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 2026-10-26, 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 747 of 3530

510(k) clearances, page 747 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K132771	Kingston Endoscopic Surgical Instruments	Qingdao Kingston Medical Devices, Ltd.	GEI	Class II	2014-10-28
K142847	CD HORIZON Spinal System	Medtronic Sofamor Danck USA, Inc.	NKB	Class II	2014-10-27
K142425	Uroflowmeter	Be Technologies, Inc.	EXY	Class II	2014-10-27
K142114	Xia® Growth Rod Conversion Set	Stryker Corp.	PGM	Class II	2014-10-27
K142070	Fortiva Porcine Dermis, Tutoplast Porcine Dermis	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	FTM	Class II	2014-10-27
K141953	Endoskeleton; Ta Ibd and Vbr, to and Tt, Tas, Tc, Tl	Titan Spine, LLC	MAX	Class II	2014-10-27
K141850	Flospine Pedicle Screw System	Flospine LLC	NKB	Class II	2014-10-27
K141809	Rmu-1000 Automated Chest Compression System	Defibtech LLC	DRM	Class II	2014-10-27
K141407	Vanguard Xp Femoral Component(gen Ii)/vanguard Xp Femoral Trial	Zimmer GmbH	MBH	Class II	2014-10-27
K141331	Biomet Orthopaedic Salvage System (Oss)	Zimmer GmbH	JDI	Class II	2014-10-27
K140940	Process Indicator Tape for Steam Sterilization	Canadian Technical Tape, Ltd.	JOJ	Class II	2014-10-27
K140225	Elia Pr3s Immunoassay, Elia Mpos Immunoassay, Elia Gbm Immunoassay, Elia Anca/gbm Positive Control 100, Elia Anca/gbm Po	Phadia AB	MOB	Class II	2014-10-27
K142784	Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface	Medtronic, Inc.	DTZ	Class II	2014-10-24
K142727	CrossCLIP Implant System	Orthodiscovery Group, LLC(D.B.A. Crossroads Extremity Systems	JDR	Class II	2014-10-24
K142574	4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 6.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture,	DePuy Mitek, Inc.	MBI	Class II	2014-10-24
K142133	Elecys Cmv Igm Immunoassay; Elecys Precicontrol Cmv Igm	Roche Diagnostics GmbH	LFZ	Class II	2014-10-24
K142079	Stalif Cti, Stalif C	Centinel Spine, LLC	OVE	Class II	2014-10-24
K141759	Oak Ridge Products Multi-Purpose Sharps Containers	Oak Ridge Products	MMK	Class II	2014-10-24
K141731	Nephros Dsu-H, Nephros Ssu-H	Nephros Inc	NHV	Class II	2014-10-24
K141714	Pro-Toe X-Flex Hammertoe Fixation System	Wrightmedicaltechnologyinc	HTY	Class II	2014-10-24
K141564	Opton Pro	Zimmer Medizinsystems Corp	ILY	Class II	2014-10-24
K141175	Renovocath Rc120	RenovoRx, Inc.	MJN	Class II	2014-10-24
K140927	Universal Navigation Instruments	Medos International SARL	OLO	Class II	2014-10-24
K140684	Clinpro Prophy Powder	3M Deutschland GmbH	PIP	Class II	2014-10-24
K140647	Xtag Gastrointestinal Pathogen Panel(gpp)/xtag Data Analysis Software for Gpp(tdas Gpp)	Luminex Molecular Diagnostics Inc	PCH	Class II	2014-10-24
K140022	Nisus Negative Pressure Wound Therapy Pump, Nisus Npwt Canister 250-Ml, Nisus Npwt Canister 500-Ml, Cork Medical Product	Cork Medical Products, LLC	OMP	Class II	2014-10-24
K133225	E-Fit Ef-1280 Ems Machine	Fit-Pro Kft, Ltd.	NGX	Class II	2014-10-24
K133069	Codent Low Speed Dental Handpieces and Accessories	Codent Technical Industry Co.,Ltd.	EFB	Class I	2014-10-24
K142876	ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound Systems	Siemens Medical Solutions USA, Inc.	IYN	Class II	2014-10-23
K142757	LiNA PowerBlade Plus HC	LiNA Medical Inc	GEI	Class II	2014-10-23
K142755	Siemens 3.0 Blanket Array Coil	Resonance Innovations, LLC	MOS	Class II	2014-10-23
K142698	PerkinElmer, XRpad 4343 F MED Flat Panel Detector	Revvity Health Sciences, Inc.	MQB	Class II	2014-10-23
K142603	Stryker Precision HD Camera System	Stryker Corp.	GCJ	Class II	2014-10-23
K142556	Flexible Video-Uretero-Choledochoscope System	Karl Storz Endoscopy-America, Inc.	FGB	Class II	2014-10-23
K142359	Vasc Band hemostat	Lepu Medical Technology (Beijing) Co., Ltd	DXC	Class II	2014-10-23
K142101	Abacus (Tm) Spacer System	Spine Wave Inc	MAX	Class II	2014-10-23
K141860	Raystation	RaySearch Laboratories AB (publ)	MUJ	Class II	2014-10-23
K141816	Hemopore	Polyganics B.V.	LYA	Class I	2014-10-23
K141560	Ethicon Physiomesh Open Flexible Composite Mesh Device	Ethicon, Inc	FTL	Class II	2014-10-23
K141339	Asahi Rg3 Guidewire/asahi Rg3 Soft Guidewire	Asahi Intecc Co., Ltd.	DQX	Class II	2014-10-23
K141325	Trc-Nw8f Plus Non-Mydriatic Retinal Camera	Topcon Corp.	HKI	Class II	2014-10-23
K141125	U-Type Contra Angle, U-Type Sectional Contra Angle	Handpiece Headquarters	EGS	Class I	2014-10-23
K140754	Cooper Surgical Leisegang Colposcope System	CooperSurgical, Inc.	HEX	Class II	2014-10-23
K140205	Pleur-Evac Sahara Plus Continuous Reinfusion and Autotransfusion System	Teleflexmedical, Inc.	CAC	Class II	2014-10-23
K133157	Tri-Optic Measurement Cell; with Balance Biosurface, with Carmeda Bioactive Surface, with Trillium Biosurface, with 6	Medtronic, Inc.	DRY	Class II	2014-10-23
K131737	Supernova C5 MRI System	Liaoning Kampo Medical System Co., Ltd.	LNH	Class II	2014-10-23
K142708	Veradius Unity	Philips Medical Systems Nethrlands BV	OWB	Class II	2014-10-22
K142670	Vericore Zirconia Blanks	Whip-Mix Corp.	EIH	Class II	2014-10-22
K142602	VALOR Hindfoot Fusion Nail System	Wrightmedicaltechnologyinc	HSB	Class II	2014-10-22
K142579	Zimmer Periarticular Plating System	Zimmer GmbH	HRS	Class II	2014-10-22