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 2026-10-21, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2991 of 3529

510(k) clearances, page 2991 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K844061	Microtek Irrigation System	Microtek Medical LLC	GBX	Class I	1985-05-21
K843725	Biogram	Giles Scientific Inc	JTN	Class II	1985-05-21
K843226	Evoked Response Electrical Stimulator	Nucleus, Ltd.	ETN	Class II	1985-05-21
K842720	Bur, Dental Gutta Percha-File-Pulp Canal	Penn-Med Technology, Inc.	EJL	Class I	1985-05-21
K842391	Acr 2500 Cardiotomy Reservoir Filter	Electromedics, Inc.	DTN	Class II	1985-05-21
K852053	Original Ultraviolet Suntanning Lamp	Mottek Intl. Corp.	FTC	Class II	1985-05-20
K851928	Hek Gencells	Genus Diagnostics	KIR	Class I	1985-05-20
K851927	Vero Gencells	Genus Diagnostics	KIR	Class I	1985-05-20
K851911	Multi Function Blood Gas Control	Bionostics, Inc.	JJS	Class I	1985-05-20
K851877	Total Protein Liquid Stable Reagent Set	Medical Analysis Systems, Inc.	CEK	Class II	1985-05-20
K851865	Amresco Flow Pac Sma Phosphate Buffer Concentrate	Amresco, Inc.	CIT	Class II	1985-05-20
K851863	Nctc-135 Medium N3262	Sigma Cell Culture Reagents	KIT	Class I	1985-05-20
K851862	Mcdb 302 Medium, M2021	Sigma Cell Culture Reagents	KIT	Class I	1985-05-20
K851849	Creatine Liquid Stable Reagent Set	Medical Analysis Systems, Inc.	CGX	Class II	1985-05-20
K851676	Tdx Total T3	Abbott Medical	CDP	Class II	1985-05-20
K851572	Novaspec Visible Spectrophotometer	Lkb Instruments, Inc.	JJQ	Class I	1985-05-20
K851538	Triglyceride(trinder) Procedure	Data Medical Associates, Inc.	CDT	Class I	1985-05-20
K851514	Ultra-Violet Glucose Reagent	Bio-Analytics Laboratories, Inc.	CFA	Class I	1985-05-20
K851513	Ultra-Violet Bun Reagent Kit	Bio-Analytics Laboratories, Inc.	CDQ	Class II	1985-05-20
K851387	Microstatic Urine Transport Tube for C & S	Analytical Luminescence Laboratory, Inc.	LIO	Class I	1985-05-20
K851151	Fisher Diagnostics Kda Calibrator II	Fisher Scientific Company L.L.C.	JIX	Class II	1985-05-20
K851150	Fisher Diagnostics Kda Calibrator I	Fisher Scientific Company L.L.C.	JIX	Class II	1985-05-20
K850943	Model 775 Bipolar Coagulator	Birtcher Corp.	GEI	Class II	1985-05-20
K850768	Toxoscan Card Test Kit	BD Becton Dickinson Vacutainer Systems Preanalytic	LLA	Class II	1985-05-20
K850749	Concept Video Imaging System	Concept, Inc.	KQM	Class I	1985-05-20
K850668	Electrosurgical Unit 774	Birtcher Corp.	GEI	Class II	1985-05-20
K850354	Sysmex E-5000, Fully Automated Hematology Sys	Toa Medical Electronics USA, Inc.	GKZ	Class II	1985-05-20
K850026	Orthopedic Implant Nails & Pins	Kirkstil Corp., Inc.	HTY	Class II	1985-05-20
K850025	Orthopedic Implant Plates	Kirkstil Corp., Inc.	HRS	Class II	1985-05-20
K850024	Orthopedic Implant Screws	Kirkstil Corp., Inc.	HWC	Class II	1985-05-20
K845021	Medical Dynamics Mcconnell Precision Elec-Insuffla	MEDLINE INDUSTRIES, LP - Northfield	HIF	Class II	1985-05-20
K844481	Neurolab II	Teca, Inc.	GWS	Class I	1985-05-20
K844435	Virogen Rubella Slide Test	Armkel, LLC	LQN	Class II	1985-05-20
K843622	Abbott Hsv Eia	Abbott Medical	LGC	Class II	1985-05-20
K843375	Elvi 655 Flame Photometer	Logos Scientific, Inc.	JJO	Class I	1985-05-20
K851957	Chiba Needle	Wilson-Cook Medical Inc.	GAA	Class I	1985-05-17
K851953	Hawkin Needle	Wilson-Cook Medical Inc.	GAA	Class I	1985-05-17
K851921	Y Connector	Sil-Med Corp.	GCD	Class I	1985-05-17
K851882	Bane Curved Rongeur, 7 Ss Type 420	The Huxley Instrument Corp.			1985-05-17
K851844	Molift	Madshus A/S	FSA	Class I	1985-05-17
K851835	Manan Greene Needle	Manan Manufacturing Co., Inc.	KNW	Class II	1985-05-17
K851830	Skytron Elite 7000 Micro-Surgery Table	Skytron, LLC	GDC	Class I	1985-05-17
K851829	Skytron Elite 3100 Surgical Table	Skytron, LLC	GDC	Class I	1985-05-17
K851823	Disposable Isolation Gown	American Threshold Industries, Inc.	FYC	Class II	1985-05-17
K851527	Utilization of Nd:yag Laser for Treatment Rectal P	Endo Lase, Inc.	GEX	Class II	1985-05-17
K850967	Sterile Cormed Mediport	Cormed, Inc., Sub. C.R.Bard, Inc.	LJT	Class II	1985-05-17
K850698	Medium Frequ. Elec. Muscle Stimulator	Chattanooga Group, Inc.	IPF	Class II	1985-05-17
K850696	Wsp Code 4300 Diomaster Diagnostic	Warne Surgical Products, Ltd.	FAP	Class II	1985-05-17
K850694	Wsp Code 4310 Stresscath	Warne Surgical Products, Ltd.	FAP	Class II	1985-05-17
K850643	Hr/bvp 100T Heart Rate Monitor	Thought Technology Ltd.	HCC	Class II	1985-05-17