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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2576 of 3530

510(k) clearances, page 2576 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K896219	Safe-T-Cap Needle Cover	Ausmedics Pty, Ltd.	DZM	Class I	1990-01-22
K896175	Herrick Lacrimal Plug Tm.	Lacrimedics, Inc.	LZU	Unclassified	1990-01-22
K896164	Asc-954 Integrator Amplifier	Astro-Med, Inc.	GWK	Class II	1990-01-22
K896159	Dahlberg Model Lp Behind-the-Ear Hearing Aid	Dahlberg Electronics, Inc.	ESD	Class I	1990-01-22
K896158	Dahlberg Model La Behind-the-Ear Hearing Aid	Dahlberg Electronics, Inc.	ESD	Class I	1990-01-22
K896157	Dahlberg Model Lh Behind-the-Ear Hearing Aid	Dahlberg Electronics, Inc.	ESD	Class I	1990-01-22
K896124	Medipart Disposable Xenon-133 Rebreathing Mp-0133	Medipart Jerry Alexander	IYT	Class II	1990-01-22
K896024	Mdt/castle Model Hdx Dental X-Ray Machine	Mdt Diagnostic Co.	EAP	Class II	1990-01-22
K895855	Phoenix	Medical and Scientific Enterprises, Inc.	KNS	Class II	1990-01-22
K895800	Advanced Surgical Solid State Bipolar Coagulator	Advanced Surgical Products, Inc.	HQR	Class II	1990-01-22
K895617	Patient Examination Gloves	Lit Seng Development Sdn. Bhd.	LYY	Class I	1990-01-22
K895383	Type Fp40 Digital Hearing Aid Analyzer	Frye Electronics, Inc.	ETW	Class II	1990-01-22
K895200	Model Eb-22 Noise Stik	Eckstein Brothers, Inc.	EWO	Class II	1990-01-22
K895167	The Optic Box Contact Lens Case	The Optic Box Co., Ltd.	LRX	Class II	1990-01-22
K894936	Protologic Model Ser-1	Protologic, Inc.	BZE	Class II	1990-01-22
K894695	Vacusafe Disp. Vacuum - Extraction System	Medistad Corp.	GCX	Class II	1990-01-22
K894641	Mesam Recorder	Madaus Medtec, Inc.	BZQ	Class II	1990-01-22
K894190	Pharmacia Cap System Rast Ria & Rast Feia	Pharmacia, Inc.	DHB	Class II	1990-01-22
K894030	Model 37 Uterine Contraction Activity Monitor	Healthdyne, Inc.	HFM	Class II	1990-01-22
K893522	Surgeon's Gloves	Thai Fuji Latex Co., Ltd.	FGO	Class II	1990-01-22
K893074	Patient Examination Gloves	Taba Gloves Pvt., Ltd.	LYY	Class I	1990-01-22
K891624	J.m. Patient Examination Gloves	Jann Maw (U.S.A.), Inc.	LYY	Class I	1990-01-22
K896345	Exercise Evaluation System 2010	Medical Graphics Corp.	BZM	Class II	1990-01-20
K900014	Milenia (Tm) Tsh	Siemens Healthcare Diagnostics Inc.	JLW	Class II	1990-01-19
K896916	Clinistat Total Protein Reagent Test	Kulzer GmbH	CEK	Class II	1990-01-19
K896819	Vamp Venous/arterial Blood Management Protection	Baxter Healthcare Corporation	KRA	Class II	1990-01-19
K896808	Igf-I by Extraction; Insulin-Like Growth Factor I	Nichols Institute Diagnostics	CFL	Class I	1990-01-19
K896788	Disp. Neonatal Blood Pressure Monitoring Cuff	Advanced Medical Instruments, Inc.	DXQ	Class II	1990-01-19
K896702	Wound Dressing	Viaderm Pharmaceuticals, Inc.	FRO	Unclassified	1990-01-19
K896415	Usci Presto Disposable Inflation Device	C.R. Bard Inc	DXT	Class II	1990-01-19
K896307	Insulation Pad	Bio-Vascular, Inc.	DWS	Class I	1990-01-19
K896257	Leinbach Hip Prosthesis	3M Company	KWY	Class II	1990-01-19
K896162	Abbott Imx Prolactin	Abbott Medical	CFT	Class I	1990-01-19
K896153	Modified Dr-2C/pmc 100	General Devices	DSH	Class II	1990-01-19
K896149	Anest-Eze Dental Drill Ra#2	Signature One Products, Inc.	DZA	Class I	1990-01-19
K896122	Amnicathdl(tm) Dt-Iupc2 Dual Lumen Trans. Tipped	Spectramed, LLC	KXO	Class II	1990-01-19
K896002	Carry-All EKG Transtelephonic Transmitter	Instromedix, Inc.	DXH	Class II	1990-01-19
K895862	Clp Normal Lipid Control	Creative Laboratory Products, Inc.	JJY	Class I	1990-01-19
K895817	Hermal Wound Care Kit	Stiefel Research Institute, Inc.	NAD	Class I	1990-01-19
K895476	Option Epidural Catheters	Opticon Medical, Inc.	CAZ	Class II	1990-01-19
K895427	Mediseal Suction Canister	DeRoyal Industries, Inc.	DWD	Class II	1990-01-19
K895318	B-D Angiographic Control Syringe	BD Becton Dickinson Vacutainer Systems Preanalytic	DXT	Class II	1990-01-19
K895289	Mec-I-Tron Mini, Model M-2	Meyer Equipment Company, Inc.	GZJ	Class II	1990-01-19
K895183	Rebox II (TENS)	Rebox (Uk), Ltd.	GZJ	Class II	1990-01-19
K895146	Guiding Catheter	Peripheral Systems Group	DQO	Class II	1990-01-19
K894944	Balloon Dilatation Catheter	Peripheral Systems Group	LIT	Class II	1990-01-19
K894631	Nka Model Mfv-3100 & Mfv-3200 Electro. Blood Flow.	Nihon Kohden America Inc	DPW	Class II	1990-01-19
K894600	Cusa System 200C,t,m,h Ultrasonic Aspirator	Medtronic, Inc.	LFL	Unclassified	1990-01-19
K894283	Comprehensive Spine Motion Analyzer	Mizuho Orthopedic Systems Inc	KQX	Class I	1990-01-19
K885120	Esi Model Ms-103	Electrical Systems Div.	GZT	Class II	1990-01-19