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 1441 of 3531

510(k) clearances, page 1441 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K032280	Siremobil ISO-C 3D	Siemens Corp.	IZL	Class II	2003-09-10
K032271	Wartner Wart Removal System, Model 66715 82000 (Product Code Number 52E022)	Wartner USA B.V.	GEH	Class II	2003-09-10
K032134	Tsh Receptor Antibody (Trab) Coated Tube (CT) Assay Kit	Kronus Market Development Associates, Inc.	JZO	Class II	2003-09-10
K031815	Intera-Sensation Family	Philips North America LLC	LNH	Class II	2003-09-10
K031800	Solarc/solrx 500 Series Ultraviolet Phototherapy Lamp Unit Family a New Medical Device Family Consisting of 5 Models:	Solarc Systems Inc.	FTC	Class II	2003-09-10
K031659	Universal Neuro System	Stryker Corp.	JEY	Class II	2003-09-10
K031563	Bindazyme Clq Cic Eia Kit	The Binding Site	DAK	Class II	2003-09-10
K031287	Steri-Drape Surgical Drapes	3M Company	KKX	Class II	2003-09-10
K030790	Osteomed Alveolar Distraction System	Osteomed	MQN	Class II	2003-09-10
K030734	Pathway Access Sheath Catheter	Vertelink Corporation	DYB	Class II	2003-09-10
K032600	Vaxcel Port, Model 45-333 and Vaxcel W/pasv Port, Model 45-233	Boston Scientific Corporation	LJT	Class II	2003-09-09
K032557	Triumph Vtx with Lifevalve Catheter	Boston Scientific Corporation	LJT	Class II	2003-09-09
K032528	Bd Eclipse Bifurcated Needle	Becton Dickinson & Co	SCL	Class II	2003-09-09
K032525	Bayer Advia Centaur Automated Chemiluminescence Analyzer	Medrad, Inc.	NBC	Class II	2003-09-09
K032492	Blood Pressure Monitor, Model Kp-7000	K-Jump Health Co., Ltd.	DXN	Class II	2003-09-09
K032238	Twister Superelastic Ligating Clip and Applier	Neurosel (Medical) Limited	FZP	Class II	2003-09-09
K032233	Medley Pca Module, Model 8120	CareFusion 303, Inc	MEA	Class II	2003-09-09
K032179	Comp. E	Parkell, Inc.	KLE	Class II	2003-09-09
K032149	Rita Model 1500X Electrosurgical RF Generator	Boston Scientific Corporation	GEI	Class II	2003-09-09
K032122	Audit Microcontrols Microfd Bnp Control	Aalto Scientific Ltd.	JJY	Class I	2003-09-09
K031970	Infinity Megacare	Siemens Medical Solutions USA, Inc.	DQK	Class II	2003-09-09
K031849	Spectrum Patient Monitor, Model 0998-00-0500-Xxxxx	Datascope Corp.	MHX	Class II	2003-09-09
K031810	Amplatzer Vascular Plug	Abbott Medical	KRD	Class II	2003-09-09
K031805	Blu-U, Model 4170	Dusa Pharmaceuticals, Inc.	GEX	Class II	2003-09-09
K030702	Immulisa Anti-Beta2 Glycoprotein I (B2gp1) Igm Elisa	Immco Diagnostics, Inc.	MSV	Class II	2003-09-09
K030701	Immulisa Anti-Beta2 Glycoprotein I (B2gp1) Igg Elisa	Immco Diagnostics, Inc.	MSV	Class II	2003-09-09
K030622	Axiom Biolaser Lllt Series-1	Axiom USA., Inc.	NHN	Class II	2003-09-09
K030563	Arabella Ncpap Masks	Hamilton Medical AG	BZD	Class II	2003-09-09
K022752	Pandin Continuous Nerve Stimulating Catheter, Models 561-18-05, 561-18-09, 561-18-15, 562-18-05, 562-18-09 & 562-18-15	Hdc Corp.	CAZ	Class II	2003-09-09
K032549	Matang Powder-Free Polychloroprene Patient Examination Gloves	Matang Mfg. Sdn. Bhd.	LZA	Class I	2003-09-08
K032524	Advia 60 Hematology Analyzer	Medrad, Inc.	GKZ	Class II	2003-09-08
K032039	Immature Granulocyte (Ig) Parameter on the Sysmex Model Xe-2100 Automated Hematology Analyzer	Sysmex America, Inc.	GKZ	Class II	2003-09-08
K031850	Durasis Dural Substitute	Cook Biotech, Inc.	GXQ	Class II	2003-09-08
K031377	Sysmex Automated Coagulation Analyzer Ca500 Series (Ca-510, -520, -530, -540. -550, and -560	Siemens Healthcare Diagnostics Inc.	GKP	Class II	2003-09-08
K031108	Synthetic (White) Vinyl Patient Examination Gloves-Powder Free	Shijiazhuang Great Vision Plastic Products Co., LT	LYZ	Class I	2003-09-08
K023582	I-Stat Kaolin Act Test	I-Stat Corp.	JBP	Class II	2003-09-08
K021471	Marquette Huber Trap Safety Infusion Set	Marquette Medical, Inc.	FPA	Class II	2003-09-08
K032594	One Dimensional Water Phantom, Wp 1D	Wellhofer Dosimetrie	IYE	Class II	2003-09-05
K032589	Enclose II Anastomosis Assist Device	Novare Surgical Systems, Inc.	DXC	Class II	2003-09-05
K032507	Interlok Bio-Modular Humeral Stems	Zimmer GmbH	KWT	Class II	2003-09-05
K032494	Pvs 1700 Steerable Delivery System Microcatheter	Precision Vascular Systems, Inc.	KRA	Class II	2003-09-05
K032430	Acueity Medical Light Source	Acueity, Inc.	FCW	Class II	2003-09-05
K032365	Benzodiazepine Enzyme Immunoassay	Lin-Zhi International Inc	JXM	Class II	2003-09-05
K032237	N/t Protein Control	Siemens Healthcare Diagnostics Inc.	JJY	Class I	2003-09-05
K032159	Carestart-Pregnancy and Carestart Plus-Pregnancy	Access Bio Incorporate	LCX	Class II	2003-09-05
K032038	Pyramis ECG Management System Model Numbers, 92600 and 92601	Quinton, Inc.	DQK	Class II	2003-09-05
K032027	Cholestech Ldx Aspartate Aminotransferase (Ast)	Cholestech Corp.	CIS	Class II	2003-09-05
K031973	Synthes 4.0 Mm Adjustable Clamp for Distal Radius Fixator-Mr Safe	Synthes (USA) Products LLC	LXT	Class II	2003-09-05
K031964	Bpcard	VectraCor, Inc.	DXN	Class II	2003-09-05
K031938	Gel Mark III Biopsy Site Marker	Senorx, Inc.	NEU	Class II	2003-09-05