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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 828 of 3530

510(k) clearances, page 828 of 3530
K number	Device	Applicant	Product code	Class	Decision date
DEN110019	Neba System	Lexicor Medical Technology, Inc.	NCG	Class II	2013-07-15
K131804	Remel Xpect Flu A&b	Remel Inc	GNX	Class I	2013-07-12
K131637	Rotation Medical Soft Tissue Staple (Rmst Staple)	Rotation Medical, Inc.	GDW	Class II	2013-07-12
K131547	Lanx Fusion System	Lanx, Inc.	OVD	Class II	2013-07-12
K131514	Ge Vivid E9 Diagnostic Ultrasound Imaging System	GE Vingmed Ultrasound AS	IYN	Class II	2013-07-12
K131424	Miplatform Medical Imaging Suite	Hinacom Software and Technology, Ltd.	LLZ	Class II	2013-07-12
K131417	Facet Fixx	Nexxt Spine LLC	MRW	Unclassified	2013-07-12
K131227	Padscan Hd Series Bladder Scanner	Carenoso Technology Co., Ltd.	IYO	Class II	2013-07-12
K131087	Sharpstank Reusable Sharps Container	Rehrig Pacific Company	MMK	Class II	2013-07-12
K131036	Yamahachi Denture Base Resins	Yamahachi Dental Manufacturing Co.	EBI	Class II	2013-07-12
K130806	Neurovision Ink Printed Endotracheal Tube Electrode	Neurovision Medical Products Inc	PDQ	Class II	2013-07-12
K130420	Solea	Convergent Dental	GEX	Class II	2013-07-12
K130315	Ipulse Hair Removal System	Cyden Limited	OHT	Class II	2013-07-12
K123599	Ingenuity Digital Pet/ct	Philips Healthcare (Cleveland)	KPS	Class II	2013-07-12
K123366	Surgitron 4.0 Dual RF S5-Iec	Ellman International, Inc.	GEI	Class II	2013-07-12
DEN110006	Verify Cronos Self-Contained Biological Indicator	STERIS Corporation	OWP	Class II	2013-07-12
DEN110004	Cabochon System	Cabochon Aesthetics, Inc.	OUP	Class II	2013-07-12
K131520	Nexus Anterior Cervical Plate System	Core-Nexus	KWQ	Class II	2013-07-11
K131282	Nexus Hemorrhoid Ligator	Inx Medical	FHN	Class II	2013-07-11
K131278	Monteris Medical Neuroblate System	Monteris Medical Corp	GEX	Class II	2013-07-11
K131248	Etch Gel	DMG America LLC	KLE	Class II	2013-07-11
K130460	Nxstage Dosing Calculator	NxStage Medical Inc	FKP	Class II	2013-07-11
K130424	Stimel-03	Stimel, Ltd.	IPF	Class II	2013-07-11
K130339	Clinical Alert Notification	Extension, Inc.	MSX	Class II	2013-07-11
K130225	Quasar C100, Baby Quasar Plus, Quasar Md Plus; Wrinkle Reduction Device	Silverbay, LLC, D/B/A Quasar Bio-Tech	OHS	Class II	2013-07-11
K123881	Heartsine Samaritan Pad 350P	HeartSine Technologies Ltd	MKJ	Class III	2013-07-11
K123343	Thermo Scientific Qms Tacrolimus Assay and Calibrators	Microgenics Corporation	MLM	Class II	2013-07-11
K123075	Buttock Muscle Stimulator Model Wl-2413B; Buttock Muscle Stimulator Mode Wl-2413E	Well-Life Healthcare Limited	NGX	Class II	2013-07-11
K121310	Mesothelium Dental Membrane	DSM Biomedical, Inc.	NPL	Class II	2013-07-11
K131738	Immunocap Specific Ige Control L, Immunocap Specific Ige Control M and Immunocap Specific Ige Control H	Phadia AB	DHB	Class II	2013-07-10
K131496	Bellavar / Custom Seamless Soft (A.k.a. Comtesse)	BSN Medical	DWL	Class II	2013-07-10
K131338	Derma Hood	Globalmedia Group, LLC	PEQ	Class I	2013-07-10
K131331	Bd Phoenix Automated Microbiology System - Vancomycin (0.5-32 Ug/ml)	Becton Dickinson & Co	LON	Class II	2013-07-10
K131269	Dlp Coronary Ostial Perfusion Cannulae	Medtronic, Inc.	DWF	Class II	2013-07-10
K131007	Aigis Rx N Medium; Aigis Rx N Large	Tyrx, Inc.	FTL	Class II	2013-07-10
K130391	Emerge Monorail Ptca Dilatation Catheter, Emerge Push Monorail Ptca Dilatation Catheter, Emerge Over-the-Wire Ptca Dilat	Boston Scientific Corporation	LOX	Class II	2013-07-10
K124062	Qdc-Pro, and Nox-Rip	Nox Medical	MNR	Class II	2013-07-10
K124045	Fuseforce Implant System	Solana Surgical, LLC	JDR	Class II	2013-07-10
K131072	Orchestra Hydrophilic Guidewire Standard Angled, Orchestra Hydrophilic Guidewire Straight Stiff, Orchestra Hydrophilic	MEDLINE INDUSTRIES, LP - Northfield	OCY	Class II	2013-07-09
K130879	Nexus IV Tubing Set with Luer-Accessbile One-Way Check Valve - IV Plus	Nexus Medical, LLC	FPA	Class II	2013-07-09
K130324	Statseal Disc	Biolife, LLC	QSY	Unclassified	2013-07-09
K131463	Wrist Automatic Blood Pressure Monitor	HONSUN (NANTONG) Co., Ltd.	DXN	Class II	2013-07-08
K130676	Ambio Remote Health Monitoring System	Arrayent Health, LLC D/B/A Ambio Health	DRG	Class II	2013-07-08
K130183	Sfi Bar Abutments	Sterngold Dental LLC	NHA	Class II	2013-07-07
K131671	Mectalif	Medacta International SA	MAX	Class II	2013-07-05
K131666	Arterial Hls Cannula 13 Fr Non-Coated, with Bioline Coating and with Softline Coating	MAQUET CARDIOPULMONARY GmbH	DWF	Class II	2013-07-05
K131606	Sofia Influenza A+b Fia	Ortho-Clinical Diagnostics, Inc.	GNX	Class I	2013-07-05
K131599	Quick Vue Influenza	Ortho-Clinical Diagnostics, Inc.	GNX	Class I	2013-07-05
K131511	Disposable Circular Stapler, Disposable Curved Cutter Stapler, Disposable Linear Staplers and Reloads, Disposable Hemorr	Changzhou Sinolinks Medical Innovation Co., Ltd.	GDW	Class II	2013-07-05
K131283	Prophecy Infinity Preoperative Navigation Alignment Guides	Wrightmedicaltechnologyinc	HSN	Class II	2013-07-05