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 785 of 3530

510(k) clearances, page 785 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K131652	Lzi Oral Fluid Methamphetamine Enzyme Immunoassay, Calibrators, Controls	Lin-Zhi International Inc	LAF	Class II	2014-03-21
K131553	Xtra	LivaNova Deutschland GmbH	CAC	Class II	2014-03-21
DEN130049	Simplexa Hsv 1&2 Direct	DiaSorin Molecular LLC	PGH	Class II	2014-03-21
K140465	Virtuoso System for Ihc Er (Sp1) with Benchmark Ultra Stainer	Ventana Medical Systems Inc	NQN	Class II	2014-03-20
K140253	Magnetom Artis Combi Suite for the Magnetom Aera/skyra/skyra with Timtx Trueshape	Siemens Medical Solutions USA, Inc.	LNH	Class II	2014-03-20
K134038	Camber Spine Diagon Oblique Cage	Camber Spine	MAX	Class II	2014-03-20
K133958	Flow-I Anesthesia System C20, C30 & C40	Maquet Critical Care AB	BSZ	Class II	2014-03-20
K133842	Tyber Medical Trauma Screw	Tyber Medical	HWC	Class II	2014-03-20
K133613	Intra-Lock Dental Implants	Intra-Lock International	DZE	Class II	2014-03-20
K133529	Camber Spine Coveris Cervical Cage	Camber Spine	ODP	Class II	2014-03-20
K133398	Stryker Pediatric Mandible Distractor	Stryker Corp.	MQN	Class II	2014-03-20
K133319	Et Lightsheer 1060, High Speed Lightsheer 1060	Lumenis Ltd	GEX	Class II	2014-03-20
K133231	Digora Optime	Palodex Group Oy	MUH	Class II	2014-03-20
K133211	Zirtough	Kuraray Noritake Dental, Inc.	EIH	Class II	2014-03-20
K133073	Cair Drive, Neutraclear	Cair LGL	FPA	Class II	2014-03-20
K132436	Varioguide Drill Kit	Mri Interventions, Inc.	HBE	Class II	2014-03-20
K132123	Trc-Pex, Radic-Sealer	Km Corporation	KIF	Class II	2014-03-20
K131971	Im60/im70 Patient Monitor	Edan Instruments, Inc.	MHX	Class II	2014-03-20
K140398	Embol-X Introducer Sheath	Edwards Lifesciences LLC	DYB	Class II	2014-03-19
K133892	Ivue 500	Optovue Inc.	HLI	Class II	2014-03-19
K133780	Speed Xl	Biomedical Ent., Inc.	JDR	Class II	2014-03-19
K133734	Seal Single-Use Biopsy Valve	Boston Scientific Corporation	OCX	Class II	2014-03-19
K133374	Streamline Oct Occipito-Cervico-Thoracic System	Pioneer Surgical Technology, Inc. (Rti Surgical, I	KWP	Class II	2014-03-19
K133217	Cirrus Photo	Carl Zeiss Meditec Inc	OBO	Class II	2014-03-19
K133144	Sonosure Sonohysterography & Endometrial Sampling Device	Crossbay Medical	PGK	Class II	2014-03-19
K132206	Melys Atrial Fibrillation Screening Monitor	Advanced Fluidics, LLC	DXH	Class II	2014-03-19
K132151	Srs Endoscopic Stapling System	Medigus, Ltd.	ODE	Class II	2014-03-19
K132078	Metallic Intramedullary Nail System	Tianjin Walkman Biomaterial Co., Ltd.	HSB	Class II	2014-03-19
K140105	Hevylite Human Iga Kappa Kit for Use on Siemens Bnii, Hevylite Human Iga Lambda Kit for Use on Siemens Bnii	The Binding Site	OPX	Class II	2014-03-18
K133894	Surflo Winged Infusion Set with Filter & Needle Protection (Surshield)	Terumo Europe N.V.	FPA	Class II	2014-03-18
K133865	Asahi Gaia First, Second, Third	Asahi Intecc Co., Ltd.	DQX	Class II	2014-03-18
K133308	Tinnitus Soundsupport	Oticon, Inc.	KLW	Class II	2014-03-18
K132975	Sphinx Jr	Allmed Systems, Inc.	GEX	Class II	2014-03-18
K131210	Electronic Thermometer	Shenzhen Pump Medical System Co., Ltd.	FLL	Class II	2014-03-18
K134054	Bovie Ids-310 High Frequency Electrosurgical Generator, Aaron A3350 High Frequency Electrosurgical Generator	Apyx Medical Corporation	GEI	Class II	2014-03-17
K133209	Foresee (4C) Imaging System	Diagnostic Photonics, Inc.	NQQ	Class II	2014-03-17
K131258	Saturn Dental Implant	Cortex Dental Implants Industries Ltd.	DZE	Class II	2014-03-17
K140388	Lumenis Pulse 120H	Lumenis Ltd	GEX	Class II	2014-03-14
K140345	The Sherlock 3Cg Tip Confirmation System (Tcs)	C.R. Bard Inc	LJS	Class II	2014-03-14
K134052	Radiance 330 Proton Therapy System	Protom International, Inc.	LHN	Class II	2014-03-14
K133893	Sterispine Lc Cage	Safe Orthopaedics	MAX	Class II	2014-03-14
K133824	Cerasmart	GC America Inc.	EBF	Class II	2014-03-14
K133608	Trinia	Bicon, LLC	EBF	Class II	2014-03-14
K133410	Diazyme 25-Oh Vitamin D Assay; Diazyme 25-Oh Vitamin D Control Set	Diazyme Laboratories, Inc.	MRG	Class II	2014-03-14
K133406	Cs 8100 3D	Trophy	OAS	Class II	2014-03-14
K133323	Volcano Ifr Modality	Volcano Corporation	IYO	Class II	2014-03-14
K133252	Healthinterlink Beacon	Healthinterlink, LLC	DRG	Class II	2014-03-14
K133227	Smart Segmentation - Knowledge Based Contouring	Varian Medical Systems, Inc.	IYE	Class II	2014-03-14
K132944	Advantagesim Md Mr Pelvic Organ at Risk Segmentation	GE Hungary Kft	KPQ	Class II	2014-03-14
K132805	Bg Morsels	Prosidyan, Inc.	MQV	Class II	2014-03-14