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 2026-10-26, 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 778 of 3530

510(k) clearances, page 778 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K131917	Neurodyn Compact, Neurodyn II	Ibramed Equipamentos Medicos	IPF	Class II	2014-04-29
K140839	Caiman Seal and Cut Technology	Aesculap Inc	GEI	Class II	2014-04-28
K140733	Constellation Multiple Electrode Recording & Pacing Catheter	Boston Scientific Corporation	MTD	Class II	2014-04-28
K140517	Surgiseal Topical Skin Adhesive/surgiseal Stylus Topical Skin Adhesive	Adhezion Biomedical, LLC	MPN	Class II	2014-04-28
K140501	Xenmatrix Surgical Graft	Bard Access Systems, Inc.	FTM	Class II	2014-04-28
K140031	Suction Pump	Ding Hwa Co., Ltd.	JCX	Class II	2014-04-28
K133857	Brella-Spec(tm) Vaginal Speculum	Proa Medical, Inc.	HIB	Class II	2014-04-28
K133821	Emprint Ablation System	Medtronic, Inc.	NEY	Class II	2014-04-28
K133653	Anatomic Peek Ptc Cervical Fusion System	Medtronic Sofamor Danek USA Inc	ODP	Class II	2014-04-28
K133652	Gsp Neonatal Total Galactose Kit	Wallac Oy, A Subsidiary of Perkinelmer, Inc.	JIA	Class I	2014-04-28
K133580	Artis One	Siemens Medical Solutions USA, Inc.	OWB	Class II	2014-04-28
K133542	Puracyn Plus Skin and Wound	Innovacyn, Inc.	FRO	Unclassified	2014-04-28
K133537	Egv1.1 Self Monitoring Blood Glucose System and Egv1.1 Pro Monitoring Blood Glucose System	Eps Bio Technology Corp.	LFR	Class II	2014-04-28
K133271	Opteo, Videograph Hd	Owandy Inc.	MUH	Class II	2014-04-28
K132184	Acessa Guidance Handpiece	Halt Medical, Inc.	HFG	Class II	2014-04-28
K132179	Arasys	Ion Genius, Inc.	NGX	Class II	2014-04-28
K132042	Amb101 System, Amblyz, Lcg System, Xpand	X6d, Ltd.	HOY	Class I	2014-04-28
K130889	Split Cath Rg	Medcomp	MSD	Class II	2014-04-28
K140857	Influenza B Lineage Genotyping Kit, Cdc Human Influenza Virus Real-Time Rt-PCR Diagnostic Panel	Centers for Disease Control and Prevention	OZE	Class II	2014-04-25
K140851	Influenza a Subtyping Kit, Cdc Human Influenza Virus Real-Time Rt-PCR Diagnostic Panel	Centers for Disease Control and Prevention	OEP	Class II	2014-04-25
K140834	Terason Usmart3400 Ultrasound System	Teratech Corp.	IYN	Class II	2014-04-25
K140771	Philips Eleva Workspot	Philips Medical Systems DMC GmbH	MQB	Class II	2014-04-25
K140764	Liquichek Immunologycontrol-Level 1,Level 2, Level 3, Minipak	Bio-Rad Laboratories Inc.	JJY	Class I	2014-04-25
K140749	Infinity Total Ankle System	Wrightmedicaltechnologyinc	HSN	Class II	2014-04-25
K140742	Reliance Anterior Cervical Plate	Reliance Medical Systems, LLC	KWQ	Class II	2014-04-25
K140677	Mylabssogno	Esaote S.p.A.	IYN	Class II	2014-04-25
K140617	Pinit Small Bone Fusion System	Arthrosurface, Inc.	HRS	Class II	2014-04-25
K140247	Mta Fillapex	Angelus Industria de Productos Odontologicos	KIF	Class II	2014-04-25
K140179	Easy Go Vac	Precision Medical, Inc.	BTA	Class II	2014-04-25
K134045	Zimmer Zfx Titanium Abutment, Base Abutment and Abutment Blank for Nobelactive Implant System	ZimVie US Corp LLC	NHA	Class II	2014-04-25
K134023	2300 Series Mgo Portable Oxygen	Ultra Electronics Limited Precision Air & Land SY	CAW	Class II	2014-04-25
K133951	Smarttouch	Nexus6, Ltd.	CAF	Class II	2014-04-25
K133588	Fora Care Blood Pressure Monitoring System	Foracare, Inc.	DXN	Class II	2014-04-25
K133237	Gel-Bead Embolization Spheres	Vascular Solutions LLC	KRD	Class II	2014-04-25
K132933	The Moses Elite Appliance	Allen J. Moses, Dds, Ltd.	LRK	Class II	2014-04-25
K131946	Entax Ultrasound Video Bronchoscope Eb-1970Uk + Hi Visin Preirus	PENTAX of America, Inc.	EOQ	Class II	2014-04-25
K123607	Octane Elevate Spinal Implant System	Exactech, Inc.	MAX	Class II	2014-04-25
K140763	Monofilament Polypectomy Snare	United States Endoscopy	FDI	Class II	2014-04-24
K140123	Polaris Spinal System -Translation Screw	Ebi, LLC	NKB	Class II	2014-04-24
K140080	Envoy Distal Access (Da) Guiding Catheter, 6F, 95Cm & 105Cm, Straight & Xb, Mpd & Xb, Mpc & Xb	Cerenovus, Inc.	DQY	Class II	2014-04-24
K134013	Lyphochek Allergen Sige Control, Negative, Lypochek Allergen Sige Control, Negative Minipak, Lyphochek Allergen Sige Co	Bio-Rad Laboratories Inc.	JJY	Class I	2014-04-24
K133870	Fluid Level Monitor	Coleman Laboratories	FLN	Class II	2014-04-24
K133278	Discovery Igs 740	GE Medical Systems SCS	OWB	Class II	2014-04-24
K133007	Dx3000-L	Dexcowin Co., Ltd.	MUH	Class II	2014-04-24
K132993	Counter OTC TENS Device	Counter Scientific Development (Gz), Ltd.	NUH	Class II	2014-04-24
K132882	Electric Breast Pump	Shantou Xinghe Electrical Apparatuses Co., Ltd.	HGX	Class II	2014-04-24
K132563	Pinook Stimulator	Pinook USA	NUH	Class II	2014-04-24
K132433	Acclarent Cyclops Multi-Angle Endoscope	Acclarent Inc	EOB	Class II	2014-04-24
K131956	Quick Relax Pro	Healthcare Innovations, LLC	NUH	Class II	2014-04-24
K131838	Diode Laser for Hiar Removal	Beijing Honkon Technologies Co., Ltd.	GEX	Class II	2014-04-24