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 984 of 3531

510(k) clearances, page 984 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K102836	Bonasil a+ Impression Materials	Dmp, Ltd.	ELW	Class II	2011-01-13
K102613	Powder-Free Vinyl Patient Examination Gloves	Hebei Favor Plastic Co., Ltd.	LYZ	Class I	2011-01-13
K102590	Fleboset Double	Laboratorios Grifols, S.A.	LHI	Class II	2011-01-13
K102460	Ambit Introducer, Ambit Needle, Ambit Sheath	Summit Medical Products, Inc.	BSO	Class II	2011-01-13
K102140	Fetal Monitors, Models F2 and F3	Edan Instruments, Inc.	HGM	Class II	2011-01-13
K101614	Heelsafe Dvt Hose, Models 00800-00804, 00805-00809	Dm Systems, Incorporated	DWL	Class II	2011-01-13
K100891	Dana Emulating Indicator	Dana Products, Inc.	JOJ	Class II	2011-01-13
K093678	Platelia Aspergillus Eia Model 62793	Bio-Rad	NOM	Class I	2011-01-13
DEN090011	Hem-Avert Perianal Stabilizer	Plexus Biomedical, Inc.	OOA	Class II	2011-01-13
K110030	Expect Endoscopic Aspiration Needle	Boston Scientific Corporation	ODG	Class II	2011-01-12
K103645	Aplio Xg Diagnostic Ultrasound System	Toshiba Medical Systems Corporation, Japan	ITX	Class II	2011-01-12
K103394	Barcode Conical Collimator Verification (Bccv)	Varian Medical Systems, Inc.	IYE	Class II	2011-01-12
K103365	Discovery 3T 16 Ch Body Array Coil (Anterior); Discovery 3T 16 Ch Body Array Coil (Posterior); Discovery 3T 32 Ch Body a	GE Healthcare Coils (USA Instruments, Inc.)	MOS	Class II	2011-01-12
K103144	Digital Color Doppler Ultrasound Imagaing System; Convex / Linear Phased Array Transducer	Shantou Institute of Ultrasonic Instruments (Siui	IYN	Class II	2011-01-12
K103070	Gps Tm, G Surgical Anterior Cervical Plate System +	G Surgical Co., Ltd.	KWQ	Class II	2011-01-12
K102915	Viewray Treatment Planning and Delivery System	Viewray Systems, Inc.	MUJ	Class II	2011-01-12
K102872	Osbone Dental	Curasan AG	LYC	Class II	2011-01-12
K102834	ISO-Elastic Cerclage System (1Mm and 2Mm Cable Diameter)	Kinamed, Incorporated	JDQ	Class II	2011-01-12
K102651	Iscreen Vision Screener	Iscreen Vision Inc.	HKI	Class II	2011-01-12
K102506	Mixed Media Marker	Cortex Manufacturing, LLC	NEU	Class II	2011-01-12
K102338	Breathscn Pro	Akers Biosciences, Inc.	DJZ	Class I	2011-01-12
K102121	Eclipse Vertebral Spacer System-Lumbar	Apollo Spine, Inc.	OVD	Class II	2011-01-12
K101904	Smartxide 50 Hs/ms	El.en. Electronic Engineering SpA	GEX	Class II	2011-01-12
K103470	Panther Group of Surgical Includes: Oanther Circular Stapler; Panther Hemorrhoidal Circular Stapler; Panther Linear Stap	B.j.zh.f.panther Medical Equipment Co.,Ltd	GDW	Class II	2011-01-11
K103275	Specialty Coils for Magnetom Aera 1.5T & Magnetim Skyra 3T Mr Systems	Siemens Medical Solutions USA, Inc.	MOS	Class II	2011-01-11
K103159	Cardio Med Model A102, H104, O101, P103, and Z100	Cardio Medical Products, Inc.	LDD	Class II	2011-01-11
K102781	Resection Button Electrode for Plasma Vaporization, HF-Resection Electrode Rollers and Needles, Loops and Bands	Olympus Winter & Ibe GmbH	FAS	Class II	2011-01-11
K101995	Capnostream 20P with Masimo Spo2 Board	Oridion Capnography, Inc.	DQA	Class II	2011-01-11
K101716	Hvr Pain Relief Device	H.V.R., Inc.	ILY	Class II	2011-01-11
K101535	Bt-Cath	Utah Medical Products, Inc	OQY	Class II	2011-01-11
K092183	Embryoscope and Embryoslide	Unisense Fertilitech A/S	MQG	Class II	2011-01-11
K103252	Camlog Vario Sr Abutments	Altatec GmbH	NHA	Class II	2011-01-10
K103209	Verigene Respiratory Virus Nucleic Acid Test +(Rvnat+)	Luminex Corporation	OCC	Class II	2011-01-10
K103110	Mini Trek(tm) Rx and Trek(tm) Rx Coronary Dilatation Catheter Mini Trek(tm) Otw and Trek(tm) Otw Dilatation Catheter	Abbott Vascular-Cardiac Therapies	LOX	Class II	2011-01-10
K103064	Avamax Vertebral Balloon	Care Fusion	NDN	Class II	2011-01-10
K103046	Hosman Usb Blood Pressure Monitor; Wrist Type and Upper Arm Type	Hosman International Co., Ltd.	DXN	Class II	2011-01-10
K103036	Allofuse Plus	Allosource	MQV	Class II	2011-01-10
K103033	Trabecular Metal Fusion Device Model 06-101-Xxxxx, 06-102-Xxxxx and 08-100-Xxxxx	Zimmer Trabecular Metal Technology, Inc.	ODP	Class II	2011-01-10
K102822	Implant-One System	Custom Dental Implants, Inc.	DZE	Class II	2011-01-10
K102617	Audit Microcv Cardiac Markers Linearity Set	Aalto Scientific Ltd.	JJY	Class I	2011-01-10
K102508	Yu Long Sheng Disposable Thermometer Sheaths, Models Yls-01 and Yls-02	Yu Long Sheng Technology Co., Ltd.	FLL	Class II	2011-01-10
K103646	Intellivue Mx40 Patient Monitor	Phillips Medical Systems	MHX	Class II	2011-01-07
K103512	Affirm Breast Biopsy Guidance System	Hologic, Inc.	IZH	Class II	2011-01-07
K103402	Elecsys Dhea-S Calcheck 5	Roche Diagnostics GmbH	JJX	Class I	2011-01-07
K103349	Backstop Catheter	Pluromed, Inc.	KOD	Class II	2011-01-07
K103224	Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe Tubing	Abbott Medical	FPA	Class II	2011-01-07
K103152	6250 Ultrasound Sytems	Esaote S.p.A.	IYN	Class II	2011-01-07
K103117	Itotal Cruciate Retaining (Cr) Knee Replacement System	ConforMIS, Inc.	JWH	Class II	2011-01-07
K103043	Colorado Catheter Sterilesure - New Name Perfic Cath	Adapta Medical, Inc.	EZD	Class II	2011-01-07
K102823	Disposable Blood Pressure Cuff	Wuxi Medical Instrument Factory Co., Ltd	DXQ	Class II	2011-01-07