FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Pathology ×
1,105 results
49–72 of 1,105
Search insights Median review: 34d Cleared: 98% Top manufacturer: J R Scientific Lead specialty: Pathology
Cleared Sep 17, 2021
Philips IntelliSite Pathology Solution
K203845 · PSY
Philips Medical Systems Nederland B.V.
Pathology · 260d
Cleared Jul 26, 2021
OncoMate MSI Dx Analysis System
K200129 · PZJ
Promega Corporation
Pathology · 552d
Cleared Jul 14, 2021
NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)
K202304 · PZM
Nyu Langone Medical Center
Pathology · 334d
Cleared Apr 15, 2021
MDPC-8127
K203364 · PSY
Barco N.V.
Pathology · 150d
Cleared Nov 05, 2020
MammaPrint
K201902 · NYI
Agendia, Inc.
Pathology · 120d
Cleared Jul 15, 2020
FullFocus
K201005 · QKQ
Paige.Ai, Inc.
Pathology · 90d
Cleared Apr 24, 2020
PGDx elio tissue complete
K192063 · PZM
Personal Genome Diagnostics
Pathology · 267d
Cleared Mar 31, 2020
Sectra Digital Pathology Module
K193054 · QKQ
Sectra AB
Pathology · 151d
Cleared Mar 06, 2020
BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra...
K193393 · MXZ
Leica Biosystems Newcastle, Ltd.
Pathology · 91d
Cleared Nov 09, 2019
Omics Core
K190661 · PZM
Nanthealth, Inc.
Pathology · 240d
Cleared Sep 27, 2019
Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and...
K190076 · OYX
Cepheid
Pathology · 254d
Cleared Sep 20, 2019
Philips IntelliSite Pathology Solution
K192259 · PSY
Philips Electronics Nederland B.V.
Pathology · 30d
Cleared May 20, 2019
Aperio AT2 DX System
K190332 · PSY
Leica Biosystems Imaging, Inc.
Pathology · 95d
Cleared Apr 25, 2019
exCellerator Cervical Collection Device
K182049 · HHT
Excell Company, LLC
Pathology · 268d
Cleared Dec 07, 2018
Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen...
K183100 · MYA
Leica Biosystems Newcastle, Limited
Pathology · 30d
Cleared Dec 07, 2018
BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) ,...
K183102 · MXZ
Leica Biosystems Newcastle, Limited
Pathology · 30d
Not Cleared Sep 28, 2018
Adaptive Biotechnologies clonoSEQ Assay
DEN170080 · QDC
Adaptive Biotechnologies Corporation
Pathology · 364d
Cleared Mar 15, 2018
Tissue of Origin Test Kit-FFPE
K173839 · OIW
Cancer Genetics, Inc.
Pathology · 87d
Not Cleared Mar 06, 2018
23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)
DEN170046 · QAZ
23AndMe, Inc.
Pathology · 182d
Cleared Jan 12, 2018
ipsogen JAK2 RGQ PCR Kit
K172287 · PSU
Qiagen, Inc.
Pathology · 168d
Cleared Dec 22, 2017
MRDx BCR-ABL Test, MRDx BCR-ABL Test Software
K173492 · OYX
MolecularMD Corporation
Pathology · 39d
Cleared Dec 21, 2017
FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294,...
K170005 · MXZ
Dako Denmark A/S
Pathology · 352d
Cleared Dec 21, 2017
FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako...
K170028 · MYA
Dako Denmark A/S
Pathology · 352d
Cleared Dec 21, 2017
MMPC-4127F1
K172922 · PZZ
Barco N.V.
Pathology · 87d