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 930 of 3530

510(k) clearances, page 930 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K103424	Safire	Siemens Medical Solutions USA, Inc.	JAK	Class II	2011-11-22
K113209	Chiba Sono	Pajunk GmbH Medizintechnologie	KNW	Class II	2011-11-21
K113174	Cd Horizon Spinal System	Medtronic Sofamor Danek USA Inc	NKB	Class II	2011-11-21
K112724	Depuy Pulse Anterior Cerical Plate System	Medos International SARL	KWQ	Class II	2011-11-21
K112551	S4 Spinal System	Aesculap Implant System, Inc.	NKB	Class II	2011-11-21
K112493	Pass Lp Spinal System	Medicrea International	MNI	Class II	2011-11-21
K112425	Infiniti Vision System Evergreen II Autosert IOL Injector Handpiece	Alcon Manufacturing, Ltd.	HQC	Class II	2011-11-21
K112405	Clydesdales Spinal System	Medtronic Sofamor Danek USA Inc	MAX	Class II	2011-11-21
K112168	Componeer	Coltene /Whaledent AG	EBF	Class II	2011-11-21
K112097	Gibralt Spine Systems Facet Screw 04.0,04.5	Exactech, Inc.	MRW	Unclassified	2011-11-21
K110614	Pad (Personal Alcohol Detector) Breath Alcohol Test System	Seju Engineering Co., Ltd.	DJZ	Class I	2011-11-21
K103530	Spirodoc	Medical International Research USA Inc.	BZG	Class II	2011-11-21
DEN100026	Aptus Steerable Endoguide with Obturator, Aptus Endostaple Applier with Endostaple Cassette, Aptus Endostaple Cassette	Aptus Endosystems, Inc.	OTD	Class II	2011-11-21
K113029	Syngo via Mi Workflows	Siemens Medical Solutions USA, Inc.	LLZ	Class II	2011-11-18
K112768	Calypso Systems with Dynamic Edge Gating	Calypso Medical Technologies, Inc.	LHN	Class II	2011-11-18
K112554	Transradial Artery Access Devices	Teleflexmedical, Inc.	DYB	Class II	2011-11-18
K112531	Vitrea CT Myocardial Analysis	Canon Medical Informatics, Inc.	LLZ	Class II	2011-11-18
K112420	Oncentra Prostate 4.0	Nucletron BV	JAQ	Class II	2011-11-18
K112219	Tapas Catheter	Thermopeutix, Inc.	MJN	Class II	2011-11-18
K112132	Krystalrad 660 Digital Radiographic Portable Retrofit System	Medicatech USA	MQB	Class II	2011-11-18
K112053	Obc Bone Anchored Hearing System	Oticon Medical AB	MAH	Class II	2011-11-18
K112050	Soundstar Eco Diagnostic Ultrasound Catheter	Biosense Webster Inc	OBJ	Class II	2011-11-18
K112002	Carotid Coil	Shanghai Chenguang Medical Technologies Co, Ltd	MOS	Class II	2011-11-18
K111983	Vista-S Device Model 08/06-401-Xxxxx, 08/06-402-Xxxxxx	Zimmer Trabecular Metal Technology, Inc.	ODP	Class II	2011-11-18
K111960	Elitech Clinical Systems Carbon Dioxide Electrode, Elitech Clinical Systems Ise Calibrators	ELITechGroup Inc	KHS	Class II	2011-11-18
K111709	Foundation Dental Resin	Unix-Japan Co., Ltd.	EBI	Class II	2011-11-18
K111642	Onco Trac Model 1, 2, 4	Translational Sciences Corporation	LLZ	Class II	2011-11-18
K111593	Guardian Inflatable Bone Expander System	BM Korea Co., Ltd.	NDN	Class II	2011-11-18
K111358	Synthes Uss	Synthes GmbH	NKB	Class II	2011-11-18
K111290	Piezo Bone Surgery	Guilin Woodpecker Medical Instrument Co., Ltd	DZI	Class II	2011-11-18
K111216	Osseotite 2 Dental Implants	ZimVie US Corp LLC	DZE	Class II	2011-11-18
K110962	Ambu Ascope 2	Ambu A/S	BTR	Class II	2011-11-18
K110762	Avo Barrier Topical Emulsion	Trigen Laboratories, Inc.	FRO	Unclassified	2011-11-18
K110596	Mw100 (Mammography) Lcd Monitor System	Wide Corporation	LLZ	Class II	2011-11-18
K110560	Medtronic Ares Antibiotic-Impregnated Catheter	Medtronic Neurosurgery	JXG	Class II	2011-11-18
K110294	High Flow Insufflation Unit Uhi-4	Olympus Medical Systems Corp.	HIF	Class II	2011-11-18
K103376	Elitech Clinical Systems Creatinne Pap Sl Model Crsl-0250, Clitech Clinical Systems Elical 2 Model Cali-0580, Elitech Cl	VitalScientific	JFY	Class II	2011-11-18
K102833	Disposable Hemodialysis Access Catheter Sets	Foshan Nanhai Bai HE Medical Technology Co., Ltd.	MPB	Class II	2011-11-18
K113234	Mobcardio System	Mobhealth Incorporation	DPS	Class II	2011-11-17
K113191	Power Free Vinyl Patient Examination Gloves, Yellow Color	Suqian Ruijang Medical Supplies Co., Ltd.	LYZ	Class I	2011-11-17
K113125	Intellivue Mx40 Patient Monitor	Philips North America LLC	DSI	Class II	2011-11-17
K113112	Clearway Rx Nb Catheter	Atrium Medical Corporation	DQY	Class II	2011-11-17
K112214	Octrodex(tm), Quattrodex(tm), Introdex(tm), Epidural Needle, Stylets	St. Jude Medical Neuromodulation	GZB	Class II	2011-11-17
K112197	Memometal Intra-Medullary Bone Fastener	Memometal Technologies	HTY	Class II	2011-11-17
K112118	Dreambond	Bisco Inc	KLE	Class II	2011-11-17
K112085	Synthes Lcp Pediatric Plate Systems	Synthes (USA) Products LLC	HRS	Class II	2011-11-17
K111982	Clearfil Dc Core Plus	Kuraray America, Inc.	EBF	Class II	2011-11-17
K111855	Hy-Bond Resiglass	Shofu Dental Corp.	EMA	Class II	2011-11-17
K110661	Acceledent	Orthoaccel Technologies, Inc.	OYH	Class II	2011-11-17
K113212	Dental Laser Therapy System	China Daheng Group, Inc.	GEX	Class II	2011-11-16