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 1471 of 3531

510(k) clearances, page 1471 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K024350	Acon H. Pylori Rapid Test Strip and Acon H. Pylori Rapid Test Device	Acon Laboratories, Inc.	LYR	Class I	2003-04-02
K023288	Cobra Bipolar Clamp, Model 15902	Boston Scientific EP Technologies	GEI	Class II	2003-04-02
K030936	Rita Clips for Infusion Pumps	Boston Scientific Corporation	MRZ	Class II	2003-04-01
K030918	Superopen 0.35T, Model Nsm-P035	Neusoft Digital Medical Systems Co., Ltd.	LNH	Class II	2003-04-01
K030740	Modification to Tina-Quant D-Dimer Test System	Roche Diagnostics GmbH	GHH	Class II	2003-04-01
K030677	Bd Phoenix Automated Microbiology System-Vancomycin Gram Positive	Becton Dickinson & Co	LON	Class II	2003-04-01
K030619	Odi 7.0Mm Cannulated Screw System	Orthopedic Designs, Inc.	HTN	Class II	2003-04-01
K030572	Henke Sass Wolf of America Nasopharyngoscope	Henke Sass Wolf of America, Inc.	EOB	Class II	2003-04-01
K030390	Synthes Large Combination Clamp and Dynamization Clip - Mr Safe	Synthes (USA) Products LLC	LXT	Class II	2003-04-01
K030382	Selitherm, Model C100	Selicor, Inc.	IMJ	Class II	2003-04-01
K030205	Consensus Unipolar Head, Cocr	Hayes Medical, Inc.	KWL	Class II	2003-04-01
K030198	Hand Innovations, Inc. Distal Radius Fracture Repair System	Hand Innovations, Inc.	HRS	Class II	2003-04-01
K030153	Zca All-Poly Acetabular Cup, Snap-in, Model 8005-946/958-32	Zimmer GmbH	JDI	Class II	2003-04-01
K030094	Disposable Powder Free Vinyl Synthetic Exam Gloves with Aloe Vera, Green Color	Shanghai Palomar Mountain Industries, Inc.	LYZ	Class I	2003-04-01
K030027	Gelflex Synergy Soft Lens Hioxfilcon 49% Water Content Clear or Blue Visitint; Gelflex Hioxifilcon Soft Contact Lens 49%	Gelflex Laboratories	LPL	Class II	2003-04-01
K023794	Constrained Liner	Encore Medical, LP	KWZ	Class II	2003-04-01
K022277	Osteomed Cranial Flap Fixation System	Osteomed	GXN	Class II	2003-04-01
K021622	Hill-Rom Air Shields/minolta Jaundice Meter, Model Jm-103	Hill-Rom Air-Shields	MQM	Class I	2003-04-01
K030721	Quick-Tap Paracentesis Tray, Kit & Needle	Ballard Medical Products	LRO	Class II	2003-03-31
K030653	Surgassist Straight Linear Stapler and Straight Linear 4 Row No Knife Digital Loading Units with Reloads	Power Medical Interventions, Inc.	GDW	Class II	2003-03-31
K030616	Cedia Cyclosporine Plus High Range Controls 4 and 5	Microgenics Corporation	LAS	Class I	2003-03-31
K030154	Ideal: System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Bracket, Adult Membrane Oxygenator	Dideco S.p.A.	KFM	Class II	2003-03-31
K030053	Jostent Selfx, Models 015Sx4406; 015Sx4408; 015Sx4410; 015Sx680; 015Sx6808; 015Sx6810	Jomed AG	FGE	Class II	2003-03-31
K030007	Iti Dental Implant System	Straumann USA, LLC	DZE	Class II	2003-03-31
K024371	Candela Gentle Lase Family of Laser System	Candela Corporation	GEX	Class II	2003-03-31
K024006	G6pdh, Glucose-6-Phoshate Dehydrogenase	Horiba Instruments Incorporated	JBF	Class II	2003-03-31
K023833	Gish Arterial Filter with Gbs Coating	Gish Biomedical, Inc.	DTM	Class II	2003-03-31
K023505	Vbl Serum Troponin I Test, Model 1001	Vancouver Biotech, Ltd.	MMI	Class II	2003-03-31
K023381	Vision Hollow Fiber Oxygenator with Guardian Coating	Gish Biomedical, Inc.	DTZ	Class II	2003-03-31
K030878	Accousonic, Model as-270	Metron Medical Australia, Pty, Ltd.	IMI	Class II	2003-03-28
K030874	Ge 3.0T Signa Infinity Twinspeed with Excite Mr System	General Electric Co.	LNH	Class II	2003-03-28
K030856	Er800 Series ECG Event Recorder	Braemar Manufacturing, LLC	MWJ	Class II	2003-03-28
K030825	Mpm-Net	Aerotel Medical Systems (1998), Ltd.	DXN	Class II	2003-03-28
K030688	Echelon Micro Catheter, Model 105-5092-150	Medtronic, Inc.	KRA	Class II	2003-03-28
K030674	Modification to Axxess Spinal Cord Stimulation Lead	Abbott Medical	GZB	Class II	2003-03-28
K030648	Vectorsurge 5 Model 470	Metron Medical Australia, Pty, Ltd.	IPF	Class II	2003-03-28
K030635	The Obsidian Pacs System	Obsidian Medical Technology, Inc.	LLZ	Class II	2003-03-28
K030625	Spinal Concepts Inc. Pathfinder	Spinal Concepts, Inc.	NKB	Class II	2003-03-28
K030571	Acuvance Plus Safety IV Catheter, Protectiv Plus Safety IV Catheter, Optiva IV Catheter	Ethicon Endo-Surgery Inc	FOZ	Class II	2003-03-28
K030386	Powder Free Synthetic Nitrile Neoprene Examination Gloves, Sizes Small,medium, Large, and X-Large	Shamrock Manufacturing Company	LZA	Class I	2003-03-28
K030351	Stainless Steel Surgical Suture, Non-Absorbable	Cp Medical	GAQ	Class II	2003-03-28
K030325	Powderfree Latex Examination Gloves with Bubblegum	Pt.Shamrock Manufacturing Corp.	LYY	Class I	2003-03-28
K030162	Lawrence Cserion, Model Cs-1	Isoray, Inc.	KXK	Class II	2003-03-28
K030073	Vermed A10021 Resting EKG Tab Electrode	Vermont Medical, Inc.	DRX	Class II	2003-03-28
K030016	Teoae25	Interacoustics A/S, Assens	EWO	Class II	2003-03-28
K024347	Express Blood Glucose Monitoring System	Arkray Factory USA, Inc.	CGA	Class II	2003-03-28
K023918	Rusch Crystal Clear Tracheostomy Sets, Cuffed and Cuffless	Rusch Intl.	JOH	Class II	2003-03-28
K023565	Oxicheck	Caradyne, Ltd.	CCL	Class II	2003-03-28
K023257	Endoscopic Laser Delivery System-Lasertx	Prosurg, Inc	GEX	Class II	2003-03-28
K023210	Seedlinks, Models 70301, 70302, 70303	Sourcetech Medical, LLC	KXK	Class II	2003-03-28