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
25–48 of 13,234
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 08, 2026
Pivot Insulin Delivery System
K253534 · LZG
Modular Medical
Chemistry · 146d
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 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 Dec 19, 2025
DBLG2
K251152 · QJI
Diabeloop
Chemistry · 249d