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 1815 of 3531

510(k) clearances, page 1815 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K974641	Futurelase 3000/3002 Erbium Laser System	Buckman Co., Inc.	GEX	Class II	1998-06-08
K974292	Nihon Kohden Tl-101T, Tl-120T and Tl-121T Spo2 Probes and Accessories	Nihon Kohden America Inc	DQA	Class II	1998-06-08
K981770	Rapidhcg Pregnancy Test	Rapid Diagnostics, Inc.	JHI	Class II	1998-06-05
K981667	Hydrophilic Coated Guidewire	Lake Region Mfg., Inc.	KNY	Class II	1998-06-05
K981447	Dio-Light 60 Laser System	Nidek, Inc.	GEX	Class II	1998-06-05
K981430	Union Medical Um-D30 Coagulator	She Medical, Inc.	GEI	Class II	1998-06-05
K981312	3Rd Generation Tsh Assay for the Bayer Immuno 1 System	Bayer Corp.	JLW	Class II	1998-06-05
K981237	Quanta Lite Ribosome P Elisa	Inova Diagnostics, Inc.	MQA	Class II	1998-06-05
K981234	Flare,file, Fill	Lone Star Technologies	EJB	Class I	1998-06-05
K981203	Rusch Blakemore 3 Lumen, Sterile	Rusch Intl.	KNT	Class II	1998-06-05
K981138	Etest Ciprofloxacin	Ab Biodisk	JWY	Class II	1998-06-05
K981133	Powdered Nitrile Examination Gloves	Servicom Services Sdn Bhd	LZA	Class I	1998-06-05
K981088	Mills Columella Prosthesis	Exmoor Plastics Limited	ETA	Class II	1998-06-05
K980996	Cobas Integra Carbon Dioxide (CO2-S), Cobas Integra Glucose Hk Liquid (Glulf)	Roche Diagnostic Systems, Inc.	KHS	Class II	1998-06-05
K980929	Derma Prene Powder-Free Synthetic Surgical Gloves	Ansell Perry	KGO	Class I	1998-06-05
K980927	Lactosorb Panels and Fasteners	Zimmer GmbH	JEY	Class II	1998-06-05
K980882	Siemens Sc 7000 & Sc 9000 Xl Infinity Modular Bedside Monitor	Siemens Medical Solutions USA, Inc.	DSI	Class II	1998-06-05
K980162	Mach-Sigma Handpiece, Ultrapush	Nsk Nakanishi, Inc.	EFB	Class I	1998-06-05
K973201	Provi Cement	S & C Polymer GmbH	EMA	Class II	1998-06-05
K972859	Flutter D	Bradstreet Clinical Research Assoc., Inc.	BYI	Class II	1998-06-05
K962959	Peracidin Dialyzer Reprocessing Concentrate	Hdc Medical, Inc.	MED	Class II	1998-06-05
K981669	Speedband Superview Multiple Band Ligator	Boston Scientific Corporation	FHN	Class II	1998-06-04
K981124	Accudexa Bone Densitometer	Schick Technologies, Inc.	KGI	Class II	1998-06-04
K980959	Vtransact: Attenuation Correction System for Dual-Head Variable Angle Gamma Camera	GE Medical Systems F.I. Haifa	KPS	Class II	1998-06-04
K980914	Emory Cardiac Tool Box	Emory University	KPS	Class II	1998-06-04
K980867	3D-Mspect	Philips North America LLC	KPS	Class II	1998-06-04
K972881	Ces Vascular Occlusion System	Cordis Neurovascular, Inc.	HCG	Class II	1998-06-04
K970689	Iab-04840-U;iab-04250-U;iab-04240-U;iab-04230-U	Arrow Intl., Inc.	DSP	Class II	1998-06-04
K981722	Quidel Home Pregnancy Test	Ortho-Clinical Diagnostics, Inc.	LCX	Class II	1998-06-03
K981687	Quickscreen Benzodiazepines Screening Test Model Numbers 9025,9026 and Quickscreen Pro Multi Drug Screening Test Model 1	Phamatech Inc.	JXM	Class II	1998-06-03
K981609	Bilirubin-Sl (Direct) Assay Catalogue Number 247-10,247-30	Sekisui Diagnostics P.E.I. Inc.	CIG	Class II	1998-06-03
K980918	Jpacs	Philips North America LLC	LMD	Class I	1998-06-03
K980850	Bard 9Fr., 40Cc. Rediguard and Taperseal Intra-Aortic Balloons	C.R. Bard Inc	DSP	Class II	1998-06-03
K974914	Shelhigh No-React Pericardial Patches	Shelhigh, Inc.	DXZ	Class II	1998-06-03
K974363	Becton Dickinson Blunt Plastic Cannula	BD Becton Dickinson Vacutainer Systems Preanalytic	FMI	Class II	1998-06-03
K974344	CT Scope	Elscint, Inc.	JAK	Class II	1998-06-03
K973888	Smartlock Safety Syringe	Medical Innovation, Ltd.	MEG	Class II	1998-06-03
K981021	Zeus Anti-Cardiolipin Igm Test System	Zeus Scientific LLC	MID	Class II	1998-06-02
K981014	Zeus Scientific, Inc. Anti-Cardiolipin Igg Elisa Test System	Zeus Scientific LLC	MID	Class II	1998-06-02
K980843	Exeter Intramedullary Bone Plug	Howmedica Corp.	JDI	Class II	1998-06-02
K980838	Reusable Megabeam Fiber Optic Delivery System	Ceram Optec, Inc.	GEX	Class II	1998-06-02
K980829	3Ml Steri-Neb Saline - 0.9% W/v Sodium Chloride Inhalation Solution Usp	Steripak, Ltd.	CAF	Class II	1998-06-02
K974792	Cs/3(tm) Monitors*	Datex-Engstrom, Inc.	DSI	Class II	1998-06-02
K981555	Diascreen Reagent Strips	Chronimed, Inc.	LJX	Class I	1998-06-01
K981398	Anatomark Noninvasive Head Reference System	Interneuron Pharmaceuticals, Inc.	LNH	Class II	1998-06-01
K981370	Miracle Mix Capsule	GC America Inc.	EMA	Class II	1998-06-01
K981230	Ultimax Distal Femoral Intramedullary Rod System	Biodynamic Technologies, Inc.	HSB	Class II	1998-06-01
K981159	Proflex Powder Free Nitrile Examination Gloves	Latexx Partners Bhd.	LZA	Class I	1998-06-01
K981139	Etest Ceftriaxone	Ab Biodisk	JWY	Class II	1998-06-01
K981062	Polymer Coated, Powder-Free Latex Examination Gloves	Ideal Quality Sdn Bhd	LYY	Class I	1998-06-01