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 1459 of 3531

510(k) clearances, page 1459 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K031495	Pinnacle Duofix Ha Acetabular Cup Prosthesis	Depuy Orthopaedics Inc.	LPH	Class II	2003-06-11
K031466	Iqmark Digital Holter	Brentwood Medical Technology Corp.	MLO	Class II	2003-06-11
K030800	Electromed Reusable Neurostimulation Electrodes	Eletromed, Inc.	GXY	Class II	2003-06-11
K030535	Ekgcard System	VectraCor, Inc.	DPS	Class II	2003-06-11
K030104	Prime ECG System	Meridian Medical Technologies, Ltd.	DPS	Class II	2003-06-11
K024192	Vectorvision Fluoro3d	Brainlab, Inc.	HAW	Class II	2003-06-11
K024010	Dover Silver Hydrogel Coated Silicone Foley Catheter	The Kendall Company Div. of Tyco Healthcare Group	EZL	Class II	2003-06-11
K023174	Disposable Temporary Pacing Wire	River Medical, Inc.	LDF	Class II	2003-06-11
K023080	Galix Pacestar	Galix Biomedical Instrumentation, Inc.	DTE	Class II	2003-06-11
K022906	Resqpod Circulatory Enhancer	Cprx, LLC	BWF	Class II	2003-06-11
K031569	Datascope Ca 40 8Fr. Iabs, Model 0684-00-04Xx	Datascope Corp.	DSP	Class II	2003-06-10
K031348	High Sensitivity Cortisol Enzyme Immunoassay	Salimetrics LLC.	NHG	Class II	2003-06-10
K031131	Klinidrape Surgical Drapes	Molnlycke Health Care	KKX	Class II	2003-06-10
K031113	Disposable Powder Free Vinyl Exam Gloves	Elite International, Inc.	LYZ	Class I	2003-06-10
K031104	Powdered Vinyl Exam Gloves, White	Glormed Intl., Inc.	LYZ	Class I	2003-06-10
K030811	Cool Cure	Samm, Inc.	EBZ	Class II	2003-06-10
K030641	Contec Light	Dentaurum Inc.	EBZ	Class II	2003-06-10
K030519	Wristjack System (Remanufactured), Sterile and Non-Sterile, Models Cfd-147-Rs, Cfd-247-Rns	Hand Biomechanics Lab Inc	JEC	Class II	2003-06-10
K024360	Instant-View H. Pylori One Step Rapid Test	Alfa Scientific Designs, Inc.	LYR	Class I	2003-06-10
K024111	Astra Tech Implants-Dental System Fixture Osseospeed	Astra Tech, Inc.	DZE	Class II	2003-06-10
K023755	Winner Ear Loop Procedure Mask, Tie-on Surgical Mask & Ear Loop Procedure Mask with Shield	Winner Industries (Shenzhen) Co., Ltd.	FXX	Class II	2003-06-10
K021360	Scintillating Fiber Dosimeter (Sfd), Model Mt-Sfd-1000	Medtec LLC	KXK	Class II	2003-06-10
K031663	Ge Vivid 7, Model Fc0003xx	General Electric Co.	IYN	Class II	2003-06-09
K031609	Swiss Orthopedic Solutions, Inc., Small Fragment Locking Plate System	Swiss Orthopedic Solutions, Inc.	HRS	Class II	2003-06-09
K030807	Caries Indicator	Confi-Dental Products Co.	LFC	Class II	2003-06-09
K030765	Hobbs Mistifier Spray Catheter	Hobbs Medical, Inc.	OCX	Class II	2003-06-09
K030761	Kaishou Vaginal Speculum	Jiangsu Kaishou Medical Apparatus Co., Ltd.	HIB	Class II	2003-06-09
K022705	Readi-Strand, Model Psstrand	Worldwide Medical Technologies, LLC	KXK	Class II	2003-06-09
K031662	Pressure Wire Sensor, Models 12004/12304	Radi Medical Systems AB	DXO	Class II	2003-06-06
K031629	Canon Non-Mydriatic Retinal Camera, Model Cr-Dgi	Canon Medical Components U.S.A., Inc.	HKI	Class II	2003-06-06
K031614	Medela Pump in Style Advanced Breast Pump	Medela AG	HGX	Class II	2003-06-06
K031594	Bak'snap Duopro Safety Syring (Duopross) Safety'tray Allergy Safety Syringe Tray	MK Meditech	MEG	Class II	2003-06-06
K031573	Synthes 3.5 Mm Low Profile Pelvic Reconstruction Plate	Synthes (USA) Products LLC	KTT	Class II	2003-06-06
K031519	Cufflok Anchor	Mitek Worldwide	MAI	Class II	2003-06-06
K031479	Ambulatory Blood Pressure (Abp) 92506 Report Management System (Rms), Model 92506	GE Healthcare	DXN	Class II	2003-06-06
K031429	Bd Phoenix Automated Microbiology System-Meropenem 0.25-16 Ug/ml	Lee Laboratories, Inc.	LON	Class II	2003-06-06
K031165	Plus Orthopedics Cemented Hip Stem	Plus Orthopedics	JDI	Class II	2003-06-06
K031004	Syva Emit II Plus Amphetamines Assay	Siemens Healthcare Diagnostics Inc.	DKZ	Class II	2003-06-06
K030965	Control Plasma Lmw Heparin	Instrumentation Laboratory Co.	GGN	Class II	2003-06-06
K030964	Calibration Plasma Lmw Heparin	Instrumentation Laboratory Co.	JIS	Class II	2003-06-06
K030951	Tesceraflo A2, Model T-21012P; Tesceraflo A2 Opaque, Model T-210120P	Bisco Inc	EBF	Class II	2003-06-06
K030842	Eni-Eye Q Toric (Acofilcon) Soft (Hydrophilic) Multifocal Contact Lens for Daily Wear, Eni-Eye (Acofilcon) Soft (Hydrop	Soflex Contact Lens Industries, Ltd.	LPL	Class II	2003-06-06
K030816	Msd Cable Reduction System	Medtronic Sofamor Danek	KWP	Class II	2003-06-06
K030738	Siemens Multiview Infinity Telemetry System	Siemens Medical Solutions USA, Inc.	MHX	Class II	2003-06-06
K030332	Modification to Bionicare Stimulator System, Model Bio-1000	Bionicare Medical Technologies, Inc.	NYN	Class II	2003-06-06
K024280	Wako Crp, Calibrator and Wako Crp Calibrator Set	FUJIFILM Healthcare Americas Corporation	DCK	Class II	2003-06-06
K022926	Genteel Wrist Digital Blood Pressure Monitor, Model Bp-100	Genteel Technology Co., Ltd.	DXN	Class II	2003-06-06
K031527	Modification to Cavermap Surgical Aid	Blue Torch Medical Technologies	FGM	Class I	2003-06-05
K031470	Puritan Bennett, Goodknight 420 Evolution, Model M-113903-US	Tyco Healthcare Nancy	BZD	Class II	2003-06-05
K030727	Potassium Nitrate/zinc Oxide Eugenol Temporary Dental Cement	Healex Products, Inc.	EMA	Class II	2003-06-05