 CM2 FLASK, CATALOG #03-401
K930384 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 56d
Cleared Mar 23, 1993
16 X 125 MM TEST TUBE, CATALOG #01-421
K930385 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 56d
Cleared Mar 23, 1993
16 X 125 MM TEST TUBE, CATALOG #01-401
K930386 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 56d
Cleared Mar 23, 1993
ONE DRAM SHELL VIAL, CATALOG #02-401
K930387 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 56d
Cleared Mar 23, 1993
16 X 125 MM TEST TUBE, CATALOG #01-241
K930388 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 56d
Cleared Mar 23, 1993
ONE DRAM SHELL VIAL, CATALOG #02-291
K930389 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 56d
Cleared Dec 07, 1992
CYTOQUANT HNFS CELLS
K924595 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 87d
Cleared Dec 07, 1992
CYTOQUANT MCCOY CELLS/ONE DRAM SHELL VIAL #02-301
K924612 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 87d
Cleared Dec 07, 1992
CYTOQUANT MCCOY CELLS 25CM2/75CM2 FLASK/#03-301
K924613 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 87d
Cleared Dec 07, 1992
CYTOQUANT H292 HUMAN PULM MUCOEPIDER CARCIN CELLS
K924614 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 87d
Cleared Dec 07, 1992
CYTOQUANT H292 CELLS 25CM2/75CM2/175CM2 FLASK
K924615 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 87d
Cleared Dec 07, 1992
CYTOQUANT HEP-2 CELLS, CATALOG #02-251
K924616 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 87d
Cleared Dec 07, 1992
CYTOQUANT HEP-2 CELLS 16 X 125 MM TUBE, #01-251
K924617 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 87d
Cleared Dec 07, 1992
CYTOQUANT HEP-2 CELLS 25CM/75CM/175CM FLASK#03-251
K924618 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 87d
Cleared Dec 07, 1992
CYTOQUANT MRC-5 CELLS 16 X 125 MM TUBE, #01-101
K924619 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 87d
Cleared Dec 07, 1992
CYTOQUANT MRC-5 CELLS, CATALOG #03-101
K924620 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 87d
Cleared Dec 07, 1992
CYTOQUANT MRC-5 CELLS, CATALOG #02-101
K924621 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 87d
Cleared Dec 07, 1992
CYTOQUANT A-549 CELLS, CATALOG #02-201
K924622 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 87d
Cleared Dec 07, 1992
CYTOQUANT A-549 CELLS, CATALOG #03-201
K924623 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 87d
Cleared Dec 07, 1992
CYTOQUANT A-549 CELLS, 16X125 MM TUBE #01-201
K924624 · Proteins Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 87d

Looking for a specific pathology device? Search by device name, K-number or manufacturer.

Search all Pathology 510(k) devices

Filter by Product Code

All categories 639 KIT Media And Components, Synthetic Cell And Tissue Culture 212 KIR Cells, Animal And Human, Cultured 65 KIS Sera, Animal And Human 20 PSY Whole Slide Imaging System 19 JTS Stains, Microbiologic 16 QKQ Digital Pathology Image Viewing And Management Software 13 IFP Formalin, Neutral Buffered 8 HYJ Hematoxylin 8 KIP Formulations, Balanced Salt Solutions 7 KEO Formulations, Paraffin, All 7 IAF Wright's Stain 7 PZM Next Generation Sequencing Based Tumor Profiling Test 7 HZJ Stain, Papanicolau 7 NQN Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity 6 PPM General Purpose Reagent 6