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 2124 of 3531

510(k) clearances, page 2124 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K931996	Model Pdexa Bone Densitometer	Norland Corp.	KGI	Class II	1995-02-01
K931381	Ame Universal Fixation System	American Medical Electronics, Inc.	KWP	Class II	1995-02-01
K930510	Radius Enteral Feeding Tube	Radius Intl., Inc.	BSS	Class II	1995-02-01
K950267	Urethral Suture Guide	Applied Medical Resources Corp	KOA	Class I	1995-01-31
K946092	Avon Sunny Days Sunglasses	Siegel,Mandell & Davidson,P.C.	HQY	Class I	1995-01-31
K946091	Avon Sunny Days Sunglasses	Siegel,Mandell & Davidson,P.C.	HQY	Class I	1995-01-31
K946004	Fi, Gordy Toy, Welljoy and Others	Fundamental Industrial Co., Ltd.	HQY	Class I	1995-01-31
K945995	Bipolar Electrosurgical Probes and Instruments	Ximed/Prosure/Injectx	GEI	Class II	1995-01-31
K945697	Sk S-Ray Grids	Seibu Techno Coproration	IXJ	Class I	1995-01-31
K945552	Duralastic Sheeting	Applied Biomaterial Technologies	MIB	Class II	1995-01-31
K945385	Vitalmax 800 Plus/vitalmax 810 Plus/minipack 300	Pace Tech, Inc.	MHX	Class II	1995-01-31
K945382	Technomed C-Scan Color Ellipsoid Topometer	Expertech Assoc., Inc.	HLQ	Class I	1995-01-31
K944680	Split Top Wing Needle Cap with Optional Tubing Anchors (and Appropriate Recap Device	Researched, Novel Medical Devices (Rn/Md)	FMI	Class II	1995-01-31
K944397	Bnos Microvent, Model Ac and Model Ao	Racal Health & Safety, Inc.	BTL	Class II	1995-01-31
K943851	All Silicone Intermittent Catheter	Rochester Medical Corp.	GBM	Class II	1995-01-31
K942921	Neurolink Eeg/ep/emg Surface Electrodes	Neuro Supplies, Inc.	GXY	Class II	1995-01-31
K941317	Dried Gram Negative/cefmetazole	Baxter Diagnostics, Inc.	JWY	Class II	1995-01-31
K941190	Clave Needle-Less Connector Open Extension Set	Abbott Medical	FPA	Class II	1995-01-31
K940635	Safe-1(Tm) Syringe	Safety 1st Medical, Inc.	FMF	Class II	1995-01-31
K935571	Duralastic Sheeting	Applied Biomaterial Technologies	MIB	Class II	1995-01-31
K934478	Alpha Stereo	Instrumentarium Corp.	IZH	Class II	1995-01-31
K925750	Relaxomat	Relaxomat, Inc.	HCC	Class II	1995-01-31
K950127	Alternate 100% Eto Sterilization Process and Alternate Sterilization Faccility	Medtronic, Inc.	GZB	Class II	1995-01-30
K946323	Unitron Model Vista 1000 Sigma, Air Conduction Hearing Aid	Unitron Industries, Inc.	ESD	Class I	1995-01-30
K946253	Maico in-the-Ear Model Rd 201	Maico Hearing Instruments, Inc.	ESD	Class I	1995-01-30
K946239	Endoxflex 5000	Michael A Clark	GCJ	Class II	1995-01-30
K946224	Certain(r) Elite Level 1, 2 and 3	Ciba Corning Diagnostics Corp.	JJS	Class I	1995-01-30
K946206	Ciba Corning 8-- Series Co-Oximeter	Ciba Corning Diagnostics Corp.	CHL	Class II	1995-01-30
K946071	Lx-Itc	Widex Hearing Aid Co., Inc.	ESD	Class I	1995-01-30
K946045	Oticon	Oticon, Inc.	ESD	Class I	1995-01-30
K945765	High Temperature Cautery	Apyx Medical Corporation	GEI	Class II	1995-01-30
K945764	High Temperature Cautery Elongated Fine Tip	Apyx Medical Corporation	KNS	Class II	1995-01-30
K945760	High Temperature Cautery	Apyx Medical Corporation	GEI	Class II	1995-01-30
K945759	High Temperature Cautery 5 Loop	Apyx Medical Corporation	GEI	Class II	1995-01-30
K945757	High Temperature Cautery Fine Adjustable	Apyx Medical Corporation	GEI	Class II	1995-01-30
K945676	Guardian Disposable TENS and Tens/nmes Electrodes	Spectramed, LLC	GZJ	Class II	1995-01-30
K945580	Dsp Option	Philips North America LLC	IZJ	Class II	1995-01-30
K945493	Ophthalmic Cautery	Apyx Medical Corporation	HQP	Class II	1995-01-30
K945492	High Temperature Cautery	Apyx Medical Corporation	GEI	Class II	1995-01-30
K945459	Dlx	General Electric Co.	IZI	Class II	1995-01-30
K945388	Dfs-700	Shimadzu Corp.	LLZ	Class II	1995-01-30
K945375	Advantx Lca	GE Healthcare	IZI	Class II	1995-01-30
K945277	Hewlett-Packard Model M1490a Wireless Patient Data Communicator	Hewlett-Packard Co.	DXJ	Class II	1995-01-30
K944971	Incare Hot/ice Cold Therapy Cooler	Hollister, Inc.	ILO	Class II	1995-01-30
K943653	Mammocore Biopsy Tray	Argon Medical Devices, Inc	FRG	Class II	1995-01-30
K943493	Discrete Photometric Chemistry Analyzer	Hamilton Co	JJE	Class I	1995-01-30
K943248	Visualine II Morphine/opiates/heroin	Sun Biomedical Laboratories, Inc.	DJG	Class II	1995-01-30
K942147	Pacific Communications Model 1100	Accucore, Inc.	DSI	Class II	1995-01-30
K941803	Prism Medical Custom Dialysis Kit	Medical Device Support Services	KOC	Class II	1995-01-30
K941112	Single Handed Breast Pump	Macneil Baby Care, Ltd.	HGX	Class II	1995-01-30