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 1920 of 3531

510(k) clearances, page 1920 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K964930	Stryker Saphenous Vein Harvest Scope	Stryker Corp.	GCJ	Class II	1997-02-28
K964893	Hansson Pin System	Osteonics Corp.	JDW	Class II	1997-02-28
K964888	Heart Aide Multple/heart Aide Plus/heart Aide Plus II	TZ Medical Inc.	DXH	Class II	1997-02-28
K964876	Sa.ef(tm) Infusion Port II - Connector and Extension Set	VLV Associates, Inc.	FPA	Class II	1997-02-28
K964863	Model 45E Handengine & Controller, Model 45Eh Handengine & Controller, Model Rx-100 Handengine & Controller, Model Eteln	Bell Intl., Inc.	EBW	Class I	1997-02-28
K964834	Isocam II (Dual Head Gamma Camera)	Park Medical Systems, Inc.	KPS	Class II	1997-02-28
K964820	Maxim 7000 Quadrature Extremity Coil Model Number Qec-Gem-15A	Us Asia Instruments, Inc.	MOS	Class II	1997-02-28
K964353	Cyberlase CO2 Laser System	Nidek, Inc.	GEX	Class II	1997-02-28
K963654	Quikstrip Onestep Marijuana (Thc) Test	Syntron Bioresearch, Inc.	LDJ	Class II	1997-02-28
K963576	Mobile Medical Monitor (M3(a))	Scientific Applications	DRT	Class II	1997-02-28
K963375	Cardiacmonitor	Vision Electronics	DXH	Class II	1997-02-28
K963120	Responder 2500 Defibrillator and Cardiac Care System	Marquette Electronics, Inc.	DRO	Class II	1997-02-28
K962534	Thera-Mist Nebulizer Model-P3000	Pegasus Research Corp.	CAF	Class II	1997-02-28
K960309	Airsep Newlife Dual Six Oxygen Concentrator (Modification)	Airsep Corp.	CAW	Class II	1997-02-28
K953076	Townley Facet/pedicular Screw Plating System	Sofamor Danek USA,Inc.	MRW	Unclassified	1997-02-28
K945117	Delta	KaVo Dental Technologies, LLC	FLE	Class II	1997-02-28
K970567	Select Shoulder Curved-Back Pegged All Poly Glenoids	Intermedics Orthopedics	KWT	Class II	1997-02-27
K970168	3M Quikplus System	3M Company	EBG	Class II	1997-02-27
K965216	Argi-Satin or Opti0-Star	Argen Precious Metals, Inc.	ELL	Class II	1997-02-27
K965073	9 X 25Mm Standard Interfernece Scre (S.i.s.) Acl Screw	Smith & Nephew, Inc.	HWC	Class II	1997-02-27
K964968	Mr Extension Set (001)	University of Michigan	FPA	Class II	1997-02-27
K964847	Ningbo Yujiang Latex Examination Gloves, Powder-Free, with Protein Labeling	Ningbo Yujiang Plastic & Rubber Co., Ltd.	LYY	Class I	1997-02-27
K964845	Jinhua Latex Exam Glove, Powder Free with Protein Labeling	Jinhua Latex Products Factory	LYY	Class I	1997-02-27
K964736	Bergen 610 Bipolar Coagulator	Bergen Mfg.	GEI	Class II	1997-02-27
K962666	Bemiss Jason-Sterile,non-Sterile,reinforced Sterile,and Reinforced Non-Sterile Surgical Gown	Bemiss-Jason Corp., Triad Medical Div.	FYA	Class II	1997-02-27
K970263	Pm 2002 Cc Proline	Planmeca Oy	EHD	Class II	1997-02-26
K970057	Ahs Omega Sp	Authorized Hearing Systems, Inc.	ESD	Class I	1997-02-26
K970039	Encore Electrosurgical Handcontrol Pencil (35001-001)	Medtrex, Inc.	GEI	Class II	1997-02-26
K965208	Polyfin Extension Set, Models 126 and 128	Medtronic, Inc.	FPK	Class II	1997-02-26
K964990	Hitachi Sx-Va30 C-Arm Fluoroscopic/angiographic System (Sx-Va30)	FUJIFILM Healthcare Americas Corporation	JAA	Class II	1997-02-26
K964813	Model 675Ge-64 Peripheral Vascular Coil Consisting of Model 665Ge-64: Lower Extremity Flexible Array and Model 538Ge-64:	Medical Advances, Inc.	MOS	Class II	1997-02-26
K964808	Spetemp	Ultradent Products Inc.	EMA	Class II	1997-02-26
K964780	Bard Director Guidewire (000560)	C.R. Bard Inc	OCY	Class II	1997-02-26
K964322	Vipor Unit	Tilane Corp.	JAA	Class II	1997-02-26
K964181	Spongetrac	Surgitrac Corp.	MRL	Class I	1997-02-26
K964112	Berenstein Coil	Target Therapeutics	KRD	Class II	1997-02-26
K964018	Phacoilluminator - Fiberoptic Sleeve	Michael Reynard, M.D.	HQC	Class II	1997-02-26
K963662	Galileo Evoked Potentialre	Biosound, Inc.	GWF	Class II	1997-02-26
K963406	Uhe Collimator (210591)	Philips North America LLC	KPS	Class II	1997-02-26
K963351	Lifeshield Blunt Cannula	Abbott Medical	FMI	Class II	1997-02-26
K961862	Models Ida-2 Plus and Ipt-1	Bio-Tek Instruments, Inc.	FRN	Class II	1997-02-26
K961809	She-Li TENS Stimulator Model Sl-101 Rx	Medi Consultants, Inc.	GZJ	Class II	1997-02-26
K970443	Hollister Retracted Penis Pouch	Hollister, Inc.	EXI	Class I	1997-02-25
K970297	Omni Grip Latex Examination Glove, Powder-Free	Omni Sales Corp.	LYY	Class I	1997-02-25
K970281	Vitros Immunodiagnostic Products Prolactin Reagent Pack/calibrators	Johnson & Johnson Clinical Diagnostics, Inc.	CFT	Class I	1997-02-25
K970126	Access Estradiol Reagents on the Access Immunoassay Analyzer (33550,33540,33545)	Bio-Rad Laboratories Inc.	CHP	Class I	1997-02-25
K965243	Endocare Electrosurgical Electrode	Varian Medical Systems, Inc.	GEI	Class II	1997-02-25
K965135	Lifecore Conical Abutment	Lifecore Biomedical LLC	DZE	Class II	1997-02-25
K965118	Endocare Monopolar Electrode	Varian Medical Systems, Inc.	FAS	Class II	1997-02-25
K965021	Non-Prescription Sunglasses	Victory Eyewear Co., Ltd.	HQY	Class I	1997-02-25