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 2220 of 3531

510(k) clearances, page 2220 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K935793	Cedia Dau Negative Calibrator	Microgenics Corporation	DKB	Class II	1994-03-14
K935442	Mahe Instruments	Mahe-Medizintechnik	GCJ	Class II	1994-03-14
K935223	Ophthalmic Surgical System	Optical Micro Systems, Inc.	HQC	Class II	1994-03-14
K935132	Home Microcurrent Hmc	Medical Devices Inc.	GZJ	Class II	1994-03-14
K934671	Hi-Flo Infusion Pump	Abbott Medical	FRN	Class II	1994-03-14
K933739	360 Degree Fixation Light	Varitronics	HPL	Class I	1994-03-14
K933518	Synthes Unreamed Humeral Nail (Urhn)	Synthes (USA) Products LLC	HSB	Class II	1994-03-14
K933012	Mxt-2 12 Lead Micro-Transmitter	Medical Electronic Record Exchange	DXH	Class II	1994-03-14
K930400	Terra Femme	Bio Business Intl, Inc.	HEB	Class II	1994-03-14
K926084	Hvgs 9000	Shevlin Medical, Inc.	IPF	Class II	1994-03-14
K925178	Pegasus	Premier Laser Systems, Inc.	GEX	Class II	1994-03-14
K922093	Haskel CPR	Haskel, Inc.	DRM	Class II	1994-03-14
K940646	Orthopedic Tray Product Line	Cushindu	LRP	Class I	1994-03-11
K940397	Acs O Dilvent Protein Dilution Matrix	Analytical Control Systems	JJY	Class I	1994-03-11
K940387	Shieldtex Sterile Patient Examination Gloves	Shieldtex Sdn Bhd	LYY	Class I	1994-03-11
K940010	Dma Amylase (Demand) Procedure	Data Medical Associates, Inc.	CIJ	Class II	1994-03-11
K936208	Valproic Acid	Seradyn, Inc.	LEG	Class II	1994-03-11
K936201	Urinary Albumin Calibrator	Dupont Medical Products	JIS	Class II	1994-03-11
K936131	Cobas-Fp Reagent for Phenytoin and Coba-Fp Phenytoin Calibrators	Roche Diagnostic Systems, Inc.	LGR	Class II	1994-03-11
K936130	Cobas-Fp Reagent for Phenobarbital and Cobas-Fp Phenobarbital Calibrators	Roche Diagnostic Systems, Inc.	LGQ	Class II	1994-03-11
K936026	Cook Laparoscopic Mini Retractor Set	Cook Incorporated	HFI	Class II	1994-03-11
K935953	Coulter Multi Q Prep	Coulter Corp.	GKH	Class I	1994-03-11
K935904	Cedia Dau Cocaine Assay Hitachi 717 and 704 Analyzers	Microgenics Corporation	DIO	Class II	1994-03-11
K935876	Access Specific Ige Assay	Bio-Rad Laboratories Inc.	DHB	Class II	1994-03-11
K935568	Paramax Phenobarbital Reagent and Calibrators	Baxter Diagnostics, Inc.	DLZ	Class II	1994-03-11
K935535	Tytin	Kerr Corporation (Danbury)	EJJ	Class II	1994-03-11
K935283	Yoke Assembly Medical Gas	American Gage & Medical, Inc.	CAM	Class I	1994-03-11
K935115	Eec Probe	Phx Technologies Corp.	GCJ	Class II	1994-03-11
K934843	Urinary/cebrospinal Fluid Protein Calibrator	E.I. Dupont de Nemours & Co., Inc.	JIT	Class II	1994-03-11
K934790	Sepp Adhesive Remover	Medi-Flex Hospital Products, Inc.	KOX	Class I	1994-03-11
K934587	Creatinine-S Assay	Sekisui Diagnostics P.E.I. Inc.	CGX	Class II	1994-03-11
K934316	Glove Seal, Powder Free Latex Examination Gloves	Contract Latex Dippers Sdn Bhd	LYY	Class I	1994-03-11
K933678	Sigma Calcium Reagent	Sigma Chemical Co.	CJY	Class II	1994-03-11
K933628	Cytology Brush	Bioteque America Inc	HHT	Class II	1994-03-11
K933394	Danniflex Cpm 600	Danninger Medical Technology, Inc.	BXB	Class I	1994-03-11
K933008	Retractors and Scraper	Baxter Healthcare Corporation	HET	Class II	1994-03-11
K932650	Erythropoietin Immunoassay Kit	Nichols Institute	GGT	Class II	1994-03-11
K931900	Computer Assisted Archival Tech. Physiology Stat.	Archival Technologies, Inc.	DQK	Class II	1994-03-11
K931557	Fuller Laboratories Mycoplasm Pneumonia Ifa-Igg Test	Fuller Laboratories, Inc.	GRZ	Class I	1994-03-11
K931529	Infant Warmer	Medix I.C.S.A.	FMT	Class II	1994-03-11
K930934	Endopath Reloadable Linear Cutter	Ethicon, Inc	HET	Class II	1994-03-11
K930243	Flexible Extender	Beacon Laboratories, Inc.	GEI	Class II	1994-03-11
K930152	Arthrex Tibial Tunnel Cannula	Arthrex GmbH	HRX	Class II	1994-03-11
K924715	Gen-Probe Direct Group a Streptococus Test	Hologic, Inc.	MDK	Class I	1994-03-11
K924057	Disposible Electro Coagulation Probe	Endoscopic Technologies, Inc.	GEI	Class II	1994-03-11
K915857	Flexible Tip Thoracoscope/laparoscope	Olympus Corp.	HET	Class II	1994-03-11
K915801	Bip-Coax-System	Uni-Quatro Industries Canada, Inc.	FCG	Class II	1994-03-11
K940410	New Gear Releasable Headgear	Ortho Kinetics Corp.	DZB	Class II	1994-03-10
K940130	Stryker Model 6110 Emergency/pole Stretcher	Stryker Corp.	FPP	Class I	1994-03-10
K936261	Catheter Insertion Tray	Medcare Custom Packaging, Inc.	FMI	Class II	1994-03-10