510(k) clearances

Premarket notifications cleared by FDA, newest decision first.

Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.

Data as of 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.

Show the numbers

510(k) clearances by decision year, the last 15 years of ingested records
Year	Clearances
2012	3,135
2013	3,052
2014	3,202
2015	3,020
2016	2,956
2017	3,200
2018	3,062
2019	2,918
2020	2,923
2021	3,023
2022	3,209
2023	3,346
2024	3,129
2025	3,225
2026	2,732

176,529 records, page 1702 of 3531

510(k) clearances, page 1702 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K990959	K-Centrum Anterior Spinal Fixation System	Spineology, Inc.	KWQ	Class II	1999-12-27
K983860	Mtm Bioscanner K Test Strips, Cat # Bsa610	Polymer Technology Systems	JMK	Class I	1999-12-27
K994068	S.m.a.r.t. Nitinol Stent Transhepatic Biliary System	Cordis US Corp.	FGE	Class II	1999-12-23
K993731	Sonata Gradients/magnetom Symphony System	Siemens Medical Solutions USA, Inc.	LNH	Class II	1999-12-23
K993651	O'neil Sterile Field Intermittent Urinary Catheter	Sc Hennig Enterprises Europe SRL	GBM	Class II	1999-12-23
K993424	The True Y Clip, the Micro Y Clip, the Laparoscopic Y Clip	Y-Clip Associates	FZP	Class II	1999-12-23
K993342	Ducprep Breast Aspirator, Model Pmpo2	Windy Hill Technology, Inc.	KNW	Class II	1999-12-23
K993209	Softlight Q-Switched Nd: Yag Laser with Optional Beam-Shrinking Handpiece Accessory	Thermolase Corp.	GEX	Class II	1999-12-23
K992074	Mpm Regenecare Wound Gel	MPM Medical	MGQ	Unclassified	1999-12-23
K992008	Pharmaseed, Model Bt-125-1	Syncor Pharmaceuticals, Inc.	KXK	Class II	1999-12-23
K990416	Omnicorder Bioscan System	Omnicorder Technologies, Inc.	LHQ	Class I	1999-12-23
K990079	Fastseal Chest Wound Dressing	Greenfield Medical Technologies, Inc.	MGP	Unclassified	1999-12-23
K994145	Vitros Immunodiagnostic Products Free T3 Reagent Pack, Vitros Immunodiagnostic Products Free T3 Calibrators	Ortho-Clinical Diagnostics, Inc.	JIS	Class II	1999-12-22
K994039	Abbott Gemstar i.v. Infusion Pump-7 Therapy Configuration, Abbott Gemstar i.v. Infusion Pump-6 Therapy Configuration, Ab	Abbott Medical	FRN	Class II	1999-12-22
K994038	Modular Reach Hip	Zimmer GmbH	LPH	Class II	1999-12-22
K993932	Solitaire 2	Kulzer GmbH	EBF	Class II	1999-12-22
K993717	Enigma Hi-Base Denture Base Material	Davis Schottlander & Davis, Ltd.	EBI	Class II	1999-12-22
K993544	Space-or Retractor	Advanced Surgical Concepts (Asc)	FFO	Class I	1999-12-22
K993487	Paragon Lens Vial	Paragon Vision Sciences, Inc.	LRX	Class II	1999-12-22
K993486	Paragon Lens Carrier	Paragon Vision Sciences, Inc.	LRX	Class II	1999-12-22
K992587	Epstein-Barr Virus Early Antigen (Ebv-Ea) Igg Ifa Test System	Stellar Bio Systems, Inc.	LSE	Class I	1999-12-22
K992402	5.0 French X 200Cm X 35Mm Tip Taper-20Mm Cutting Wire, 5.0 French X 200Cm X 35Mm Tip Taper-30Mm Cutting Wire, 5.0 French	TeleMed Systems	KNS	Class II	1999-12-22
