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 2167 of 3531

510(k) clearances, page 2167 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K943526	Megabeam Lateral Fire Fiber Optic Delivery System	Ceram Optec, Inc.	GEX	Class II	1994-08-26
K943445	Megabeam Fiber Optic Delivery System	Ceram Optec, Inc.	GEX	Class II	1994-08-26
K943444	Megabeam Lateral Fire	Ceram Optec, Inc.	GEX	Class II	1994-08-26
K943149	Access Red Blood Cell Folate Assay	Siemens Healthcare Diagnostics Inc.	CGN	Class II	1994-08-26
K942485	Mdt Urology Table	Mdt Corp., Inc.	MMZ	Class II	1994-08-26
K942443	Auraflex Systems	bioMerieux, Inc.	JJE	Class I	1994-08-26
K942290	Star I Workstation	Standard Engineering	JQW	Class I	1994-08-26
K942284	Clp Total Iron and Uibc/tibc Linearity Control Set	Creative Laboratory Products, Inc.	JJX	Class I	1994-08-26
K942204	Argon Curing Laser	Bio-Laser Technology, Inc.	GEX	Class II	1994-08-26
K941907	Apex Disposable Instruments	Apex Ent., Inc.	MDM	Class I	1994-08-26
K941837	Roche Reagent for Creatinine	Roche Diagnostic Systems, Inc.	CGX	Class II	1994-08-26
K941711	Hyperflex Flexible Guidewires	Linvatec Corporation	LXH	Class I	1994-08-26
K940124	Ey-20 Reagent Tubes	E-Y Laboratories, Inc.	JTO	Class I	1994-08-26
K940020	Strep-a-Chek(tm) Reagent Strips	E-Y Laboratories, Inc.	JTO	Class I	1994-08-26
K936271	Fresh Cells Multi-Well Plate Cultures and Shell Vial Culture	Ortho-Clinical Diagnostics, Inc.	KIR	Class I	1994-08-26
K935270	Modular Forcep and Scissor System	Richard Wolf Medical Instruments Corp.	GCJ	Class II	1994-08-26
K934208	Slt Prism/refracting Probe	Surgical Laser Technologies, Inc.	GEX	Class II	1994-08-26
K934129	Strep-a-Chek	E-Y Laboratories, Inc.	JTO	Class I	1994-08-26
K933757	Hand-Held Irrigation Pump	Ximed Medical Systems	BTA	Class II	1994-08-26
K933680	Gambro Lundia Pro 200 Dialyzer	Cobe Renal Care, Inc.	FJG	Class II	1994-08-26
K926218	Eisman-Tries Mep (Multiple Electrode Probe)	Diversatek Healthcare Inc	HIR	Class II	1994-08-26
K925193	Aquaciser II	Aquaciser, Inc.	ILJ	Class II	1994-08-26
K943916	Videotoscope	Welch Allyn Inc	ERA	Class I	1994-08-25
K943864	Stryker 8000 Surgery Stretcher	Stryker Medical	FPO	Class II	1994-08-25
K943177	Boston(r) 7 - 30(Enflufocon a)	Polymer Technology Corp.	HQD	Class II	1994-08-25
K942937	Sharpsafe Cat No. 4105, 4115 and 4120	Smiths Industries Medical Systems, Inc.	FMI	Class II	1994-08-25
K942933	Pressure Infusion Cuff	Circulatory Technology, Inc.	KZD	Class I	1994-08-25
K942818	Deep Suture	Automated Medical Products Corp.	MDM	Class I	1994-08-25
K942817	Ccd Endocam Office 5510	Richard Wolf Medical Instruments Corp.	GCJ	Class II	1994-08-25
K942624	Lok-on Needle Disposal Container	Medical Safety Products, Inc.	FMI	Class II	1994-08-25
K942564	Argyle Neo-Sert	Sherwood Medical Co.	FOS	Class II	1994-08-25
K941996	Edge	Philips North America LLC	LNH	Class II	1994-08-25
K941781	Rigiscan Plus Rigidity Assessment System	Dacomed Corp.	LIL	Unclassified	1994-08-25
K941681	Arthrex Circular Harvesting Saw	Arthrex GmbH	HSZ	Class I	1994-08-25
K941673	Mediaid Universal Thermometer	Polymedica Industries, Inc.	FLK	Class II	1994-08-25
K940573	Hepa Air Cleaner	Duracraft Corp.	FRF	Class II	1994-08-25
K936179	Winrad Teleradiology System	Line Imaging Systems	LLZ	Class II	1994-08-25
K935693	Autoneb Breath Actuated Controller and Accessory Kit	Vortran Medical Technology 1, Inc	CAF	Class II	1994-08-25
K933918	Sharplan Model 1080S CO2 Surgical Laser	Sharplan Lasers, Inc.	GEX	Class II	1994-08-25
K933289	Thick Tibial Insert	Wrightmedicaltechnologyinc	JWH	Class II	1994-08-25
K931029	Disposable Concentric Needle Electrode	Chalgren Enterprises, Inc.	IKT	Class II	1994-08-25
K943816	Trocars,cannulae, Sheaths	Karl Storz Endoskop GmbH	EOB	Class II	1994-08-24
K943719	Visistat Stapler	Pilling Weck, Inc.	GDT	Class I	1994-08-24
K943570	Avl Compact 1 Ph/blood Gas Analyzer	Avl Scientific Corp.	CHL	Class II	1994-08-24
K943330	Action-Lift Chair	Alc, Inc.	INO	Class II	1994-08-24
K943281	Polyethylene Vent Tubes	Micromed Development Corp.	ETD	Class II	1994-08-24
K943190	C-Flex Vent Tubes	Micromed Development Corp.	ETD	Class II	1994-08-24
K943066	Interacoustics Computer Audiometer Ba 20	Precision Acoustics Ind., Inc.	EWO	Class II	1994-08-24
K943048	Microgenics Thc Control Sets	Microgenics Corporation	LAS	Class I	1994-08-24
K942773	Ck-Mb Assay, Catalogue Number 317-10	Sekisui Diagnostics P.E.I. Inc.	CGS	Class II	1994-08-24