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 873 of 3530

510(k) clearances, page 873 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K121651	Ortholoc 3Di Midfoot/flatfoot System	Wrightmedicaltechnologyinc	HRS	Class II	2012-10-12
K121624	Biomet Microfixation Neuro Plating System	Biomet Microfixation	GWO	Class II	2012-10-12
K121598	Me Hair2go	Syneron Medical, Ltd.	ONF	Class II	2012-10-12
K121317	Cochlear Baha Implant System	Cochlear Americas	MAH	Class II	2012-10-12
K121002	Etest Ceftaroline	bioMerieux, Inc.	JWY	Class II	2012-10-12
K120831	Anchorsure	Neomedic International S.L.	PBQ	Class II	2012-10-12
K120652	Rapicide Opa-28 Test Strip	Serim Research Corp.	JOJ	Class II	2012-10-12
K120595	Unisyn Plus Hip Stem	Consensus Orthopedics, Inc.	LWJ	Class II	2012-10-12
K120199	Glycosylated Hemoglobin Assay; Clinical Chemistry	Siemens Healthcare Diagnostics Inc.	LCP	Class II	2012-10-12
K111981	Tregor Dual Mobility Acetabular System	Aston Medical	LZO	Class II	2012-10-12
K122910	Archon Anterior Cervical Plate Syste,	Nu Vasive, Incorporated	KWQ	Class II	2012-10-11
K122798	Integrip Acetabular Shell, Integrip Revision Acetabular Shell	Exactech, Inc.	LPH	Class II	2012-10-11
K122796	Cxi Support Catheter	Cook Inc.	KRA	Class II	2012-10-11
K122778	Profemur Z Revision Hip Stem	Wrightmedicaltechnologyinc	KWA	Class III	2012-10-11
K122600	Lifepak 1000 Defibrillator	Physio Control, Inc.	MKJ	Class III	2012-10-11
K122463	Aperfix Am Femoral Implant with Inserter, 9X24 Aperfix Am Femoral Implant with Inserter, 10X24 Aperfix Femoral Implant W	Cayenne Medical Inc.	MBI	Class II	2012-10-11
K122233	Capsure(r) Ps System	Spine Wave Inc	MNI	Class II	2012-10-11
K122178	Flash-C Ptca Balloon Dilatation Catheter - 4Mm X 14Mm X 135Cm, Flash-C Ptca Balloon Dilatation Catheter - 4Mm X 19Mm X 1	Verge Medical Inc.	LOX	Class II	2012-10-11
K122168	Visualif Challenging Access Plate	Spine Smith Partners L.P.	OVD	Class II	2012-10-11
K121883	Prevena Incision Management System with Customizable Dressing, Prevena Customizable Dressing Kit	Kci USA, Inc. (Kinetic Concepts, Inc.)	OMP	Class II	2012-10-11
K121796	Weck Reusable Obturator	Teleflexmedical, Inc.	GCJ	Class II	2012-10-11
K121722	Esa620 Electrical Safety Analyzer	Fluke Biomedical	DRT	Class II	2012-10-11
K121696	Wireless Thermometer	Raling Medical Company	FLL	Class II	2012-10-11
K121679	Accu-Chek Inform II Blood Glucose Monitoring System	Roche Diagnostics GmbH	NBW	Class II	2012-10-11
K121591	Flavored Powder Free and Polymer Coated Examination Glove (Vanlla, Grape and Strawberry)	Tekmedic (M) Sdn Bhd	LYY	Class I	2012-10-11
K121543	Zimmer Trabecular Metal Reverse Shoulder System, Base Plates & Humeral Stems	Zimmer GmbH	KWT	Class II	2012-10-11
K121379	Pneuton Mini Ventilator Pneuton Mini Non-Invasive Ventilation (Niv) Kit Accessory	Airon Corporation	CBK	Class II	2012-10-11
K121083	True Dilatation Percutaneous Transluminal Valvuloplasty Catheter, 20Mm X 4.5Cm, True Dilatation Percutaneous Translumina	Loma Vista Medical	OZT	Class II	2012-10-11
K122504	Femoral Heads, 2.5 and 7.5 Mm Neck Length	United Orthopedic Corp.	LPH	Class II	2012-10-10
K121754	Blue Sui Sling	Boston Scientific Corporation	OTN	Class II	2012-10-10
K112826	Noorvms-Oxy Tissue Oxygen and Temperture Monitor	Moor Instruments Ltd.	MUD	Class II	2012-10-10
K122842	Radrex-I, Sw V4.00 Model Drad-3000E	Toshiba America Medical Systems, In.C	MQB	Class II	2012-10-09
K122816	Axcess Soft Tip Wire Guide	Wilson-Cook Medical Inc.	OCY	Class II	2012-10-09
K122773	Cross-Over Acetabular Shell & Liner	Globus Medical, Inc.	OQG	Class II	2012-10-09
K122769	Remstar Se	Respironics, Inc.	BZD	Class II	2012-10-09
K122531	Shiley Neonatal Tracheostomy Tube Cuffless, Shiley Pediatric Tracheostomy Tube Cuffless, Shiley Pediatric Tracheostomy T	Medtronic, Inc.	JOH	Class II	2012-10-09
K122031	Nextra Ti Hammertoe Correction System	Medartis AG	HWC	Class II	2012-10-09
K122025	Brightglass Brightglass M	Ktk Medical Supplies GmbH	EBG	Class II	2012-10-09
K121758	Cerner Fetalink+(version1.0)	Cerner Corporation	HGM	Class II	2012-10-09
K121076	Ultraextend Fx, Ultrasound Workstation Package	Toshiba America Medical Systems, In.C	LLZ	Class II	2012-10-09
K112837	Vilex Ez-Staple (Memory Bone Fixation Staple)	Vilex LLC	JDR	Class II	2012-10-09
K122921	C1-6-D Ultrasound Transducer	GE Healthcare	ITX	Class II	2012-10-05
K122843	Md211g3 21.3 Diagnostic Imaging Lcd Monitor	Prodigy Technology Consultant Co., Ltd.	LLZ	Class II	2012-10-05
K122757	Ace Cholesterol Reagent, Ace Hdl-C Reagent, Ace Ldl-C Reagent, Ace Triglycerides Reagent	Alfa Wassermann Diagnostic Technologies, Inc.	CHH	Class I	2012-10-05
K122697	Porta 100Hf	Job Corporation	IZL	Class II	2012-10-05
K122589	Dfp4343c7	Mdi Consultants, Inc.	KPR	Class II	2012-10-05
K122099	Bencox II Stem, Bencox Metal Head	Corentec Co., Ltd.	LPH	Class II	2012-10-05
K121728	Tiger Spine System	Corelink, LLC	NKB	Class II	2012-10-05
K121716	Tbs Insight	Medimaps Group SA	KGI	Class II	2012-10-05
K121652	Cvue Advanced Hydra Vue	Unilens Corp., USA	LPL	Class II	2012-10-05