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 1890 of 3531

510(k) clearances, page 1890 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K961465	2008H on Line Clearance Monitor	Fresenius USA, Inc.	KDI	Class II	1997-07-03
K961044	Noviguard Quick Dry	Dr. Novis Smith & Co., Inc.	LRJ	Class I	1997-07-03
K971861	Ultrasonic Hand Instruments	United States Surgical, A Division of Tyco Healthc	LFL	Unclassified	1997-07-01
K971536	Restraints (Vests and Jackets)	E.M. Adams Co., Inc.	FMQ	Class I	1997-07-01
K971472	Sil-Tec Nonreinforced Sheeting, Reinforced Sheeting, Radiopaque Sheeting, Reinforced Radiopaque Sheeting, Extra Firm Gra	Technical Products, Inc.	FTL	Class II	1997-07-01
K971462	Sunglasses	D.G. Prove Co.	HQY	Class I	1997-07-01
K971384	(Brand Name)	Long in Time Ent. Co., Ltd.	HQY	Class I	1997-07-01
K971328	Olympus Cd-6C-1 Coagulation Electrode	OLYMPUS Corporation of the Americas	FFE	Class II	1997-07-01
K971254	Transend Ex Platinum Guidewire	Boston Scientific Corporation	DQX	Class II	1997-07-01
K971101	Hsv-2 Antigen Control Slides	Viral Antigens, Inc.	GQN	Class II	1997-07-01
K970657	Lmi Thrombectomy Catheter	Lucas Medical, Inc.	DXE	Class II	1997-07-01
K970484	Accu-Prep	Bisco, Inc.	KOJ	Class II	1997-07-01
K970481	V2	Survivalink Corp.	LDD	Class II	1997-07-01
K970338	Tweezer-Type Epilator	Igia Direct, Inc.	KCX	Class I	1997-07-01
K965236	System 96 Intra-Aortic Balloon Pump (Iabp)	Datascope Corp.	DSP	Class II	1997-07-01
K964874	Hsv-1 Antigen Control Slides	Viral Antigens, Inc.	GQN	Class II	1997-07-01
K963190	Qa-40M Defibrillator Tester	Metron U.S., Inc.	DRL	Class II	1997-07-01
K972234	Rct Gel Root Canal Therapy Gel	Dentsply Intl.	EIC	Class I	1997-06-30
K971927	Hi Dense Tc	Shofu Dental Corp.	EMA	Class II	1997-06-30
K971750	Welch Allyn Phaco Illuminator	Welch Allyn Inc	HQC	Class II	1997-06-30
K971694	Etest for Ceftazidime	Ab Biodisk	JWY	Class II	1997-06-30
K971583	Medpor Ocular Screw and Acceossories	Porex Technologies Corp.	MQU	Class II	1997-06-30
K971578	Endosseous Dental Implant	Straumann USA, LLC	DZE	Class II	1997-06-30
K971527	Innosense Pelvic Floor Stimulation and Electromyography System	Empi	KPI	Class II	1997-06-30
K971469	Coulter Act Tron Cell Control	Coulter Corp.	JPK	Class II	1997-06-30
K971250	Laserscope Microbeam IV Micromanipulator	Laserscope	GEX	Class II	1997-06-30
K970420	Mastercap Am 5.0/Mastercap Rm 5.0	Pharmacia, Inc.	JQW	Class I	1997-06-30
K965147	Biliary Stent, Biliary Stent System, Biliary Endoprosthesis	Boston Scientific Corporation	FGE	Class II	1997-06-30
K964593	Diascope Traveller Plus (4053)	S & W Medico Teknik	DSI	Class II	1997-06-30
K963578	Pc Based Electrocardiograph System (Pc-ECG)	Intl. Products, Inc.	DPS	Class II	1997-06-30
K971778	Osteo Small and Mini Bone Screws	Osteonics Corp.	HWC	Class II	1997-06-27
K971753	Denver Pleurx Pleural Catheter Kit, Catalog No. 50-7000, Denver Pleurx Home Drainage Kit, Catalog No. 50-7500	Denver Biomaterials, Inc.	DWM	Class II	1997-06-27
K971716	Procainamide Assay for the Bayer Immuno 1 System	Bayer Corp.	LAR	Class II	1997-06-27
K971692	Osteopower System and Accessories	Osteomed	KMW	Class II	1997-06-27
K971682	J-Fx Cerclage System	Johnson & Johnson Professionals, Inc.	LRN	Class II	1997-06-27
K971676	Limited Reuse Endoscopic Blades	Smith & Nephew, Inc.	HRX	Class II	1997-06-27
K971665	Smart - Fit, Powderfree Nitrile Examination Gloves	Sj Medical Products (M) Sdn Bhd	LZA	Class I	1997-06-27
K971602	Array Systems Rheumatoid Factor (Rfmpe) Reagent	Beckman Instruments, Inc.	DHR	Class II	1997-06-27
K971537	Pyloriset Eia-G (68926)	Orion Diagnostica, Div. Orion Corp.	LYR	Class I	1997-06-27
K971307	Amsco Surgical Table	STERIS Corporation	FQO	Class I	1997-06-27
K971293	Lifeshield Primary i.v. Set with Backcheck Valve	Abbott Mfg., Inc.	FPA	Class II	1997-06-27
K971282	Anchorlok and Anchorlok Rl Soft Tissue Anchor System	Wrightmedicaltechnologyinc	MBI	Class II	1997-06-27
K971188	Smith & Nephew Images Endoscopes and Accessoris/semi-Rigid and Flexible Manual Instruments	Smith & Nephew, Inc.	HIH	Class II	1997-06-27
K971178	Rand Surgical Sponge	Trans Aire	EFQ	Unclassified	1997-06-27
K971130	Defend Fluid Resistant Pleated Mask	Carl Parker Associates, Inc.	FXX	Class II	1997-06-27
K971123	Stone Extractor	Phx Technologies Corp.	OCZ	Class II	1997-06-27
K971121	Encore Bond	Centrix, Inc.	KLE	Class II	1997-06-27
K971103	Aia Nexia-Automated Enzyme Immunoassay System	Tosoh Medics, Inc.	KHO	Class I	1997-06-27
K970977	Latex Examination Gloves, Powder Free	Arista Medi Prima	LYY	Class I	1997-06-27
K970720	Endopath Ez45 Endoscopic Linear Cutter and the Endopath Ez45 No Knife Endoscopic Linear Stapler	Ethicon Endo-Surgery Inc	OCW	Class II	1997-06-27