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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 1469 of 3531

510(k) clearances, page 1469 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K030362	Skintact Cool Contact Electrosurgical Grounding Plates	Leonhard Lang GmbH	GEI	Class II	2003-04-14
K030186	Polris Lv	Syneron Medical, Ltd.	GEX	Class II	2003-04-14
K024237	Urine Monovette Boric Acid	Sarstedt ApS	JSM	Class I	2003-04-14
K024207	Vinco Brand Acupuncture Needle	Helio Medical Supplies, Inc.	MQX	Class II	2003-04-14
K024170	L1 System	Pelikan Technologies, Inc.	FMK	Class II	2003-04-14
K023308	Lifestent Sds Biliary Endoprosthesis, Lifestent Xl Sds Biliary Endoprosthesis	Orbusneich Medical, Inc.	FGE	Class II	2003-04-14
K031003	Stimulus/dissection Instruments, Ball-Tip Probes	Medtronic Xomed, Inc.	ETN	Class II	2003-04-11
K030772	Rdi Extended Range Crp Calibrator Set	Reference Diagnostics, Inc.	JIT	Class II	2003-04-11
K030696	Retrograde Coronary Sinus Perfusion Cannula with No Pressure Line (15 French, Manual and Auto Inflate)	Medtronic Perfusion Systems	DWF	Class II	2003-04-11
K030555	Gps Platelet Separation Kit with Anticoagulant Acd-a	Zimmer GmbH	JQC	Class I	2003-04-11
K030498	Hl888ha	Health & Life Corporation	DXN	Class II	2003-04-11
K030340	Autologel Process Centrifuge, Model B4360 (100-103, 100-129)	Cytomedix	JQC	Class I	2003-04-11
K030320	Wako Autokit Micro Albumin, Wako Autokit Micro Calibrator Set, Micro Albumin Control Set	FUJIFILM Healthcare Americas Corporation	JIS	Class II	2003-04-11
K030270	3F X 60 Cm Single Lumen Silisone Vascu-Picc, 4F X 60Cm Single Lumen Silicone Vascu-Picc, 5F X 60 Cm Single Lumen Silicon	Medcomp	LJS	Class II	2003-04-11
K030213	Online Dat II Cannabinoids II	Roche Diagnostics GmbH	LDJ	Class II	2003-04-11
K022864	Sk Med M201 Mixer	Sk Med	BZR	Class II	2003-04-11
K021154	Goldway Patient Monitor, Model # Ut4000f	Goldway (Us), Inc.	MWI	Class II	2003-04-11
K030953	Ge 3.0T General Purpose Flex Coil	GE Healthcare	MOS	Class II	2003-04-10
K030909	Aap Acroplate	AAP Implantate AG	HRS	Class II	2003-04-10
K030881	Avanta Carpal Fusion Plating System	Avanta Orthopaedics, Inc.	HRS	Class II	2003-04-10
K030833	Depuy Acromed Vbr System	Depuyacromed	MQP	Class II	2003-04-10
K030804	Bayer Advia 1650 Special Chemistry Calibrator	Medrad, Inc.	JIX	Class II	2003-04-10
K030594	I-125 Rapid Strand, Model 7000	Amersham Health	KXK	Class II	2003-04-10
K030437	Relaxor Perfect Touch Air Massaging System	Salton, Inc.	IRP	Class II	2003-04-10
K030151	Consensus Hip System, Unisyn Hip System	Hayes Medical, Inc.	LZO	Class II	2003-04-10
K030072	Everstick Perio	Stick Tech Ltd.	EBI	Class II	2003-04-10
K023872	Vitalcare Urethral Catheter Red Rubber	Vitalcare, Inc.	EZD	Class II	2003-04-10
K023621	Bioflex Professional Therapy System	Meditech International Inc	ILY	Class II	2003-04-10
K023096	Contoured Articular Prosthesis (Cap) Humeral Head Resurfacing System	Std Mfg., Inc.	HSD	Class II	2003-04-10
K022449	Hystereoscopy Pump Hm4	Novanta Medical GmbH	HIG	Class II	2003-04-10
K022417	Care Stim	Care Rehab and Orthopaedic	GZJ	Class II	2003-04-10
K021237	Coopersurgical Laparoscopic Instruments	CooperSurgical, Inc.	HET	Class II	2003-04-10
K030999	Eptfe Vascular Prosthesis; Sealptfe	Vascutek, Ltd.	DSY	Class II	2003-04-09
K030940	Nomad Nd1000m Augmented Vision System	Microvision Incorporated	GCJ	Class II	2003-04-09
K030905	Medamicus Flowguard Peelable Introducer	Greatbatch Medical	DYB	Class II	2003-04-09
K030870	Wbr, Model Hr	U.C.G. Technologies, Ltd.	KPS	Class II	2003-04-09
K030823	Algo 3I Newborn Hearing Screener	Bio-Logic Systems Corp.	GWJ	Class II	2003-04-09
K030801	Bayer Advia 1650 Special Chemistry Control	Medrad, Inc.	JJY	Class I	2003-04-09
K030798	Mirage Activa Mask	ResMed Corp	BZD	Class II	2003-04-09
K030414	Genie Ultra Hydrophilic Impression Material	Sultan Chemists, Inc.	ELW	Class II	2003-04-09
K023412	Thermo Buddy, Models Tb-100, Tb-110, Tb-120	Hubdic Co., Ltd.	FLL	Class II	2003-04-09
K023311	Loop Microwave Ablation Probe	Vivant Medical, Inc.	GEI	Class II	2003-04-09
K023037	Mid Stream Pregnancy Test	Advanced Diagnostics, Inc.	LCX	Class II	2003-04-09
K030982	Syngo Colonography Software Package	Siemens Medical Solutions USA, Inc.	LLZ	Class II	2003-04-08
K030850	Enhance Human Serum Albumin	Conception Technologies	MQL	Class II	2003-04-08
K030806	Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery	Bioplate Inc	JEY	Class II	2003-04-08
K030799	Micros 60	Horiba Instruments Incorporated	GKZ	Class II	2003-04-08
K030656	Envan Heart Rate Monitor	Envan, LLC	DRT	Class II	2003-04-08
K030457	Rex, Version 3.0	Pointdx, Inc.	LLZ	Class II	2003-04-08
K030395	Empi Action Patch Iontophoresis System	Empi	EGJ	Class II	2003-04-08