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 2026-11-02, 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 1023 of 3531

510(k) clearances, page 1023 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K100211	Pearlscent Black Textured Powder-Free Latex Examination Gloves, Coated with Aloe Vera	Shen Wei (USA), Inc.	LYY	Class I	2010-05-11
K100160	Zzoma Positional Sleeper Model 001	Sleep Specialists, LLC	MYB	Class II	2010-05-11
K093978	Exactech Equinoxe Proximal Humerus Fracture Plate System	Exactech, Inc.	HRS	Class II	2010-05-11
K093649	Aesculap Sterilcontainer S	Aesculap Inc	FRG	Class II	2010-05-11
K093268	Intellivue Patient Monitor	Philips Medizinsysteme Boeblingen GmbH, Cardiac an	MHX	Class II	2010-05-11
K093094	Vela Ventilator	Cardinal Health 207, Inc.	CBK	Class II	2010-05-11
K092812	Synthes (USA) 2.7Mm/ 3.5Mm Lcp Anterolateral Distal Tibia Plates	Synthes (USA) Products LLC	HRS	Class II	2010-05-11
K092507	Zit-Z	Ziterion	DZE	Class II	2010-05-11
K092190	Synthes Distraction Osteogenesis System, Mr Conditional with Expanded Indications	Synthes (USA) Products LLC	KTT	Class II	2010-05-11
K082044	Ace Stapler, Model F0031	Barosense, Inc.	OCW	Class II	2010-05-11
K101078	Bl Healthcare Remote Care Management System	Bl Healthcare, Inc.	DRG	Class II	2010-05-10
K100289	Advia Chemistry Systems Carbon Dioxide Liquid (C02_l) Assay, Model Ref 07987100, 07506781	Siemens Healthcare Diagnostics Inc.	KHS	Class II	2010-05-10
K100274	Miar (Minimally Invasive Aortic Root) Cannula with Flow-Guard, Models 11012L and 11014L	Medtronic, Inc.	DWF	Class II	2010-05-10
K100257	Vloc9absorbable Wound Closure Device	Surgical Devices, A Division of Tyco Healthcare	GAM	Class II	2010-05-10
K100182	Salvin Dental Specialties Fixation Screw	Salvin Dental Specialties, LLC	DZL	Class II	2010-05-10
K100095	Central Vision Analyzer Model 1000	Vimetrics,Llc.	HOX	Class I	2010-05-10
K100006	Hs Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene), Riverlon (Nylon) Model Veries by Size/need	Riverpoint Medical, LLC	GAT	Class II	2010-05-10
K093863	Epidrum	Exmoor Plastics Limited	FMF	Class II	2010-05-10
K093813	Occlusin 500 Artificial Embolization Device	Imbiotechnologies Ltd	KRD	Class II	2010-05-10
K093327	Intco Tab Electrode	Shanghai Intco Electrode Manufacturing Co Ltd	DRX	Class II	2010-05-10
K093161	Actiprotect Uf N95 Respirator	Glaxosmithkline Consumer Healthcare	ONT	Class II	2010-05-10
K092955	Redsense-Home Use	Redsense Medical AB	ODX	Class II	2010-05-10
K092349	Clearview Exact II Influenza a & B Test	Inverness Medical, Inc.	PSZ	Class II	2010-05-10
K101067	Suresigns Vm4, Suresigns Vm6, Suresigns Vm8 Model: 863063, 863064, 863065, 863066, 863068	Philips North America LLC	MHX	Class II	2010-05-07
K100619	Symbia.net, Symbia.net Select Model 10520828, 10520827	Siemens Medical Solutions USA, Inc.	LLZ	Class II	2010-05-07
K100056	Medcom Rt-Viewer System	Medcom GmbH	MUJ	Class II	2010-05-07
K094039	Hyalo Gyn	Fidia Farmaceutici S.P.A	NUC	Class II	2010-05-07
K094002	Spartek Variable Angle Pedicle Screw Posterior Fusion System	Spartek Medical, Inc.	NKB	Class II	2010-05-07
K093766	Vitalogik 6000/6500	Mennen Medical, Inc.	DSI	Class II	2010-05-07
K093747	Align and Align to Urethral Support Systems	C.R. Bard Inc	OTN	Class II	2010-05-07
K093739	Blood Pressure Monitor/ Models	Ningbo Diaier Electronic Co., Ltd.	DXN	Class II	2010-05-07
K092476	Sport-Elec Body Control System, Model 4M	Sport-Elec	NGX	Class II	2010-05-07
K091812	Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic, Mandible Reconstruction and Mesh Systems	Frontier Devices, Inc.	JEY	Class II	2010-05-07
K091336	Ivnow Modular Fluid Warmer, 120V, Model Ivnow-1, Ivnow-2, Ivnow-3, Ivnow-6, Ivnow Modular Fluid Warmer 230V	Enthermics Medical Systems, Inc.	LGZ	Class II	2010-05-07
K100974	Spectrum Turbo-Ject Picc Set	Cook Incorporated	FOZ	Class II	2010-05-06
K100852	Stryker Switchpoint Infinity 3 Control System, Model: 067-8001-000	STRYKER Communications, Inc.	OCS	Class II	2010-05-06
K100142	Aequalis Reversed Shoulder Prosthesis	TORNIER Inc.	PHX	Class II	2010-05-06
K093909	Busse Surgical Drapes IV	Busse Hospital Disposables	KKX	Class II	2010-05-06
K093862	Carevent Handheld CPAP System	O-Two Medical Technologies, Inc.	BTL	Class II	2010-05-06
K092560	Pari Sinus	Pari Respiratory Equipment, Inc.	CAF	Class II	2010-05-06
K092467	Vectorvision Cranial, Vectorvision ENT, Kolibri Cranial, Kolibri ENT, Cranial Essential, Cranial Unlimited	Brainlab, Inc.	HAW	Class II	2010-05-06
K092097	A.b. Korkor Medical Skinnysafe Introducer Sheath	A.B. Korkor Medical, Inc.	DYB	Class II	2010-05-06
K091615	Med Contour	General Project S.r.l.	IMI	Class II	2010-05-06
K101197	Parie Tene Progrip Mesh	Sofradim Production	FTL	Class II	2010-05-05
K100830	M7/m7t Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	IYN	Class II	2010-05-05
K100778	Dimension Exl Loci Thyroid Calibrator, Model Rc 610A	Siemens Healthcare Diagnostics Inc.	JIX	Class II	2010-05-05
K100508	Carematix Wellness System, Model Cws-5000.1-B	Carematix Inc.	DRG	Class II	2010-05-05
K100486	Powder-Free Vinyl Patient Examination Gloves, Yellow Color	Zibo Yinghao Medical Products Co., Ltd.	LYZ	Class I	2010-05-05
K100412	Biolox Delta Ceramic Femoral Heads	Smith & Nephew, Inc.	LZO	Class II	2010-05-05
K100320	Slendertone System Ultra Model E70/x70	Bio-Medical Research, Ltd.	NGX	Class II	2010-05-05