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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 909 of 3530

510(k) clearances, page 909 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K120602	Apaceram Bone Graft Substitute	Hoya Corporation	MQV	Class II	2012-03-23
K120593	Myosure Control Unit	Hologic, Inc.	HIH	Class II	2012-03-23
K120538	Palls M Spinal System	Korea Bone Bank Co., Ltd.	MNI	Class II	2012-03-23
K120049	Bd Veritor System for the Rapid Detection of Flu A+b	Becton Dickinson & Co	PSZ	Class II	2012-03-23
K113866	Porcine Dermal Xenografts Porcine Dermal Matrix	Brennen Medical, Inc.	KGN	Unclassified	2012-03-23
K113748	Imris Mr/x-Ray Head Fixation Device (Hfd)	Imris, Inc.	HBL	Class II	2012-03-23
K113733	Small and Large Fragments Osteosynthesis System Neofix	Neoortho Produtos Ortopedicos S/a	HRS	Class II	2012-03-23
K113304	Bladder Scanner	MEDA Co., Ltd.	IYO	Class II	2012-03-23
K112469	General Prupose Localizers and Adapters-New Accessories for Sonowand System	Sonowand AS	HAW	Class II	2012-03-23
K112377	Bs-400 Chemistry Analyzer, Clc 720 Chemistry Analyzer	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	CFR	Class II	2012-03-23
K112064	Resorb X-G	KLS-Martin L.P.	JEY	Class II	2012-03-23
K111501	I-Lipo System	Chromogenex Technologies Limited	OLI	Class II	2012-03-23
K110520	Biolis 12I	Tokyo Boeki Medisys, Inc.	CEM	Class II	2012-03-23
K103704	Remotely Controlled Mandibular Positioner, Rcmp	Zephyr Sleep Technologies	LRK	Class II	2012-03-23
K113798	Infinity Acute Care System, Infinity Mcable- Masimo Rainbow Set	Draeger Medical Systems, Inc.	MHX	Class II	2012-03-22
K113657	Intellivue Patient Monitor	Philips Medizin Systeme Boblingen GmbH	MHX	Class II	2012-03-22
K113441	Physiological Monitor, Patient Monitor	Philips Medizinsysteme Boeblingen GmbH, Cardiac an	MHX	Class II	2012-03-22
K113265	Genii Gi 4000 Electrosugical Generator	Genii, Inc.	GEI	Class II	2012-03-22
K113220	Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation Catheter (Over-the-Wire)	Boston Scientific Corporation	LOX	Class II	2012-03-22
K113117	Nihon Kohden EEG-1200A with Je-120A Multi Channel Electrode Junction Box	Nihon Kohden America Inc	GWQ	Class II	2012-03-22
K113051	Spacelabs Arkon Anesthesia Workstation	GE Healthcare	CBK	Class II	2012-03-22
K112573	Ezsleep Sleep Quality Recorder	Platinum Team Co., Ltd.	MWJ	Class II	2012-03-22
K112478	Visi Mobile Monitoring System	Sotera Wireless	MWI	Class II	2012-03-22
K111702	Amicus Separator System- Use in Therapeutic Plasma Exchange and Filter Set for Amicus Tpe	Fenwal Inc	LKN	Unclassified	2012-03-22
K120154	Intrauterine Insemination (Iui) Catheter	Biomerics	MQF	Class II	2012-03-21
K120070	Synthes Variable Angle Lcp Elbow System	Synthes (USA) Products LLC	HRS	Class II	2012-03-21
K113865	Pultol	Sharp Corporation	DQA	Class II	2012-03-21
K113818	Embrace Wetbond Pit and Fissure Sealant, Low Fill	Pulpdent Corporation	EBC	Class II	2012-03-21
K113357	Posey Bed	J. T. Posey Co.	OYS	Class I	2012-03-21
K112887	Upstream Needle Holder, Upstream Needle Holder with Shut-Off Connector	Upstream Peripheral Technologies Ltd.	DYB	Class II	2012-03-21
K112432	Zoll X Series	ZOLL Medical Corporation	MKJ	Class III	2012-03-21
K112012	Non-Sterile, Powder-Free Blue, Nitrile Examination Gloves	UG Healthcare (USA), Inc.	LZA	Class I	2012-03-21
K112005	Non-Sterile, Powder-Free, Green Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less)	UG Healthcare (USA), Inc.	LYY	Class I	2012-03-21
K102900	Heiter 3000 Hyperthermic Perfusion System	Hei, Inc.	LGZ	Class II	2012-03-21
K120540	Biobolt	Arthrex GmbH	MAI	Class II	2012-03-20
K120363	Syngo Rt Interface	Siemens Medical Solutions USA, Inc.	MUJ	Class II	2012-03-20
K113475	Estech Cobra Adhere Xl 2 Surgical System	Endoscopic Technologies, Inc. D/B/A Estech	OCL	Class II	2012-03-20
K113122	Pipeline Cr Primary Knee System	Pipeline Orthopedics	JWH	Class II	2012-03-20
K112411	Mammotome Elite Biopsy System	Devicor Medical Products Inc	KNW	Class II	2012-03-20
K112100	M2 Navigation Catheter and Guideliner Navigation Catheter	Vascular Solutions LLC	DQY	Class II	2012-03-20
K111756	V1 System	Olympus Medical Systems Corp.	FDF	Class II	2012-03-20
K103623	Newdeal Interphalangeal Implant	Newdeal SAS	HTY	Class II	2012-03-20
K120557	Solitarie Peek Anterior Spinal System-to Be Called Colitaire 35	Biomet Spine & Bone Healing Technologies	OVD	Class II	2012-03-19
K120544	Response Electrophysiology Catheters with Lumen	Abbott Medical	DRF	Class II	2012-03-19
K120453	Filtek Bulk Fill Flowable Restorative	3M ESPE Dental Products	EBF	Class II	2012-03-19
K120197	Abl90 Flex	Radiometer Medical ApS	CHL	Class II	2012-03-19
K113854	Pleurx Peritoneal Catheter System	Care Fusion	PNG	Class II	2012-03-19
K113808	The Sherlock 3Cg Tip Confirmation System (Tcs)	C.R. Bard Inc	LJS	Class II	2012-03-19
K113618	Clearcorrect System	ClearCorrect, LLC	NXC	Class II	2012-03-19
K112682	Metha Hip System	Aesculap Inc	LZO	Class II	2012-03-19