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 1493 of 3531

510(k) clearances, page 1493 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K022928	Hudson 2020, 2040, 2060,Ultrasound Scanners	Hudson Diagnostic Imaging, LLC	IYO	Class II	2002-12-11
K022888	Acubeam, Super Nova, Dio	Light Force Therapy, Inc.	ILY	Class II	2002-12-11
K021039	Bowti Anterior Buttress Staple System	Depuyacromed	KWQ	Class II	2002-12-11
K014277	Ksea Deployable Cardiovascular Clamp	Karl Storz Endoscopy-America, Inc.	DXC	Class II	2002-12-11
K014152	Nxstage Cartridge Express	NxStage Medical Inc	KDI	Class II	2002-12-11
K023876	Vitros Chemistry Products Mg Slide, Vitros Chemistry Products Calibrator Kit 1	Ortho-Clinical Diagnostics, Inc.	JIX	Class II	2002-12-10
K023875	Vitros Chemistry Products Alb Slide, Vitros Chemistry Products Calibrator Kit 4	Ortho-Clinical Diagnostics, Inc.	CIX	Class II	2002-12-10
K023811	Modification to Viabahn Endoprosthesis	W. L. Gore & Associates, Inc.	JCT	Class II	2002-12-10
K023786	Depuy Pinnacle Metal-on-Metal Acetabular Cup Liner	Depuy Orthopaedics Inc.	KWA	Class III	2002-12-10
K023732	Cibasoft Progressive Toric (Tefilcon) Soft (Hydrophilic) Contact Lens for Daily Wear	Alcon Laboratories	LPL	Class II	2002-12-10
K023469	Victus i.v. Administration Set, Models 27058, 27059,27062	Victus, Inc.	FPA	Class II	2002-12-10
K023391	Bioporta G	Wieland Dental + Technik GmbH & Co. KG	EJT	Class II	2002-12-10
K023320	Agiltrac .035 Peripheral Dilatation Catheter	Boston Scientific Corporation	DQY	Class II	2002-12-10
K023161	Smartstep System	Andante Medical Device, Ltd.	IRN	Class II	2002-12-10
K023077	Ocu-Flex Pediatric Aphakic (Ocufilcon B) Spherical Soft Contact Lens for Daily Wear (Lathe-Cut)	Ocu-Ease Optical Products, Inc.	LPL	Class II	2002-12-10
K023019	Vomed Urethra Olive, Models 1420 000, 1425 000, 1430 000	Vomed Volzer Medizintechnik GmbH & Co.	FGI	Class II	2002-12-10
K022377	The Trabecular Metal Glenoid-Bigliani/flatow the Complete Shoulder Solution, Model 4306	Implex Corp.	KWT	Class II	2002-12-10
K022284	Snore-Aid Max	Dental Imagineers, LLC	LRK	Class II	2002-12-10
K022133	Bd Directigen Ez Rsv Kit	Becton Dickinson & Co	GQG	Class I	2002-12-10
K020085	Sintea Biotech Posterior Lumbar System, Model Pls 00.T5.x	Sintea Biotech, Inc.	MNH	Class II	2002-12-10
K014296	Cd Horizon Spinal System	Medtronic Sofamor Danek	KWP	Class II	2002-12-10
K023551	Wiener Lab Got (Ast) UV Aa Liquida	Wiener Laboratories Saic	CIT	Class II	2002-12-09
K023550	Wiener Lab Uricostat Enzimatico Aa Liquida	Wiener Laboratories Saic	KNK	Class I	2002-12-09
K023549	Wiener Lab Amilasa 405 Aa Liquida	Wiener Laboratories Saic	JFJ	Class II	2002-12-09
K023369	Access Total T4 Assay	Siemens Healthcare Diagnostics Inc.	KLI	Class II	2002-12-09
K023362	Fisher Diagnostics Thromboscreen 1000; Pacific Hemostasis Fibrinogen Reagent Plus Kaolin	Fisher Diagnostics	GKP	Class II	2002-12-09
K023304	Immulite/immulite 1000 Calcitonin, Model Lkcl and Immulite 2000 Calcitonin, Model L2kcl	Siemens Healthcare Diagnostics Inc.	JKR	Class II	2002-12-09
K023276	Amsino Tracheostomy Care Tray	Amsino International, Inc.	LRO	Class II	2002-12-09
K023098	Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser Infusion Kit	Mckinley Infuser	MEB	Class II	2002-12-09
K022693	Instant-View Tca Urine Test	Alfa Scientific Designs, Inc.	MLK	Class II	2002-12-09
K022313	Surgassist Right Angle Linear Cutter Dlu 30Mm, 45Mm & 60Mm - Vascular with Reloads, Models Ralc30v, Ralc45v & Ralc60v	Power Medical Interventions, Inc.	GDW	Class II	2002-12-09
K021798	Smith & Nephew Image Guided Surgical Instruments for Hip Applications	Smith & Nephew, Inc.	HAW	Class II	2002-12-09
K021233	Aap Cannulated Screws	AAP Implantate AG	HWC	Class II	2002-12-09
K023891	St Aia-Pack Ca 125 Enzyme Immunoassay	Tosoh Medics, Inc.	LTK	Class II	2002-12-06
K023846	Mr Compatible Rita Model 90 Electosurgical Accessory	Boston Scientific Corporation	GEI	Class II	2002-12-06
K023789	O.b. Tampons	Mcneil-Ppc, Inc.	HEB	Class II	2002-12-06
K023661	Linical RF-Crp Calibration Verifiers Levels a-E for Beckman Coulter Synchron Cx Systems	Cliniqa Corporation	JJY	Class I	2002-12-06
K023577	Powder Free Latex Exam Gloves, Poly Coated Natural And/or Colored, with Protein Labeling (<50Un/g)	Yty Industry (Manjung) Sdn. Bhd.	LYY	Class I	2002-12-06
K023392	Agc Special Alloy	Wieland Dental + Technik GmbH & Co. KG	EJT	Class II	2002-12-06
K023389	Porta Geo Ti	Wieland Dental + Technik GmbH & Co. KG	EJT	Class II	2002-12-06
K023347	Vital Stim	Chattanooga Group, Inc.	IPF	Class II	2002-12-06
K023281	Online Dat II Cocaine II	Roche Diagnostics GmbH	DIO	Class II	2002-12-06
K023219	Becton Dickinson Diabetes Software	Becton Dickinson & Co	NBW	Class II	2002-12-06
K022997	Spectrum Cervical Spinal System	Spinal Innovations, LLC	KWQ	Class II	2002-12-06
K021548	Fotona Dualis Nd:yag/er:yag Laser System	Fotona D.D.	GEX	Class II	2002-12-06
K023757	Cryocare Surgical System, Model Cryo 20	Varian Medical Systems, Inc.	GEH	Class II	2002-12-05
K023716	Spsmedical Sporview Bacterial Spore Strip	Spsmedical Supply Corp.	FRC	Class II	2002-12-05
K023007	Distal Radius Fracture Repair System	Hand Innovations, Inc.	HRS	Class II	2002-12-05
K022985	Ascendent Acetabular System	Sulzer Orthopedics, Inc.	LZO	Class II	2002-12-05
K023871	M3046a (M2/m3/m4) Compact Portable Patient Monitor and Mp60 & Mp70 Intellivue Patient Monitor with Portal Technology	Philips North America LLC	MHX	Class II	2002-12-04