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 1773 of 3531

510(k) clearances, page 1773 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K984014	Synchron Systems Enzyme Validator Set Levels 1 and 2	Siemens Healthcare Diagnostics Inc.	JIX	Class II	1998-12-23
K983716	Vitalcare Disposable Vaginal Speculum	Vitalcare Group, Inc.	HIB	Class II	1998-12-23
K983714	Solartec Source 270, Model # 90123	Cogent Light Technologies, Inc.	FFS	Class II	1998-12-23
K983528	Micro Dynamic Mesh	Howmedica Corp.	JEY	Class II	1998-12-23
K983516	Transmission Kit, Trans-CT, Model Nstr-050A	Toshiba America Medical Systems, In.C	KPS	Class II	1998-12-23
K983514	Positron Option, Model Nsco-050A	Toshiba America Medical Systems, In.C	KPS	Class II	1998-12-23
K983486	System U3 for Norfloxacin	Ab Biodisk	JWY	Class II	1998-12-23
K983374	Agatha-a-H2010	Midian Intl.	EFS	Class I	1998-12-23
K983366	Trip Tonometry Catheter, 16F	Datex-Engstrom, Inc.	KNT	Class II	1998-12-23
K982897	Powder Free Latex Examination Glove with Protein Content Labeling Claim (50 Micrograms or Less)	P.T. Maja Agung Latexindo	LYY	Class I	1998-12-23
K982832	Proguard, Rr-1, Rr-2	Emerson & Co. S.r.l.	LZC	Class I	1998-12-23
K984479	Liquichek Anti-Sm Control, Eia, Model 208	Bio-Rad	LKP	Class II	1998-12-22
K984478	Liquichek Anti-Ss-B Control, Eia, Model 210	Bio-Rad	LKJ	Class II	1998-12-22
K984476	Liquichek Anti-Rnp Control, Eia, Model 207	Bio-Rad	LKO	Class II	1998-12-22
K984475	Liquichek Anti-Scl-70 Control, Eia, Model 212	Bio-Rad	LKJ	Class II	1998-12-22
K984473	Liquichek Ana Control, Eia Screen, Model 205	Bio-Rad	LKJ	Class II	1998-12-22
K984470	Liquichek Anti-Ss-a Control, Eia, Model 209	Bio-Rad	LKJ	Class II	1998-12-22
K984464	Liquichek Anti-Jo 1 Control, Eia, Model No. 211	Bio-Rad	LKJ	Class II	1998-12-22
K984462	Liquichek Ena Control, Eia Screen, Model No. 206	Bio-Rad	LLL	Class II	1998-12-22
K984327	Architect Total T3 Mastercheck, Model Number 6C51-05	Bio-Rad	JJX	Class I	1998-12-22
K984319	Architect Free T3 Mastercheck, Model Number 6C48-05	Bio-Rad	JJX	Class I	1998-12-22
K984173	The Aptus (Automated) Application of the Anti-Cardiolipin Iga Elisa Test System	Zeus Scientific LLC	MID	Class II	1998-12-22
K984112	Advent	Bisco Inc	EBF	Class II	1998-12-22
K983965	CO2 Laser Coupler	L.A.S.E.R., Inc.	GEX	Class II	1998-12-22
K983914	Reaads Monoclonal Free Protein S Antigen Test Kit	Corgenix, Inc.	GGP	Class II	1998-12-22
K983904	Rogozinski Spinal Rod System	United States Surgical, A Division of Tyco Healthc	KWP	Class II	1998-12-22
K983899	Thoracolumbar Spinal Rod System (Empower)	United States Surgical, A Division of Tyco Healthc	KWQ	Class II	1998-12-22
K983853	Depuy Ace Timax Meta Plate	Depuy Ace Medical Co.	HRS	Class II	1998-12-22
K983773	Benz G-5X (Hioxifilcon a) Soft Daily Wear Contact Lens	Benz Research and Development LLC	LPL	Class II	1998-12-22
K983653	Radii Diagnostic Electrophysiology Catheter, Model # 30411 B, C and D	Cardiac Pathways Corp.	DRF	Class II	1998-12-22
K983477	Super Seal	Phoenix Dental, Inc.	EJK	Class II	1998-12-22
K983470	Super Porcelain Stain- Pure White	Noritake Co., Inc.	EIH	Class II	1998-12-22
K983404	Type 3 Femoral Components	Howmedica Corp.	LZO	Class II	1998-12-22
K982434	Reaads Iga Anti-B2gp 1 Test Kit	Corgenix, Inc.	MSV	Class II	1998-12-22
K982344	Durasoft 3 UV (Phemfilcon a) Optifit Toric (Hydrophilic Contac Lenses, Durasoft 3 UV (Phemfilcon a) Spherical (Hydrophis	Wesley Jessen Corp.	LPL	Class II	1998-12-22
K982091	Cs/3 Compact Airway Module, M-Covx	Datex-Engstrom, Inc.	MHX	Class II	1998-12-22
K981824	Opticoat T3 Eia Kit	Biotecx Laboratories, Inc.	CDP	Class II	1998-12-22
K981554	Micratome Ms7000 -Advanced Corneal/refractive Instrumentation (Acri)	Micra Instruments	HNO	Class I	1998-12-22
K981363	One Step Urine Drug of Abuse: Phencyclidine (Pcp) Test	Tcpi, Inc.	LCM	Unclassified	1998-12-22
K980675	Summit Krumeich-Barraquer Microkeratome	Summit Technology, Inc.	HNO	Class I	1998-12-22
K972975	Light Diagnostics Rabies Dfa Reagent	Light Diagnostics	GOI	Class II	1998-12-22
K972788	Crosslaps Elisa	Devices and Diagnostics Consulting Group	JMM	Class I	1998-12-22
K971981	Ls Series 200 Flovision System	Systam	CAF	Class II	1998-12-22
K970829	Phusis Absorbable Interference Screw	TORNIER Inc.	HWC	Class II	1998-12-22
K983974	Owen Mumford 3Ml Autopen	Owen Mumford USA, Inc.	FMF	Class II	1998-12-21
K983909	Mir Spirobank Spirometer	Mir Medical Intl. Research SRL	BZG	Class II	1998-12-21
K983877	Philips Integris 3D Ra Option	Philips North America LLC	IZI	Class II	1998-12-21
K983731	Pall Dental Filtration System with Inline Handpiece Housing and Filter Membrane	Pall Medical	EIA	Class I	1998-12-21
K983640	Synchron Systems Lipid Calibrator	Siemens Healthcare Diagnostics Inc.	JIS	Class II	1998-12-21
K983594	Embryo Transfer Catheters/sets	Cook Ob/Gyn	MQF	Class II	1998-12-21