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 2180 of 3531

510(k) clearances, page 2180 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K942749	Hi-Pro/noah Universal Hearing Instrument	Madsen Electronics (Canada), Ltd.	ESD	Class I	1994-07-18
K942573	Costello-Everett Laser Cystoscope Sheath	Richard Hamer Assoc., Inc.	FED	Class II	1994-07-18
K942282	Med-Tec Breast Support System	Medtec LLC	IYE	Class II	1994-07-18
K942120	Advantage Windows Diagnostic X-Ray Workstation	GE Healthcare	IZI	Class II	1994-07-18
K942066	Acs Hi-Torque Extra S'port Guide Wire	Advanced Cardiovascular Systems, Inc.	DQX	Class II	1994-07-18
K941773	Medicam 900 Remote	M.P. Video, Inc.	GCJ	Class II	1994-07-18
K941719	360 Deg. Rotating 1/2 Beam Block	Medtec LLC	IXI	Class II	1994-07-18
K941714	Chlamydia Trachomatis Antigen Test	Neogenex	LJP	Class I	1994-07-18
K941705	Nerve Fiber Analyzer	Carl Zeiss Meditec Inc	HLI	Class II	1994-07-18
K941489	Ace Clinical Chemistry System	Schiapparelli Biosystems, Inc.	DIS	Class II	1994-07-18
K941447	Simpla S4, S5, S7	Simpla Plastics, Ltd.	KNX	Class II	1994-07-18
K941264	Richard Rod Lens Laryngoscope	Smith & Nephew Richards, Inc.	EOQ	Class II	1994-07-18
K941169	Tec 2101 (Model Mt-Hplgd)	Medtec LLC	IWE	Class I	1994-07-18
K940540	Velo Ace	Emix U.S.A., Inc.	IXW	Class II	1994-07-18
K940416	Neurological Leads (Packaging Modification)	Medtronic, Inc.	GZB	Class II	1994-07-18
K940373	Ophthalmic Cryo Unit	Dutch Ophthalmic USA, Inc.	HPS	Class II	1994-07-18
K940289	Abbott Prism Analyzer	Abbott Mfg., Inc.	JJE	Class I	1994-07-18
K936282	Transit Infusion Catheter (Neurovascular Use)	Cordis Neurovascular, Inc.	DQO	Class II	1994-07-18
K936010	Thyroglobulin Autoantibody Enzyme Immunoassay	Biomerica	DDC	Class II	1994-07-18
K935951	Kirschner C-2 Osteocap Total Hip System	Kirschner Medical Corp.	JDI	Class II	1994-07-18
K935412	Med-Tec, Inc. Breast Board, Mt-200	Medtec LLC	IYE	Class II	1994-07-18
K935411	Med-Tec, Inc. Breast Board, Mt-250	Medtec LLC	IYE	Class II	1994-07-18
K935300	Vac-Lok Immobilization System	Medtec LLC	IYE	Class II	1994-07-18
K934484	Quickvue in-Line One-Step Strep a Test	Ortho-Clinical Diagnostics, Inc.	GTZ	Class I	1994-07-18
K933672	Xomed-Treace Scopesheath	Xomed-Treace, Inc.	EOB	Class II	1994-07-18
K933227	Uni-Frame Head Immobilization System	Medtec LLC	IYE	Class II	1994-07-18
K932482	Medix Biotech Bestest Strep a Cat. No. Bsf1010	Medix Biotech, Inc.	GTZ	Class I	1994-07-18
K932291	Eutra Gel for Wound Dressing	Swiss American Products, Inc.	MGQ	Unclassified	1994-07-18
K931651	Natural-Knee Congruent Tibial Insert with Screw	Intermedics Orthopedics	JWH	Class II	1994-07-18
K942783	Non-Prescription Sunglasses	Sunpoint Import Co., Inc.	HQY	Class I	1994-07-15
K942642	Surgi-Wipe	Surgin Surgical Instrumentation, Inc.	HOZ	Class II	1994-07-15
K942513	Seiko Eyeglass Frame	Seiko Optical Products of America, Inc.	HQZ	Class I	1994-07-15
K942119	U-Top Enterprise Co Spectacle Frames & Sunglasses	U-Top Enterprise Co., Ltd.	HQY	Class I	1994-07-15
K941495	Return Path Diathermy Handle	Mira, Inc.	HQR	Class II	1994-07-15
K936302	Nidek Model Vt-4000, Modification	Nidek, Inc.	HQE	Class II	1994-07-15
K936072	Non-Prescription Sunglasses	King'S Sunglass Corp.	HQY	Class I	1994-07-15
K930431	Arthrostim Manipulator	Freeman Procedure Seminars	LXM	Unclassified	1994-07-15
K925038	Pacing Lead Model 1188T	Siemens-Pacesetter, Inc.	DTB	Class III	1994-07-15
K915444	Dupel Iontophoresis Device	Empi	EGJ	Class II	1994-07-15
K913601	Microphor	Life-Tech Intl., Inc.	EGJ	Class II	1994-07-15
K942430	Agalloy, Disalloy, Epsilon and Lambda	Fen Dental Mfg., Inc.	EJJ	Class II	1994-07-14
K942181	Sof-Set Qr Infusion Sets, Models Mmt-115 and Mmt-116	Medtronic, Inc.	FPA	Class II	1994-07-14
K941940	Immobile Sterile and Immobile A/c Sterile	TNT Moborg Intl. Ltd.	KMK	Class I	1994-07-14
K941850	Immobile Non-Sterile and Immobile A/c Non-Sterile	TNT Moborg Intl. Ltd.	KMK	Class I	1994-07-14
K941645	Biopsy Tray	Cush Medical Products	FRG	Class II	1994-07-14
K941498	Biomek Sl with Biomek Sl Incubator	Beckman Analytical and Biotechnology Development	JQW	Class I	1994-07-14
K941315	Stanbio Y-Gt (Liquicolor) Test Set	Stanbio Laboratory	JQB	Class I	1994-07-14
K940980	Charged Supor(r) Filter Extension Set	B. Braun of America, Inc.	FPB	Class II	1994-07-14
K936229	Aia-Pack Tt3 Assay	Tosoh Medics, Inc.	CDP	Class II	1994-07-14
K934796	Ipi Low Profile Import	Pudenz-Schulte Medical Research Corp.	LJT	Class II	1994-07-14