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.

1109
Total
1086
Cleared
214d
Avg (2y)
1976
Since
914 Pathology devices
526–550 of 914
Cleared Apr 27, 1987
INTRA-ARTICULATED ARTHRO POWER SYSTEM
K871250 · Richard Wolf Medical Instruments Corp.
KIT · Media And Components, Synthetic Cell And Tissue Culture · 28d
Cleared Apr 14, 1987
DU PONT STERICELL CELL CULTURE SYSTEM
K871324 · E.I. Dupont DE Nemours & Co., Inc.
KJA · Flask, Tissue Culture · 11d
Cleared Apr 08, 1987
GRAM IODINE
K871286 · Remel Co.
HYI · Iodine, Grams · 8d
Cleared Apr 03, 1987
TB QUICK STAIN(TM) KIT
K871117 · Bd Becton Dickinson Vacutainer Systems Preanalytic
ICJ · Carbol Night Blue · 15d
Cleared Apr 03, 1987
(DMF/F-12) HYBRI-MAX(TM) W/L-GLUTAMINE
K871191 · Sigma Chemical Co.
KIT · Media And Components, Synthetic Cell And Tissue Culture · 10d
Cleared Mar 30, 1987
DULBECCO'S MOD. EAGLE MED. NUT. MIX. F-12 #D2906
K870478 · Sigma Chemical Co.
KIT · Media And Components, Synthetic Cell And Tissue Culture · 55d
Cleared Mar 30, 1987
(DME) HYBRI-MAX W/L-GLUTAMINE PRODUCT NO. D6780
K870479 · Sigma Chemical Co.
KIT · Media And Components, Synthetic Cell And Tissue Culture · 55d
Cleared Mar 30, 1987
NCTC 135 MEDIUM HYBRI-MAX W/L-GLUTAMINE #N5138
K870480 · Sigma Chemical Co.
KIT · Media And Components, Synthetic Cell And Tissue Culture · 55d
Cleared Mar 30, 1987
(S-MEM) AUTO-MOD PRODUCT NO. M7272
K870481 · Sigma Chemical Co.
KIT · Media And Components, Synthetic Cell And Tissue Culture · 55d
Cleared Mar 30, 1987
(D-PBS) MODIFIED HYBRI-MAX PRODUCT NO. D7030
K870482 · Sigma Chemical Co.
KIP · Formulations, Balanced Salt Solutions · 55d
Cleared Mar 30, 1987
WILLIAMS' MEDIUM E W/L-GLUTAMINE #W4125
K870483 · Sigma Chemical Co.
KIT · Media And Components, Synthetic Cell And Tissue Culture · 55d
Cleared Mar 30, 1987
HANKS' BALANCED SALTS (HBSS) NO. H1387
K870484 · Sigma Chemical Co.
KIP · Formulations, Balanced Salt Solutions · 55d
Cleared Mar 30, 1987
LACTALBUMIN HYDROLYSATE (ELAH) NO. L3762
K870485 · Sigma Chemical Co.
KIT · Media And Components, Synthetic Cell And Tissue Culture · 55d
Cleared Mar 30, 1987
EARLE'S BALANCED SALTS (EBSS) HYBRI-MAX #E9509
K870486 · Sigma Chemical Co.
KIP · Formulations, Balanced Salt Solutions · 55d
Cleared Mar 30, 1987
H-Y MEDIUM (DME:NCTC109, 7:1 MIX.) HYBRI-MAX H9014
K870487 · Sigma Chemical Co.
KIT · Media And Components, Synthetic Cell And Tissue Culture · 55d
Cleared Mar 30, 1987
RPMI 1640 MEDIUM DEFI. MODIFICATION NO. R7130
K870488 · Sigma Chemical Co.
KIT · Media And Components, Synthetic Cell And Tissue Culture · 55d
Cleared Mar 30, 1987
RPMI 1640 MEDIUM W/L-GLUTAMINE NO. R8755
K870489 · Sigma Chemical Co.
KIT · Media And Components, Synthetic Cell And Tissue Culture · 55d
Cleared Mar 30, 1987
(DME) W/1000 MG GLUCOSE/L NO. D4655
K870490 · Sigma Chemical Co.
KIT · Media And Components, Synthetic Cell And Tissue Culture · 55d
Cleared Mar 30, 1987
KREBS-RINGER BICARBONATE BUFFER PRODUCT NO. K4002
K870491 · Sigma Chemical Co.
KIP · Formulations, Balanced Salt Solutions · 55d
Cleared Mar 30, 1987
DULBECCO'S MODIFIED EAGLE MEDIUM BASE NO. D5030
K870492 · Sigma Chemical Co.
KIT · Media And Components, Synthetic Cell And Tissue Culture · 55d
Cleared Mar 30, 1987
NUTRIENT MIXTURE F-12 (HAM) (HEPES BUFFERED) N4388
K870493 · Sigma Chemical Co.
KIT · Media And Components, Synthetic Cell And Tissue Culture · 55d
Cleared Mar 30, 1987
RPMI-1640 HYBRI-MAX PRODUCT NO. R8005
K870494 · Sigma Chemical Co.
KIT · Media And Components, Synthetic Cell And Tissue Culture · 55d
Cleared Mar 30, 1987
(DME) AUTO-MOD MODIFIED FOR AUTOCLAVING #D5280
K870495 · Sigma Chemical Co.
KIT · Media And Components, Synthetic Cell And Tissue Culture · 55d
Cleared Mar 30, 1987
DULBECCO MODI EAGLE MED((DME) HYBRI-MAX (TM)
K870496 · Sigma Chemical Co.
KIT · Media And Components, Synthetic Cell And Tissue Culture · 55d
Cleared Mar 30, 1987
BGJB MED(FITTON JACKSON MOD)W/L-GLUT/W/O SOD BICAR
K870497 · Sigma Chemical Co.
KIT · Media And Components, Synthetic Cell And Tissue Culture · 55d

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All categories 914 KIT Media And Components, Synthetic Cell And Tissue Culture 228 KIR Cells, Animal And Human, Cultured 123 JTS Stains, Microbiologic 27 PSY Whole Slide Imaging System 23 KIS Sera, Animal And Human 20 NQN Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity 15 QKQ Digital Pathology Image Viewing And Management Software 14 MXZ Immunohistochemistry Assay, Antibody, Progesterone Receptor 13 NOT 13 NQI System, Immunomagnetic, Circulating Cancer Cell, Enumeration 13 MYA Immunohistochemistry Antibody Assay, Estrogen Receptor 12 IAF Wright's Stain 12 IEO Processor, Tissue, Automated 11 NYI Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer 10 NUA System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection 10