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 1871 of 3531

510(k) clearances, page 1871 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K972651	In-Sling	Influence, Inc.	OTN	Class II	1997-09-19
K972599	Acufex Screw Cannula	Smith & Nephew Endoscopy, Inc.	HWC	Class II	1997-09-19
K972568	Depuy Motech Moss-Miami Spinal System	Depuy, Inc.	MNH	Class II	1997-09-19
K972458	Lyocell Wound Dressing/surgical Sponge	Courtaulds Fibers, Inc.	MGP	Unclassified	1997-09-19
K972415	Minisitebipolar Forceps* Device	United States Surgical, A Division of Tyco Healthc	GEI	Class II	1997-09-19
K972410	Impervious Isolation Gown	Kentron Health Care, Inc.	FYC	Class II	1997-09-19
K972393	Inter-Op Ha Porous Acetabular System (Ha/csti)	Sulzer Orthopedics, Inc.	LPH	Class II	1997-09-19
K972347	Modified Coherent Versapulse Aesthetic Surgical Laser	Lumenis Ltd	GEX	Class II	1997-09-19
K972325	Pulsemaster 1000 St Dental Laser System	American Dental Technologies, Inc.	GEX	Class II	1997-09-19
K972008	Endoscopic Electrosurgical Instruments and Electrodes	European Surgical, Inc.	GEI	Class II	1997-09-19
K971984	Amplatz Thrombectomy Device(atd 603,602,801,802)/Foot Pedal Assembly(ak 200)	Microvena Corp.	MCW	Class II	1997-09-19
K971917	Kentron's Isolation Gown	Kentron Health Care, Inc.	FYC	Class II	1997-09-19
K971913	Gr100f Urine Flowmeter	Albyn Medical, Ltd.	EXY	Class II	1997-09-19
K971728	Pioneer Elec-Trocar Device	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	GEI	Class II	1997-09-19
K971586	Digene Cervical Brush	Qiagen	HHT	Class II	1997-09-19
K971569	Dinamap Mps Portable Monitor	Johnson & Johnson MEDICAL GmbH	MSX	Class II	1997-09-19
K971067	Digi-Injector	Medical Instrument Development Laboratories, Inc.	MRH	Class II	1997-09-19
K965154	Tst Control Integrator for Steam Autoclave	Sybron Dental Specialties, Inc.	LRT	Class II	1997-09-19
K973101	Prostate Specific Antigen Method	Dade Chemistry Systems, Inc.	LTJ	Class II	1997-09-18
K972949	Aurelux Bio Y85pf	Aurex Precious Metal Industries (Pty)Ltd	EJT	Class II	1997-09-18
K972540	S-357 Video Imaging System	Sopro	FET	Class II	1997-09-18
K972527	Phaseal, System for Sealed Handling of Chemotherapeutic Agents	Quality System Consulting	FPA	Class II	1997-09-18
K972505	Resuable Hot Biopsy Forceps	United States Endoscopy Group, Inc.	KGE	Class II	1997-09-18
K972493	Nipro Disposable Solution Infusion Set	Nipro Medical Corporation	FPA	Class II	1997-09-18
K972424	Silentnite	Glidewell Laboratories	LRK	Class II	1997-09-18
K972317	Montgomery Thyroplasty Implant System	Boston Medical Products, Inc.	MIX	Class II	1997-09-18
K972311	Model 20 Bipolar Coagulator	Boston Surgical Products, Inc.	GEI	Class II	1997-09-18
K971543	Luxmatic 12-15 Isc Portable Electric Breast Pump	Kaweco GmbH	HGX	Class II	1997-09-18
K970780	One-Way Valve (with Connector)	Instrumentation Industries, Incorporated	CBP	Class II	1997-09-18
K962379	Seager Electroejaculator	National Rehab Hospital	LNL	Unclassified	1997-09-18
K973016	Norma Kamlali/alfred Sung/roots of Canada/steel Maxx Sunglass	Optimaxx Intl.	HQY	Class I	1997-09-17
K972875	Cosmopost	Ivoclar North America, Inc.	ELR	Class I	1997-09-17
K972850	Sunglasses	Indoptica, S.A.	HQY	Class I	1997-09-17
K972827	Ips Empress Cosmo Ingot	Ivoclar North America, Inc.	EIH	Class II	1997-09-17
K972417	The 6.0 X 8.0Mm Dental Implant System	Bicon, LLC	DZE	Class II	1997-09-17
K972301	Big Ben Square, Big Ben Round	Rudolf Riester GmbH & Co. KG	DXQ	Class II	1997-09-17
K972290	Acs Hi-Torque Ruler Guide Wire	Boston Scientific Corporation	DQX	Class II	1997-09-17
K972283	Sims 1St Response Manual Resuscitator, Adult	Sims	BTM	Class II	1997-09-17
K971508	Rhmk II Cell Culture, an Expanded Primary Rhesus Monkey Kidney Cell Culture	Bio-Whittaker, Inc., A Cambrex Co.	KIR	Class I	1997-09-17
K971145	Glucosite Test System	Gds Technology, LLC	CGA	Class II	1997-09-17
K970589	Microetcher Ap	Danville Engineering, Inc.	KOJ	Class II	1997-09-17
K972943	Aurecast 92	Aurex Precious Metal Industries (Pty)Ltd	EJT	Class II	1997-09-16
K972890	Enlight (Tentative Name)	Sybron Dental Specialties, Inc.	DYH	Class II	1997-09-16
K972573	Liqcrylic Pro Dental Resin	Dentsply Intl.	EBI	Class II	1997-09-16
K972398	Stealthstation Passive Instrument Option	Surgical Navigation Technologies, Inc.	HAW	Class II	1997-09-16
K972354	Abbott Cell-Dyn 3200 System	Abbott Medical	GKZ	Class II	1997-09-16
K972313	The Maestro System	BioHorizons Implant Systems Inc	DZE	Class II	1997-09-16
K971923	Drager-Vapor 2000	Draeger, Inc.	CAD	Class II	1997-09-16
K971470	Micro21 with Cerebrospinal Fluid	Triangle Biomedical Sciences, Inc.	JOY	Class II	1997-09-16
K971095	Opportunity Suture Removal Kit	Opportunity, Inc.	EFQ	Unclassified	1997-09-16