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 2311 of 3531

510(k) clearances, page 2311 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K925062	Permaflex Permanent Soft Denture Reliner	Protech Professional Products, Inc.	EBI	Class II	1993-03-31
K924805	Orthodontic Arch Wire	Ultimate Wireforms, Inc.	DZC	Class I	1993-03-31
K924513	Lido(r) Linea	Loredan Biomedical, Inc.	BXB	Class I	1993-03-31
K924378	Restobond 4	Lee Pharmaceuticals	KLE	Class II	1993-03-31
K924211	Ejector	Glenroe Technologies	DYN	Class I	1993-03-31
K924089	Opti-Shield	Fuji Optical Systems, Inc.	EFB	Class I	1993-03-31
K923991	Zoe Laser, Contact Nd:yag Laser System	Lca, Inc.	GEX	Class II	1993-03-31
K923963	Nk Digi-Grip Sensor, Model Dgr001	Nk Biotechnical Engineering Co.	LBB	Class II	1993-03-31
K923837	Dimpled Multi Modulus Arch Wire	Ultimate Wireforms, Inc.	DZC	Class I	1993-03-31
K923815	Total Protective Breatheable Surgical Gowns	Laivan Corp.	FYA	Class II	1993-03-31
K923643	Medicool	Micromedic Systems	ILO	Class II	1993-03-31
K923443	Natural-Knee All-Poly Tibia	Intermedics Orthopedics	JWH	Class II	1993-03-31
K923440	Apex Direct Bonded Brackets	Apex Orthodontics, Inc.	EJF	Class I	1993-03-31
K923191	Switchable Tip System	Trimedyne, Inc.	GEX	Class II	1993-03-31
K922984	Orthodontic Bite	American Orthodontics	LRK	Class II	1993-03-31
K922919	Dynacyt Biopsy Aspiration Device	Buckman Co., Inc.	MJG	Class I	1993-03-31
K922809	General Procedural Stretchers (P880- P886)	Hill-Rom Inc.	FPO	Class II	1993-03-31
K922808	Hill-Rom via Stretcher (P1300 - P1303)	Hill-Rom Inc.	FPO	Class II	1993-03-31
K921000	Sonacare Sound Massager	Honor Trading, Ltd.	ISA	Class I	1993-03-31
K920930	Mdt/castle 10/90 Dual Load Station	Mdt Corp., Inc.	FLF	Class II	1993-03-31
K920334	Laserphotonics Ml300 Stonelaser Alexandrite Lith.	Laser Photonics, Inc.	GEX	Class II	1993-03-31
K913404	Implandrill - Threaded Dental Implant	Impladrill, Ltd.	DZE	Class II	1993-03-31
K926575	Mammotest Product, Modification	Fischer Imaging Corp.	EHD	Class II	1993-03-30
K926291	Schul-Tec Immobilizer	Medical Emergency Support Equipment	IQK	Class I	1993-03-30
K926231	Duracon Unicompartmental Knee System	Howmedica Corp.	HSX	Class II	1993-03-30
K926116	Codman Sofwire(tm) Kit	Cerenovus, Inc.	JDQ	Class II	1993-03-30
K924094	Mend Apc	Mend Technologies, Inc.	JEA	Class I	1993-03-30
K924058	Trocar	Endo Technic Corp.	GCJ	Class II	1993-03-30
K923360	Port-Xd	Mobile Dental Equipment Corp.	EHD	Class II	1993-03-30
K922797	Aesculap Trocar Instrument Set	Aesculap Inc	GCJ	Class II	1993-03-30
K913412	Ps Medical Csf-Access Device	Pudenz-Schulte Medical Research Corp.	JXG	Class II	1993-03-30
K930660	Creatine Kinase (Ck) Reagent Set	Horiba Instruments Incorporated	CGS	Class II	1993-03-29
K930609	Sas(tm) Monoclonal Hcg-Slide	SA Scientific, Ltd	JHJ	Class II	1993-03-29
K930533	Bnos Microvent(tm), Model Ac and Model Ao	Bnos Meditech, Ltd.	BZT	Class II	1993-03-29
K930262	Treatment Table, Model #825-100	Biodan Medical Systems, Ltd.	INO	Class II	1993-03-29
K926574	Model 330 Screening Audio Meter, Modified	Virtual Corp.	GWJ	Class II	1993-03-29
K926469	Variant(tm) Hemoglobin a 1C Program	Bio-Rad	LCP	Class II	1993-03-29
K926386	Vista Prolactin Assay	Syva Co.	CFT	Class I	1993-03-29
K925794	Trace Microprotein Reagent	Trace America, Inc.	JGQ	Class II	1993-03-29
K925687	Interferential Stimulator Model Imf4150/a	BioMedical Life Systems Inc.	LIH	Class II	1993-03-29
K925387	Liberator	Prentke Romich Co.	ILQ	Class II	1993-03-29
K925361	Biopsy Forceps, Electric	United States Endoscopy Group, Inc.	KGE	Class II	1993-03-29
K924353	Nidek Model Vst-4000	Nidek, Inc.	HQE	Class II	1993-03-29
K923543	Mis	Ceram Optec, Inc.	HLJ	Class II	1993-03-29
K922127	Hospital Kit Gp 103	Savoy Medical Supply Co., Inc.	MDM	Class I	1993-03-29
K921185	Telemedic Teleradiology System	Meditron AS	LMD	Class I	1993-03-29
K921179	Olympus-Keymed Disinfectant Fume Extractor Dfe-20	Keymed, Inc.	FEB	Class II	1993-03-29
K930757	Rheumelisa II Jo-1 Antibody Test Kit	Biowhittaker Molecular Applications, Inc.	LLL	Class II	1993-03-26
K930118	Stetskins	Nova Diversified Concepts	BZS	Class I	1993-03-26
K926545	Dried Gram-Negative Mic/combo Panels	Baxter Diagnostics, Inc.	JWY	Class II	1993-03-26