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 2390 of 3531

510(k) clearances, page 2390 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K920561	Dw242-07 Non-Precious Alloy F/ Porcelain Fus. Met.	Ivoclar North America, Inc.	EJH	Class II	1992-03-02
K920560	Dw236-34 Alloy for Porcelain Fused to Metal	Invoclar North America, Inc.	EJS	Class II	1992-03-02
K920504	Medix Biotech Lh Enzyme Immunoassay Test Kit	Medix Biotech, Inc.	CEP	Class I	1992-03-02
K920270	Continuous Passive Motion Modality Accessory	Sports Medical Synergy	BXB	Class I	1992-03-02
K920247	Amerlite Mab Ft4 Assay	Eastman Kodak Company	CEC	Class II	1992-03-02
K920214	Cedia Digoxin Assay (Modification)	Microgenics Corporation	KXT	Class II	1992-03-02
K920180	Quickie P100	Sunrise Medical Quickie Designs, Inc.	ITI	Class II	1992-03-02
K920124	Turbiquant	Behring Diagnostics, Inc.	DHR	Class II	1992-03-02
K920069	Magni-Cam	Innoventions, Inc.	HJG	Class I	1992-03-02
K920017	Improved Dental Operating Light	Den-Tal-Ez Mfg Co., Inc.	KLC	Class I	1992-03-02
K920016	Improved Dental Chair	Den-Tal-Ez Mfg Co., Inc.	KLC	Class I	1992-03-02
K915847	Automix Dental Amalgamator	Kerr Corporation (Danbury)	EFD	Class I	1992-03-02
K915830	Prisma Universal Bond(r) 3	Dentsply Intl.	KLE	Class II	1992-03-02
K915774	Prolene Polypropylene Mesh Plug W/ Onlay Patch	Ethicon, Inc	FTM	Class II	1992-03-02
K915727	Acth Irma Kit II Mitsubishi Yuka	Mitsubishi Yuka America, Inc.	CKG	Class II	1992-03-02
K915654	Keralloy-D Caps	Wilde-USA, Inc.	EJJ	Class II	1992-03-02
K915630	Ophtimplant	Oculo Plastik, Inc.	HPZ	Class II	1992-03-02
K915565	Immobile	TNT Moborg Intl. Ltd.	KGX	Class I	1992-03-02
K915435	Interlocking Tibial Nailing System	Stryker Corp.	HSB	Class II	1992-03-02
K915325	Tsh Control	Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, LLC	JJX	Class I	1992-03-02
K915249	Vera Pds & Vera Pdi	Aalba Dent, Inc.	EJH	Class II	1992-03-02
K915164	Sri Testosterone Enzyme Immunoassay	Serono-Baker Diagnostics, Inc.	CDZ	Class I	1992-03-02
K914886	Sri(tm) Cortisol Enzyme Immunoassay(mag Sol Phase)	Serono-Baker Diagnostics, Inc.	CGR	Class II	1992-03-02
K914728	Kodak Ektascan Imagelink Ultrasound System	Eastman Kodak Company	LMB	Class I	1992-03-02
K914476	Vitapan Acrylic Denture Teeth	Vident	ELM	Class II	1992-03-02
K914393	Retina Tester	Retina Tester	HLX	Class II	1992-03-02
K914385	Optical Valvulotome	Intramed Laboratories, Inc.	MGZ	Class II	1992-03-02
K914035	Mini-Mill	Biomedical Composites, Ltd.	EMI	Class I	1992-03-02
K912506	Critic-Aid Wound Dressing	Sween Corp.	KMF	Class I	1992-03-02
K910069	Sr-Isosit Spectra Link System	Ivoclar North America, Inc.	KLE	Class II	1992-03-02
K903562	Cw Doppler 2.25 Mhz Probe	Diasonics, Inc.	ITX	Class II	1992-03-02
K920040	Intraducer	Taut, Inc.	GCJ	Class II	1992-02-28
K915523	Flo-Gard(r) 6301	Baxter Healthcare Corporation	FRN	Class II	1992-02-28
K915522	Flo-Gard(r) 6201	Baxter Healthcare Corporation	FRN	Class II	1992-02-28
K915448	Cortical Bone Screw	Dow Corning Wright	HWC	Class II	1992-02-28
K915430	Skin Staple Remover Kit	Cypress Medical Products LLC	GDT	Class I	1992-02-28
K915406	Davol Electrosugical Probes	Davol, Inc.	HFG	Class II	1992-02-28
K915085	Dl100 C02 Surgical Laser System	Mnlase, Inc.	GEX	Class II	1992-02-28
K914960	Instrument Organizer	O.R. Concepts, Inc.	KDC	Class I	1992-02-28
K914578	Rts Technology Models 721,722,723,724	Rts Technology, Inc.	JAQ	Class II	1992-02-28
K914112	Metal Ureteral Basket Stone Dislodger, Flat Wire	Annex Medical, Inc.	FGO	Class II	1992-02-28
K914111	Metal Ureteral Basket Stone Dislodger, Helical	Annex Medical, Inc.	FGO	Class II	1992-02-28
K914110	Grasping Forceps	Annex Medical, Inc.	FGO	Class II	1992-02-28
K912924	Rambach Agar	Rantran, Inc.	JSS	Class I	1992-02-28
K920570	Puritan-Bennet Infant Manual Resuscitator Modified	Medtronic, Inc.	BTM	Class II	1992-02-27
K920507	Emit II Monoclonal Amphetamine/ Methamph. Assay	Syva Co.	DKZ	Class II	1992-02-27
K920466	Extend-Ear	Sonovation, Inc. dba Avr Sonovation	ESD	Class I	1992-02-27
K920418	Il Test Cannabinoid, 35282	Instrumentation Laboratory Co.	LDJ	Class II	1992-02-27
K920311	Cannabinoid Eia Test	Diagnostic Reagents, Inc.	LDJ	Class II	1992-02-27
K915783	S.a.a. Eye Glass Frames	Yau Yee Optical Co., Ltd.	HQZ	Class I	1992-02-27