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 2026-11-02, 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 2513 of 3531

510(k) clearances, page 2513 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K904106	Spa Shell	Century Manufacturing Co.	ILJ	Class II	1990-09-18
K903624	Plain and Chromic Gut Suture	Look, Inc.	GAL	Class II	1990-09-18
K902921	Rayon Neurological Sponge	American Silk Sutures, Inc.	HBA	Class II	1990-09-18
K902878	Mt-336 Automatic Perimeter	Marco Technologies	HPT	Class I	1990-09-18
K902876	Phacotron Systems Plus III Phacoemulsifier Aspi.	Intraoptics Surgical, Inc.	HQC	Class II	1990-09-18
K900189	Curapuls 403 Diathermy Unit	Henley Intl.	IMG	Class II	1990-09-18
K904069	Broda Nursing Care Chair	Broda Ent., Inc.	INN	Class I	1990-09-17
K903981	Wheelchairs, Transit/folding/glideabout/access	D.M.A., Ltd.	IOR	Class I	1990-09-17
K903926	Kodak Surecell Herpes (Hsv) Control Fluid Set	Eastman Kodak Company	LGC	Class II	1990-09-17
K903924	Biotrack Theophylline Quality Controls	Biotrack, Inc.	LAW	Class I	1990-09-17
K903905	Series 9000 Lift-Recline Chair	Equi-Tron Mfg., Inc.	INO	Class II	1990-09-17
K903743	Il Gentamicin Assay System	Instrumentation Laboratory Co.	LCD	Class II	1990-09-17
K903739	Sunglasses W/non Prescript Lenses W/photo Sensitiv	Nouveau Eyewear, Inc.	HQY	Class I	1990-09-17
K903698	Statspin Micro-Hematocrit Reader for 75Mm Tubes	Statspin Technologies	JPI	Class II	1990-09-17
K903659	Stage III	Unique Flotation Systems, Inc.	IOQ	Class II	1990-09-17
K903574	Chiroflex Lens Microsert	Chiron Ophthalmics	KYB	Class I	1990-09-17
K903203	Mrp-20: Hs/mr Head Coil 3-D Ft Reconstruction	Summit World Trade Corp.	LNH	Class II	1990-09-17
K902967	Micro-Emed-System	Novel Electronics, Inc.	IKE	Class I	1990-09-17
K902685	Defiance Model Fus 336	Defiance Electronics, Inc.	EAZ	Class I	1990-09-17
K901459	Ds60 Toothbrush Sanitizer	Associated Mills, Inc.	MCF	Class I	1990-09-17
K900983	Tri-Tech Urine Specimen Kit	Tri-Tech, Inc.	FMH	Class I	1990-09-17
K903729	Gold Gators	Lead-Lok, Inc.	DRY	Class II	1990-09-14
K903713	Osteotome Model Numbers 2500-228 & 2500-229	Micro-Aire Surgical Instruments, Inc.	HSZ	Class I	1990-09-14
K903650	Oscillating Saw Blades # So-305,Mo-305 and Zo-305	Micro-Aire Surgical Instruments, Inc.	HWE	Class I	1990-09-14
K903605	Cintex	Nanopac, Inc.	ILQ	Class II	1990-09-14
K903541	Safety Injection Port	Du-Call Miller Plastics, Inc.	FPA	Class II	1990-09-14
K903513	Sanoflex-Sterile Latex Surgical Gloves	Lowenkamp Intl., Inc.	KGO	Class I	1990-09-14
K903484	Select 20, Dental Alloy	Leach and Dillon Co., Inc.	EJT	Class II	1990-09-14
K903123	Raichem(tm) Spia(tm) Microalbulmin Reagent	Reagents Applications, Inc.	JIQ	Class I	1990-09-14
K903081	Neos (Tm) 02 B Pulse Generator	BIOTRONIK AG	DXY	Class III	1990-09-14
K902924	Biosite Diagnostics Opiate Screening Test	Biosite Incorporated	DJG	Class II	1990-09-14
K902843	Biosearch Anal Biofeedback Device	Biosearch Medical Products, Inc.	FAP	Class II	1990-09-14
K902676	Microguard, Orthopedic Pin Protectors	Micro-Aire Surgical Instruments, Inc.	LYT	Class II	1990-09-14
K902374	Cadd-Tpn Model 5700 Ambulatory Infusion System	Pharmacia Deltec, Inc.	FRN	Class II	1990-09-14
K902053	K-Cap-I Orthopedic Fixation Wire Cap	Westcon Orthopedics, Inc.	LYT	Class II	1990-09-14
K901991	Silicone Elastomer Putty	Crown Delta Corp.	MDA	Class I	1990-09-14
K901990	Vinyl Silicone Elastomer Material	Crown Delta Corp.	MDA	Class I	1990-09-14
K901206	Rotablator	Heart Technology, Inc.	MCW	Class II	1990-09-14
K900435	Acsys Shearer Acetabular Cup Prosthesis	3M Company	LWJ	Class II	1990-09-14
K900320	Cri Cynosar Catheter	Catheter Research C/O Burditt, Bowles & Radzius	DRA	Class II	1990-09-14
K900262	Acsys Selftap Acetabular Cup Prosthesis	3M Company	LWJ	Class II	1990-09-14
K900261	Acsys Prefix Acetabular Cup Prosthesis	3M Company	JDI	Class II	1990-09-14
K894959	Cypress Cervical Traction Equipment, Cypress Halo	Alphatec Spine, Inc.	JEC	Class II	1990-09-14
K892222	9.5F Percu Double Lumen Intra-Aortic Balloon	Kontron Instruments, Inc.	DSP	Class II	1990-09-14
K904007	Bicarbonate Reagents Amresco Product #4326020	Amresco, Inc.	KHS	Class II	1990-09-13
K903896	Calcium Arsenazo III Reagent	Trace Scientific, Ltd.	CIC	Class II	1990-09-13
K903885	Kinamed Ath 22Mm Cocr Total Hlip Femoral Head	Kinamed Inc	KWL	Class II	1990-09-13
K903884	Kinamed Ath 26Mm Cocr Total Hip Femoral Head	Kinamed Inc	KWL	Class II	1990-09-13
K903664	Micro-Aire Wire Pass and Craniotome Drill	Micro-Aire Surgical Instruments, Inc.	HBE	Class II	1990-09-13
K903063	Synermed Glucose Reagent Kit	Synermed, Inc.	CGA	Class II	1990-09-13