K992390	Hot Biopsy Forceps Feenestrated 230 Cm Oval Cup, Hot Biopsy Forceps Serrated 160 Cm Oval Cup, Hot Biopsy Forceps Serratd	TeleMed Systems	KGE	Class II	1999-12-22
K992211	Spo2 Wrap Sensor	Epic Medical Equipment Services, Inc.	DQA	Class II	1999-12-22
K992092	Stat-Shell Disposable Spo2 Sensor	Epic Medical Equipment Services, Inc.	DQA	Class II	1999-12-22
K991139	Guglielmi Detachable (Gdc)	Boston Scientific Corporation	HCG	Class II	1999-12-22
K994187	Synthes Cervifix System	Synthes (USA) Products LLC	KWP	Class II	1999-12-21
K994175	Modification to Sodem High Speed System for Neurosurgical Use	Sodemsystems	HBB	Class II	1999-12-21
K994110	Lipoprotein (a) Spq III Antibody Reagent Set	Diasorin/American Standard Companies	DFC	Class II	1999-12-21
K994101	E. Histolytica II	Techlab, Inc.	KHW	Class II	1999-12-21
K994045	Primus Liquid Calibrator for Ghb/a1c Level 1 and Level 2	Trinity Biotech (Primus Corporation dba Trinity Biotech)	LCP	Class II	1999-12-21
K994009	Cg-2100 ECG Transmitter	Card Guard Scientific Survival, Ltd.	DXH	Class II	1999-12-21
K993994	Hardydisk Azithromycin 15Mcg	Hardy Diagnostics	JTN	Class II	1999-12-21
K993962	Pensil Trauma, Model Wws6100	Wuestec Medical, Inc.	KPR	Class II	1999-12-21
K993947	Koordinant Angiographic and Operating Room Model X-Ray Table Family	Siemens Corp.	IZI	Class II	1999-12-21
K993935	Durasoft 3 UV (Phemfilcon a) Optifit Toric (Hydrophilic) Contact Lenses, Durasoft 3 UV (Phemfilcon a) Spherical (Hydropi	Wesley Jessen Corp.	LPL	Class II	1999-12-21
K993883	M-Pact Corneal Light Shield	M-Pact Corp.	HOZ	Class II	1999-12-21
K993868	The Soundvaser Dissection System	Solta Medical, Inc.	LFL	Unclassified	1999-12-21
K993812	Cvm Transport, Model R96,viral Transport, Model R99, Cvm Transport Kit, Model R96 K, Viral Transport Kit, Model R99 K	Hardy Diagnostics	JSM	Class I	1999-12-21
K993796	Rapid Drug Screen 5-Panel Drug Screening Test for Cocaine, Marijuana, Opiates, Amphetamine and Methamphetamine	American Bio Medica Corp.	LDJ	Class II	1999-12-21
K993755	Emit Calibrater/control Level 0, Level 1, Level 2, Level 3, Level 4, Level 5	Syva Co.	DKB	Class II	1999-12-21
K993727	Bindazyme Anti-Dsdna Eia Kit	The Binding Site	LRM	Class II	1999-12-21
K993716	Pa Gel 35% in Blue and Pa Gel 10% in Green or Blue	Harry J. Bosworth Co.	EBF	Class II	1999-12-21
K993710	Modification of Parapost Cement	Coltene /Whaledent AG	EMA	Class II	1999-12-21
K993687	Uroview 2800	GE Dec Medical Systems	OWB	Class II	1999-12-21
K993681	Digitec Two Stage Compression Kit	Digitec Medical Service Corp.	IZH	Class II	1999-12-21
K993673	Snn Fluoro Navigation System	I.S.G. Technologies, Inc.	HAW	Class II	1999-12-21
K993655	Micro-France Electrosurgical Instruments, Various	Xomed, Inc.	GEI	Class II	1999-12-21
K993645	Ct/e Computed Tomography Scannner System	GE Healthcare	JAK	Class II	1999-12-21
K993612	Bindazyme Anti-Tissue Transglutaminase Iga Eia	The Binding Site	MVM	Class II	1999-12-21