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 2026-11-02, 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 1002 of 3531

510(k) clearances, page 1002 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K101994	Apex Knee Modular Tibia System	Omnlife Science	JWH	Class II	2010-09-28
K101710	Luxatemp Ultra /Star	Dmg USA, Inc.	EBG	Class II	2010-09-28
K101566	Vitek 2 Yeast Caspofungin	bioMerieux, Inc.	NGZ	Class II	2010-09-28
K101477	Biotene Dry Mouth Mouthwash, Biotene Pbf Dry Mouth Mouthwash	Glaxosmithkline Consumer Healthcare (Gskch)	LFD	Unclassified	2010-09-28
K100550	Poly-Chem 90 Direct Hdl Cholesterol, Poly-Chem 90 Direct Ldl Cholesterol, Poly-Chem 90 Cholesterol, Poly-Chem 90 Triglyc	Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, LLC	LBS	Class I	2010-09-28
K100112	Somona Cwg Clavicle Fracture Repair Device Model Sonoma Cwg Xyyy(x=dia, Yyy=length-in Mm)	Sonoma Orthopedic Products, Inc.	HSB	Class II	2010-09-28
K093137	K-Assay Cystatin C Reagent, Calibrator and Control	Kamiya Biomedical Company, LLC	NDY	Class II	2010-09-28
K091956	Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712	Encore Medical, LP	OIY	Class II	2010-09-28
K102136	Vessel Guardian	Lexion Medical, LLC.	HIF	Class II	2010-09-27
K102098	Powder Free Vinyl Patient Examination Gloves	Hong di Plastic Products Co., Ltd.	LYZ	Class I	2010-09-27
K101962	Mini Maxlock Extreme Plating System	TORNIER Inc.	HRS	Class II	2010-09-27
K101814	Direct Crown Natural 1	Candulor USA, Inc.	EBG	Class II	2010-09-27
K101812	Construx Mini Peek Spacer System	Orthofix SRL	ODP	Class II	2010-09-27
K100971	Atek Surgical Gowns	Hangzhou Atek Medical & Textile Co., Ltd.	FYA	Class II	2010-09-27
K100421	Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)	Tangshan Yonkshun Glove, Co., Ltd.	LYZ	Class I	2010-09-27
K094062	Percu-Pro Guidewire	Cardiosolutions, Inc.	DQX	Class II	2010-09-27
K093047	Smith & Nephew Circular Fixation System	Smith & Nephew, Inc.	KTT	Class II	2010-09-27
K091618	Vitomatrix	DSM Biomedical, Inc.	LYC	Class II	2010-09-27
K091445	Cd Horizon Spinal System	Medtronic Sofamor Danek	NKB	Class II	2010-09-27
K102437	Gmk Revision Knee System	Medacta International SA	JWH	Class II	2010-09-24
K102266	Isoled Ac-Powered LED Headlight System	Isolux, LLC	FST	Class II	2010-09-24
K102260	Fdi Glucose Control Solutions	Fujirebio Diagnostics, Inc.	JJX	Class I	2010-09-24
K102219	Socorro Smi Tunnel Release Device	Socorro Medical, Inc.	GCJ	Class II	2010-09-24
K102040	Patient Monitor	Guangdong Biolight Meditech Co., Ltd	MHX	Class II	2010-09-24
K101918	Quickvue Rsv 10	Ortho-Clinical Diagnostics, Inc.	GQG	Class I	2010-09-24
K101301	Stalif Midline	Centinel Spine, LLC	MAX	Class II	2010-09-24
K100992	Neuralmas	Innovative Surgical Solutions, LLC ("Iss")	ETN	Class II	2010-09-24
K102018	Norian Reinforced, Norian Reinforced Fast Set Putty	Synthes (USA) Products LLC	GXP	Class II	2010-09-23
K101791	Rosa Surgical Device	MedTech SAS	HAW	Class II	2010-09-23
K101729	Neowire Pta/ptca Guidewire	Neometrics, Inc.	DQX	Class II	2010-09-23
K101601	Affirm Do Diode Laser	Cynosure, LLC	GEX	Class II	2010-09-23
K101573	Accusculpt II Laser System	Lutronic Corporation	GEX	Class II	2010-09-23
K101015	Guide Catheters and Accessories	Merit Medical Systems, Inc.	DQY	Class II	2010-09-23
K100540	Ascent F-Coat Model: 006-00097	Cao Group, Inc.	LBH	Class II	2010-09-23
K100037	Advanced Vertebral Solutions Express Bfd	Advanced Vertebral Solutions, LLC	MAX	Class II	2010-09-23
K091561	Zoll AED Plus Version 5.32 Software Release	ZOLL Medical Corporation	MKJ	Class III	2010-09-23
K101697	Ensite Verismo Segmentation Tool V.2.0	Abbott Medical	LLZ	Class II	2010-09-22
K101097	Calgaeseal Model: Cas	BZ Medical Inc.	QSY	Unclassified	2010-09-22
K100793	Urostation 3D Prostate Suite	Koelis	LLZ	Class II	2010-09-22
K100578	Asahi Sion Ptca Guide Wire Model Ahw14r001s & Ahw14r301s	Asahi Intecc Co., Ltd.	DQX	Class II	2010-09-22
K102462	System 1E Liquid Chemical Sterilant Processing System	STERIS Corporation	MED	Class II	2010-09-21
K101983	Critical Care Assessment	Critical Patient Care, Inc.	JOM	Class II	2010-09-21
K101761	Exactech Novation Empire Acetabular Augment with Integrip Model 186-01-08/11/13, 186-02-08/11/13, 186-03-08/11/13	Exactech, Inc.	LPH	Class II	2010-09-21
K100845	Pathfinder II, Minimally Invasie Pedicle Screw System Model 3500 Series	Zimmer Spine, Inc.	NKB	Class II	2010-09-21
K100479	Parallax Contour Vertebral Augmentation Device	ArthroCare Corporation	NDN	Class II	2010-09-21
K102356	Fully Automatic Electronic Blood Pressure Monitor Model Md-534	Andon Health Co., Ltd	DXN	Class II	2010-09-20
K102017	Sc2000 Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	IYN	Class II	2010-09-20
K101771	Reline-It Model Reline-It	Majestic Drug Co., Inc.	EBP	Class II	2010-09-20
K101740	Albosure Polyester Vascular Patch	LeMaitre Vascular Inc.	DXZ	Class II	2010-09-20
K101689	Emm Equipment Cover-Polythylene	Exact Medical Manufacturing, Inc.	KKX	Class II	2010-09-20