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 1984 of 3531

510(k) clearances, page 1984 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K960953	Sunglasses	Galilee Optics	HQY	Class I	1996-05-31
K960818	Sunglasses	Visard SRL	HQY	Class I	1996-05-31
K960668	Mistral Sunglasses	Mistral Optical	HQY	Class I	1996-05-31
K955453	Acticoat Silver Coated Dressing	Westaim Technologies, Inc.	KMF	Class I	1996-05-31
K954962	Spacelabs Medical Multigas Analyzer	Spacelabs, Inc.	CBR	Class II	1996-05-31
K945301	Laryngoscope Cover	Sotiria Mourkidou, M.D.	CCW	Class I	1996-05-31
K961708	Life and Life Fast Set	Sybron Dental Specialties, Inc.	EJK	Class II	1996-05-30
K961328	Bec Shrouded Plastic Cannula	Biological & Environmental Control Laboratories	FMI	Class II	1996-05-30
K961276	Gastrin Eia Model 06B-555017	Biosyn, Ltd.	CGC	Class I	1996-05-30
K961236	Ubi Magiwel Triiodothyronine(t3) Quantitative	United Biotech	CDP	Class II	1996-05-30
K961042	Microscan Rapid Gram-Negative Indentification Type 3 Panel	Dade Microscan, Inc.	LRH	Class I	1996-05-30
K960983	Medtronic Everst 30 Inflation Device/survival Kit	Medtronics Interventional Vascular	MAV	Class II	1996-05-30
K960909	H292 Cell Culture	Neogenex	KIR	Class I	1996-05-30
K960449	Pc ECG 1200 ECG and Stress Electrocardiography Testing System(version 2.90)	Biosensor Corp.	DPS	Class II	1996-05-30
K960234	Tas Hmt Controls	Cardiovascular Diagnostics, Inc.	GGN	Class II	1996-05-30
K955905	Stc Diagnostics Auto-Lyte Urinary Protein Assay	Solarcare Technologies Corp,Inc.	CEK	Class II	1996-05-30
K955711	Breathe Right Nasal Strip	Cns, Inc.	LWF	Class I	1996-05-30
K955460	Meadox Medicals, Inc., Expanded & Externally Supported Expanded PTFE Vascular Graft	Meadox Medicals, Div. Boston Scientific Corp.	DSY	Class II	1996-05-30
K955303	Diastat Anti-Cardiolipin Kit	Shield Diagnostics, Ltd.	MID	Class II	1996-05-30
K955278	Behring Coagulation Timer	Behring Diagnostics, Inc.	GGN	Class II	1996-05-30
K954951	Taylor General Purpose Monitoring Electrode	Taylor Industries, Inc.	GZJ	Class II	1996-05-30
K954706	Kendall Blunt Tuohy Epidural Needle	Kendall Healthcare Products Co. Div.Of Tyco Health	CAZ	Class II	1996-05-30
K952791	Directigen Meningitis Combo Test	BD Becton Dickinson Vacutainer Systems Preanalytic	GTJ	Class II	1996-05-30
K941505	Ventanna Anti-Cd3 Primary Antibody	Ventana Medical Systems Inc	DEH	Class II	1996-05-30
K936054	Imx Select Chlamydia	Abbott Medical	LJC	Class I	1996-05-30
K961743	Eclipse 600 Manually Operated Wheelchair	Pdg Product Design Group Inc	IOR	Class I	1996-05-29
K961729	Argosy Programmable	Argosy Electronics	ESD	Class I	1996-05-29
K961663	Electric Seat Lift Chair	Ken Kemmerer	INO	Class II	1996-05-29
K961653	Phonak Sona P2	Phonak, Inc.	ESD	Class I	1996-05-29
K961447	Scout Sport - a Modification to (Formerly Emav) Otoacoustic Emissions (Oae) Test Instrument	Bio-Logic Systems Corp.	EWO	Class II	1996-05-29
K960973	Movable Add-on Couch for Outlook	Philips North America LLC	LNH	Class II	1996-05-29
K960956	Sterngold M-Pf Yellow Crown & Bridge Alloy Model 1127200	Sterngold/Implamed	EJT	Class II	1996-05-29
K960911	Netra Workstation System & Netra Md Software	Scimage, Inc.	LMD	Class I	1996-05-29
K960901	Medrad Phased Array 1.5T Shoulder Imaging Surface Coil	Medrad, Inc.	LNH	Class II	1996-05-29
K960859	Medpor Ocular Peg System and Accessories	Porex Technologies Corp. of Georgia	HPZ	Class II	1996-05-29
K960832	Occlusion Balloon Catheter	Interventional Therapeutics Corp.	MJN	Class II	1996-05-29
K960831	Ventrak Rmms 1550	Novametrix Medical Systems, Inc.	BZC	Class II	1996-05-29
K960714	Isg Viewing Wand	I.S.G. Technologies, Inc.	HAW	Class II	1996-05-29
K960466	Ivex-2 Extension Set with Y-Injection Site (Modification)	Abbott Medical	LHI	Class II	1996-05-29
K954852	Solar 9000 Anesthesia Information Monitor	Marquette Electronics, Inc.	DSI	Class II	1996-05-29
K954283	Energized Container System (Modification)	Abbott Medical	FPA	Class II	1996-05-29
K952559	Erythropoietin Immunoassay Kit	Nichols Institute	GGT	Class II	1996-05-29
K961863	Paracentesis Trays	Tri-Med, Inc.	LRO	Class II	1996-05-28
K961618	Monotube Tube to Ring Clamp	Howmedica Corp.	JEC	Class II	1996-05-28
K961616	Telescoping Penevac (Modification)	I.C. Medical, Inc.	GEI	Class II	1996-05-28
K961581	Emerald Sterile Gauze Sponge	Emerald Medical, Inc.	EFQ	Unclassified	1996-05-28
K961446	Aq Hydrophilic Stent	Cook Incorporated	FAD	Class II	1996-05-28
K961430	Innerdyne Step Trocar Expandable Port, Ministep	Innerdyne, Inc.	GCJ	Class II	1996-05-28
K961291	Finesse Low-Fusing Porcelain System Auxiliary Products	Dentsply Intl.	EIH	Class II	1996-05-28
K961248	Bard Plat. Class 3 French Ureteroscopic Flat Wire Stone, Torque Helical Stone Baskets/grasping Forceps	C.R. Bard Inc	FFL	Class II	1996-05-28