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 1363 of 3531

510(k) clearances, page 1363 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K042183	Glucose Tolerance Beverage	Ever Scientific	MRV	Class II	2004-10-27
K042161	Anti-Snoring/sleep Apnea Device	Rj & VK Bird Pty, Ltd.	LRK	Class II	2004-10-27
K042077	Bitech Bipolar Scissors	Guenter Bissinger Medizintechnik GmbH	GEI	Class II	2004-10-27
K041669	Veritas Dry Collagen Matrix, Veritas Dry or Veritas Psd	SYNOVIS LIFE TECHNOLOGIES, Inc. (A Subsidiary of Baxter International Inc.)	FTM	Class II	2004-10-27
K040574	Galileo Gold	Hamilton Medical AG	CBK	Class II	2004-10-27
K040518	Select Fabricators, Inc., Agmed Tex Wound Dressing	Select Fabricators, Inc.	FRO	Unclassified	2004-10-27
K040170	Friadent Plus Dental Implant Systems	Friadent GmbH	DZE	Class II	2004-10-27
K042802	H & L Full Automatic (Nibp) Blood Pressure Monitor, Models Hl168h, Hl168j & Hl168q	Health & Life Corporation	DXN	Class II	2004-10-26
K042756	Endorez	Ultradent Products Inc.	KIF	Class II	2004-10-26
K042435	Cooper Prosthetic	CooperVision, Inc.	LPL	Class II	2004-10-26
K042376	Acumen Sheath, Model Ttw7807	Acumen Medical, Inc.	DYB	Class II	2004-10-26
K042375	Smk, Cx, Cxe, Rcn	Technomed Europe	GXI	Class II	2004-10-26
K042302	Zoll Autoclavable Internal Handles, Zoll Autoclavable Internal Handles with Integrated Electrodes, Zoll Autoclavable	ZOLL Medical Corporation	LDD	Class II	2004-10-26
K042075	Quill Synthetic Absorbable Barbed Suture	Quill Medical, Inc.	NEW	Class II	2004-10-26
K042048	Gelato Prophylaxis Paste	Deepak Products, Inc.	EJR	Class I	2004-10-26
K042034	Nuvasive Maxcess Light Guide	NuVasive Inc	FST	Class II	2004-10-26
K042021	Exactech Equinoxe Shoulder System	Exactech, Inc.	KWS	Class II	2004-10-26
K041775	Ge Datex-Ohmeda Engstrom Carestation	GE Healthcare	CBK	Class II	2004-10-26
K041102	Immulisa Antinuclear Antibody Screen Elisa	Immco Diagnostics, Inc.	LJM	Class II	2004-10-26
K042457	Uro Pro	Novanta Medical GmbH	LJH	Class II	2004-10-25
K042380	Silicone Block	National Medical Devices, Inc.	MIB	Class II	2004-10-25
K042300	Amt Introducer: Mini Button Delivery System	Applied Medical Technology Inc	KNT	Class II	2004-10-25
K041912	Scb/valleylab Force Fx Interface Unit	Karl Storz Endoscopy-America, Inc.	ODA	Class II	2004-10-25
K041149	Given Diagnostic System with M2a Eso Capsule	Given Imaging Ltd.	NSI	Class II	2004-10-25
K042821	Digital Detector, Model Gr17	Anrad Corp.	MQB	Class II	2004-10-22
K042799	Qrs-Card Cardiology Suite	Pulse Biomedical, Inc.	DQK	Class II	2004-10-22
K042728	Camino Slim-Line Intracranial Monitoring System	Novus Monitoring, Ltd.	GWM	Class II	2004-10-22
K042698	Unfors Patient Skin Dosimeter (Psd)	Unfors, Inc.	JAA	Class II	2004-10-22
K042604	Vally Forge Scientific Malis Bipolar Disposable Finger Operated Electrosurgical Instruments	Valley Forge Scientific Corp.	GEI	Class II	2004-10-22
K042591	Smartmix Pre-Filled Mixing System	Depuy Orthopaedics Inc.	KIH	Class I	2004-10-22
K042357	Idi-Mrsa Assay	Infectio Diagnostic (I.D.I.), Inc.	NQX	Class II	2004-10-22
K042224	Rm3 Renal Preservation System	Waters Instruments, Inc.	KDN	Class II	2004-10-22
K041755	Cromax High Speed Turbine Handpiece	J.R. Medical Technologies, Inc.	EFB	Class I	2004-10-22
K041703	Iplan!	Brainlab, Inc.	HAW	Class II	2004-10-22
K041633	Gyrus Plasmacision Laparoscopic Spatula	Gyrus ACMI, Inc.	GEI	Class II	2004-10-22
K041486	Vasostasis Vascular Closure System	Cardiva Medical, Inc.	DXC	Class II	2004-10-22
K041136	Modification to Silhouette Ic or Silhouette; Laser-Lok Surface Treatment -Optional Surface Modification to Implants	Bio-Lok Intl., Inc.	DZE	Class II	2004-10-22
K040223	Polyvac Instrument Delivery System	Symmetry Medical USA, Inc.	KCT	Class II	2004-10-22
K042779	Radiotherapy Solution Based on Cr	Agfa Corp.	IXK	Class II	2004-10-21
K042693	IV Administration Set B400 Sp	Codan US Corp.	FPA	Class II	2004-10-21
K042545	Hoveround Mpv-5 Powerchair	Hoveround Corp.	ITI	Class II	2004-10-21
K042444	Litestream 500E	Pride Mobility Products Corp	IOR	Class I	2004-10-21
K042305	Ossaplast Ortho, O.5ml, Model# 221 900, Ossaplast Ortho, 1.0Ml, Model# 221 901, Ossaplast Ortho, 3.0Ml, Model# 221 903	Ossacur AG	MQV	Class II	2004-10-21
K042212	Implantmaster	I-Dent	LLZ	Class II	2004-10-21
K042209	Control Plasma N and Control Plasma P	Siemens Healthcare Diagnostics Inc.	GGN	Class II	2004-10-21
K042104	American Bantex, Model Ms 3	American Bantex Corp.	INI	Class II	2004-10-21
K041408	Polymedco Oc Auto Micro 80 Fob Test	Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, LLC	OOX	Class II	2004-10-21
K033523	Collagen-Orc Antimicrobial Matrix	Johnson & Johnson MEDICAL GmbH	FRO	Unclassified	2004-10-21
K042770	Modification to Acuson Cv70 Cardiovascular System	Siemens Medical Solutions USA, Inc.	IYN	Class II	2004-10-20
K042759	Optima Mx	Bien-Air SA Switzerland	EIA	Class I	2004-10-20