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 1249 of 3531

510(k) clearances, page 1249 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K061367	Bluesky Vista Wound Vacuum System, Model 100.0500	Blue Sky Medical Group Incorporated	OMP	Class II	2006-08-10
K061215	Volcano S51 Family of Imaging Systems	Volcano Corporation	IYO	Class II	2006-08-10
K061086	Dm-3000 Digital Blood Pressure Monitor	Nihon Seimitsu Sokki Co., Ltd.	DXN	Class II	2006-08-10
K061017	Easyspine System	Ldr Spine USA	MNI	Class II	2006-08-10
K053289	Cobas Amplicor Ct/ng Test for Neisseria Gonorrhoeae	Roche Diagnostics GmbH	LSL	Class II	2006-08-10
K053287	Cobas Amplicor Ct/ng Test for Chlamydia Trachomatis	Roche Diagnostics GmbH	MKZ	Class I	2006-08-10
K050590	Enzy-Well Syphilis Igg, Model 91106	Diesse Diagnostica Senese S.P.A	LIP	Class II	2006-08-10
K062126	Embocath Plus Infusion Microcatheter, Model Ecp-100 and Ecp-135	Biosphere Medical, S.A.	DQO	Class II	2006-08-09
K062008	Endo Car Compression Anastomosis Ring (Car)	Niti Medical Technologies, Ltd.	FZP	Class II	2006-08-09
K061938	Verte-Stack Spinal System	Medtronic Sofamor Danek	MQP	Class II	2006-08-09
K061936	Kendall Argyle Neonatal/pediatric Picc, Model 43311	Kendall	LJS	Class II	2006-08-09
K061491	Lac-Mac Innerbloc o.r. Gown	Lac-Mac Limited	FYA	Class II	2006-08-09
K061335	Enhance Dental Implant System	Coastal Biocare	DZE	Class II	2006-08-09
K061179	Powerhickman Long-Term Intravascular Catheter	C.R. Bard Inc	LJS	Class II	2006-08-09
K060367	Tenolig	Fournitures Hospitalieres Industrie	GAT	Class II	2006-08-09
K042850	Cardiodrive, Model 001-004115 (Non-Sterile); 001-1169-1 (Sterile)	Stereotaxis Inc	DQY	Class II	2006-08-09
K062108	Comcaset Safety IV Catheter	Pitango Medical, Ltd.	FOZ	Class II	2006-08-08
K062091	Porous Media Humidiflow Humidifier for Universal Humidification	Pentair Filtration Solutions	BTT	Class II	2006-08-08
K061904	Compudent Sta	Milestone Scientific, Inc.	EJI	Class II	2006-08-08
K061500	Sicace Dental Implant System and Sic Angled Abutments	Sic Invent AG	DZE	Class II	2006-08-08
K061107	Dpc T60i Kusti, Model 984248; Dpc T60i, Model 984247	Thermo Electron Oy	CEM	Class II	2006-08-08
K060690	Online Valproic Acid	Roche Diagnostics GmbH	LEG	Class II	2006-08-08
K060318	Hepatic Enzymes on Abx Pentra 400 Clinical Chemistry Analyzer	Horiba Abx	CIT	Class II	2006-08-08
K060151	Orbital Tissue Expander (Ote)	Innovia, LLC	NFM	Class II	2006-08-08
K062055	Dimension Vista Protein 1 Calibrator, Control Low, Control Medium, Control High	Siemens Healthcare Diagnostics Inc.	JIX	Class II	2006-08-07
K062053	Monochrome Lcd Monitor, Radiforce, Gs320	Eizo Nanao Corporation	LLZ	Class II	2006-08-07
K061834	Xcat; Xcat for Neuro	Xoran Technologies, LLC	JAK	Class II	2006-08-07
K061831	Medchannel Hts System	Medchannel, LLC	IYN	Class II	2006-08-07
K061810	Cougar Wheelchair	R82 a/S	IOR	Class I	2006-08-07
K061801	2.8 & 3.5Mm Lactoscrew Suture Anchors	Arthrotek, Inc.	JDR	Class II	2006-08-07
K061793	Dimension Vista Iron Flex Reagent Cartridge and Calibrator	Siemens Healthcare Diagnostics Inc.	JIY	Class I	2006-08-07
K061755	Mylab15/20 New Indications Ultrasound System	Esaote Europe B.V.	IYO	Class II	2006-08-07
K061727	Gore Preclude Vessel Guard	W. L. Gore & Associates, Inc.	MFX	Class II	2006-08-07
K061404	Mono-Crawford Naso-Lacrimal Intubation Device	Fci Ophthalmics, Inc.	OKS	Unclassified	2006-08-07
K061306	Co-1000 Colposcope, Multiple	Gynex Corp.	HEX	Class II	2006-08-07
K060936	Paragolfer	Parabasetec, GmbH	IPL	Class II	2006-08-07
K060810	One Step Drug Test - Amp/met/mor/thc/coc	Ind Diagnostic, Inc.	DKZ	Class II	2006-08-07
K060760	Rapidone-Buprenorphine Test	American Bio Medica Corp.	DJG	Class II	2006-08-07
K060355	Acro Biotech Llc Rapid Mdma Urine Test, Catalog Mdma0010000	ACRO BIOTECH Inc.	DJC	Class II	2006-08-07
K053570	Trep-Sure Treponemal Antibody Eia	Phoenix Biotech Corp.	LIP	Class II	2006-08-07
K062219	Prodrive Systems Replacement Turbine	Prodrive Systems, Inc.	EFB	Class I	2006-08-04
K061963	Micrus Microcatheter Courier Pre-Shaped, Models Mps170045-00, Mps170090-00, Mps190045-00, Mps190090-00	Micrus Endovascular Corporation	DQO	Class II	2006-08-04
K061955	Rayhack Low Profile Locking Plate and Instruments	Creative Medical Designs, Inc.	HRS	Class II	2006-08-04
K061827	Sonix Ultrasound Scanner	Ultrasonix Medical Corporation	IYN	Class II	2006-08-04
K061779	Competitor Unicondylar All-Poly Tibial Baseplate	Smith & Nephew, Inc.	HSX	Class II	2006-08-04
K061753	Synthes (USA) Clavicle Hook Plates	Synthes (USA) Products LLC	HRS	Class II	2006-08-04
K061730	Osmetech Opti R Critical Care Analyzer, Model Gd7044	Opti Medical Systems Inc	CEM	Class II	2006-08-04
K061638	Best Strand and Best Spacer	Best Medical International, Inc.	KXK	Class II	2006-08-04
K061589	Solarc / Solrx Handheld Ultraviolet Phototherapy Lamp Unit Family	Solarc Systems Inc.	FTC	Class II	2006-08-04
K061450	Hospira Latex-Free Advanced Sensor Catheters; Hospira Latex-Free Critical Care Catheters	Abbott Medical	DQE	Class II	2006-08-04