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
241–264 of 13,234
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 21, 2023
PAXgene® Blood DNA Tube
K231469 · PJE
Preanalytix GmbH
Chemistry · 30d
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 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