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
265–288 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 16, 2023
Healgen URS Test Strips
K231045 · LJX
Healgen Scientific, LLC
Chemistry · 65d
Cleared Jun 12, 2023
Atellica® CH Diazo Direct Bilirubin (D_DBil)
K223078 · CIG
Siemens Healthcare Diagnostics, Inc.
Chemistry · 255d
Cleared Jun 07, 2023
Fenom Pro
K213611 · MXA
Caire Diagnostics, Inc.
Chemistry · 569d
Cleared Jun 05, 2023
Alinity i Total ß-hCG Reagent Kit, GLP systems Track
K230937 · DHA
Abbott Laboratories
Chemistry · 63d
Cleared May 19, 2023
Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c...
K230790 · DHA
Abbott Laboratories
Chemistry · 58d
Cleared May 19, 2023
iLet® ACE Pump
K223846 · QFG
Beta Bionics, Inc.
Chemistry · 150d
Cleared May 19, 2023
iLet® Dosing Decision Software
K220916 · QJI
Beta Bionics, Inc.
Chemistry · 415d
Not Cleared May 18, 2023
B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System
DEN220027 · QWH
Brahms GmbH, Part of Thermo Fisher...
Chemistry · 381d
Cleared May 15, 2023
Dexcom G7 Continuous Glucose Monitoring (CGM) System
K231081 · QBJ
Dexcom, Inc.
Chemistry · 28d
Cleared May 04, 2023
Alinity i STAT High Sensitivity Troponin-I
K230994 · MMI
Abbott Laboratories Diagnostics Division
Chemistry · 27d
Cleared Apr 24, 2023
Omnipod GO Insulin Delivery Device
K223372 · LZG
Insulet Corporation
Chemistry · 171d
Cleared Apr 13, 2023
FreeStyle Libre 3 Continuous Glucose Monitoring System
K223435 · QBJ
Abbott Diabetes Care, Inc.
Chemistry · 150d
Cleared Apr 13, 2023
AUTION MAX AX-4060 Urinalysis System
K193514 · JIL
Arkray, Inc.
Chemistry · 1211d
Cleared Apr 07, 2023
Elecsys FT4 IV
K220456 · CEC
Roche Diagnostics
Chemistry · 414d
Cleared Mar 30, 2023
ONLINE TDM Phenytoin - Free Phenytoin application
K230161 · MOJ
Roche Diagnostics
Chemistry · 69d
Cleared Mar 20, 2023
Atellica® CH Diazo Total Bilirubin (D_TBil)
K222104 · CIG
Siemens Healthcare Diagnostics, Inc.
Chemistry · 245d
Cleared Mar 15, 2023
Digital Routines
K221924 · NDC
Gnc Holdings, LLC
Chemistry · 257d
Cleared CT Mar 03, 2023
FreeStyle Libre 2 Flash Glucose Monitoring System
K222447 · QBJ
Abbott Diabetes Care, Inc.
Chemistry · 200d
Cleared Mar 01, 2023
Bigfoot Unity® Diabetes Management System
K222280 · QLG
Bigfoot Biomedical, Inc.
Chemistry · 215d
Cleared Feb 28, 2023
MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)
K230038 · LCX
Guangzhou Decheng Biotechnology Co.,...
Chemistry · 53d
Cleared Feb 21, 2023
FreeStyle Libre 2 System, FreeStyle Libre 3 System
K223537 · QLG
Abbott Diabetes Care, Inc.
Chemistry · 90d
Cleared Feb 08, 2023
Access Cortisol
K223038 · CGR
Beckman Coulter, Inc.
Chemistry · 132d
Cleared Feb 03, 2023
Access AMH
K223679 · PQO
Beckman Coulter, Inc.
Chemistry · 57d
Cleared Jan 27, 2023
GEM Premier ChemSTAT
K223090 · CGA
Instrumentation Laboratory CO
Chemistry · 119d