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 2140 of 3531

510(k) clearances, page 2140 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K943635	Ultra-Line Rongeur	V. Mueller Neuro/Spine	HAE	Class II	1994-12-07
K943532	Panoramic Corporation Hdlx	Panoramic Corp.	JAA	Class II	1994-12-07
K943239	Visualine II Hcg	Sun Biomedical Laboratories, Inc.	JHI	Class II	1994-12-07
K943199	Motorized Depth Dose Apparatus	Medtec LLC	IYE	Class II	1994-12-07
K943028	Hdl Qvet	Prisma Systems	LBS	Class I	1994-12-07
K943006	Chloride Qvet	Prisma Systems	CHJ	Class II	1994-12-07
K942962	Ggt Qvet	Prisma Systems	JQB	Class I	1994-12-07
K942861	Medvision Enviroment/medvision 2.0	Evergreen Technologies, Inc.	LMD	Class I	1994-12-07
K942856	Powder-Free Latex Examination Gloves	Pacificlink Exp.Industries Private, Ltd.	LYY	Class I	1994-12-07
K941970	Fast-Patch	Physio Control, Inc.	MKJ	Class III	1994-12-07
K940173	Candela Q-Switched Alexandrite Laser	Candela Corporation	GEX	Class II	1994-12-07
K940108	Diagnostic Ultrasound Imaging Catheter	Boston Scientific Corporation	ITX	Class II	1994-12-07
K940085	Force Recording and Analysis System, Model 01	Sense Technology, Inc.	LXM	Unclassified	1994-12-07
K936268	Comfit Blue Powdered Examination Gloves	Wembley Rubber Products (M) Sdn Bhd	LYY	Class I	1994-12-07
K924277	Disposable Hypodermic Monoplar Needle Recording	Chalgren Enterprises, Inc.	HLT	Class II	1994-12-07
K944672	Insurg Laptie Needle Driver Suturing Devices	Boston Scientific Corporation	GCJ	Class II	1994-12-06
K944383	Orion Red Urethral Catheter	Regulatory & Marketing Services, Inc.	EZD	Class II	1994-12-06
K944382	Orion All Silicone Foley Catheter	Regulatory & Marketing Services, Inc.	EZL	Class II	1994-12-06
K944377	Orion's Urinary Drainage Set	Regulatory & Marketing Services, Inc.	KNX	Class II	1994-12-06
K944255	Dma Calcium Plus Procedure	Data Medical Associates, Inc.	CJY	Class II	1994-12-06
K944125	Abbott Lte Infusion Pump	Abbott Medical	FRN	Class II	1994-12-06
K943154	Karl Stortz Obturator)sharp/blunt)/cannulae/sheaths	Karl Storz Endoscopy-America, Inc.	HRX	Class II	1994-12-06
K942350	Carepak	Precision Medical, Inc.	CAF	Class II	1994-12-06
K940065	Ses100	Southwest Ergonomics	ISD	Class II	1994-12-06
K931592	Metricide Plus 30 Liquid Chemical Germicide	Metrex Research	MED	Class II	1994-12-06
K931466	Pfc Modular Total Knee System, Porous Coated Sacri	Johnson & Johnson Orthopaedics, Inc.	JWH	Class II	1994-12-06
K931052	Metricide 28	Metrex Research	MED	Class II	1994-12-06
K930284	Metricide	Metrex Research	MED	Class II	1994-12-06
K945474	Scanlan(r) Thoracoscopic Scissors, Clamp, Forceps, Needle Holder	Scanlan Intl., Inc.	GCJ	Class II	1994-12-05
K945336	Peanut Dissector	Lorrex Health Products	GDY	Class I	1994-12-05
K945334	Cherry Pit Dissector	Lorrex Health Products	GDY	Class I	1994-12-05
K945332	Rosebud Dissector	Lorrex Health Products	GDY	Class I	1994-12-05
K945006	Collegiate Colors	Trey Optics	HQY	Class I	1994-12-05
K944941	Piston Syringe	Martell Medical Products, Inc.	CBT	Class I	1994-12-05
K944363	Model Pbd Esu Pencil	Coral Medical, Inc.	GEI	Class II	1994-12-05
K944356	Kis-II Implant System/drills	Implant Center of the Palm Beaches	DZE	Class II	1994-12-05
K944252	Biopsy Device Accessory	Biopsys Medical, Inc.	FCK	Class II	1994-12-05
K944119	Sure-Flo Irrigation Y Tubing Set	O.R. Resources, Inc.	JCX	Class II	1994-12-05
K943627	Surgisilk	Sutures, Ltd.	GAP	Class II	1994-12-05
K943527	Megabeam Lateral Fire	Ceram Optec, Inc.	GEX	Class II	1994-12-05
K943270	Surface Temperature Probes	Coast Medical Corp.	FLL	Class II	1994-12-05
K943223	Surgidek B	Sutures, Ltd.	GAR	Class II	1994-12-05
K943222	Surgidek S	Sutures, Ltd.	GAR	Class II	1994-12-05
K943221	Surgibond	Sutures, Ltd.	GAT	Class II	1994-12-05
K943220	Sutulene	Sutures, Ltd.	GAT	Class II	1994-12-05
K943218	Chromic Catgut	Sutures, Ltd.	GAL	Class II	1994-12-05
K943217	Plain Catgut	Sutures, Ltd.	GAL	Class II	1994-12-05
K943216	Surgidek	Sutures, Ltd.	GAR	Class II	1994-12-05
K943126	Electroflex	Medical Devices Inc.	GXY	Class II	1994-12-05
K942945	Cassette System for Storz	Surgin Surgical Instrumentation, Inc.	HQC	Class II	1994-12-05