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 2599 of 3530

510(k) clearances, page 2599 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K894645	Immulon 1,2,3,And 4 Dividastrips Tm	Dynatech Laboratories, Inc.	JTC	Class I	1989-10-17
K894633	Cordis Steerable Coated Guidewire	Cordis US Corp.	DQX	Class II	1989-10-17
K894578	Iq Ldh	BD Becton Dickinson Vacutainer Systems Preanalytic	CFH	Class II	1989-10-17
K894564	Reliance Light Cure Retainer Acrylic	Reliance Orthodontic Products, Inc.	EBI	Class II	1989-10-17
K894512	Phacoemulsification Unit to Remove Catarac. Lens	Intl. Ophthalmic Industries Corp.	HQC	Class II	1989-10-17
K894511	Magnetron Munich Model Electronic Control Unit	Intl. Ophthalmic Industries Corp.	HQC	Class II	1989-10-17
K894504	Whiteside Ortholoc M.a. Tibial Base	Dow Corning Wright	JWH	Class II	1989-10-17
K894494	Labeling Changes to Pulse Gene. & Pulse Gene. Lead	BIOTRONIK AG	DXY	Class III	1989-10-17
K894033	Disposable Catheter Pressure Transducer	Deseret Medical, Inc.	DXO	Class II	1989-10-17
K893888	Hollister Feeding Tube Attachment Device	Hollister, Inc.	KNT	Class II	1989-10-17
K893541	Vinyl Bag W/gravity Administration Set	Sandoz Nutrition	KNT	Class II	1989-10-17
K893540	Vinyl Bag W/pump Administration Set	Sandoz Nutrition	KNT	Class II	1989-10-17
K890875	Cardiotest Ek53/ek53r, Cardiognost Ek56/ek512	Ppg Industries, Inc.	DPS	Class II	1989-10-17
K890434	Ems 300 Muscle Stimulators	Paranamics, Inc.	IPF	Class II	1989-10-17
K895692	Fortress Model 2001Lx Electric 3-Wheeler	Fortress Scientific, Ltd.	INI	Class II	1989-10-16
K895685	Small Joint Hand Instruments	Leonard Medical, Inc.	HRX	Class II	1989-10-16
K895526	Cobas Ready Glucose Reagent	Roche Diagnostic Systems, Inc.	CGA	Class II	1989-10-16
K895382	Vibra-Trac Traction Table	Vibra-Trac Industries	ILZ	Class I	1989-10-16
K895196	Model Dc-1200 Diode Laser Photocoagulator	Nidek, Inc.	HQF	Class II	1989-10-16
K895041	Optical Catheter(tm) Introducer Sets	Medical Dynamics, Inc.	KGZ	Class I	1989-10-16
K895029	Slt Contact Laser Systems for Photocoagulation	Surgical Laser Technologies, Inc.	GEX	Class II	1989-10-16
K894932	Fiax Eb Vca-M Test Kit	Whittaker Bioproducts, Inc.	LSE	Class I	1989-10-16
K894914	Model 100 Portable Clinical Analyzer and Test Pack	I-Stat Corp.	JGS	Class II	1989-10-16
K894846	Unscented Menstrual Tampon	Personal Products Co.	HEB	Class II	1989-10-16
K894780	Immuno/aso	Immunostics, Inc.	GTQ	Class I	1989-10-16
K894626	Epstein-Barr Virus-Nuclear Antigen	Bion Ent., Ltd.	LLM	Class I	1989-10-16
K894624	Mumps Virus	Bion Ent., Ltd.	GRA	Class I	1989-10-16
K894623	Respiratory Syncytial Virus	Bion Ent., Ltd.	LKT	Class I	1989-10-16
K894554	Clp Ck/ld Isoenzyme Control	Creative Laboratory Products, Inc.	JJT	Class I	1989-10-16
K894546	Immunodot Rubella Test	General Biometrics, Inc.	LFX	Class II	1989-10-16
K894262	Rubella Antigen and Control Antigen	Microbix Biosystems, Inc.	GON	Class II	1989-10-16
K894261	Toxoplasma Gondii-Cf Antigen and Control Antigen	Microbix Biosystems, Inc.	GMN	Class II	1989-10-16
K893753	Directigen 1-2-3 Disseminated Candidiasis Test	BD Becton Dickinson Vacutainer Systems Preanalytic	LHK	Class II	1989-10-16
K893647	Copolyester Film Dressing	Centurion Medical Products, LP	KGN	Unclassified	1989-10-16
K891404	Sterile Latex Surgeon's Gloves	Shinheng Corp.	KGO	Class I	1989-10-16
K891331	Uni-Stick Plastic Ligatures	American Orthodontics	EJF	Class I	1989-10-16
K882387	Agar 4000 Neuromuscular Stimulator	Solcoor, Inc.	IPF	Class II	1989-10-16
K881777	Likon	Northwood Intl., Corp.	IPF	Class II	1989-10-16
K895743	Latex Patient Examination Gloves	Rubbertech Industry Co., Ltd.	LYY	Class I	1989-10-13
K895739	Micromedics Surgical Drill System	Micromedics, Inc.	HBB	Class II	1989-10-13
K895722	Citrex Latex Examination Gloves	Pt Citra Latex Lestari	LYY	Class I	1989-10-13
K895715	Hanaulux(r) 2000	W.C. Heraeus GmbH	FTD	Class II	1989-10-13
K895667	Sterile Surgical Gown	Clinitech, Inc.	FYE	Class I	1989-10-13
K895604	Soft-Ez Reusable Self-Adhering Pigtail Electrodes	Medical Design & Manufacturing Corp.	GXY	Class II	1989-10-13
K895486	Bird (Vdr) Sinusoidal Percussionators	Percussionaire Corp.	CBK	Class II	1989-10-13
K895431	Johnson & Johnson Tube Securement Device	Johnson & Johnson Patient Care, Inc.	KMK	Class I	1989-10-13
K895169	Manual Disposable Pulmonary Resuscitator	F.L.W. Plastics, Inc.	BTM	Class II	1989-10-13
K895132	Connell-Stephens Endo Aness Tube	The Traumafuse Co.	BTR	Class II	1989-10-13
K894993	Stratus(r) Total Triiodothyronine (T3) F.e.i.	Baxter Healthcare Corporation	CDP	Class II	1989-10-13
K894912	Sri 100 Radiotherapy Imaging System	Philips North America LLC	IYE	Class II	1989-10-13