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 914 of 3530

510(k) clearances, page 914 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K113737	Surefire Guide Sheath	Surefire Medical, Inc.	DQO	Class II	2012-02-23
K113430	Proultra Piezo Ultrasonic	Satelec-Acteon Group	ELC	Class II	2012-02-23
K113222	Nd Lowspeed Airmotor,nd Highspeed Airturbine Handpiece	Nakamura Dental Handpiece Mfg. Co., Ltd.	EFB	Class I	2012-02-23
K112886	Upstream Support Catheter	Upstream Peripheral Technologies Ltd.	DQY	Class II	2012-02-23
K112758	Kat Implants System One-Piece Implants 2.5X10	Kat Implants, LLC	DZE	Class II	2012-02-23
K111970	Kneetec Pfj&hls Kneetec Patellar Component	TORNIER Inc.	KRR	Class II	2012-02-23
K110375	Blueshine's Gold Series	Blueshine SRL	PDZ	Class II	2012-02-23
K100624	Invendo C20 Colonoscopy System	Invendo Medical Gbmh	FDF	Class II	2012-02-23
K120189	Bonetrap	Berni Farns Incorporated	KNW	Class II	2012-02-22
K113757	Aspire Max Aspiration Catheter	Control Medical Technology	QEZ	Class II	2012-02-22
K113588	Spectra Laser System	Lutronic Corporation	GEX	Class II	2012-02-22
K113570	Integra Cusa Nxt Inferior Foward Bone Tip	Radionics, Inc.	LFL	Unclassified	2012-02-22
K113514	Smartheart	SHL TeleMedicine International	DXH	Class II	2012-02-22
K113065	Rl, Ul, Sl, El, and Epl Vertical Platform Lifts	Bella Elevator, LLC	ING	Class II	2012-02-22
K112812	Leforte Neuro System Bone Plate	Jeil Medical Corporation	GWO	Class II	2012-02-22
K112679	Simplant Navigator Personalized Dental Care System	Materialise Dental NV	LLZ	Class II	2012-02-22
K111755	Virtuoso System for Ihc Ki-67 (30-9)	Ventana Medical Systems Inc	NOT	Class II	2012-02-22
K110179	Incontrol	Incontrol Medical, LLC	KPI	Class II	2012-02-22
K113520	System 1E Liquid Chemical Sterilant Processing System	STERIS Corporation	MED	Class II	2012-02-21
K111141	Bokang Semi-Auto / Automatic / Wrist Digital Blood Pressure Monitor	Wenzhou Bokang Instruments Co., Ltd.	DXN	Class II	2012-02-21
K120321	Clearvue 350/550 Diagnostic Ultrasound System	Philips Health Care	IYN	Class II	2012-02-17
K120272	Ameritus Medical Enteral Feeding Extension Set	Kentec Medical, LLC	KNT	Class II	2012-02-17
K120163	Acute Innovations Biobridge Resorbable Plating System	Acute Innovations, LLC	HRS	Class II	2012-02-17
K120155	Arthrex Knotless Suturetak Anchor	Arthrex GmbH	MBI	Class II	2012-02-17
K120147	Ace Stapler and Cartridge	Barosense, Inc.	OCW	Class II	2012-02-17
K120081	Norm-O-Temp Hyperthermia System Incliding Blankets/pads	Gentherm Medical, LLC	DWJ	Class II	2012-02-17
K113664	Closer to Nature Electric Breast Pump	Mayborn Group Limited	HGX	Class II	2012-02-17
K113627	Hemasorb Resorbable Hemostatic Bone Putty	Orthocon, Inc.	MTJ	Unclassified	2012-02-17
K113556	Wagner Cone Prosthesis System	Zimmer GmbH	LZO	Class II	2012-02-17
K113505	Vacuette Quickshield with Snappy Tube Holder	Greiner Bio-One North America, Inc.	FMI	Class II	2012-02-17
K113452	Acu-Cut Vertebral Augmentation System	Ascendx Spine, Inc.	NDN	Class II	2012-02-17
K113206	Nanoblutm 500	Draeger Medical Systems, Inc.	LBI	Class II	2012-02-17
K113054	Equivital	Hidalgo Limited	MHX	Class II	2012-02-17
K112781	Tag Respiratory Viral Panel Tag Data Analysis Software (Tdas Rvp-I)	Luminex Molecular Diagnostics Inc	OCC	Class II	2012-02-17
K112654	Powderfree Polyisoprene Surgical Gloves	PT. Medisafe Technologies	KGO	Class I	2012-02-17
K112353	Geodesic EEG Mobile 100 (Gem 100)	Electrical Geodesics, Inc.	GWQ	Class II	2012-02-17
K111976	Vitek 2 Streptococcus Erythromycin	bioMerieux, Inc.	LON	Class II	2012-02-17
K111935	Ti-Base Abutment, 1 Connect Abutment	Nt-Trading GmbH and CO KG	NHA	Class II	2012-02-17
K111463	Valeo Vt-601 Series Ir Thermometer	Valeo Corp.	FLL	Class II	2012-02-17
K111421	Sirona Dental Cad/cam System	Sirona Dental Systems GmbH	NHA	Class II	2012-02-17
K120392	Chromophare F 628 and F 528	Berchtold GmbH & Co. KG	FSY	Class II	2012-02-16
K120337	I-Port Advance Injection Port	Unomedical A/S	FOZ	Class II	2012-02-16
K120143	Eclipse Vertebral Spacer System-Cervical	Apollo Spine, Inc.	ODP	Class II	2012-02-16
K120121	Comprehensive Reverse Shoulder-Mini Baseplate	Zimmer GmbH	PHX	Class II	2012-02-16
K113701	Visia Neuro	Mevis Medical Solutions AG	LLZ	Class II	2012-02-16
K113526	Codman Certas Programmable Valve System	Medos International SARL	JXG	Class II	2012-02-16
K113518	Arena-C Cervical Intervertebral Body Fusion System	SPINEFRONTIER, Inc. dba LESspine Innovations	ODP	Class II	2012-02-16
K113442	3Di	Shina Systems Ltd.	LLZ	Class II	2012-02-16
K113419	Cs Imaging	Trophy	LLZ	Class II	2012-02-16
K112841	Surface Beacon Transponders	Calypso Medical Technologies, Inc.	IYE	Class II	2012-02-16