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
49–72 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 02, 2026
Tina-quant Cardiac high sensitivity CRP III
K260026 · NQD
Roche Diagnostics
Chemistry · 87d
Cleared Mar 24, 2026
Access BNP II
K252169 · NBC
Beckman Coulter, Inc.
Chemistry · 257d
Cleared Mar 13, 2026
BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin...
K252040 · JKA
Becton, Dickinson and Company
Chemistry · 256d
Cleared Mar 12, 2026
MiniMed Flex pump
K253743 · QFG
Medtronic Minimed, Inc.
Chemistry · 108d
Cleared Feb 27, 2026
Atellica CH Diazo Total Bilirubin (D_TBil)
K251998 · CIG
Siemens Healthcare Diagnostics, Inc.
Chemistry · 245d
Cleared Feb 20, 2026
QSCHECK UISACR
K252619 · JFY
Qstag, Inc.
Chemistry · 185d
Cleared Feb 18, 2026
Alere NT-proBNP for Alinity i
K253539 · NBC
Axis-Shield Diagnostics, Ltd.
Chemistry · 97d
Cleared Feb 12, 2026
ISE indirect K for Gen.2
K253491 · CEM
Roche Diagnostics
Chemistry · 111d
Cleared Feb 12, 2026
Glucose HK Gen.3
K253490 · CFR
Roche Diagnostics
Chemistry · 111d
Cleared Feb 06, 2026
Atellica® IM TSH3-Ultra II (TSH3ULII)
K251543 · JLW
Siemens Healthcare Diagnostics, Inc.
Chemistry · 262d
Cleared Feb 03, 2026
Dexcom G7 Continuous Glucose Monitoring (CGM) System
K253737 · QBJ
Dexcom, Inc.
Chemistry · 71d
Cleared Feb 03, 2026
SmartGuard Technology
K253701 · QJI
Medtronic Minimed
Chemistry · 71d
Cleared Jan 21, 2026
Nova Max Creat eGFR Monitoring System
K251281 · SHB
Nova Biomedical Corporation
Chemistry · 272d
Cleared Jan 15, 2026
MiniMed 780G Insulin Pump (MMT-1884)
K253470 · QFG
Medtronic Minimed, Inc.
Chemistry · 97d
Cleared CT Jan 14, 2026
SmartGuard technology
K253585 · QJI
Medtronic Minimed, Inc.
Chemistry · 58d
Cleared Jan 09, 2026
Nova Allegro UACR Assay, Nova Allegro Analyzer
K252206 · CGX
Nova Biomedical Corporation
Chemistry · 179d
Cleared Jan 09, 2026
Core Metabolic
K251157 · CIX
Truvian Health
Chemistry · 269d
Cleared Jan 08, 2026
MiniMed Go App
K253512 · NDC
Medtronic Minimed
Chemistry · 63d
Cleared Jan 06, 2026
Medconn 8K Glycated Hemoglobin Test System
K252749 · PDJ
Shanghai Medconn Medical Technology...
Chemistry · 130d
Cleared Dec 30, 2025
Lipids
K251091 · CHH
Truvian Health
Chemistry · 264d
Cleared Dec 23, 2025
UpDoc
K253281 · NDC
Updoc, Inc.
Chemistry · 85d
Cleared Dec 23, 2025
Healgen® URS Test Strips
K251800 · JMT
Healgen Scientific, LLC
Chemistry · 194d
Cleared CT Dec 19, 2025
DBLG2
K251152 · QJI
Diabeloop
Chemistry · 249d
Cleared Dec 19, 2025
Tru Liver Health Test Panel
K251074 · CJE
Truvian Health
Chemistry · 255d