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 2066 of 3531

510(k) clearances, page 2066 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K952658	Hearing Aid	Philips Hearing Instruments Co.	ESD	Class I	1995-07-28
K952638	4.5F Imagecath Coronary Angioscope, Model Cov45 [Subsequently Referred to as the Modified Angioscope[	Baxter Edwards	LYK	Class II	1995-07-28
K952518	Safe Cap Needle Recapping/uncapping Device	Medi-Dose, Inc.	FMI	Class II	1995-07-28
K952344	Satin Touch Deodorant Tampon Junior, Regular, Super, Super Plus	Tambrands Inc.	HIL	Class II	1995-07-28
K952035	Niplette	Avent America, Inc.	HGY	Class I	1995-07-28
K944947	Electrosurgical Cutting & Coagulation Device & Access	Boston Surgical Products, Inc.	GEI	Class II	1995-07-28
K944222	Codman-Medos Valve Shunt System	Johnson & Johnson Professionals, Inc.	JXG	Class II	1995-07-28
K941398	El-Rf/3 (Igm-Igg-Iga) Kit	Theratest Laboratories, Inc.	DHR	Class II	1995-07-28
K931534	Ovamed Intrauterine Access Catheter	Ovamed Corp.	MOV	Class II	1995-07-28
K931476	Novy Cornual Cannulation Set	Cook Ob/Gyn	MOV	Class II	1995-07-28
K952872	Sscimed Coronary Guide Wire/infusion Catheter	Scimed Life Systems, Inc.	KRA	Class II	1995-07-27
K952870	Remanium: Cs & G-Soft	Dentauraum, Inc.	EJH	Class II	1995-07-27
K952867	Remanium:gm 700, Gm 380, Gm 800, Gfh	Dentauraum, Inc.	EJH	Class II	1995-07-27
K952866	Rematitan Titanium	Dentauraum, Inc.	EJH	Class II	1995-07-27
K952152	Proclear Daily Wear Contact Lens	Biocompatibles, Ltd.	LPL	Class II	1995-07-27
K952074	Solution Set with 1.2 Micron Air Eliminating Filter	Baxter Healthcare Corporation	FPA	Class II	1995-07-27
K952028	Cold Light Source Los Xl-a 100	Laser-Optik-Systeme GmbH & Co. KG	GCT	Class II	1995-07-27
K951689	Titanium Mandibulat Reconstruction System	Medicon, E.G.	JEY	Class II	1995-07-27
K951687	Mesh Titanium Implant System	Medicon, E.G.	JEY	Class II	1995-07-27
K951447	Dynabite Cardiovascular Biopsy Forceps	Portlyn Corp.	DWZ	Class II	1995-07-27
K941322	Echo-Scan	Tomographic Tech	IYO	Class II	1995-07-27
K934785	Multipace	Electro-Catheter Corp.	LDF	Class II	1995-07-27
K953266	Resound Personal Hearing System Bt250 Mz W/remote Control Option	Resound Corp.	ESD	Class I	1995-07-26
K952989	Wide Str-Tp-4K, Pros Str, Cly-Str-Tp 4	Implant Center of the Palm Beaches	DZE	Class II	1995-07-26
K952988	Wide Screws Tp-4K, Pros-G4, Tools G4 or 17-4 Ss	Implant Center of the Palm Beaches	DZE	Class II	1995-07-26
K952940	Personal Programmer 2000	Siemens Hearing Instruments, Inc.	ESD	Class I	1995-07-26
K952865	Remanium: 200,Cs, 380, and Cd	Dentauraum, Inc.	EJH	Class II	1995-07-26
K952832	Disposable Bipolar Electrode	Neuro Navigational Corp.	GEI	Class II	1995-07-26
K952785	Brimfield Precision Detachable Scissor	Springfield Surgical Instruments	GCJ	Class II	1995-07-26
K952504	Tecnol Transparent Wound Dressing	Tecnol Medical Products, Inc.	MGP	Unclassified	1995-07-26
K952419	Sterigauze Gel Dressing	Acacia Laboratories, Inc.	MGQ	Unclassified	1995-07-26
K952302	Amuchina	Amuchina Intl., Inc.	LRJ	Class I	1995-07-26
K952284	Amerlite Tbg Assay	Johnson & Johnson Clinical Diagnostics, Inc.	CEE	Class II	1995-07-26
K952247	Burnshield Trauma Dressing	Golightly International Corp.	MGQ	Unclassified	1995-07-26
K952243	Extension Set/i.v. Set	Coast Medical Corp.	FPK	Class II	1995-07-26
K952093	Ergomat 5000 System	Ergo-Air, Inc.	FNM	Class II	1995-07-26
K952092	Ergomat 8000 System	Ergo-Air, Inc.	FNM	Class II	1995-07-26
K952070	Nezhat-Dorsey Electrosurgical Hand Control Attachments, Pencil-Grip Handles & Trumpet Valve W/cutting & Coagulation Hans	American Hydro-Surgical Instruments, Inc.	KNF	Class II	1995-07-26
K952025	Robocap	Pharmacia, Inc.	JQW	Class I	1995-07-26
K952008	Karl Storz Drill	Karl Storz Endoscopy-America, Inc.	GEY	Class I	1995-07-26
K951691	Cms Cranio Maxillo Facial Titanium Implant System	Medicon, E.G.	JEY	Class II	1995-07-26
K951690	Titanium Miniplate System	Medicon, E.G.	JEY	Class II	1995-07-26
K951688	Micro Titanium Plate System	Medicon, E.G.	JEY	Class II	1995-07-26
K951624	Argus Medical Company Laparoscopic Discectomy Instrument System	Argus Medical Co., Inc.	HRX	Class II	1995-07-26
K951618	Imz - Dental Implant O-Ring Attachment	Imz, GmbH	DZE	Class II	1995-07-26
K951617	Imz - Dental Implant Castable Csr Attachment	Imz, GmbH	DZE	Class II	1995-07-26
K951615	Imz - Dental Implant Components	Imz, GmbH	DZE	Class II	1995-07-26
K951614	Imz - Dental Implant	Imz, GmbH	DZE	Class II	1995-07-26
K951612	Imz - Dental Implant Components	Imz, GmbH	DZE	Class II	1995-07-26
K951610	Imz - Dental Implant	Imz, GmbH	DZE	Class II	1995-07-26