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 994 of 3531

510(k) clearances, page 994 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K100607	Coulter 4C-Ex 300 Cell Control	Siemens Healthcare Diagnostics Inc.	JPK	Class II	2010-11-18
K100450	I-Root	S-Denti Co., Ltd.	LQY	Unclassified	2010-11-18
K093891	Aquilion One Version 4.6 W/dual Energy Scan System, Model Tsx-301A/2	Toshibamedical Systems Corporation	JAK	Class II	2010-11-18
K092272	Randox Methadone Assay	Randox Laboratories, Limited	DJR	Class II	2010-11-18
K103100	Mountaineer Oct Spinal System	DePuy Spine, Inc.	MNI	Class II	2010-11-17
K102807	Cd Horizon Spinal System	Medtronic Sofamor Danek	NKB	Class II	2010-11-17
K102669	Diode Laser Therapy System	China Daheng Group, Inc.	GEX	Class II	2010-11-17
K102668	Etest Tobramycin 0.016-256 Ug/ml and 0.064-1024 Ug/ml	bioMerieux, Inc.	JWY	Class II	2010-11-17
K102657	Concentric Balloon Guide Catheter	Concentric Medical, Inc.	DQY	Class II	2010-11-17
K102650	Cyberknife Robotic Radiosurgery System	Accuray Incorporated	IYE	Class II	2010-11-17
K102603	Sa Flowable Adhesive	Dmg USA, Inc.	EBF	Class II	2010-11-17
K102555	Cd Horizon Spinal System	Medtronic Sofamor Danek USA Inc	NKB	Class II	2010-11-17
K102546	Chitogauze	Hem Con Medical Technologies, Inc.	QSY	Unclassified	2010-11-17
K102531	Mucograft	Ed. Geistlich Soehne AG Fur Chemische Industrie	NPL	Class II	2010-11-17
K102159	Powerpicc Sv Catheters	C.R. Bard Inc	LJS	Class II	2010-11-17
K102097	Powder Free Vinyl Patient Examination Gloves	Shijiazhuang Great Vision Plastic Products Co., LT	LYZ	Class I	2010-11-17
K101436	Pearlescent Powder Free Nitrile Examination Glove with Aloe Vera (Yellow, Red, Green, Black, Blue)	Shen Wei (USA), Inc.	LZC	Class I	2010-11-17
K093758	Bgm Galectin -3	Bg Medicine, Inc.	OSX	Class II	2010-11-17
K093071	Fundus Photo Ophthalmic Digital Imaging System, Model Cfd-440	Fundus Photo	HKI	Class II	2010-11-17
K103282	Laparoscopic Dissector	Applied Medical Resources Corp	GEI	Class II	2010-11-16
K102540	PTFE Portable Introducer	Great Batch Medical	DYB	Class II	2010-11-16
K102171	Powder Free Vinyl Patient Examination Gloves	Wuxi Bingfa Gainlite Gloves Cp., Ltd.	LYZ	Class I	2010-11-16
K102068	Miniaturize Chest Compressor (Mcc)	Resuscitation International	DRM	Class II	2010-11-16
K100565	Dura Padz (Reusable Electrode), Dura Padz Gel (Disposable Hydrogel) Model 8900-0300, 8900-0325	ZOLL Medical Corporation	MKJ	Class III	2010-11-16
K103215	Cianna S1, Single Lumen Balloon Applicator Kit	Cianna Medical, Inc.	JAQ	Class II	2010-11-15
K102326	Parcus 3.5Mm Peek Cf Push-in Suture Anchor	Parcus Medical, L.L.C.	HWC	Class II	2010-11-15
K102204	Choice Spine Starfire Pedicle Screw System	Choicespine, LP	NKB	Class II	2010-11-15
K101762	Viper F2 Facet Fixation System	DePuy Spine, Inc.	MRW	Unclassified	2010-11-15
K100888	Modification to Lanx Posterior Cervicothoracic Spinal Fixation System	Lanx, Inc.	KWP	Class II	2010-11-15
K093054	Scalp Dura Retractor, Model Ks00474	Karl Storz Endoscopy-America, Inc.	GZT	Class II	2010-11-15
K102626	Vega Medical Suction Equipment, Model Su-01/Su-Dc01	Vega Technologies Inc.	JCX	Class II	2010-11-12
K102558	Powder Free Vinyl Patient Examination Gloves, Colored (White)	Tangshan Hengda Plastic Products Co., Ltd.	LYZ	Class I	2010-11-12
K101619	Welch Allyn 1500 Patient Monitor	Schiller, AG	MHX	Class II	2010-11-12
K101285	Constellation Vision System	Alcon Manufacturing, Ltd.	HQC	Class II	2010-11-12
K101174	Atricure Bipolar System Including Isolator Synergy Dual Electrode Clamps Model Oll2, Osl2, Emr2, Eml2	AtriCure, Inc.	OCL	Class II	2010-11-12
K103184	Silk'n Flash N Go	Home Skinovations, Ltd.	OHT	Class II	2010-11-10
K103165	Blood Sampling Set	Acacia, Inc.	FPA	Class II	2010-11-10
K103164	Vonflex Heavy, Vinflex Light	Vericom Co., Ltd.	ELW	Class II	2010-11-10
K103052	V-Loc(tm) Nonabsorbable Wound Closure Device	Medtronic, Inc.	GAT	Class II	2010-11-10
K103012	Exactech Bioloxdelta / Biolox Femoral Heads, 28Mm Od, 32Mm Od, 36Mm Od, Exactech Biolox Option Adapters/femoral Heads	Exactech, Inc.	LZO	Class II	2010-11-10
K102445	Rostam Scented and Unscented Biodegradable Plastic Applicator Tampons	Rostam, Ltd.	HEB	Class II	2010-11-10
K102240	Nivo Nebulizer System	Aerogen (Ireland), Ltd.	CAF	Class II	2010-11-10
K102162	Parcus Peek Cf Push-in Suture Anchor	Parcus Medical, L.L.C.	HWC	Class II	2010-11-10
K101912	The Infrared Forehead Thermometer, Model Fs-300&301	Hubdic Co., Ltd.	FLL	Class II	2010-11-10
K101654	Improvis Imaging System	American Dental Partners, Inc.	LLZ	Class II	2010-11-10
K101106	Powdered, Natural Color, Latex Examination Glove Model: Mep1	Best Putra Gloves Sdn Bhd	LYY	Class I	2010-11-10
K101105	Powder-Free, Natural Color, Latex Examination Glove Model: Mepf1	Best Putra Gloves Sdn Bhd	LYY	Class I	2010-11-10
K100797	Fetal Maternal Monitor Model F9 Express and Express	Edan Instruments, Inc.	HGM	Class II	2010-11-10
K100590	Edge CO2 Laser System	Jm System Co., Ltd.	ONG	Class II	2010-11-10
K100100	Dio Steady External Implant System	Dio Corporation	DZE	Class II	2010-11-10