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 1551 of 3531

510(k) clearances, page 1551 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K020407	Lorenz Blue Device	Biomet Microfixation	MQN	Class II	2002-02-22
K020274	Wmt Modular Ulnar Head Implant	Wrightmedicaltechnologyinc	KXE	Class II	2002-02-22
K020266	Inion Cps Bsso Screw	Inion Oy	HWC	Class II	2002-02-22
K020240	Slim Gliding Nail System	Plus Orthopedics	KTT	Class II	2002-02-22
K020161	Agiltrac .018 Peripheral Dilatation Catheter	Boston Scientific Corporation	DQY	Class II	2002-02-22
K020092	Temphase	Kerr Dental Materials Center	EBG	Class II	2002-02-22
K014174	Harvey Pv Dry Sterilizer, Model # St127325; St127320; St127320-33	Barnstead/Thermolyne Corp.	FLE	Class II	2002-02-22
K014079	Dr. Hays Bite Guard	Inventive Resources, Inc	MQC	Unclassified	2002-02-22
K014042	D.sign 84	Ivoclar Vivadent, Inc.	EJS	Class II	2002-02-22
K014033	Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers	Syntermed, Inc.	KPS	Class II	2002-02-22
K014027	Optibond Solo Plus 4	Kerr Dental Materials Center	KLE	Class II	2002-02-22
K013993	Neocalex	Stephen M Koral, Dmd	EIK	Class I	2002-02-22
K013975	Cp-Sleeve	Cp Medical	KXK	Class II	2002-02-22
K013919	Torflex Transseptal Guiding Sheath	Baylis Medical Co., Inc.	DBY	Class I	2002-02-22
K013543	Bond-1 C & B	Jeneric/Pentron, Inc.	KLE	Class II	2002-02-22
K012958	Breathing Circuit Filter	Emergency Filtration Products, Inc.	CAH	Class II	2002-02-22
K011569	Biosorbfx O/m 2.0/2/4 System	Bionx Implants, Inc.	JEY	Class II	2002-02-22
K011488	Spirabrush Cx Biopsy Instrument	Trylon Corp.	HFB	Class I	2002-02-22
K011404	Fabius Gs Anesthesia System, Model Fabius Gs	Draeger, Inc.	BSZ	Class II	2002-02-22
K020494	Modification to M2376a Devicelink System	Philips North America LLC	MWI	Class II	2002-02-21
K020204	Telescopic Plate Spacer Thoracolumbar (Tps-Tl) Spinal System, Models 8123, 8124, 8132, 8133, 8156, 8157, 8158, & 8189	Interpore Cross Intl.	MQP	Class II	2002-02-21
K020197	Modification to Datacaptor	Capsule Technologie	MWI	Class II	2002-02-21
K020018	Modification to Bernoulli Ventilator Management System Software	Cardiopulmonary Corp.	MSX	Class II	2002-02-21
K014102	Provox Hme Cassette, Model 7240; Provox Adhesive, Model 7251	Atos Medical AB	JOH	Class II	2002-02-21
K013862	Bci 1621 Oximetry Data Management Program	Bci, Inc.	DQA	Class II	2002-02-21
K013252	Patil Emergency Cricothyrotomy Catheter Set	Cook Inc.	BWC	Class II	2002-02-21
K013241	Arndt Emergency Cricothyrotomy Catheter Set	Cook Inc.	BWC	Class II	2002-02-21
K012487	Sphygmocor Px Model Scor-Px	ATCOR MEDICAL Pty Ltd	DXN	Class II	2002-02-21
K020143	Vasoview 5 Harvesting Cannula	Guidant Corporation, Cardiac Surgery	HET	Class II	2002-02-20
K020087	Synthes Cranial Plates	Synthes (USA) Products LLC	JEY	Class II	2002-02-20
K014202	Complete Brand Multi-Purpose Solution	Allergan	LPN	Class II	2002-02-20
K013997	Unifil Bond	GC America Inc.	KLE	Class II	2002-02-20
K013930	Neurosensor	Novus Monitoring, Ltd.	GWM	Class II	2002-02-20
K013547	Babycom	Pmg Medica, Ltd.	KNG	Class II	2002-02-20
K013360	Dfiner Urological Catheter	Neoseed Technology,Llc	FGI	Class II	2002-02-20
K013259	Portable Non-Contact Tonometer, Model Pt100	Leica Microsystems, Inc. O.I.D.	HKX	Class II	2002-02-20
K011708	Modification to Wartner Wart Removal System	Wartner Medical Products	GEH	Class II	2002-02-20
K011273	Si Ascope	Astron Clinica Limited	PSN	Class II	2002-02-20
K003744	Enraf-Nonius Endomed 182 System	Henley Healthcare, Inc.	GZJ	Class II	2002-02-20
K020328	Microscan Synergies Plus Gram Negative Mic/combo Panels with Cefuroxime (1-64 Ug/ml)	Siemens Healthcare Diagnostics Inc.	LON	Class II	2002-02-19
K020277	Siemens Medical Infromation Bus (Mib II) Protocol Converter	Siemens Medical Solutions USA, Inc.	DRQ	Class II	2002-02-19
K020080	Bonart Art-E1 Electrosurgery Unit	Diagnostic Data, Inc.	EKZ	Class II	2002-02-19
K014293	K-Assay Ferritin, K-Assay Ferritin Calibrator Set	Kamiya Biomedical Company, LLC	DBF	Class II	2002-02-19
K014258	Sensititre Haemophilus/streptococcus Pneumoniae (Hp) Mic Plate	Trek Diagnostic Systems, Ltd.	JWY	Class II	2002-02-19
K014252	Jetstream	Deldent, Ltd.	KOJ	Class II	2002-02-19
K014249	Jetpolisher	Deldent, Ltd.	KOJ	Class II	2002-02-19
K014239	Medsurg Equipment Covers	Intl. Medsurg Connection, Inc.	MMP	Class II	2002-02-19
K014167	Liberty Blood Glucose Monitoring System	Polymedica Pharmaceuticals, U.S.A., Inc.]	NBW	Class II	2002-02-19
K013970	Prime-Dent Hema Desensitizer	Prime Dental Manufacturing, Inc.	EBF	Class II	2002-02-19
K013874	Clearplane Easy Ovulation Test	Unipath, Ltd.	CEP	Class I	2002-02-19