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 795 of 3530

510(k) clearances, page 795 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K133675	Aap Loqteq Distal Anterolateral Tibia Plate 3.5	AAP Implantate AG	HRS	Class II	2014-01-23
K133622	Mac 2000 ECG Analysis System	Wipro GE Healthcare	DPS	Class II	2014-01-23
K133100	Carefine Pen Needle	Facet Technologies, LLC.	FMI	Class II	2014-01-23
K133037	Grindguard	Grind Guard Technologies, LLC	OBR	Unclassified	2014-01-23
K132989	Speed 808 Diode Laser System	Beijing Toplaser Technology Co., Ltd.	GEX	Class II	2014-01-23
K132928	Medrad Mark 7 Arterion Injection System / Syringe, Twist & Go Syringe	Medrad, Inc. / Bayer Medical Care, Inc.	DXT	Class II	2014-01-23
K132841	Zyno Medical Administration Set	Zyno Medical LLC.	FPA	Class II	2014-01-23
K132725	Juvora Dentqal Disc	Juvora	EBI	Class II	2014-01-23
K131580	Automated Gylcohemoglobin Analyzer Hlc-723G8	Tosoh Bioscience Inc	PDJ	Class II	2014-01-23
K131490	Ellipse Precice Intramedullary Limb Lengthening System	Ellipse Technologies, Inc.	HSB	Class II	2014-01-23
K130666	Khan Kinetic Treatment (Kkt-M2)	Optima Health Solutions International Corp.	LXM	Unclassified	2014-01-23
K133960	Lypochek Specialty Immunoassay Control	Bio-Rad Laboratories Inc.	JJY	Class I	2014-01-22
K133950	Activapin Ht, Fuse Link (Private Labled for Footmind, Inc.)	Bioretec Ltd.	HTY	Class II	2014-01-22
K133938	Endo Gia Reinforced Reload with Tri-Staple Technology	Medtronic, Inc.	GDW	Class II	2014-01-22
K133907	Vsp System	Medical Modeling - a 3D Systems Company	DZJ	Class II	2014-01-22
K133414	Reprocessed Closure System	Sterilmed Inc	NLM	Class II	2014-01-22
K133301	Zoe Fluid Status Monitor	Noninvasive Medical Technologies, Inc.	DSB	Class II	2014-01-22
K133152	Jts Extendible Distal Femoral Implant	Stanmore Implants Worldwide, Ltd.	KRO	Class II	2014-01-22
K133030	Dynacad/prostate Interventional (Dynaloc/prostate)	Invivo Corporation	LLZ	Class II	2014-01-22
K132879	Mpact Extension	Medacta International SA	LPH	Class II	2014-01-22
K132722	Hemosil Recombiplastin 2G (8 Ml Vial)	Instrumentation Laboratory Co.	GJS	Class II	2014-01-22
K132609	Eds Ultrasonic Tips	Essential Dental Systems, Inc.	ELC	Class II	2014-01-22
K132421	Aesculap Peek Xp Spinal Implant System	Aesculap Inc	MAX	Class II	2014-01-22
K132286	Hyperion Long Pulsed Nd: Yag Laser	Scarlet Rf, Inc.	GEX	Class II	2014-01-22
K132122	Kestrel Posterior Cervical Spine System	Omni Surgical, LLC dba Spine360	KWP	Class II	2014-01-22
K131837	CO2 Fractional Laser	Beijing Honkon Technologies Co., Ltd.	GEX	Class II	2014-01-22
K131644	Ankylos Syncone Abutment 5(Degree)	Dentsply International, Inc.	NHA	Class II	2014-01-22
K131135	Biomet Stage One Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis	Biomet Manufacturing Corp	MBB	Class II	2014-01-22
K130613	Cannulated Screw and Kirschner (Kwire) System	Laura Cattabriga	HWC	Class II	2014-01-22
K132764	Motion Watch and Pro-Diary	Camntech	LEL	Class II	2014-01-21
K132499	Icrco Clarity Viewer	Icrco, Inc.	LLZ	Class II	2014-01-21
K132125	A.b. Dental Devices Dental Implants System	A.B. Dental Devices Ltd	DZE	Class II	2014-01-21
K133875	The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.2, the Motion Normalizer Patient Handling and Data	Wenzel Spine	LLZ	Class II	2014-01-17
K133869	Cdc Human Influenza Virus Real-Time Rt-PCR Diagnostic Panel, Influenza A/b Typing Kit	Center for Disease Control and Prevention (Cdc)	OZE	Class II	2014-01-17
K133833	Nuvis Diagnostic Ultrasound System	Philips North America LLC	IYN	Class II	2014-01-17
K133464	Modified Trevo Provue Retriever	Concentric Medical, Inc.	NRY	Class II	2014-01-17
K133424	Somatom Emotion 6 CT Systems, Somatom Emotion 16	Siemens Medical Solutions USA, Inc.	JAK	Class II	2014-01-17
K133375	Banyan Medical Disposable Secondary Cannula and Trocar	Banyan Medical, LLC	GCJ	Class II	2014-01-17
K133277	Xario 100	Toshibamedical Systems Corporation	IYN	Class II	2014-01-17
K133228	Iconacy I-Hip System, Gradual Transitioning (Gt) Femoral System	Iconacy Orthopedic Implants, LLC	LPH	Class II	2014-01-17
K133197	Fdi Level I and Level II Glucose Controls for the Embrace No Code	Fujirebio Diagnostics, Inc.	JJX	Class I	2014-01-17
K132931	Apollo System	Penumbra Inc.	GWG	Class II	2014-01-17
K132921	Galaxy Plus	Medien International Co, Ltd.	MQB	Class II	2014-01-17
K132890	Suprapubic Catheter and Introducer Set	Mediplus Ltd.	KOB	Class II	2014-01-17
K132682	Phoenix 5F Tracking Atherectomy Catheter, Phoenix 6F Tracking Atherectomy Catheter, Phoenix 7D Deflecting Atherectomy Ca	Atheromed, Inc.	MCW	Class II	2014-01-17
K132668	Iob Disposable Speculum	Iob Medical, Inc.	HIB	Class II	2014-01-17
K132410	Discovery CT 590 Rt, Optima CT 580, Optima CT 580 Rt, Optima CT 580 W	GE Healthcare	JAK	Class II	2014-01-17
K132065	Injection Needle	Boston Scientific Corporation	FBK	Class II	2014-01-17
K131623	Smartdop Xt	Koven Technology, Inc.	JOP	Class II	2014-01-17
K131245	Oregon Scintific	Idt Technology Limited	DXN	Class II	2014-01-17