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 1555 of 3531

510(k) clearances, page 1555 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K002102	Gentle Colonics Irrigation System	Gentle Colonics, Inc.	KPL	Class II	2002-02-06
K020155	Dyna-Lok Classic Spinal System	Medtronic Sofamor Danek	KWP	Class II	2002-02-05
K020141	Modification to Ebi Xfix Vision Fixation System	Ebi, LLC	KTT	Class II	2002-02-05
K020082	Erecaid Classic System; Erecaid Esteem Manual System; Erecaid Esteem Battery System	Varian Medical Systems, Inc.	LKY	Class II	2002-02-05
K014086	Ctl Body / Spine Array Coil	GE Healthcare Coils	MOS	Class II	2002-02-05
K014011	Canvas N-Vas-D 2.0	Vassol, Inc.	LNH	Class II	2002-02-05
K013891	Synocta Angled Abutments for the Iti Wide Neck Implant	Straumann USA, LLC	DZE	Class II	2002-02-05
K013719	Becker Band Cranial Remolding Orthosis	Becker Orthopedic Appliance Co.	MVA	Class II	2002-02-05
K013700	Orthosis Helmet Molding	Precision Prosthetics & Orthotics, Inc.	MVA	Class II	2002-02-05
K013692	Trapsystem Set	H.S. Hospital Service S.p.A.	KNW	Class II	2002-02-05
K012861	Vascupuncture Access Wire	Neometrics, Inc.	DQX	Class II	2002-02-05
K012463	Lifecare 55 Cm Square, Lifecare 44 Cm Square, Lifecare 5 Cm Round, Lifecare 7.5 Cm Round, Lifecare 4*6 Cm Oval	Everyway Medical Instruments Co., Ltd.	GXY	Class II	2002-02-05
K012274	Medtronic Physio-Control Lifepak 20 Defibrillator/monitor/pacemaker	Physio Control, Inc.	LDD	Class II	2002-02-05
K011838	Centrifugal Pump	Stockert Instrumente GmbH	DWA	Class II	2002-02-05
K020148	pHoenix ISE Reagents FOR Olympus AU Chemistry Systems	Phoenix Diagnostics, Inc.	CGZ	Class II	2002-02-04
K014179	Demetron Lc	Sybron Dental Specialties, Inc.	EBZ	Class II	2002-02-04
K014077	Powder Free (Blue) Nitrile Patient Examination Gloves	Shijiazhuang Great Vision Plastic Products Co., LT	LZA	Class I	2002-02-04
K013955	Veraviewepocs, Model Ve	J. Morita USA, Inc.	EHD	Class II	2002-02-04
K013895	Tempfil	Sybron Dental Specialties, Inc.	EBG	Class II	2002-02-04
K013701	Endo-Glide	Sonotech, Inc.	GCJ	Class II	2002-02-04
K013668	Berchtold Elektrotom 106 Hitt	Berchtold Corp.	GEI	Class II	2002-02-04
K013655	Nxstage Dialysate Concentrate, Model Rfc-100	NxStage Medical Inc	KPO	Class II	2002-02-04
K013640	Eg-3630Ur, Ultrasund Video Gastroscope	Pentax Precision Instrument Corp.	FDS	Class II	2002-02-04
K013254	Polycoat Powdered Latex Examination Glove with Aloe Vera & Protein Content Labeling Claim (200 Micrograms or Less)	Top Quality Mfg., Inc.	LZA	Class I	2002-02-04
K012694	Reprocessed Used Disposable Arthroscopic Blades and Burs	Adven Medical	HWE	Class I	2002-02-04
K012676	Reprocessed Used, Disposable Blades, Burs, Bits and Taps	Adven Medical	HWE	Class I	2002-02-04
K012549	Advanced Air Purification System; Hepa Air Cleaning System	Healthway Products, Inc.	FRF	Class II	2002-02-04
K012502	Medigroup Catheter Extender/repair Kit	Janin Group, Inc.	FJS	Class II	2002-02-04
K020245	Modification to Isobar Spinal System	Scien'Tx USA, Inc.	MNH	Class II	2002-02-01
K020129	Phoenix Eletrolyte Calibration Set for the Roche Cobas Ise Module	Phoenix Diagnostics, Inc.	JIX	Class II	2002-02-01
K020070	Jb-70 Intraoral X-Ray System, Models 30-A0001/a0002	Progeny, Inc.	EHD	Class II	2002-02-01
K020036	Exs-63 Small Extremity Array Coil	Mri Devices Corp.	MOS	Class II	2002-02-01
K020022	Dinamap Pro Series Monitor, Models 110, 210, 310, 410	GE Medical Systems Information Technologies, Inc.	MWI	Class II	2002-02-01
K014198	Biotech B990k Vivi Wheelchair	Taiwan Armada Enterprise Co., Ltd.	IOR	Class I	2002-02-01
K014105	Spectral's Troponin I	Spectral Diagnostics, Inc.	MMI	Class II	2002-02-01
K014104	Vacuette Edta K2 Tubes	Greiner Bio-One North America, Inc.	PJE	Class II	2002-02-01
K014056	Salter Labs Modified Nebutech Nebulizer	Salter Labs	CAF	Class II	2002-02-01
K014016	Enguard Chc Dual Reservoir Cardioplegia Heater/cooler	Medivators Inc	DWC	Class II	2002-02-01
K013994	Modification to Viewsend Medical	Klt Telecom, Inc.	LLZ	Class II	2002-02-01
K013985	Machnet Bilateral Open Breast Coil. Catalog # Mics-Gsxx	Machnet BV	MOS	Class II	2002-02-01
K013971	Bd Vacutainer Safety Coagulation Tube	Becton Dickinson & Co	JKA	Class II	2002-02-01
K013893	Scanx	Air Techniques, Inc.	MUH	Class II	2002-02-01
K013885	Blackstone Spinal Fixation System Posterior Hooks	Blackstone Medical, Inc.	MNI	Class II	2002-02-01
K013879	Tm2000, Model 1	Card Guard Scientific Survival, Ltd.	DXH	Class II	2002-02-01
K013826	Axiom Aristos Fx (Multi Purpose Radiography System)	Siemens Medical Solutions USA, Inc.	KPR	Class II	2002-02-01
K013707	Softique, Model Gi 11001	Global TV Concepts, Ltd.	IMC	Class II	2002-02-01
K013614	Trojan Crystal Clear Liquid	Armkel, LLC	NUC	Class II	2002-02-01
K013611	Henke Sass Wolf Saphenous Vein Laparoscope	Henke Sass Wolf of America, Inc.	GCJ	Class II	2002-02-01
K013511	Xenalight Models # Ax9125 (100-120V~); # Ax9225 (220-240V~)	Aculux	FSW	Class II	2002-02-01
K012966	Roche Cobas Taqman Analyzer	Roche Molecular Systems Inc	JJF	Class I	2002-02-01