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 2026-11-09, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,227 of the 176,624 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	2,827

176,624 records, page 1720 of 3533

510(k) clearances, page 1720 of 3533
K number	Device	Applicant	Product code	Class	Decision date
K992536	Technosanat Kryo Tsk 2005	Technosanat Innovative Medizintechnik GmbH	GEX	Class II	1999-10-08
K992507	Pasco Mic and Mic/id Panels, Trovafloxacin	Pasco Laboratories, Inc.	JTN	Class II	1999-10-08
K992409	The Implex Modular Elliptical Porous Acetabular Cup, Model Xx-2Yy-Zzzz	Implex Corp.	JDI	Class II	1999-10-08
K992377	Rc Tack	Innovasive Devices, Inc.	MBI	Class II	1999-10-08
K992366	Vitros Immunodiagnostic Products Troponin I Reagent Pack	Ortho-Clinical Diagnostics, Inc.	MMI	Class II	1999-10-08
K992351	Sealouette Fibrin Sealant Applicator	Biosurgical Corp.	FMF	Class II	1999-10-08
K992347	Cordis Super Torque Mb Angiographic Catheter with Radiopaque Marker Bands	Cordis US Corp.	DQO	Class II	1999-10-08
K992340	Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop -Adt-Adult/pediatric Disposable Sensor, Masimo Lnop -Pdt-Pe	Masimo Corporation	DQA	Class II	1999-10-08
K992334	Endosseous Implants and Abutments- Tin Coating	ZimVie US Corp LLC	DZE	Class II	1999-10-08
K992333	Ebi Omega 21 System	Electro-Biology, Inc.	MNI	Class II	1999-10-08
K992326	3M Clinpro Sealant	3M Company	EBC	Class II	1999-10-08
K992319	Rx Megalink Sds Biliary Stent System, Otw Megalink Sds Biliary Stent System	Boston Scientific Corporation	FGE	Class II	1999-10-08
K992238	Masimo Set Radical Pulse Oximeter, Lnop-Adt, Lnop-Pdt, Lnop-Neo, Lnop-Neo Pt, Lnop-Dci, Patient Cable (Pc04, Pc08, Pc12)	Masimo Corporation	DQA	Class II	1999-10-08
K992195	Quantec-E Irrigation System 2	Sybron Dental Specialties, Inc.	EIA	Class I	1999-10-08
K991709	Browne Cidex Opa Indicator	Sybron Dental Specialties, Inc.	JOJ	Class II	1999-10-08
K991658	Permobil Powered Wheelchair 1280	Permobil, AB	ITI	Class II	1999-10-08
K991487	Cidex Opa Solution	Advanced Sterilization Products	MED	Class II	1999-10-08
K991256	Viewpoint Ent/orthopedic Option	Philips North America LLC	HAW	Class II	1999-10-08
K990153	Virgo MRI System	Millennium Technology Services	LNH	Class II	1999-10-08
K983864	Etco2 Vital Signs Module	Mennen Medical, Inc.	CCK	Class II	1999-10-08
K993038	Toshiba Rtp9211j-G11, J-Advanced Image Intensifier (i.i.)	Toshiba America Medical Systems, In.C	JAA	Class II	1999-10-07
K992983	Baho Autoclavable Cystoscope	Innovative Endoscopy Components, LLC.	FAJ	Class II	1999-10-07
K992966	Reference	Espe Dental AG	EBF	Class II	1999-10-07
K992869	Xomed Ball-Tip Monopolar Stimulator Probe	Xomed, Inc.	ETN	Class II	1999-10-07
K992696	ECG Minimonitor, Model Cg-5000	Card Guard Scientific Survival, Ltd.	DXH	Class II	1999-10-07
K992575	Cardiovascular Workstation, Model Cws 5000/Cws 3000	Infimed, Inc.	LLZ	Class II	1999-10-07
K992450	Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers	Emory University	KPS	Class II	1999-10-07
K992335	Beacon-P, Model 211059	Philips North America LLC	KPS	Class II	1999-10-07
K992309	Introducer Sheath, Vessel Dilator	Boston Scientific Corporation	DYB	Class II	1999-10-07
K992028	Refresh Contacts Lubricating and Rewetting Drops	Allergan	LPN	Class II	1999-10-07
K991857	Airflow Handy	E.M.S. - Electro Medical Systems SA	EFB	Class I	1999-10-07
K991687	Modification to Liner II: Soft Reline Liquid	Bosworth Co.	EBI	Class II	1999-10-07
K991452	Cobe Optimin Hollow Fiber Membrane Oxygenator	LivaNova USA, Inc.	DTZ	Class II	1999-10-07
K990990	Cet Prostate Applicator Set, Part Number 089.066	Nucletron BV	JAQ	Class II	1999-10-07
K990638	Aneroid Sphygmomanometer	Genmed, Inc.	DXN	Class II	1999-10-07
K984590	0.9% Sodium Chloride Flush Syringe	Baxter Healthcare Corporation	FOZ	Class II	1999-10-07
K993100	Redi-Screen	Redwood Biotech, Inc.	DJC	Class II	1999-10-06
K993064	Prisma Cfm (Continuous Fluid Management System)	Gambro Renal Care Products	KDI	Class II	1999-10-06
K993004	Alta Fully Threaded Cross-Locking 5.0 Mm Screw	Howmedica Osteonics Corp	JDS	Class II	1999-10-06
K992956	Lucitone Frs Flexibel Dental Resin	Dentsply Intl.	EBI	Class II	1999-10-06
K992922	Sensi-Pro, Disposable Powdered Vinyl Synthetic Examination Gloves, White Color	Shijiazhuang Hongray Plastic Products Co., Ltd.	LYZ	Class I	1999-10-06
K992861	Synthetic Powder Free (Yellow) Vinyl Patient Examination Gloves	Shijiazhuang Great Eagle Plastic Products Co., Ltd.	LYZ	Class I	1999-10-06
K992685	Quickscreen Workplace Drug Screening Test, Model 9147 25C	Phamatech Inc.	MVO	Unclassified	1999-10-06
K992274	Modification to Imx Homocysteine	Axis Biochemicals, ASA	LPS	Class II	1999-10-06
K991914	Super Soother	Mart Tiller Corp.	FLL	Class II	1999-10-06
K991474	Health-Plus, Sanitex, Reliance, Pre-Powdered Multi-Ply Examination Glove, (Natural Latex Laminated with Nitrile, Externa	Pamitex Industries Sdn Bhd	LYY	Class I	1999-10-06
K990977	Seraquest Eb Vac Igm	Quest Intl., Inc.	LJN	Class I	1999-10-06
K993111	Ascent Knee System	Biomet Manufacturing Corp	JWH	Class II	1999-10-05
K993083	Alcyon 300I (with Ise Module) Analyzer	Abbott Medical	CEM	Class II	1999-10-05
K993057	Mba	Merit Medical Systems, Inc.	DTL	Class II	1999-10-05