FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

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

Filters: Chemistry ×
13,234 results
361–384 of 13,234
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 15, 2021
Dexcom G6 Continuous Glucose Monitoring (CGM) System
K201328 · QBJ
Dexcom, Inc.
Chemistry · 422d
Cleared Jul 13, 2021
Finetest Lite Blood Glucose Monitoring System
K203562 · NBW
Osang Healthcare Co. , Ltd.
Chemistry · 218d
Cleared Jul 13, 2021
ADVIA Centaur® Total hCG assay
K200210 · DHA
Siemens Healthcare Diagnostics, Inc.
Chemistry · 532d
Cleared Jul 02, 2021
ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay
K200256 · PDJ
Siemens Healthcare Diagnostics, Inc.
Chemistry · 515d
Cleared Jun 04, 2021
Insulia Diabetes Management Companion
K202596 · NDC
Voluntis Sa.
Chemistry · 269d
Cleared May 10, 2021
Yumizen C1200 Creatinine PAP
K193649 · JFY
HORIBA ABX SAS
Chemistry · 497d
Cleared May 07, 2021
Bigfoot Unity Diabetes Management System
K202145 · QLG
Bigfoot Biomedical, Inc.
Chemistry · 280d
Cleared Apr 13, 2021
IDS Cortisol
K202136 · CGR
Immunodiagnostic Systems , Ltd.
Chemistry · 256d
Cleared Jan 15, 2021
IMMULITE/IMMULITE® 1000 Cortisol
K203270 · CGR
Siemens Healthcare Diagnostics...
Chemistry · 71d
Cleared Dec 04, 2020
Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program...
K200876 · QBJ
Dexcom, Inc.
Chemistry · 247d
Cleared Oct 16, 2020
Finetest Lite Smart Blood Glucose Monitoring System
K201396 · NBW
Osang Healthcare Co. , Ltd.
Chemistry · 141d
Cleared Oct 15, 2020
LIAISON Testosterone xt
K201908 · CDZ
DiaSorin, Inc.
Chemistry · 98d
Cleared Oct 01, 2020
SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+
K200544 · CEM
Diamond Diagnostics, Inc.
Chemistry · 212d
Cleared Sep 30, 2020
IDS-iSYS Ostase BAP
K200475 · CIN
Immunodiagnostic Systems , Ltd.
Chemistry · 217d
Cleared Sep 25, 2020
BD Preset Syringe & BD A-Line Syringe
K202446 · JKA
Becton, Dickinson and Company
Chemistry · 30d
Cleared Sep 11, 2020
GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose...
K193340 · NBW
Microtech Medical, Inc.
Chemistry · 284d
Cleared Sep 09, 2020
KetoSens BT Blood B-Ketone Monitoring System
K201551 · JIN
I-Sens, Inc.
Chemistry · 92d
Cleared Sep 09, 2020
CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV
K192730 · CHW
Biosystems S.A.
Chemistry · 348d
Cleared Aug 28, 2020
DreaMed Advisor Pro
K201476 · QCC
DreaMed Diabetes, Ltd.
Chemistry · 86d
Cleared Aug 24, 2020
ST AIA-PACK BNP
K192380 · NBC
Fujirebio Diagnostics,Inc.
Chemistry · 360d
Cleared Aug 20, 2020
Distinct® Early Detection Pregnancy Test
K193318 · LCX
ACON Laboratories, Inc.
Chemistry · 262d
Cleared Aug 17, 2020
23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
K193492 · QDJ
23AndMe, Inc.
Chemistry · 244d
Cleared Aug 13, 2020
hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream
K200133 · LCX
Safecare Biotech (Hangzhou) Co., Ltd.
Chemistry · 205d
Cleared Aug 13, 2020
AncestryDNA Saliva Collection Kit
K192947 · OYJ
Ancestry Genomics, Inc.
Chemistry · 300d