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 2026-10-19, 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 3029 of 3529

510(k) clearances, page 3029 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K844667	Dixon Scissors, Starinless Steel, Operating Type	William Dixon Co.			1984-12-12
K844654	Sharp Collection System-Sharp-a-Gator	Devon Industries, Inc.	MMK	Class II	1984-12-12
K844652	C.a.s.e. Container	General Medical Co.	FSM	Class I	1984-12-12
K844581	80 Mg/dl Glucose Control	Boehringer Mannheim Corp.	JIS	Class II	1984-12-12
K844462	Dosimetric Release in the Processing of Gamma Ster	Washington-Greene County Branch Pennsylvania Assoc			1984-12-12
K844004	Eschmann Tdb50 Bipolar Coagulation	Storz Instrument Co.	GEI	Class II	1984-12-12
K843806	Vis-1000 Video System	Vistek Corp.	KQM	Class I	1984-12-12
K843686	Ams Ana Card	Vitek Systems, Inc.	JSP	Class I	1984-12-12
K843535	Ortho Brain Thromboplastin Diluent	Ortho Diagnostic Systems, Inc.	GJS	Class II	1984-12-12
K843532	Uropaper Eiken 8	Syn-Kit, Inc.	KHE	Class II	1984-12-12
K843485	Tri-Count Laser	Hematology Marketing Assoc.	JPK	Class II	1984-12-12
K843459	Hemotec Act I System	Hemotec, Inc.	JBP	Class II	1984-12-12
K843295	Med. Dynamics High Resolution Solid St	MEDLINE INDUSTRIES, LP - Northfield	KQM	Class I	1984-12-12
K843294	Med. Dynamics Satican Video Camera 5410	MEDLINE INDUSTRIES, LP - Northfield	KQM	Class I	1984-12-12
K842886	Teca Ms-20 Mystro Electrophysiological	Teca, Inc.	GWN	Class II	1984-12-12
K844658	Spectable Frame - Prodesign Sun Club	Pro Design Intl. AS	HQZ	Class I	1984-12-11
K844657	Spectable Frame Magnifying Brillette	Pro Design Intl. AS	HOJ	Class I	1984-12-11
K844646	Siegen Surface Electrodes	Siegen Corp.	GXY	Class II	1984-12-11
K844586	Il Genesis 21, Clinical Chemistry Analytical Sys	Instrumentation Laboratory Co.	JJF	Class I	1984-12-11
K844585	Referril Calibrators	Instrumentation Laboratory Co.	JIX	Class II	1984-12-11
K844553	Micra Diamond Knife Micra Adjustable Knife	Cerenovus, Inc.	HNN	Class I	1984-12-11
K844510	Oms Scissors	Optical Micro Systems, Inc.	HQE	Class II	1984-12-11
K844468	Triglyceride Calibrator	Sigma Diagnostics, Inc.	JIT	Class II	1984-12-11
K844408	Amerlex-M Specific Estriol Unconjugated	Amersham Corp.	CGI	Class I	1984-12-11
K844374	O.m.s. Guillotine Cutter	Optical Micro Systems, Inc.	HQE	Class II	1984-12-11
K844362	Ophthalmic Chair	Luneau Laboratories	HMF	Class I	1984-12-11
K844325	Coe-Lite Polymerization Unit	Coe Laboratories, Inc.	EBZ	Class II	1984-12-11
K844233	Autotraction Table	Chattanooga Group, Inc.	JFB	Class II	1984-12-11
K844204	Emit Qst Ethosuximide Assay	Syva Co.	DLF	Class II	1984-12-11
K844170	Theophylline Radioimmunoassay Aria Ht System	BD Becton Dickinson Vacutainer Systems Preanalytic	KLS	Class II	1984-12-11
K844150	Medical Optics Phacoemulsification Kit	American Medical Optics	HQC	Class II	1984-12-11
K844097	Canmed 103 9300 Electrode	Medtronic, Inc.	GXY	Class II	1984-12-11
K843812	Woodlyn Classic Cataract Acuity Test	Woodlyn, Inc.	HLI	Class II	1984-12-11
K843581	Prom Naid	Lossing Orthopedic, Inc.	ITH	Class II	1984-12-11
K843574	Hearing Aid - All in the Ear	Auralogics Lab	ESD	Class I	1984-12-11
K843530	Corning 614 Na/k Analyzer	Corning Medical & Scientific	JGS	Class II	1984-12-11
K843406	Chew-Dent	Senair-Mot	JEW	Class I	1984-12-11
K843284	Ovustick Self-Test	Monoclonal Antibodies, Inc.	CEP	Class I	1984-12-11
K843101	Karl Storz 27086Kc Ultrasonic Lithotri	Karl Storz Endoscopy-America, Inc.	FEO	Class II	1984-12-11
K842945	Coopervision System VI	CooperVision, Inc.	HQC	Class II	1984-12-11
K842847	Wako Automated Reagents for Hitachi 705	FUJIFILM Healthcare Americas Corporation	CJW	Class II	1984-12-11
K842582	Care 5000 Central Monitor Ms5220 Etc.	Care Monitoring Systems	DRT	Class II	1984-12-11
K842189	Multiple Lens, Spectacles Custom	Hanmy Optical Industrial Co.	HQG	Class I	1984-12-11
K842188	Multiple-Lens, Spectacles, Custom	Gold Cadillac Co.	HQE	Class II	1984-12-11
K842187	Multiple Lens, Spectacles, Custom	Pavuna, Ltd.	HQG	Class I	1984-12-11
K842024	Ultrasonic Lithotriptor 300A	Fibra Sonics, Inc.	FEO	Class II	1984-12-11
K841654	Del Mar Avionics 509 Neurocorder Ambul	Del Mar Avionics	DSH	Class II	1984-12-11
K844498	Sandare Alkaline Phosphatase Procedure	Sandare Chemical Co., Inc.	CIO	Class II	1984-12-10
K844398	Coat-a-Count Androstenedione Ria Kit	Siemens Healthcare Diagnostics Inc.	CIZ	Class I	1984-12-10
K844295	Abl300 Acid Base Laboratory	Radiometer America, Inc	CHL	Class II	1984-12-10