Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Chemistry ×
13,257 results
385–408 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared Aug 11, 2020
Pointe Scientific Creatinine Kinase (CK) Reagent Set
K191296 · CGS
Medtest DX
Chemistry · 455d