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 1463 of 3531

510(k) clearances, page 1463 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K030527	Lumenis Family of Ipl and Combination Ipl/nd:yag Systems	Lumenis Ltd	GEX	Class II	2003-05-20
K030518	Ameritek Sure-Point Tracker System	Amertek Medical, Inc.	ITX	Class II	2003-05-20
K030508	Depilase Trio Lase Laser System	Depilase Group, Ltd.	GEX	Class II	2003-05-20
K030507	T.e.a.r. Tech3 Model #44Tt03	Vision Quest Industries, Inc.	IPF	Class II	2003-05-20
K030502	14.5F X 55Cm Hemo-Flow Double Lumen Catheter, Models Hfs-55, Hft-55	Medcomp	MSD	Class II	2003-05-20
K030497	Fresenius Naturalyte Granuflo Dry Acid Concentrate 10Xx Series, 24Xx Series, 30Xx Series	Fresenius Medical Care	KPO	Class II	2003-05-20
K030494	Sr-130	Source-Ray, Inc.	IZL	Class II	2003-05-20
K030356	Comfort Powered Wheelchair, Traveller Ly-Eb 103	Comfort Orthopedic Co., Ltd.	ITI	Class II	2003-05-20
K030355	Comfort Powered Wheelchair, Conqueror Ly-Eb 202	Comfort Orthopedic Co., Ltd.	ITI	Class II	2003-05-20
K030131	Ossatura Bcp Bone Void Filler	Isotis NV	MQV	Class II	2003-05-20
K022998	Home Care Vareious Models of Powered Muscle Stimulator, Ht-311, Ht-311N, Ht-312	Home Care Technology Co., Ltd.	IPF	Class II	2003-05-20
K022849	Body Clock TENS N' Tone	Body Clock Health Care Ltd	GZJ	Class II	2003-05-20
K031285	Mega 2000 Soft Dual Cord Patient Return Electrode Pad	Megadyne Medical Products, Inc	GEI	Class II	2003-05-19
K031122	Hemosil Factor X Deficient Plasma	Instrumentation Laboratory Co.	GJT	Class II	2003-05-19
K030952	Dolphin 2000 Pulse Oximetry Sensors Models 2010, 2311 Adult, 2312 Pediatric, 2313 Infant, 2314 Neonatal, 2421	Dolphin Medical, Inc.	DQA	Class II	2003-05-19
K030631	Zippere - Bioabsorbable/non-Absorbable Polymer Sling & Surgical Mesh	Prosurg, Inc	FTL	Class II	2003-05-19
K031218	Modification to Tornier Total Elbow Prosthesis	TORNIER Inc.	JDB	Class II	2003-05-16
K031210	Model 4951M Myocardial Unipolar Lead	Metronic, Inc.	DTB	Class III	2003-05-16
K031080	Everest Bipolar Lyons Dissecting Forceps & Gyrus Bipolar Lyons Dissecting Forceps	Gyrus ACMI, Inc.	GEI	Class II	2003-05-16
K031078	Everest Bipolar Macro, Micro & Molly Forceps & Gyrus Bipolar Macro, Micro & Molly Forceps	Gyrus ACMI, Inc.	GEI	Class II	2003-05-16
K030986	Bd Phoenix Automated Microbiology System Trimethoprim - Gn 0.5-16 Ug/ml	Becton Dickinson & Co	LON	Class II	2003-05-16
K030932	Cd Horizon Spinal System	Medtronic Sofamor Danek	MNI	Class II	2003-05-16
K030714	Peak Motus	Peak Performance Technologies, Inc.	LXJ	Class II	2003-05-16
K023908	Interpore Cross Cement Restrictor	Interpore Cross Intl.	JDK	Class II	2003-05-16
K023857	Platelia Aspergillus Eia, Models 62793 and 62794	Bio-Rad	NOM	Class I	2003-05-16
K031343	Tpsa Flex Reagent Cartridge	Siemens Healthcare Diagnostics Inc.	LTJ	Class II	2003-05-15
K031332	Bard Pelvisoft Acellular Collagen Biomesh	C.R. Bard Inc	FTM	Class II	2003-05-15
K031295	Bard Innerlace Biourethral Support System	C.R. Bard Inc	PAG	Class II	2003-05-15
K031069	Surgisis Nerve Cuff	Cook Biotech, Inc.	JXI	Class II	2003-05-15
K030947	Alveolus Inc., Tb-Sts Tracheobronchial Stent System	Alveolus, Inc.	JCT	Class II	2003-05-15
K030925	Proximate Hcs Hemorrhoidal Circular Stapler and Accessories, Model Pph01	Ethicon Endo-Surgery Inc	GDW	Class II	2003-05-15
K030921	Collagen Topical Wound Dressing	Collagen Matrix, Inc	KGN	Unclassified	2003-05-15
K030840	Modification to Horizon Spinal System	Medtronic Sofamor Danek	MNI	Class II	2003-05-15
K023594	Teno Fix	Ortheon Medical, LLC	GAQ	Class II	2003-05-15
K022506	Morpheus 1, Automated Sleep Study Scoring & Data Management System	Widemed, Ltd.	MNR	Class II	2003-05-15
K031300	Ibc Flopump with Gbs Coating	Gish Biomedical, Inc.	KFM	Class II	2003-05-14
K031277	Jowire Asahi Ptca Catheter Guide Wires, Models Ag145300,141300,142300,132200,14m350,14m345,14m360,143390,141002	Jomed, Inc.	DQX	Class II	2003-05-14
K031168	Matrix Stretch Resistant Detachable Coil	Boston Scientific Corporation	HCG	Class II	2003-05-14
K031149	Olympic Cfm 6000	Olympic Medical Corp.	OMA	Class II	2003-05-14
K031123	Codman Bactiseal Barium Striped Catheters	Cerenovus, Inc.	HCA	Class II	2003-05-14
K031086	Camino Single Parameter Monitor, Model Spm-1	Integra NeuroSciences	GWM	Class II	2003-05-14
K030917	Gem; Hawk; Eagle; Models 004110, 0044120, 004130	Collins Medical, Inc.	BZG	Class II	2003-05-14
K030748	Aquasoft (Ocufilcon D) Daily Wear Contact Lens Clear and Visibility Tint, with UV Blocker	Clearlab Pte, Ltd.	LPL	Class II	2003-05-14
K030549	Hi-Torque Pilot 50 Guide Wire with Hydrocoat Hydrophilic Coating, Hi-Torque Pilot 150 Guide Wire with Hydrocoat Hydrophg	Guidcorp	DQX	Class II	2003-05-14
K030512	Guidant Vasoview Endoscopic Vessel Harvesting System	Boston Scientific Corporation	GCJ	Class II	2003-05-14
K030510	Depilase Twin Yag Laser System	Depilase Group, Ltd.	GEX	Class II	2003-05-14
K030505	Capiox Cardiotomy Reservoir	Terumo Cardiovascular Systems Corporation	DPW	Class II	2003-05-14
K030480	L600 Hair Removal	A&M Technology	GEX	Class II	2003-05-14
K023733	Coa-Comp/m, Automated Bipolar Coagulator	Ingenjorsfirman Bjorn Bergdahl AB	GEI	Class II	2003-05-14
K021944	Cozart Eia Cotinine Urine Kit	Cozart Bioscience, Ltd.	MKU	Class I	2003-05-14