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 1520 of 3531

510(k) clearances, page 1520 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K011891	Panag	Panag International	GZJ	Class II	2002-07-30
K022200	Pentra 120/Pentra 120 Retic Options Sps, Model Pentra 120	Horiba Instruments Incorporated	GKZ	Class II	2002-07-29
K022174	Modification to Cardeon Aegis Catheter	Cardeon Corp.	DWF	Class II	2002-07-29
K022161	Modification to Coulter Lh 750 Hematology Analyzer, Model 6605632	Siemens Healthcare Diagnostics Inc.	GKZ	Class II	2002-07-29
K022130	Bd Vacutainer Plus Pst II Tube	Becton Dickinson & Co	JKA	Class II	2002-07-29
K022121	Psg Input Box, Model Je-912Ak	Nihon Kohden America Inc	OLV	Class II	2002-07-29
K021881	Endius Title Spinal Fixation System	Endius, Inc.	MNH	Class II	2002-07-29
K021842	Admira Seal	Voco GmbH	EBC	Class II	2002-07-29
K021780	Advantage Sim 6.0	General Electric Medical Systems	KPQ	Class II	2002-07-29
K021757	Crpex-Br C-Reactive Protein Lit Assay, Crpex-Br Crp Calibrator Set	Good Biotech Corp.	DCN	Class II	2002-07-29
K021653	Codman Bactiseal Evd Catheter Set	Cerenovus, Inc.	JXG	Class II	2002-07-29
K021604	Mayfield Radiolucent Skull Pins, Model 4-0-a-2020	Ohio Medical Instrument Co., Inc.	HBL	Class II	2002-07-29
K021429	Herpeselect 1 Elisa Igg, Model El0910g	Focus Technologies, Inc.	MXJ	Class II	2002-07-29
K021408	Resorbable Cranial Clamps	Synthes (USA) Products LLC	GXR	Class II	2002-07-29
K021194	Raichem Crp High Sensitivity Test System	Hemagen Diagnostics, Inc.	DCK	Class II	2002-07-29
K020657	Acculaser Pro Low Level Laser Therapy Device	Acculaser, Inc.	NHN	Class II	2002-07-29
K020434	Microplex Coil System (Mcs)	Terumo Cardiovascular Systems Corporation	HCG	Class II	2002-07-29
K020337	Readi-Strand; Model Psstrand	Worldwide Medical Technologies, LLC	KXK	Class II	2002-07-29
K020222	Wisorb Malleolar Screw	Cambridge Scientific	HWC	Class II	2002-07-29
K013263	Fred Hutchinson Cancer Research Center Enzyme Anti-Sr Protein Antibody Test	Fred Hutchinson Cancer Research Center	LKP	Class II	2002-07-29
K012644	Reprocessed Trocars and Cannulas	Surgical Instruments Service and Savings, Inc.	NLM	Class II	2002-07-29
K022164	Zeta Diagnostic Retinal Imaging System	Zeta Development Laboratories	HKI	Class II	2002-07-26
K022116	Elph Injection System	Mallinckrodt Inc., Liebel-Flarsheim Business	DXT	Class II	2002-07-26
K021968	Ceraloy Solder	Neirynck & Vogt NV	EJH	Class II	2002-07-26
K021965	Chroloy Solder	Neirynck & Vogt NV	EJH	Class II	2002-07-26
K021641	Xtd Thrombectomy Catheter, Xx Cm	Xtrak Medical, Inc.	QEW	Class II	2002-07-26
K021638	Ilt Advancing Mechanism, Model A115ami	Intra Luminal Therapeutics, Inc.	DQX	Class II	2002-07-26
K021602	Fossa Ureteral Stone Sweeper	Fossa Industries, Inc.	FAD	Class II	2002-07-26
K020882	Sharpoint Ultraplug Extended Wear Plug	Surgical Specialties Corp	LZU	Unclassified	2002-07-26
K011329	Eccovision Acoustic Diagnostic Imaging Acoustic Pharyngometer	E. Benson Hood Lab, Inc.	BXQ	Class II	2002-07-26
K022255	Modofocation to Synthes Ankle Arthrodesis Plates	Synthes (USA) Products LLC	HRS	Class II	2002-07-25
K022225	Vector Medical, Inc., Vector Targeting System	Vector Medical, Inc.	HSB	Class II	2002-07-25
K022169	Clearview Plus Bone and Vertebral Body Biopsy Needles	Parallax Medical, Inc.	KNW	Class II	2002-07-25
K022129	Bd Phoenix Automated Microbiology System Moxifloxacin 0.125-8 Ug/ml	Becton Dickinson & Co	LON	Class II	2002-07-25
K022119	Ems Air-Flow Handy 2 Dental Handpiece	E.M.S. - Electro Medical Systems SA	EFB	Class I	2002-07-25
K022108	Thermo Dma Data-Cal Calibrator, Model 1905-050	Thermo Dma, Inc.	JIX	Class II	2002-07-25
K022094	Par 5 Acetabular Component with & without Hydroxyapatite Coating	Zimmer GmbH	JDI	Class II	2002-07-25
K022085	J&s Medical Sentry Urine Dipstick Control	J & S Medical Assoc., Inc.	JJW	Class I	2002-07-25
K022077	36Mm V40 Femoral Head Components (Lfit and Non-Lfit)	Howmedica Osteonics Corp	JDI	Class II	2002-07-25
K021926	Auropal 60	Wieland Dental + Technik GmbH & Co. KG	EJT	Class II	2002-07-25
K021918	Clarren Helmet (Orthomerica)	Orthomerica Products, Inc.	OAN	Class II	2002-07-25
K021892	Bright Gold	Ivoclar Vivadent, Inc.	EJT	Class II	2002-07-25
K021713	Stat Profile Phox Plus C Analyzer	Nova Biomedical Corporation	CHL	Class II	2002-07-25
K021660	K-Assay Lp(a) Assay	Kamiya Biomedical Company, LLC	DFC	Class II	2002-07-25
K021504	Tuttnauer Ehs Series Table-Top Autoclave, Model 2540	Tuttnauer USA Co. Ltd.	FLE	Class II	2002-07-25
K021336	Novabone-Resorbable Bone Graft Substitute	Novabone Products, LLC	MQV	Class II	2002-07-25
K021330	Magnetom Trio Quadrature Tx/rx Head Coil	GE Healthcare Coils	MOS	Class II	2002-07-25
K021327	Orthopilot Hto Module	Aesculap Inc	HAW	Class II	2002-07-25
K021316	Ultra N-Geneous Hdl Cholesterol Reagent 1/Reagent2; Ultra N-Geneous Hdl Cholestreol Calibrator	Genzyme Corporation	LBS	Class I	2002-07-25
K021061	Modification to Cd Horizon Spinal System	Medtronic Sofamor Danek	KWP	Class II	2002-07-25