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 2026-11-02, 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 1018 of 3531

510(k) clearances, page 1018 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K101017	Angiodynamics, Inc., Smart Port CT Series Port Access Systems	Boston Scientific Corporation	LJT	Class II	2010-06-17
K100896	Gyrus Acmi Halo Pks Cutting Forceps	Gyrus ACMI, Inc.	GEI	Class II	2010-06-17
K100861	R T Vue with Software 5.0 Model: R I Vue 100	Optovue Inc.	HLI	Class II	2010-06-17
K100539	Preventech Prophylaxis Paste with Fluoride	Preventive Technologies, Inc.	EJR	Class I	2010-06-17
K100425	Haskal Torque Device	Elcam Medical A.C.A.L.	DQX	Class II	2010-06-17
K093619	Evolution Esophageal Stent Fully Covered, Models Evo-Fc-18-23-8-E, Evo-Fc-18-23-10-E, Evo-Fc-18-23-12-E	Cook Ireland Ltd.	ESW	Class II	2010-06-17
K093466	Hi Vision Preirus Doagnostic Ultrasound Scanner Model Hi Vision Preirus	FUJIFILM Healthcare Americas Corporation	IYO	Class II	2010-06-17
K093395	Olympus Gf Type Uc180, Olympus Gf Type Uct180 Evis Exera II Ulatrasound Gastrovideoscope	Olympus Medical Systems Corp.	IYN	Class II	2010-06-17
K092564	O-Arm Imaging System	Medtronic Navigation, Inc	OXO	Class II	2010-06-17
K101406	Angiojet Solent Proxi Thrombectomy Set Model 109676-001	Medrad Interventional/Possis	QEZ	Class II	2010-06-16
K101119	Syngo Dosimetrist Workspace V2.7 Model: 1056864	Siemens Medical Solutions USA, Inc.	MUJ	Class II	2010-06-16
K100929	Unimom Allegro	Blue Egg Co	HGX	Class II	2010-06-16
K100893	Cheveux Diode Laser System	Sandstone Medical Technologies, LLC	GEX	Class II	2010-06-16
K100836	Clearpoint System	Surgivision, Inc.	ORR	Class II	2010-06-16
K100815	Oxiblue Fingertip Pulse Oximeter Model Md300c318, Oxipro Fingertip Pulse Oximeter Model Md300c316	Oxypulse	DQA	Class II	2010-06-16
K100176	Ascension Ankle Fusion Plate System	Ascension Orthopedics, Inc.	HRS	Class II	2010-06-16
K100043	Coroent Xlr Standalone System	NuVasive Inc	OVD	Class II	2010-06-16
K093949	Olympic Brainz Monitor Model Obm70001	Bio-Logic Systems Corp.	OMA	Class II	2010-06-16
K093800	Robinson Medsurg Quickscrew Rack	Robinson Medsurg, LLC	KCT	Class II	2010-06-16
K093351	Collawound Art	Collamatrix Co., Inc.	FRO	Unclassified	2010-06-16
K092194	Polybone Dental	Kyung Won Medical Co., Ltd.	LYC	Class II	2010-06-16
K091928	10 X 10 Vision	Bioptics, Inc.	MWP	Class II	2010-06-16
K101421	Medical Plates, Lateral Plates, Posterior Lateral Plates, Olecranon Plates Model 131218704-708; 851318704-708, 131218204	Depuy Orthopaedics Inc.	HRS	Class II	2010-06-15
K093951	Ouchless Model Pn10114	Occam Design	MLY	Unclassified	2010-06-15
K092638	Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01, 12101-21, 12101-22, 12101-23	Abbott Medical	NBW	Class II	2010-06-15
K092107	Vitriblast, Thermoblast, Model Vb-010, Tb-010	Nidacon International AB	MQL	Class II	2010-06-15
K101529	Bd Directigen Ez Flu A+b Assay	Becton Dickinson & Co	PSZ	Class II	2010-06-14
K101444	Autosuture Endo Gia Single Use Tan Reload with Tri-Staple Technology	Surgical Devices, A Global Business Unit Tyco	GDW	Class II	2010-06-14
K101341	Powdered Vinyl Patient Examination Gloves	Shijiazhuang Universal Channel Plastic Co., Ltd.	LYZ	Class I	2010-06-14
K101333	Cryocare Cs Surgical System	Varian Medical Systems, Inc.	GEH	Class II	2010-06-14
K100981	United Stem, Psa Type	United Orthopedic Corp.	JWH	Class II	2010-06-14
K100800	Tidi Facemask	Tidi Products, LLC	FXX	Class II	2010-06-14
K100604	Otis -C Plus	Sciences et Bio Materiaux (Sbm)	HRS	Class II	2010-06-14
K100366	Medicina Enteral Feeding Tubes and Accessories Model Mgx/yy	Maxter Catheters	KNT	Class II	2010-06-14
K100233	Sudoscan	Impeto Medical	GZO	Class II	2010-06-14
K100099	Oral/enteral Syringes	Philips Children'S Medical Ventures	FPD	Class II	2010-06-14
K094009	Halt 2000Gi Electrosurgical RF Ablation System Model Halt 2000Gi	Halt Medical, Inc.	GEI	Class II	2010-06-14
K090608	Minta Ryan RF Thermocouple Electrode (Ryan-50, 100, 150 and 200), Minta Intermediate Cable (Ryan-C, -R, -B)	Minta Medical Limited	GXI	Class II	2010-06-14
K082102	Gastric Port, Models: Gap-0016-00, Gap-0018-00, Gap-0020-00	Apollo Endosurgery, Inc.	FED	Class II	2010-06-14
K101419	Ensite Velocity System, Model Ee3000	Abbott Medical	DQK	Class II	2010-06-11
K101334	Jetstream G3 Se System, Jetstream G3 Sf System Model Pv31230 (Jetstream G3 Se Catheter and Control Pod); Pvcn100 (Pv Con	Pathway Medical Technologies, Inc.	MCW	Class II	2010-06-11
K101274	Vasoview Hemopro 2 Endoscopic Vessel Harvesting System	Maquet Cardiovascular LLC	GEI	Class II	2010-06-11
K101242	Genesis Dm Model: 6053000A1	Honeywell Hommed, LLC	DRG	Class II	2010-06-11
K101127	Patient Monitor, Model Pm50	Contec Medical System Co., Ltd.	MWI	Class II	2010-06-11
K101075	Elecsys Insulin Calcheck 5	Roche Diagnostics GmbH	JJX	Class I	2010-06-11
K100821	Prevena Incision Management System	KCI USA, Inc.	OMP	Class II	2010-06-11
K100746	Fiber One	American Medical Systems, Inc.	GEX	Class II	2010-06-11
K100630	G-Force Peek Suture Anchor System	Wrightmedicaltechnologyinc	MBI	Class II	2010-06-11
K100480	Rota-Trach Tracheostomy Tube Model Rota-Trach	Vitaltec Corporation	BTO	Class II	2010-06-11
K100430	Urgotul Ag, Antimicrobial Wound Dressing with Silver	Laboratoires Urgo	FRO	Unclassified	2010-06-11