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 1238 of 3531

510(k) clearances, page 1238 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K062520	Powdered Vinyl Patient Examination Gloves	Jiangsu Jaysun Glove Co., Ltd.	LYZ	Class I	2006-10-11
K060163	Cardioflon, Cardioxyl	Peters Surgical	GAT	Class II	2006-10-11
K053585	Vanguard Reprocessed Suture Passer	Stryker Sustainability Solutions	NLM	Class II	2006-10-11
K050158	Sinclair Seborrhea Emulsion	Sinclair Pharmaceuticals Ltd	FRO	Unclassified	2006-10-11
K062829	Diachex Blood Glucose Monitoring System	Tyson Bioresearch, Inc.	NBW	Class II	2006-10-10
K062777	Microscan Microstrep Plus Panel, Clindamycin	Siemens Healthcare Diagnostics Inc.	LTT	Class II	2006-10-10
K062729	Surgisis Rvp Recto-Vaginal Fistula Plug	Cook Biotech, Inc.	FTM	Class II	2006-10-10
K062421	Mentor Resterilizable Gel Breast Implant Sizer	Mentor	MRD	Unclassified	2006-10-10
K062309	Karma Manual Wheelchair, Models S-Ergo 305 and S-Ergo 105	Karma Medical Products Ltd.	IOR	Class I	2006-10-10
K062257	Starion Instruments Thermal Litigating Shears	Microline Surgical, Inc	GEI	Class II	2006-10-10
K062209	Basx Bladeless Trocar	Ethicon Endo-Surgery Inc	GCJ	Class II	2006-10-10
K061660	Stryker RF Parallel Bipolar Adaptor Cable	Stryker Corp.	GEI	Class II	2006-10-10
K061417	Genicon Disposable Electrosurgical Instrumentation, Model 533-005-910	Genicon, Inc.	GEI	Class II	2006-10-10
K060538	Beaverite Body Fat Scales, Models 8901, 8903, 8905, 8909, 8911, 8915, 9563 and 9568	Beaverite International Limited	MNW	Class II	2006-10-10
K053538	Modification to Phytacare Alginate Hydrogel Wound Filler	Curapharm, Inc.	FRO	Unclassified	2006-10-10
K062818	Flexitouch System	Tactile Systems Technology Inc	JOW	Class II	2006-10-06
K062685	Ebi Aray Spinal System	Ebi, LLC	NKB	Class II	2006-10-06
K062634	Orthoxp	Imaging Dynamics Company, Ltd.	KPR	Class II	2006-10-06
K062609	Modification to Angiodynamics Profiler Pta Balloon Catheter	Boston Scientific Corporation	DQY	Class II	2006-10-06
K062552	Rtvue	Optovue Inc.	OBO	Class II	2006-10-06
K062302	Millicore Ab Digivent Chest Drainage System	Millicore AB	KDQ	Class II	2006-10-06
K062136	Pass 2 Spinal System	Medicrea	MNI	Class II	2006-10-06
K062054	5 Megapixel Monochrome Lcd Monitor, Radiforce Gs510	Eizo Nanao Corporation	LLZ	Class II	2006-10-06
K061804	Zerion Alpha, ; Zerion Beta	Etkon International GmbH	EIH	Class II	2006-10-06
K061614	Terraquant Mq2000 V. 5 and Handyrx Mq2007 Lasers	Escada International, Inc.	ILY	Class II	2006-10-06
K061362	Pigalileo Total Knee Replacement (Tkr) System	Plus Orthopedics	HAW	Class II	2006-10-06
K061232	Acryderm Silver Antimicrobial Thin Film, Model 2006	Acrymed, Inc.	FRO	Unclassified	2006-10-06
K061219	D-Stat Dry Hemostatic Bandage	Vascular Solutions LLC	QSX	Unclassified	2006-10-06
K060927	Ceres Pta Catheter Models Pta018,pta035 Various Sizes	Ceres Medical Systems, LLC	DQY	Class II	2006-10-06
K053590	Silverlon Ca (Calcium Alginate)	Argentum Medical, LLC	FRO	Unclassified	2006-10-06
K052223	Access Epo Assay	Siemens Healthcare Diagnostics Inc.	GGT	Class II	2006-10-06
K050197	Minitube Temperature Control Unit Sc-2000 + 2045	Minitube of America, Inc.	MQG	Class II	2006-10-06
K062779	Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens Protector (Delp)	New Wave Surgical Corporation	GCJ	Class II	2006-10-05
K062730	Non-Spermicidal Lubricated Male Latex Condoms	Biogreen Medical Sdn. Bhd.	HIS	Class II	2006-10-05
K062686	Universal Spinal Anterior Locking Plate System	Advanced Spine Technology, Inc.	KWQ	Class II	2006-10-05
K062680	Bd Phoenix Automated Microbiology System - Ticarcillin (Gn) 1-128 Ug/ml	Becton Dickinson & Co	LON	Class II	2006-10-05
K062556	Echelon Shoulder Coil	FUJIFILM Healthcare Americas Corporation	MOS	Class II	2006-10-05
K062529	Belmax Cm Model X168	Takara Belmont USA, Inc.	MUH	Class II	2006-10-05
K062516	Access Thyroglobulin Antibody II Assay, Models A32898 (Reagent) and A36920 (Calibrators)	Siemens Healthcare Diagnostics Inc.	JNL	Class II	2006-10-05
K062387	Small Peripheral Cutting Ballon, Monorail Delivery System	Boston Scientific Corporation	PNO	Class II	2006-10-05
K062386	Qangio CT	Medis Medical Imaging Systems, B.V.	JAK	Class II	2006-10-05
K062360	Bransist Safire	Shimadzu Corp.	IZI	Class II	2006-10-05
K062351	Syngo Dual Energy	Siemens Medical Solutions USA, Inc.	JAK	Class II	2006-10-05
K062337	Modular Laparoscopy Accessories, Handle; Sissors (Straight and Curved); Grasper (Aggressive, Allis, Ataumatic; Dissector	Apyx Medical Corporation	GEI	Class II	2006-10-05
K062138	Powder Free Sterile Nitrile Examination Gloves, Blue; Powder Free Polychloroprene Sterile Examination Glove	Molnlycke Health Care	LZA	Class I	2006-10-05
K062061	Urassist	Preferred Medical Devices, Inc.	NZU	Class I	2006-10-05
K062047	Adaptable Monopolar Adaptable And/or Retractable Electrodes	Pajunk GmbH Medizintechnologie	GEI	Class II	2006-10-05
K062032	Accusoft, Accusoft Xl	Direx Systems Corp.	MUJ	Class II	2006-10-05
K061984	Treasure	Asahi Intecc Co., Ltd.	DQX	Class II	2006-10-05
K061626	Vasoring* Vrc Vascular Ring Connector	Sunwei Tech Co., Ltd.	DSY	Class II	2006-10-05