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 1583 of 3531

510(k) clearances, page 1583 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K012067	Clincare Latex Surgeon's Glove	TTK Healthcare Limited	KGO	Class I	2001-09-17
K012032	First Spep	Bisco Inc	DYH	Class II	2001-09-17
K011911	Suction Pump for Intracorporeal Ultrasound Lithotripter and Accessories, Model 2207.Xxx	Richard Wolf Medical Instruments Corp.	FFK	Class II	2001-09-17
K011613	Powder-Free Green Barrier-Pro Synthetic Butadiene Copolymer Examination Glove	Shield Gloves Manufacturer (M) Sdn Bhd	LZA	Class I	2001-09-17
K011059	Infared Ear Thermometer, Model Th8 Series	Radiant Innovation Inc.	FLL	Class II	2001-09-17
K012845	Simplicity Soft Qd Micro Infusion Set	Sterling Medivations, Inc.	FPA	Class II	2001-09-14
K012837	Modification to: Datex-Ohmeda Cardiocap 5 (Rev B) and Accessories	GE Healthcare	MLD	Class II	2001-09-14
K012747	Trillium Bio Disposable Blood Flow Probe (Models Dp38t & Fp38p)	Medtronic Perfusion Systems	DPT	Class II	2001-09-14
K012743	Trillium Tri-Optic Measurement Cell, Model Tmc 25T, Tmc38 T, Tmc 50T	Medtronic Perfusion Systems	DRY	Class II	2001-09-14
K012742	Teethmate F-1	Kuraray Medical, Inc.	EBC	Class II	2001-09-14
K012740	Clearfil Ap-X	Kuraray Medical, Inc.	EBF	Class II	2001-09-14
K012737	Chroma Zone Color Stain	Kuraray Medical, Inc.	EBF	Class II	2001-09-14
K012735	Clearfil Dc Cement	Kuraray Medical, Inc.	EMA	Class II	2001-09-14
K012734	Clearfil New Bond	Kuraray Medical, Inc.	KLE	Class II	2001-09-14
K012733	Caries Detector	Kuraray Medical, Inc.	LFC	Class II	2001-09-14
K012526	Bioteque Scalp Vein Set	Bioteque Corp.	FPA	Class II	2001-09-14
K012386	Acticlot Protein S, Model 843L	Sekisui Diagnostics, LLC	GGP	Class II	2001-09-14
K012103	Bandview System	Applied Spectral Imaging, Ltd.	LNJ	Class II	2001-09-14
K011979	Allersharp Allergy Skin Tester	Hmb Medical Concepts, Ltd.	SCL	Class II	2001-09-14
K011898	E-Steth Electronic Stethoscope	E-Med Innovations, Inc.	DQD	Class II	2001-09-14
K010849	Vertex Etchant	Apex Dental Materials, Inc.	EBF	Class II	2001-09-14
K010827	Copeland Mb/ha Resurfacing Humeral Heads	Biomet Orthopedics, Inc.	HSD	Class II	2001-09-14
K010657	Copeland Mb Resurfacing Humeral Heads	Biomet Manufacturing Corp	HSD	Class II	2001-09-14
K012871	Synergy Ti Integral Open Screws Models # 6193, 6194, 6195,6196, 6173, 6174, 6175, 6176, 6177	Interpore Cross Intl.	KWP	Class II	2001-09-13
K012730	Clearfil Porcelain Bond Activator	Kuraray Medical, Inc.	KLE	Class II	2001-09-13
K012729	Clearfil Repair	Kuraray Medical, Inc.	KLE	Class II	2001-09-13
K012707	Estenia	Kuraray Medical, Inc.	EBF	Class II	2001-09-13
K012086	Aquariusnet Server	Terarecon, Inc.	LLZ	Class II	2001-09-13
K012009	Mx8000 Idt CT System	Marconi Medical Systems, Inc.	JAK	Class II	2001-09-13
K011338	Oto-Cem	Ototech, Ltd.	NEA	Class II	2001-09-13
K011240	Evencare Blood Glucose Monitoring System	MEDLINE INDUSTRIES, LP - Northfield	NBW	Class II	2001-09-13
K001687	Colormate Tlc Bilitest System	Chromatics Color Sciences Intl., Inc.	MQM	Class I	2001-09-13
K012887	Sa6000ii Diagnostic Ultrasound System	Medison America, Inc.	IYO	Class II	2001-09-12
K012867	Sonoace 9900 Diagnostic Ultrasound System	Medison America, Inc.	IYN	Class II	2001-09-12
K012741	Liquichek Tdm Control	Bio-Rad	DIF	Class I	2001-09-12
K012565	Sensititre Haemophilus/streptococcus Pneumoniae (Hp) Mic Plate	Trek Diagnostic Systems, Ltd.	JWY	Class II	2001-09-12
K012318	Randox Therapeutic Drug Calibrator	Randox Laboratories, Limited	DKB	Class II	2001-09-12
K012266	Sherwood 224, 324 Feeding Pump & K524 Intri-Flush, Model N7213iwc2	National Custom Ent., Inc.	MRZ	Class II	2001-09-12
K012262	Baxter As40a, As41 Syringe Pump, Model N61wc	National Custom Ent., Inc.	MRZ	Class II	2001-09-12
K012259	Medfusion 2001 & 2010, Model N7215iwc	National Custom Ent., Inc.	MRZ	Class II	2001-09-12
K012205	Glucometer Dex Test Sensor	Bayer Corp.	NBW	Class II	2001-09-12
K012116	Acryderm Silver Antimicrobial Perforated Wound Dressing	Acrymed, Inc.	FRO	Unclassified	2001-09-12
K012023	Anchor Guide Lesion Localization Device; Ancor Guide Holder; RF Generator Cable	Senorx, Inc.	KNW	Class II	2001-09-12
K011980	Adapter, Pacing Analyzer/universal Pacing Adapter, Models 4820 and 4825	Pace Medical	DTE	Class II	2001-09-12
K011945	Rigid Gas Permeable Contact Lens Solution	Polymer Technology Corp.	HQD	Class II	2001-09-12
K011918	Nihon Kohden Bsm-2300A Series Bedside Monitor and Accessories, Model Bsm-2300A Series	Nihon Kohden America Inc	MHX	Class II	2001-09-12
K011857	Synthes (USA) Trochanteric Fixation Nail (Tfn) System	Synthes (USA) Products LLC	HSB	Class II	2001-09-12
K010602	Vectorvision Hip	Brainlab, Inc.	HAW	Class II	2001-09-12
K012705	Clearfil Photo Core	Kuraray Medical, Inc.	EBF	Class II	2001-09-11
K012233	Stratus Cs Troponin I Calibrator	Siemens Healthcare Diagnostics Inc.	JIT	Class II	2001-09-11