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 1439 of 3531

510(k) clearances, page 1439 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K032169	Carbon Fiber Composite Circular Fixation (Cirfix) Device (Half Ring)	Cyberorthology, Inc.	LXT	Class II	2003-09-22
K032110	Proclass Press Fit Hip Stem	Globus Medical, Inc.	LWJ	Class II	2003-09-22
K032065	Medline Band Bags and Equipment Covers	MEDLINE INDUSTRIES, LP - Northfield	MMP	Class II	2003-09-22
K031955	Macropore Surgi-Wrap Mast Bioresorbable Sheet	Macropore Biosurgery, Inc.	FTL	Class II	2003-09-22
K031945	Arthrex Trimit Screw, Model Ar-4161B	Arthrex GmbH	HWC	Class II	2003-09-22
K031889	Alexis Wound Retractor	Applied Medical Resources Corp	KKX	Class II	2003-09-22
K031604	Glycomark	Tomen America, Inc.	NOZ	Class II	2003-09-22
K031280	Ultra-Drive 3	Zimmer GmbH	JDX	Class II	2003-09-22
K030867	Eska Modular Hip System Cemented	Eska Implants GmbH	JDI	Class II	2003-09-22
K024125	Halm Zielke Instrumentation System	Micomed Ortho GmbH	KWQ	Class II	2003-09-22
K023983	Modification to Highgate Curved Rod System	Highgate Orthopaedics	KWQ	Class II	2003-09-22
K032760	Apax Pacs System	Tis, Inc.	LLZ	Class II	2003-09-17
K032611	Lyphochek Coagulation Control, Level 4, Model 743	Bio-Rad	GGN	Class II	2003-09-17
K032584	Rubicor Encapsule Breast Biopsy Device, Model 30629	Rubicor Medical, Inc.	GEI	Class II	2003-09-17
K032582	Unity Network Patient Data Server	GE Medical Systems Information Technologies, Inc.	MSX	Class II	2003-09-17
K032578	Tsrh Spinal System	Medtronic Sofamor Danek	MNI	Class II	2003-09-17
K032567	Bd Phoenix Automated Microbiology System-Cefoxitin-Gram Negative	Becton Dickinson & Co	LON	Class II	2003-09-17
K032495	The Lifecore Stage-1 Angled Abutment System	Lifecore Biomedical LLC	DZE	Class II	2003-09-17
K032269	Synthes (USA) 3.5/4.5Mm Lcp Medial Proximal Tibia Plates	Synthes (USA) Products LLC	HRS	Class II	2003-09-17
K032267	R&d Designation Ap-052-5	Jensen Industries, Inc.	EJT	Class II	2003-09-17
K032137	Precise Rx Nitinol Stent Transhepatic Biliary System	Cordis US Corp.	FGE	Class II	2003-09-17
K032075	Conductivity Standard Solution-Metercare	Ibp Instruments GmbH	FKH	Class II	2003-09-17
K031967	Tsrh Spinal System	Medtronic Sofamor Danek	MNI	Class II	2003-09-17
K031925	Proceed Trilaminate Surgical Mesh	Ethicon, Inc	FTL	Class II	2003-09-17
K031902	Online Tdm Carbamazepine	Roche Diagnostics GmbH	KLT	Class II	2003-09-17
K031855	Spinal Concepts, Inc. Insight Pedicle Screw System	Spinal Concepts, Inc.	KWQ	Class II	2003-09-17
K031351	Flex-Neck Pd Catheter, Infant	Medigroup	FJS	Class II	2003-09-17
K031099	Sorb+hisorb+cartridge	Renal Solutions, Inc.	FKT	Class II	2003-09-17
K030836	D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic Bandage	Vascular Solutions LLC	QSX	Unclassified	2003-09-17
K030832	Primosplint System	Cosmedent, Inc.	MQC	Unclassified	2003-09-17
K030821	Simuplan Treatment Planning System, Model V. 7.5	Simuplan S.L.	MUJ	Class II	2003-09-17
K030815	Akers Laboratories Inc. Blood Cell Separator	Akers Laboratories, Inc.	JKA	Class II	2003-09-17
K030691	Fetal Spiral Electrode, Model Fse07000	Clinical Innovations, LLC	HGP	Class II	2003-09-17
K030570	Blue Line Ultra Suctionaid Tracheostomy Tube	Abbott Medical	BTO	Class II	2003-09-17
K030180	Crescent Tinnitus Retaining Sound Generator	Starkey Laboratories, Inc.	KLW	Class II	2003-09-17
K030145	Galix Winter	Galix Biomedical Instrumentation, Inc.	DQK	Class II	2003-09-17
K023758	Becker Transnasal Lacrimal (Intubation Sets)	Fci Ophthalmics, Inc.	OKS	Unclassified	2003-09-17
K032749	Bedside Monitor, Model Opv-1500	Nihon Kohden America Inc	MWI	Class II	2003-09-16
K032674	Belmont Fluid Management System, Model Fms2000	Belmont Medical Technologies	LGZ	Class II	2003-09-16
K032615	Asahi Ptca Catheter Guide Wires, Models Agh147000 and Agh147300	Asahi Intecc Co., Ltd.	DQX	Class II	2003-09-16
K032569	Short Introducer Sheath	Rex Medical LP	DYB	Class II	2003-09-16
K032542	Modification to Contour Se Microspheres	Boston Scientific Corporation	HCG	Class II	2003-09-16
K032529	Hydrocision Arthrojet System with Cautery, Turboburr and Curette, Models 51300, 51310	Hydrocision, Inc.	HRX	Class II	2003-09-16
K032165	Vintage Al	Shofu Dental Corp.	EIH	Class II	2003-09-16
K031948	Peripatch Sheet, Models 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16	Pm Devices, Inc.	DXZ	Class II	2003-09-16
K031933	Medline Reusable Surgical Gowns (100X)	MEDLINE INDUSTRIES, LP - Northfield	FYA	Class II	2003-09-16
K031632	Osseotite IOL Implants and Osseotite Certain IOL Implants	ZimVie US Corp LLC	DZE	Class II	2003-09-16
K031593	Sopro 61D	Sopro	GCJ	Class II	2003-09-16
K031499	Diobeam 830	Soft-Core Texas, Inc.	NHN	Class II	2003-09-16
K030846	Candela Smoothbeam Laser System	Candela Corporation	GEX	Class II	2003-09-16