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 872 of 3530

510(k) clearances, page 872 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K122499	Aircast Venaflow Elite System	DJO, LLC	JOW	Class II	2012-10-18
K121881	Domain Surgical System	Omni-Guide Holdings, Inc.	HGI	Class II	2012-10-18
K121861	Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew Ultra Fast-Fix Ab Meniscal Repair System, Smith & N	Smith & Nephew, Inc.	GAT	Class II	2012-10-18
K121849	Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx Catheter Insertion Stylet, Pleurx Integral Valved Pee	Care Fusion	DWM	Class II	2012-10-18
K121741	4-Web Cervical Sts (Spinal Truss System)	4-Web, Inc.	ODP	Class II	2012-10-18
K120420	Sterile Blunt for Single Use	Shanghai Double Dove Industrial Co., Ltd.	FMI	Class II	2012-10-18
K120053	Ips E.max Press - Abutment Solutions	Ivoclar Vivadent, Inc.	NHA	Class II	2012-10-18
K113471	Nipro Huber Infusion Set, Excel Huber Infusion Set	Nipro Medical Corporation	FPA	Class II	2012-10-18
K113469	Nipro Huber Infusion, Excel Huber Needle	Nipro Medical Corporation	FMI	Class II	2012-10-18
DEN090012	Virulite Cold Sore Machine	Virulite, LLC	OKJ	Class II	2012-10-18
K122856	Charter Guidewire	Brivant, Ltd.	DQX	Class II	2012-10-17
K122844	Inspire 8F Dual Hollow Fiber Oxygenator with Integrated Arterial Filter and Hardshell Reservoir	Corcym Inc.	DTZ	Class II	2012-10-17
K122838	Liquickek Immunoassay Plus Control, Level 1 Model 267, Liquichek Immunoassay Plus Control, Level 2 Model 268, Liquichek	Bio-Rad Laboratories Inc.	JJY	Class I	2012-10-17
K122149	Qbtes	Qbtech AB	LQD	Unclassified	2012-10-17
K122131	Powder Free Nitrile Examination Glove-Blue (Chemotherapy)	Matang Mfg. Sdn. Bhd.	LZA	Class I	2012-10-17
K122085	Stingray Cervical Cage	Omni Surgical, LP dba Spine360	ODP	Class II	2012-10-17
K121581	Box Peek Vbr System,	Innovasis, Inc	MAX	Class II	2012-10-17
K121344	Nu Sleep	Rh Associates, LLC	LRK	Class II	2012-10-17
K120947	Ths Instrument Tray	Hologic, Inc.	KCT	Class II	2012-10-17
K120641	Global Medi Products Retractable Safety Syringe	Global Medi Products	MEG	Class II	2012-10-17
K113706	Endowrist Stapler System	Intuitive Surgical, Inc.	NAY	Class II	2012-10-17
K113470	Nipro Safe Touch Huber Infusion Set	Nipro Medical Corporation	FPA	Class II	2012-10-17
K123066	Accumesh Deployment System	Medtronic, Inc.	ORQ	Class II	2012-10-16
K122465	Midas Touch, Nitrile Examination Gloves, Powder-Free, Pink	Industrial Clothings, Ltd.	LZA	Class I	2012-10-16
K122332	Towerlox Pedicle Screw System	CAPTIVA SPINE, Inc.	MNI	Class II	2012-10-16
K122139	Smith & Nephew R3 Constrained Liners	Smith & Nephew, Inc.	KWZ	Class II	2012-10-16
K121992	Powder-Free Nitrile Patient Examination Gloves, Blue Color	Xinwei (Shandong) Plastic and Rubber Products Co Ltd.	LZA	Class I	2012-10-16
K121805	Ams Large Pore Polyprophlene Mesh	American Medical Systems, Inc.	OTO	Class II	2012-10-16
K121564	Endoscopic Ultrasound Center EU-Y0006	Olympus Medical Systems Corp.	IYN	Class II	2012-10-16
K120192	Disposable Surgical Gowns	Weihai Hongyu Nonwoven Fabric Products Co.,Ltd	FYA	Class II	2012-10-16
K112217	Me Again(r) Long Lasting Vaginal Moisturizer, Vh Essentials (R) Long Lasting Vaginal Moisturizer	Polichem SA	NUC	Class II	2012-10-16
K122837	Autoject 2 for Glassy Syringe	Owen Mumford Limited	KZH	Class II	2012-10-15
K122547	Gram Postitve Clindamycin	bioMerieux, Inc.	LON	Class II	2012-10-15
K122497	Asfora Anterior Cervical Plate System, One Level, 14Mm Asfora Anterior Cervical Plate System, One Level, 16Mm	Medical Design, LLC	KWQ	Class II	2012-10-15
K122348	Quartz Splint System (Ud, Woven, Rope, Mesh) Quartz Spint Resin Qs Flow	Recherches Techniques Dentaires (R.T.D.)	EBI	Class II	2012-10-15
K122331	Cavity Varnish	Dentsply International, Inc.	LBH	Class II	2012-10-15
K121721	Laminar Flow Phaco Tips and Irrigation Sleeve (21G, Reusable)	Advanced Medical Optics, Inc.	HQC	Class II	2012-10-15
K121697	Fingertip Pulse Oximeter	Andon Health Co., Ltd	DQA	Class II	2012-10-15
K121627	Smith & Nephew Redapt Revision Femoral System	Smith & Nephew, Inc.	MEH	Class II	2012-10-15
K121483	Reusable Cutaneous Electrode	Ampcare, LLC	GXY	Class II	2012-10-15
K121272	Protech Dent	Akervall Technologies	OBR	Unclassified	2012-10-15
K120889	Aeskuslides Ana Hep-2	Aesku Diagnostics	DHN	Class II	2012-10-15
K112087	Tyvek Self-Seal Pouches ,Tyvek Heat-Seal Rolls	Advanced Sterilization Products	KCT	Class II	2012-10-15
K122811	Connector Components with Balance Biosurface	Medtronic, Inc.	DTL	Class II	2012-10-12
K122574	Digital Ultrasonic Diagnostic Imaging System, Model D3 and D6	Edan Instruments, Inc.	IYO	Class II	2012-10-12
K122445	Aespire 7900, Aespire View	GE Healthcare	BSZ	Class II	2012-10-12
K122398	Rapidpoint 500 System Measurement Cartridge with Calibrators	Siemens Healthcare Diagnostics Inc.	JIX	Class II	2012-10-12
K122293	Pioneer Sternal Cable Plate System	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	HRS	Class II	2012-10-12
K122074	Ifuse Implant System	SI-Bone, Inc.	OUR	Class II	2012-10-12
K121688	Multi-Unit Abutments with Angulations 17 and 30 for Tapered Implant System	Prismatik Dentalcraft, Inc.	NHA	Class II	2012-10-12