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 1510 of 3531

510(k) clearances, page 1510 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K022882	Modification to Playtex Tampons #24002	Playtex Products, Inc.	HIL	Class II	2002-09-16
K022702	Powdered Synthetic Vinyl Exam Gloves	Shijiazhuang Holy Plastics Co., Ltd.	LYZ	Class I	2002-09-16
K022639	Synthetic Powder Free Vinyl Patient Exam Gloves	Shijiazhuang Holy Plastics Co., Ltd.	LYZ	Class I	2002-09-16
K022600	Powder Free Synthetic Vinyl Examination Gloves	Shijiazhuang Wally Plastics Co., Ltd.	LYZ	Class I	2002-09-16
K022343	Glovetex Powder Free Latex Examination Gloves, Non Sterile (Protein Content Labeling Claim 50Ug/g or Less)	Pt. Wrp Buana Multicorpora	LYY	Class I	2002-09-16
K021983	Ulti Guard Home Insulin Syringe Container	Ultimed, Inc.	MMK	Class II	2002-09-16
K020462	Sanidad Thermal Far-Infrared Wave Lamp, Model Ap-2018	Rolor Electronics Corp.	ILY	Class II	2002-09-16
K022880	Guidant Proximal Seal System, Models Pss-4500 & Ps-4500	Boston Scientific Corporation	DXC	Class II	2002-09-13
K022825	Manual Wheelchair	Major Mobility Products, Inc.	IOR	Class I	2002-09-13
K022738	Agiltrac .035 Peripheral Dilatation Catheter	Boston Scientific Corporation	DQY	Class II	2002-09-13
K022722	Pta and Ptv	Numed Inc	DQY	Class II	2002-09-13
K022700	Deluxe Manual Wheelchair Hw 4000	Forever Young Ent. Co., Ltd.	IOR	Class I	2002-09-13
K022699	Transfer Companion Hr 3000 Manual Wheelchair	Forever Young Ent. Co., Ltd.	IOR	Class I	2002-09-13
K022617	Comfy High Riser Wheelchair	Lenjoy Medical Engineering, Inc.	IOR	Class I	2002-09-13
K022537	Press-Mate Pm-2100 Vital Sign Monitor	Colin Medical Instruments Corp.	MWI	Class II	2002-09-13
K022339	Total Bilirubin	Abbott Medical	CIG	Class II	2002-09-13
K022269	Coated Vicryl* (Polyglactin 910) Suture	Ethicon, Inc	GAM	Class II	2002-09-13
K022231	Normed Distal Radius Reconstruction System	Osteomedics, Inc.	HRS	Class II	2002-09-13
K022135	Ureteral Access Sheath Set (Uass)	Boston Scientific Corporation	KOD	Class II	2002-09-13
K022006	Conductive Gel	The Dezac Group	GYB	Class II	2002-09-13
K022003	Titan Micro Catheter, Model 105-5074-153; Hd Injector, Model 103-0305	Medtronic, Inc.	DYB	Class II	2002-09-13
K021989	Selector Integra Ultrasonic Surgical Aspirator, Model Om 1530000M3	Integra NeuroSciences	LFL	Unclassified	2002-09-13
K021975	Lasersystem Beautystar 532	Asclepion-Meditec AG	GEX	Class II	2002-09-13
K021687	Binax Now Rsv Test (27 Test), Binax Now Nasopharyngeal Swab Specimen Accessory Pack	Binax, Inc.	GQG	Class I	2002-09-13
K021483	Rich-Mar Therasound 6.5 Therapeutic Ultrasound	Rich-Mar Corp.	IMI	Class II	2002-09-13
K021172	Rsv Oia	Thermo Biostar, Inc.	GOG	Class I	2002-09-13
K020429	Ab Belt Pro	The Dezac Group	NGX	Class II	2002-09-13
K020427	Ab Belt	The Dezac Group	NGX	Class II	2002-09-13
K014141	Digibio Digtial Blood Pressure Monitor Model D11	Digibio Technology Corp.	DXN	Class II	2002-09-13
K022981	Inion Cps 2.5/2.8 Screw	Inion Oy	HWC	Class II	2002-09-12
K022872	Ge Road Warrior Pet CT Imaging System	General Electric Co.	KPS	Class II	2002-09-12
K022724	Surestep Blood Glucose Monitoring System	Lifescan, Inc.	NBW	Class II	2002-09-12
K022459	Auropal Solder M-1	Wieland Dental + Technik GmbH & Co. KG	EJT	Class II	2002-09-12
K022454	Porta Op Solder W-2	Wieland Dental + Technik GmbH & Co. KG	EJT	Class II	2002-09-12
K022295	G-Rinse, Model 10031	Vitrolife Sweden AB	MQL	Class II	2002-09-12
K022292	Impax Diagnostic Display Station,impax Clinical Review Station,impax for Cardiology Clinical Review Satation,impax Ortho	Agfa Corp.	LLZ	Class II	2002-09-12
K022278	Tmd Safety Syringe (Fa12 Series 3Ml/fa13 Series 5Ml)	Taiject Medical Device Co., Ltd.	MEG	Class II	2002-09-12
K022275	Delta 32; Delta 32 Tact	Instrumentarium Corp. Imaging Division	IZH	Class II	2002-09-12
K022110	Kawasumi Laboratories Antineedle Stick Protector for Use with Port Access Infusion Sets.	Kawasumi Laboratories Co., Ltd.	LJT	Class II	2002-09-12
K021977	Hybrid Fs & Hybrid Fs Toric (Hycofocon a) Rgp Contact Lens for Daily Wear	Contamac Ltd.	HQD	Class II	2002-09-12
K021276	Fg-36Ux Fiber Ultrasound Gastroscope	Pentax Precision Instrument Corp.	ODG	Class II	2002-09-12
K020624	Breast Bolster	Beekley Corporation	IZH	Class II	2002-09-12
K013644	Acqplan 5.0	Philips North America LLC	MUJ	Class II	2002-09-12
K022876	Modification to Infant Life Support Module-20	International Biomedical, Ltd.	FPL	Class II	2002-09-11
K022875	Modification to Bd Vacutainer Push Button Blood Collection Set	Becton Dickinson & Co	JKA	Class II	2002-09-11
K022831	Modification to Disetronic D-Tronplus Insulin Infusion Pump	Disetronic Medical Systems	LZG	Class II	2002-09-11
K022776	Ness System	Ness-Neuromuscular Electrical Stimulation Systems	IPF	Class II	2002-09-11
K022684	Portable Therapeutic Oxygen Concentration System (Ptocs)	Essex Cryogenics of Missouri, Inc.	CAW	Class II	2002-09-11
K022677	Medley Spo2 Module, Model 8210 & Spo2 Sensors & Cable	CareFusion 303, Inc	DQA	Class II	2002-09-11
K022528	Iq Products Triple-Color Flow Cytometry Reagents, Iq Products Cd45-Fitc/cd4-Pe/cd3-Cyq, Iq Products Cd45-Fitc/cd8-Pe/cdq	Iq Corp.	GKZ	Class II	2002-09-11