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 963 of 3531

510(k) clearances, page 963 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K111079	Syngo.via Web Viewer	Siemens AG Medical Solutions	LLZ	Class II	2011-05-13
K110978	Onestep Pediatric Mfe's	ZOLL Medical Corporation	MKJ	Class III	2011-05-13
K110948	Health Care System Software	Taidoc Technology Corporation	NBW	Class II	2011-05-13
K110853	Vr Medical Enteral Oral Syringe	Vr Medical	FPD	Class II	2011-05-13
K110775	Electronic Sphygmomanometer	Contec Medical Systems Co., Ltd.	DXN	Class II	2011-05-13
K110774	Electronic Sphygmomanometer	Contec Medical System Co., Ltd.	DXN	Class II	2011-05-13
K110771	Bd Single Use, Hypodermic Syringe	Becton Dickinson & Co	FMF	Class II	2011-05-13
K110540	Terumo Support Catheter	Terumo Medical Corp.	DQY	Class II	2011-05-13
K110454	Cougar Ls Lateral Cage System	Johnson & Johnson	MAX	Class II	2011-05-13
K110449	Endobon Xenograft Granules	ZimVie US Corp LLC	LYC	Class II	2011-05-13
K110252	Beautibond Multi Pr Plus	Shofu Dental Corp.	KLE	Class II	2011-05-13
K110235	Beautibond Multi	Shofu Dental Corp.	KLE	Class II	2011-05-13
K110225	Angiodynamics, Inc. Venacure 1470 Laser	Boston Scientific Corporation	GEX	Class II	2011-05-13
K110146	Nitrile Powder Free Patient Examination Gloves	Tangshan Kaiyue Glove Co., Ltd.	LZA	Class I	2011-05-13
K110102	Powderfree Nitrile Examination Gloves Coated with Allogel,colors Blue,magneta,copper and without Allogel,colors Blue,mag	Preventive Care, Inc.	LZA	Class I	2011-05-13
K103635	Continuous Nebulization Tube Set (Cnts) Tubing: Ag-As3075 + Syringe: Ag-As3085; Continous Nebulization Tube Set (Cnts) S	Aerogen Ltd.	CAF	Class II	2011-05-13
K103589	Neoblue Blanket LED Phototherapy System	Natus Medical Incorporated	LBI	Class II	2011-05-13
K103545	Bt-350	Bistos co., Ltd.	HGM	Class II	2011-05-13
K103473	Zoll Rescuenet Epcr Model Rescuenet Epcr	ZOLL Medical Corporation	DXJ	Class II	2011-05-13
K103407	Cotronic Digital Thermometer	Cotronic Manufacturing	FLL	Class II	2011-05-13
K103025	Given Pillcam Platform with Rapid 6.5 / Given Pillcam Platform with Pillcam Eso 3 Capsules	Given Imaging Ltd.	NEZ	Class II	2011-05-13
K102845	Mahe Fixation Plate and Screw System	Mahe Medical GmbH	HRS	Class II	2011-05-13
K102748	31P/1h Head Coil 3T; 23Na/1h Head Coil 3T; 13C/1h Head Coil 3T	Rapid Biomedical GmbH	MOS	Class II	2011-05-13
K102619	Computed Raddiography Scanner	3Disc Americas	MQB	Class II	2011-05-13
K102598	Hi-Dow-Xp	Hi-Dow International Inc.	NUH	Class II	2011-05-13
K102510	Dimensions Hb1c Kit, Model Df105a	Siemens Healthcare Diagnostics Inc.	LCP	Class II	2011-05-13
K102328	Blunt Fill Needle and Blunt Plastic Cannula	ShanDong WeiGao Group Medical Polymer Co., Ltd	FMI	Class II	2011-05-13
K100987	Invader Mthfr 677	Hologic, Inc.	OMM	Class II	2011-05-13
K110692	Streamline Tl Spinal System	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	NKB	Class II	2011-05-12
K110628	Simpleabi	Newman Medical	JAF	Class II	2011-05-12
K110613	Elecsys Prolactin II Calcheck 5	Roche Diagnostics GmbH	JJX	Class I	2011-05-12
K110433	Clearblue Easy Pregnancy Test	SPD Development Company Limited	LCX	Class II	2011-05-12
K110159	Activecare Sft	Medical Compression Systems (Dbn), Ltd.	JOW	Class II	2011-05-12
K110122	Mustang Balloon Dilataion Catheters	Boston Scientific Corporation	FGE	Class II	2011-05-12
K103744	Dropper A1c Diabetes Control	Quantimetrix Corp.	JJX	Class I	2011-05-12
K103716	Roche Elecsys Folate Rbc; Roche Elecsys Folate Rbc Calset	Roche Diagnostics GmbH	CGN	Class II	2011-05-12
K103312	Upd-Y0003	Olympus Medical Systems Corp.	FDF	Class II	2011-05-12
K103211	Avea Ventilator	Care Fusion	CBK	Class II	2011-05-12
K102026	Seaspine Spacer System	Seaspine, Inc.	MAX	Class II	2011-05-12
K101155	Auradorm (Neuromuscular Sleep)	Sleepwright	LRK	Class II	2011-05-12
K110965	Renovis T 710 Large External Fixation System	Renovis Surgical Technologies, LLC	KTT	Class II	2011-05-11
K110528	Integra LED Surgical Headlight System	Integra LifeSciences Corporation	FSR	Class II	2011-05-11
K110430	Dolphin Imaging	Patterson Dental Supply, Inc.	LLZ	Class II	2011-05-11
K110413	Power Processor Sample Processing System with Generic Connections	Siemens Healthcare Diagnostics Inc.	CDD	Class II	2011-05-11
K110409	Aspira Pleural Drainage System	C.R. Bard Inc	DWM	Class II	2011-05-11
K103633	Achilles	GE Medical Systems China Co., Ltd.	MUA	Class II	2011-05-11
K103525	A750i Transport Incubator with Masimo Pluseox, A750i Transport Incubator with Nellor Pulseox	International Biomedical, Ltd.	FPL	Class II	2011-05-11
K103523	185A+ Transport Incubator with Masimo Pulseox, 185A+ Transport Incubator with Nellcor Pulseox	International Biomedical, Ltd.	FPL	Class II	2011-05-11
K100910	Immulite 2000 3Gallergy Specific Ige Assay Kit, Model L2kun6	Siemens Healthcare Diagnostics Inc.	DHB	Class II	2011-05-11
K110996	Baha 3 Power Sound Processor	Cochlear Americas	LXB	Class II	2011-05-10