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 1432 of 3531

510(k) clearances, page 1432 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K032559	Synthes 4.0Mm Titanium (Ti.) Locking Screws	Synthes (USA) Products LLC	HRS	Class II	2003-10-22
K032532	Taras Threaded Fixation Pin	Union Surgical, LLC	JDW	Class II	2003-10-22
K032523	T2 Nailing System	Howmedica Osteonics Corp	HSB	Class II	2003-10-22
K032477	Ge Logiq Book	General Electric Co.	IYN	Class II	2003-10-22
K032449	Thermassage Energy Product, Model Hy5000	Migun Medical Instrument Co., Ltd.	JFB	Class II	2003-10-22
K032420	Modified Coated Vicryl Plus Antibacterial (Polyglactin 910) Synthetic Absorbable Suture	Ethicon, Inc	GAM	Class II	2003-10-22
K032392	Morales Protraction Facemask	Ortosim, S.A. de C.V.	DZB	Class II	2003-10-22
K032374	Powder-Free Nitrile Patient Chemotherapy Examination Glove, Blue Colored	Perusahaan Getah Asas Sdn. Bhd.	LZC	Class I	2003-10-22
K032093	Pariefix	Sofradim Production	GCJ	Class II	2003-10-22
K031953	West Nile Virus Elisa Igg, Model El0300g	Focus Technologies, Inc.	NOP	Class II	2003-10-22
K031952	West Nile Virus Igm Capture Elisa, Model El0300m	Focus Technologies, Inc.	NOP	Class II	2003-10-22
K031875	Inter-Os Limb Lengthener	Inter-Os Technologies	KTT	Class II	2003-10-22
K031455	Conklusion Pedicle Screw System	Signus Medical, LLC	MNI	Class II	2003-10-22
K031329	Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared Probe (Optional Accessory)	Dynatronics Corp.	IMI	Class II	2003-10-22
K031307	Ferris Polymem Silver Wound Dressing	Ferris Mfg. Corp.	FRO	Unclassified	2003-10-22
K023139	Romed Latex Surgical Gloves, Powdered, Sterile	Van Oostveen Medical B.V.	KGO	Class I	2003-10-22
K022679	Raphael	Hamilton Medical AG	CBK	Class II	2003-10-22
K033253	S21 Transcutaneous Electrical Nerve Stimulator	Micro Current Technology, Inc.	GZJ	Class II	2003-10-21
K032985	Glucoleader Enhance Self-Monitoring of Blood Glucose System	HMD Biomedical, Inc.	NBW	Class II	2003-10-21
K032974	Ge Logiq 5 Pro or Expert	General Electric Co.	IYN	Class II	2003-10-21
K032917	Navitrack System - Total Hip Replacement CT-Free	Orthosoft, Inc.	HAW	Class II	2003-10-21
K032608	Gonotec Calibration Solution 300 Mosmol/kg for Osmometer	Gonotec Gesellschaft Fuer Mess-Und Regeltechnik MB	JIS	Class II	2003-10-21
K032465	Mini l.e.d., Model: Mini l.e.d., Model Smartlite Mini	Satelec	EBZ	Class II	2003-10-21
K032351	The Maestro System 3.0Mm Diameter Implant	BioHorizons Implant Systems Inc	DZE	Class II	2003-10-21
K032337	Hemedex Cranial Bolt Models, 3601, 3602	Hemedex Incorporated	GWM	Class II	2003-10-21
K032312	Attain 6226Def Deflectable Catheter Delivery System	Medtronic, Inc.	DQY	Class II	2003-10-21
K032166	Binax Now Rsv Test, Model 430-000 and Binax Now Nasopharyngeal Swab Accessory Pack, Model 400-065	Binax, Inc.	GQG	Class I	2003-10-21
K032074	Linical Esoterics Calibration Verifiers Levels a-E for Beckman Coulter Synchron Analyzers	Cliniqa Corporation	JJY	Class I	2003-10-21
K030348	Biopure Portable Ro System,biopure 4400 Series Ro System, Biopure 8400 Series Ro System,biopure Water Purfication Pretre	Biolab Equipment Canada, Ltd.	FIP	Class II	2003-10-21
K030256	ISO-Elastic Cerclage System	Kinamed Inc	JDQ	Class II	2003-10-21
K023885	Combi-Screen, Models 10Sl and 11Sl	Analyticon Biotechnologies AG	JIL	Class II	2003-10-21
K033248	Hitachi Cb Mercuray Dental Cone-Beam X-Ray System	FUJIFILM Healthcare Americas Corporation	MUH	Class II	2003-10-20
K033243	Iti Synocta Meso Abutments	Straumann USA, LLC	NHA	Class II	2003-10-20
K033121	1.3 & 1.5Mm Contourable Titanium (Ti.) Mesh Plates	Synthes (USA) Products LLC	JEY	Class II	2003-10-20
K032978	Modification to Ciba Vision Centurion Ses Spikeratome	Alcon Laboratories	HNO	Class I	2003-10-20
K032939	Ept Certainty Pregnancy Test	Unipath, Ltd.	LCX	Class II	2003-10-20
K032819	Glucose Control Solution for Chdiagnostics Senova, Chdignostics Senova Blood Glucose Test System	Bionostics, Inc.	JJX	Class I	2003-10-20
K032289	Fit Checker II	GC America Inc.	ELW	Class II	2003-10-20
K032947	Nellcor Compatible Dolphin 2000 Y Oximetry Sensor, Model 2210	Dolphin Medical, Inc.	DQA	Class II	2003-10-17
K032899	Radius Cougar Wire	Radius Medical Technologies, Inc.	DQX	Class II	2003-10-17
K032842	Microgenics Cyclosporine Control Kit	Microgenics Corporation	LAS	Class I	2003-10-17
K032801	Modified Browne Packaging and Label Steam Process Indicator	Sybron Dental Specialties, Inc.	JOJ	Class II	2003-10-17
K032746	Shanghai Giantmax Clear Vinyl Powder Free Examination Gloves	Shanghai Giantmax Plastic Product Corp.	LYZ	Class I	2003-10-17
K032745	Shanghai Giantmax Powdered Clear Vinyl Examination Gloves	Shanghai Giantmax Plastic Product Corp.	LYZ	Class I	2003-10-17
K032501	Maxter Sterile Powder Free Surgical Gloves	Maxter Glove Manufacturing Sdn Bhd	KGO	Class I	2003-10-17
K032395	Prophy-Mate	Nakanishi Inc.	EFB	Class I	2003-10-17
K032311	Roche Diagnostics Omni S Analyzer	Roche Diagnostics GmbH	CEM	Class II	2003-10-17
K031497	Amedica Drug Screen Mdma-Bar-Bzo-Mtd-Tca Test	Amedica Biotech, Inc.	DJC	Class II	2003-10-17
K031066	Viewmate Ultrasound Imaging System	Abbott Medical	IYN	Class II	2003-10-17
K030922	Vivasens	Ivoclar Vivadent, Inc.	LBH	Class II	2003-10-17