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 1706 of 3531

510(k) clearances, page 1706 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K990643	Ps 15 Polysulfone Hollow Fiber Membrane Hemodialyzer, Model 239-015	Althin Medical AB an Affiliate of Baxter Intl	KDI	Class II	1999-12-07
K990329	Philips Easyvision Workstation	Philips North America LLC	LNH	Class II	1999-12-07
K984168	Barrett's Esophageal Cytology Device	United States Endoscopy Group, Inc.	FCF	Class II	1999-12-07
K993907	Viridia Information Center Software for M3154a Opt C22	Agilent Technologies, Inc.	MHD	Class II	1999-12-06
K993854	Ora-50 S Autotemp Electrothermal Spine System and Accessories	Oratec Interventions, Inc.	GEI	Class II	1999-12-06
K993808	Synergy Integral Screws, Model Numbers 2161,2162,2163,2164,2165,2166,2167,2168,2169,2210,2211,2212,2215,2216,2217,2220	Interpore Cross Intl.	MNH	Class II	1999-12-06
K993688	AED Laparoscope	National Advanced Endoscopy Devices, Inc.	GCJ	Class II	1999-12-06
K993566	Promptflow	Espe Dental AG	EBF	Class II	1999-12-06
K993508	V-Supra Plus, Alloy No. 5025	Metalor Dental USA Corp.	EJT	Class II	1999-12-06
K993507	V-Supragold, Alloy No. 5024	Metalor Dental USA Corp.	EJT	Class II	1999-12-06
K993482	K-Assay Fibrinogen	Kamiya Biomedical Company, LLC	GIS	Class II	1999-12-06
K993445	Omnisonic Endoscopic Deflector	Omnisonics Medical Technologies	GCM	Class II	1999-12-06
K993435	Manual Bone Marrow Biopsy Device	Promex, Inc.	KNW	Class II	1999-12-06
K993353	Troponin I Assay for the Bayer Immuno 1 System ( in Vitro Diagnostic System)	Bayer Corp.	MMI	Class II	1999-12-06
K993314	Synthes Light Guide	Synthes (USA) Products LLC	FQP	Class II	1999-12-06
K993309	Bayer Diagnostics Acs:180 and Advia Centaur Troponin I Assay	Bayer Corp.	MMI	Class II	1999-12-06
K993304	Autostat II Rheumatoid Factor Igg Elisa	Cogent Diagnotics, Ltd.	DHR	Class II	1999-12-06
K993255	Biosonic Uc-70 Sterilizable Instrument Cassette	Coltene /Whaledent AG	FRG	Class II	1999-12-06
K993073	Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025, 239030	Bionx Implants, Inc.	MAI	Class II	1999-12-06
K993008	Quantitative Sentinel System	Marquette Medical Systems, Inc.	HGM	Class II	1999-12-06
K992759	Colon Alert Test	Immunostics, Inc.	KHE	Class II	1999-12-06
K992712	Sigma Diagnostics Alexin Ls, Models A1219, A1334	Sigma Diagnostics, Inc.	GFO	Class II	1999-12-06
K992711	Sigma Diagnostics Alexin Hs, Models A0969, A1094	Sigma Diagnostics, Inc.	GFO	Class II	1999-12-06
K992188	Nichols Advantage Chemiluminescence Soluble Transferrin Receptor Immunoassay, Model 62-7028	Nichols Institute Diagnostics	JNM	Class II	1999-12-06
K991339	Tyrode's Solution-Acidified	FUJIFILM Biosciences Inc.	MQL	Class II	1999-12-06
K990115	Disposable ECG Monitoring Electrodes, Models, 4420, 4440	Maersk Medical A/S	DRX	Class II	1999-12-06
K990113	Disposable ECG Monitoring Electrodes, Models 4500,4530, 4533, 4539, 4540, and 4560	Maersk Medical A/S	DRX	Class II	1999-12-06
K990112	Disposable ECG Monitoring Electrodes, Models 4060, 4610	Maersk Medical A/S	DRX	Class II	1999-12-06
K990111	Disposable ECG Monitoring Electrodes, Models 4520, 4535, 4570	Maersk Medical A/S	DRX	Class II	1999-12-06
K990110	Disposable ECG Monitoring Electrodes, Model 4110, 4140	Maersk Medical A/S	DRX	Class II	1999-12-06
K984088	Optistar Mr Injector System	Mallinckrodt Inc., Liebel-Flarsheim Business	DXT	Class II	1999-12-06
K993860	Catheter Innovations Implantable Port	Catheter Innovations, Inc.	LJT	Class II	1999-12-03
K993819	Qwh-300 Wrist Array Coil	Mri Devices Corp.	MOS	Class II	1999-12-03
K993776	Obc-300 Breast Array Coil	Mri Devices Corp.	MOS	Class II	1999-12-03
K993752	Glovco, Powder-Free Chlorinated Latex Examination Gloves with Protein Labeling Claim (50 Micrograms or Less)	Glovco (M) Sdn. Bhd.	LYY	Class I	1999-12-03
K993749	Gyrus Hysteroscopic Resectoscope	Gyrus ACMI, Inc.	HIH	Class II	1999-12-03
K993729	Modification to Carto Ep Navigation System	Biosense Webster Inc	DQK	Class II	1999-12-03
K993708	Biomagnetic Technologies Magnes 3600 Whole Head Meg	Biomagnetic Technologies, Inc.	OLX	Class II	1999-12-03
K993454	Powderfree Latex Examination Gloves (Polymer Coated) (Protein Label Claim - 50 Micrograms or Less)	Sri Johani Sdn. Bhd.	LYY	Class I	1999-12-03
K993001	Cobe Smarxt Hvr 4000 Surface Modified Hardshell Venous Reservoir, Filtered & Nonfiltered	LivaNova USA, Inc.	DTN	Class II	1999-12-03
K992992	Automatic Image Registration Software, Model Nsfu-050A	Toshiba America Medical Systems, In.C	KPS	Class II	1999-12-03
K991575	Primus Steam Sterilizers	PRIMUS Sterilizer Company LLC	FLE	Class II	1999-12-03
K990807	Hl148 & Hl168	Health & Life Corporation	DXN	Class II	1999-12-03
K981655	Spacelabs Medical Disposable Sp02 Sensor	GE Healthcare	DQA	Class II	1999-12-03
K993944	Rita Model 1500 Electrosurgical Generator, Power Cord,footswitch,main Cable, Dispersive Electrode	Boston Scientific Corporation	GEI	Class II	1999-12-02
K993820	Powder Free Latex Examination Gloves, Non-Sterile with Protein Labeling Claim 50 Microgram or Less	Felda Rubber Corp.	LYY	Class I	1999-12-02
K993703	Clearview Easy Hcg Pregnancy Test	Unipath, Ltd.	JHI	Class II	1999-12-02
K993692	Duracon Inset Patella, 25Mm	Howmedica Osteonics Corp	JWH	Class II	1999-12-02
K993634	Careside Analyzer	Careside, Inc.	JJF	Class I	1999-12-02
K993500	Powderfree Latex Examination Gloves (Polymer Coated) (Protein Label of 50 Mcrogram or Less)	Besglove Medicare Sdn. Bhd.	LYY	Class I	1999-12-02