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
1–24 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 30, 2026
Safe AQ Easy Blood Glucose Monitoring System
K260738 · NBW
Changsha Sinocare, Inc.
Chemistry · 238d
Cleared Oct 23, 2026
EASYMAX Voice Blood Glucose Monitoring System
K261293 · NBW
Eps Bio Technology Corp.
Chemistry · 186d
Cleared Oct 21, 2026
Mint ACE Pump
K263422 · QFG
Beta Bionics, Inc.
Chemistry · 26d
Cleared Oct 20, 2026
Access BNP II
K262597 · NBC
Beckman Coulter, Inc.
Chemistry · 85d
Cleared Oct 16, 2026
BD Vacutainer® Serum Blood Collection Tubes
K252344 · JKA
Becton, Dickinson and Company
Chemistry · 445d
Cleared CT Oct 15, 2026
twiist Loop Algorithm
K262576 · QJI
Deka Research and Development Corp.
Chemistry · 80d
Cleared Oct 09, 2026
VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System
K260687 · NBW
Vivachek Biotech (Hangzhou) Co., Ltd.
Chemistry · 220d
Cleared Oct 05, 2026
Glucommander
K261939 · NDC
Glytec, LLC
Chemistry · 117d
Cleared Oct 02, 2026
CVS Advanced PLUS Blood Glucose Monitoring System
K260689 · NBW
I-Sens, Inc.
Chemistry · 213d
Cleared Oct 02, 2026
H100Plus Hemoglobin Testing System
K260468 · PDJ
Shenzhen Lifotronic Technology Co., Ltd.
Chemistry · 232d
Cleared Sep 30, 2026
Eonis™ SMA kit
K262893 · QUE
Revvity, Inc.
Chemistry · 44d
Cleared Sep 22, 2026
Instant-View® hCG Combo II Cassette Test
K262299 · JHI
Alfa Scientific Designs, Inc.
Chemistry · 77d
Cleared Sep 21, 2026
Access NT-proBNP
K262109 · NBC
Beckman Coulter, Inc.
Chemistry · 90d
Cleared Sep 18, 2026
Biolinq Shine Autonomous Time-in-Range Microsensor
K262599 · SFU
Biolinq Incorporated
Chemistry · 53d
Cleared Sep 16, 2026
iOS CamAPS FX
K261896 · QJI
CamDiab
Chemistry · 100d
Cleared Sep 11, 2026
iLet Dosing Decision Software
K262763 · QJI
Beta Bionics, Inc.
Chemistry · 38d
Cleared Sep 11, 2026
Mint ACE Pump
K260001 · QFG
Beta Bionics, Inc.
Chemistry · 252d
Cleared Sep 08, 2026
MODI System
K260062 · QRX
DreaMed Diabetes, Ltd.
Chemistry · 243d
Cleared Sep 02, 2026
Pivot Insulin Delivery System
K262153 · LZG
Modular Medical, Inc.
Chemistry · 68d
Cleared Sep 01, 2026
AMI™ Plasma Cartridge, AMI™
K260613 · JID
Sequitur Health Corp.
Chemistry · 188d
Cleared Aug 27, 2026
CONTOUR® PLUS BLUE Blood Glucose Monitoring System
K260545 · NBW
Ascensia Diabetes Care
Chemistry · 190d
Not Cleared Aug 25, 2026
Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System
DEN250049 · SJD
Abbott Diabetes Care
Chemistry · 330d
Cleared Aug 11, 2026
Stelo Glucose Biosensor System
K262472 · SBH
Dexcom, Inc.
Chemistry · 25d
Cleared Jul 24, 2026
Atellica CH Acetaminophen 2 (ACTM)
K261364 · LDP
Siemens Healthcare Diagnostics, Inc.
Chemistry · 88d