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 880 of 3530

510(k) clearances, page 880 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K120052	Cvinsight	Intelomed, Inc.	DQA	Class II	2012-09-04
K113770	Orthofix Galaxy Fixation System	Orthofix SRL	KTT	Class II	2012-09-04
K113321	TENS Back Pain Relief System	Savia Limited	NUH	Class II	2012-09-04
K122291	Thermo Scientific Mas Omni-Cardio	Microgenics Corporation	JJY	Class I	2012-08-31
K121859	Tyshak Nucleus	Numed Inc	DQY	Class II	2012-08-31
K121505	Disposable Hemostasis Chip	Wilson-Cook Medical Inc./Cook Endoscopy	PKL	Class II	2012-08-31
K121196	Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation Catheter (Over-the-Wire)	Boston Scientific Corporation	LOX	Class II	2012-08-31
K121012	Flexlab 3.6, Accelerator A3600	Inpeco S.p.A.	CEM	Class II	2012-08-31
K120819	Stalif C	Centinel Spine, LLC	OVE	Class II	2012-08-31
K113705	Pintler Patient Warming System	Pintler Medical	DWJ	Class II	2012-08-31
K113508	Dacryocath	Armadillo Biomedical, LLC	OKS	Unclassified	2012-08-31
K122444	Cervical Cage	Eisertech, LLC	ODP	Class II	2012-08-30
K122394	Rubicon 18 Support Catheter	Boston Scientific Corporation	DQY	Class II	2012-08-30
K122353	Crainfix 2 Titanium Clamp System	Aesculap Inc	GXN	Class II	2012-08-30
K122201	Protura Couch Software	Med-Tec, Inc. D/B/A Civco Medical Solutions	JAI	Class II	2012-08-30
K122066	Human Beta-2 Microglobulin Urine Kit for Use on the Spaplus	The Binding Site Group Ltd.	JZG	Class II	2012-08-30
K121678	Dtad	Gyrus ACMI, Inc.	ERL	Class II	2012-08-30
K121311	Thixo-Gel Ultrasound Spray	Cloverline International Pharma Services GmbH	MUI	Class II	2012-08-30
K121040	Smartlyte Electrolyte Analyzer	DIAMOND DIAGNOSTICS Inc	CEM	Class II	2012-08-30
K113830	Vantera Clinical Analyzer	Liposcience	CDT	Class I	2012-08-30
K113753	Zimmer Dental Tapered Screw-Vent X	ZimVie US Corp LLC	DZE	Class II	2012-08-30
K113652	Loqteq Small Fragment Set Loqteq Cortical Screw3.5, Small Head, T15, Self Tapping Loqteq Cortical Screw 3.5, T15, Self T	AAP Implantate AG	HRS	Class II	2012-08-30
K113472	Precise Shp Diode Laser	Cao Group, Inc.	GEX	Class II	2012-08-30
K113291	Simex Negative Pressure Wound Therapy Powered Suction Pumps Series: Sim-Ex200 and Sim-Ex300	Simex Medizintechnik GmbH	OMP	Class II	2012-08-30
K122439	Intellivue Patient Monitor	Philips Medizin Systeme Boeblingen GmbH	MHX	Class II	2012-08-29
K122317	Tetris II	Signus Medizintechnik GmbH	MAX	Class II	2012-08-29
K122316	Azur Detachable 35	Terumo Cardiovascular Systems Corporation	KRD	Class II	2012-08-29
K122281	Padnet 2.0	Biomedix Wai	JOM	Class II	2012-08-29
K122276	Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip	AtriCure, Inc.	FZP	Class II	2012-08-29
K122275	Artisan Extend Control Catheter	Hansen Medical, Inc.	DRA	Class II	2012-08-29
K122084	Introducer Set, Model Adelante-S Series	Oscor Inc.	DYB	Class II	2012-08-29
K121934	Tomotherapy Treatment System	Accuray Incorporated	IYE	Class II	2012-08-29
K121932	Hem-7200-Z (Bp742)	Omron Healthcare Co., Ltd.	DXN	Class II	2012-08-29
K121889	Staxx Xd System	Spine Wave Inc	MQP	Class II	2012-08-29
K121760	Capstone Spinal System	Medtronic Sofamor Danek USA Inc	MAX	Class II	2012-08-29
K121476	Infill Graft Delivery System	Pinnacle Spine Group, LLC	FMF	Class II	2012-08-29
K121351	Sinus Dilation System	Entrigue Surgical, Inc.	LRC	Class I	2012-08-29
K121276	Neuro Vention Laminplasty Plating System	Neurovention, LLC	NQW	Class II	2012-08-29
K121230	Ips Empress Direct Color Ips Empress Direct Opaque	Ivoclar Vivadent, Inc.	EBF	Class II	2012-08-29
K122528	Ulthera System	Merz North America, Inc.	OHV	Class II	2012-08-28
K122359	Vitek 2 Strptococcus Ceftriaxone	bioMerieux, Inc.	LON	Class II	2012-08-28
K122323	Dimension Vista Alkaline Phosphatase (Alpi) Flex Reagent Cartridge Dimension Vista Alkaline Phosphatase Calibrator (Alpi	Siemens Healthcare Diagnostics Inc.	CJO	Class II	2012-08-28
K122297	Enluxtra Humifiber Wound Dressing	Basf Venture Capital America, Inc.	FRO	Unclassified	2012-08-28
K122296	Sl-Plus Mia Femoral Stems with Ti/ha Coating	Smith & Nephew, Inc.	LZO	Class II	2012-08-28
K122249	Terumo Surguard3 Safety Needle & Hypodermic Syringe with Safety Needle	Terumo (Philippines) Corporation	FMI	Class II	2012-08-28
K122027	Arrow Flexblock Continuous Peripheral Nerve Block Catheter	Arrow International LLC (subsidiary of Teleflex Incorporated)	CAZ	Class II	2012-08-28
K121482	Instrument System for Endoscopic Spinal Surgery	Theken Companies LLC	HRX	Class II	2012-08-28
K121400	Pax-Uni3d, Pht-7500	Vatech Co., Ltd.	OAS	Class II	2012-08-28
K121257	Laryngeal Electrode	Technomed Europe	ETN	Class II	2012-08-28
K121251	Icerod Cx Cryoablation Needle Icerod Cx Cryoablation Needle Multipack	Galil Medical Ltd.	GEH	Class II	2012-08-28