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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 885 of 3530

510(k) clearances, page 885 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K120734	Microsoft Amalga Uis Image Processing Module	Microsoft Corp.	LLZ	Class II	2012-08-02
K120430	Microlife Wrist Watch Blood Preeure Monitor, Bp3mo1-3P	Microlife Intellectual Property GmbH	DXN	Class II	2012-08-02
K112864	Softseal-C	Chitogen Inc	QSY	Unclassified	2012-08-02
K112620	Disital Blood Pressure Monitor	Nihon Seimitsu Sokki Co., Ltd.	DXN	Class II	2012-08-02
K111534	Abacus 3Cp	Diatron US Inc	GKZ	Class II	2012-08-02
K121987	Wondfo Amphetamine Urine Test Wondfo Barbiturates Urine Test Wondfo Benzodiazepines Urine Test	Guangzhou Wondfo Biotech Co., Ltd.	DKZ	Class II	2012-08-01
K121938	Medilas H Rfid Laser Fiber	Dornier Medtech America, Inc.	GEX	Class II	2012-08-01
K121014	Solar Gi	Medical Measurement Systems B.V.	FFX	Class II	2012-08-01
K113560	Celox Gauze Pro	Medtrade Products Ltd.	QSY	Unclassified	2012-08-01
K113289	Orion Micro Catheter	Medtronic, Inc.	KRA	Class II	2012-08-01
K121578	Atom 1 (Model: Brc 2200)	Bioelectric Research Corporation	GZJ	Class II	2012-07-31
K121053	Diazyme Homocysteine Poc Test Kit	Diazyme Laboratories, Inc.	LPS	Class II	2012-07-31
K120838	Synthes Matrix System	Synthes GmbH	NKB	Class II	2012-07-31
K120426	Victus Laser Platform	Technolas Perfect Vision GmbH	OOE	Class II	2012-07-31
K120414	Osseospeed Plus	Astra Tech, Inc.	DZE	Class II	2012-07-31
K120283	Dimer Dual Cure Permanent/temporary Resin Cement	Novocol, Inc.	EMA	Class II	2012-07-31
K113849	Hqs Introducer	Alseal	DYB	Class II	2012-07-31
K113118	Stentube Lacrimal Intubation Set	Quest Medical, Inc	OKS	Unclassified	2012-07-31
K112818	Vidas D-Dimer Exclusion II (Dex2)	bioMerieux, Inc.	DAP	Class II	2012-07-31
K112545	Quanta Flash Pr3, Quanta Flash Mpo, Quanta Flash Gbm	Inova Diagnostics, Inc.	MOB	Class II	2012-07-31
K121734	Plato Microcath 27 Microcatheter	Scientia Vascular	DQO	Class II	2012-07-30
K121544	Dynasty Biofoam Shell	Wrightmedicaltechnologyinc	KWA	Class III	2012-07-30
K121308	Hip Systems	Howmedica Osteonics Corp	LPH	Class II	2012-07-30
K121301	Xpressway Rx Catheter (6F Ld-Verison)	Kaneka Pharma America, LLC	QEZ	Class II	2012-07-30
K121299	Sterispineps Pedicle Screw, Sterispineps Rod	Safe Orthopaedics	NKB	Class II	2012-07-30
K121292	Dynapbv Body Software	Siemens Medical Solutions USA, Inc.	LLZ	Class II	2012-07-30
K121231	Ind Drug Home Multi-Panel Test (2-5) Ind Morphine Home Test	Ind Ndiagnostic, Inc.	NGT	Class II	2012-07-30
K120668	Sentinel	C-Rad Positioning AB	IYE	Class II	2012-07-30
K120511	Ageless Wonder Facial Muscle Stimulation System	Leto Enterprise, Ltd.	NFO	Class II	2012-07-30
K120467	Spinal Elements Posterior Cervical/thoracic Spinal System	Spinal Elements, Inc	NKB	Class II	2012-07-30
K113199	Kevo Npwt-Ahemo30 and a Hemo45 Foam Dressing Kit	Kevo Medical Supplies	OMP	Class II	2012-07-30
K121897	Protexis Latex Basic Sterile Powder-Free Surgical Gloves	Medtronic, Inc.	KGO	Class I	2012-07-27
K121879	Vega Knee System	Aesculap Inc	JWH	Class II	2012-07-27
K121748	The Powerwand Safety Introducer with and Extended Dwell	Access Scientific, Inc.	DYB	Class II	2012-07-27
K121617	Sensicardiac	Diacoustic Medical (Pty)	DQD	Class II	2012-07-27
K121604	Anospec Disposable Ansoscope with Light	Obp Corporation	FER	Class II	2012-07-27
K121569	Matisse Anterior Cervical Interbody Fusion Cage System	Accel Spine	ODP	Class II	2012-07-27
K121359	Ips 99 One and Ips 99 Ceram	Ivoclar Vivadent, Inc.	EIH	Class II	2012-07-27
K121338	Zeobi	Ivivi Health Science, LLC	ILX	Class II	2012-07-27
K120926	Endobeam Holmium Laser Fibers	C.R. Bard Inc	GEX	Class II	2012-07-27
K120797	Powder-Free Vinyl Patient Examination Gloves, Clear (Non-Colored)	Shandong Shouguang Kingliyuan Medical Apparatus	LYZ	Class I	2012-07-27
K120463	Mojo, Veraseal	SleepNet Corporation	BZD	Class II	2012-07-27
K120230	Powder-Free Vinyl Patient Examination Gloves, Non-Sterile	Shandong Taixiang Medical Products Co., Ltd.	LYZ	Class I	2012-07-27
K120202	Eon Cholesterol Reagent	ELITechGroup Inc	CHH	Class I	2012-07-27
K113544	Electronic Pulse Massager TENS Electronic Pulse Massager	Prospera Corporation	GZJ	Class II	2012-07-27
K113489	Orion	Asclepion Laser Technologies GmbH	GEX	Class II	2012-07-27
K113307	Gl Goodlife Series Blood Glucose Monitoring Sysmtem	HMD Biomedical, Inc.	LFR	Class II	2012-07-27
K113073	Io-Tome Device	Baxano, Inc.	HAE	Class II	2012-07-27
K110425	Hc-Bios Dental Implant	Hung Chun Bio-S Co., Ltd.	DZE	Class II	2012-07-27
K103555	Multiplate 5.0 Aggregometer	Verum Diagnostica GmbH	JOZ	Class II	2012-07-27