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 1095 of 3531

510(k) clearances, page 1095 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K083854	Cardiac Trigger, Model: Ctm300	Ivy Biomedical Systems, Inc.	DRT	Class II	2009-02-13
K083827	Orthopedic Salvage System (Oss) 9Cm Cobalt - Chrome Tibial Bodies	Biomet Manufacturing Corp	KRO	Class II	2009-02-13
K083740	Mammodiagnost Vu	Philips Medical Systems Nederland B.V.	LLZ	Class II	2009-02-13
K083503	Drad30003/radrex-I	Toshiba America Medical Systems, In.C	KPR	Class II	2009-02-13
K083475	Lucent Magnum	Spinal Elements, Inc	OVD	Class II	2009-02-13
K083469	Metasurg Cannulated Tiatanium Hemi Implant, Model Hm-1000	Metasurg	KWD	Class II	2009-02-13
K083457	Tactipen	Haselmeier GmbH	FMF	Class II	2009-02-13
K083438	Bifix Se	Voco GmbH	EMA	Class II	2009-02-13
K083309	Zargis Acoustic Cardioscan, Version 9.33	Zargis Medical Corp.	DQD	Class II	2009-02-13
K083205	Nobelactive 8.5 Mm & 18.0 Mm	Nobel Biocare AB	DZE	Class II	2009-02-13
K083193	Revac Auto Retractable Safety Syringe	Revolutions Medical Corporation, Inc.	FMF	Class II	2009-02-13
K083165	Palomar Aspire Laser Platform	Palomar Medical Products, Inc.	GEX	Class II	2009-02-13
K082988	Medivators Advantage Plus Endoscope Reprocessing System, Rapicide Pa High Level Disinfectant	Medivators Reprocessing Systems	FEB	Class II	2009-02-13
K082930	Cardiva Catalyst III System with Protamine Sulfate	Cardiva Medical, Inc.	DXC	Class II	2009-02-13
K082321	Terumo Rocsafe Hybrid Perfusion System	Terumo Cardiovascular Systems Corporation	KFM	Class II	2009-02-13
K082027	Flu-Admin, Models 60150, 60150C, 60151C, 60153C, 60160	Genesisbps LLC	FPA	Class II	2009-02-13
K081264	Statstrap Neonatal Incubator Safety Strap, Models Ss-001, Ss-002	Children'S Health First, Inc.	FMQ	Class I	2009-02-13
K080636	Duo-Max Blood Pressure & Glucose Monitor Hmf-100	Hubdic Co., Ltd.	CGA	Class II	2009-02-13
K080635	Medtoxscan	MEDTOX Diagnostics, Inc.	DKZ	Class II	2009-02-13
K080105	Endotracheal Tube	Chilecom Medical Devices Co Ltd	BTR	Class II	2009-02-13
K090102	Niagara, Niagara Slim-Cath, and Brevia Short-Term Curved Extension Hemodialysis Catheters	C.R. Bard Inc	MPB	Class II	2009-02-12
K090089	Belmont Hyperthermia Pump	Belmont Medical Technologies	LGZ	Class II	2009-02-12
K090085	Merci Retriever, Models 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113	Concentric Medical, Inc.	NRY	Class II	2009-02-12
K083857	Ldr Spine Roi-C Implant	Ldr Spine USA	MQP	Class II	2009-02-12
K083742	Synoss Collagen Synthetic Mineral-Collagen Bone Graft Matrix	Collagen Matrix, Inc	LYC	Class II	2009-02-12
K083655	Elecsys Toxo Igg Calcheck	Roche Diagnostics GmbH	JJX	Class I	2009-02-12
K083531	Liquiband Ultima, Model Lb0004	Medlogic Global Limited	MPN	Class II	2009-02-12
K083500	Medilas D Family Lasers, Including Medilas D Litebeam, Litebeam +, Urobeam, Multibeam, Flexipulse and Magnapulse	Dornier Medtech America, Inc.	GEX	Class II	2009-02-12
K083268	Tornier, Inc., Insite Suture Anchors	TORNIER Inc.	MAI	Class II	2009-02-12
K083180	Third Eye Retroscope Auxiliary Endoscopy System	Avantis Medical Systems, Inc.	FDF	Class II	2009-02-12
K083047	Powder-Free Vinyl Patient Examination Gloves	Zibo Wanci Plastic & Rubber Co., Ltd.	LYZ	Class I	2009-02-12
K082845	Infiniti Vision System with Ozil Ip	Alcon Laboratories	HQC	Class II	2009-02-12
K082565	Microsurgeon Microwave Tissue Ablation Device, Model Mtad-200	Microsurgeon, Inc.	NEY	Class II	2009-02-12
K073121	Nubrace Invisible Removable Orthodontics	Nubrace, Inc.	NXC	Class II	2009-02-12
K090220	Colon View, Model Cscv-001A	Toshibamedical Systems Corporation	JAK	Class II	2009-02-11
K090181	Waterlase Md	Biolase MG LLC	GEX	Class II	2009-02-11
K090103	100Kgy E-Poly Acetabular Liners- Additional Profiles: +3 Maxrom and +3 Hi-Wall	Zimmer GmbH	MAY	Class II	2009-02-11
K083926	Cd4 Count	Streck LLC	GGL	Class II	2009-02-11
K083828	Sleuth at Implantable Cardiac Monitoring System -6 Cm and 8Cm Antenna, Personal Diagnostics Manager (Pdm) Accessory Kit	Transoma	MXC	Class II	2009-02-11
K083734	Axxent Surface Applicator, Model 710257	Xoft, Inc.	JAD	Class II	2009-02-11
K083561	Neoss Proactive Implant	Neoss, Ltd.	DZE	Class II	2009-02-11
K083121	Neo Mapcath Sensor Stylet	Halyard Health	OMF	Class II	2009-02-11
K080949	Keratec Wound Dressings	Keratec Limited	FRO	Unclassified	2009-02-11
K080436	Rapidsense Drugs of Abuse Cocaine (Coc) 300 Device, Model 900-0052	Quantrx Biomedical Corporation	DIO	Class II	2009-02-11
K090255	Blood Tubing Sets (Sterile Fluid Path)	NxStage Medical Inc	FJK	Class II	2009-02-10
K090101	Equistream Long-Term Hemodialysis Catheters	C.R. Bard Inc	MSD	Class II	2009-02-10
K083824	Humanscan M5s-D Ultrasound Transducer	Humanscan Co., Ltd	ITX	Class II	2009-02-10
K083737	Halo Ablation Catheter	Barrx Medical, Incorporated	GEI	Class II	2009-02-10
K083624	Powder Free Nitrile (Blue and White) Examination Gloves	Comfort Rubber Gloves Ind. Sdn. Bhd.	LZA	Class I	2009-02-10
K083468	Caresens N Blood Glucose Monitoring System, Caresens N Meter, Model Gm5051a or Gm5051b or Gm5051c (Color)	I-SENS, Inc.	NBW	Class II	2009-02-10