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 883 of 3530

510(k) clearances, page 883 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K121615	4Cis Vane Spine System	Solco Biomedical Corp.	MNI	Class II	2012-08-15
K121352	Armada 14Xxt Pta Catheter	Abbott Vascular	DQY	Class II	2012-08-15
K120902	Gid 700	The Gid Group, Inc.	MUU	Class II	2012-08-15
K112548	Altomec Arthroscope	Altomec Endoscopy, Inc.	HRX	Class II	2012-08-15
K122285	Tablet Commander	Cardiocom, LLC	DRG	Class II	2012-08-14
K122265	Vialok Single Vial Access Device Vented	Yukon Medical, LLC	LHI	Class II	2012-08-14
K122126	Direct Ldl/hdl Cholesterol Calibrator	Randox Laboratories, Limited	JIS	Class II	2012-08-14
K121776	Agility Steerable Guidewire Neuroscout Steerable Gudiewire	Cerenovus, Inc.	DQX	Class II	2012-08-14
K121396	Dynaflex	Dyna Flex	NXC	Class II	2012-08-14
K121334	Varioeco	Thommen Medical AG	NHA	Class II	2012-08-14
K120789	Exactrac X-Ray X-Ray	Brainlab, Inc.	IYE	Class II	2012-08-14
K120320	Connected Care Clinical Application	WATERMARK MEDICAL Inc	DXN	Class II	2012-08-14
K120158	Coronary Sinus Guide and Lateral Vein Introducer Kits	Merit Medical Systems, Inc.	DYB	Class II	2012-08-14
K113045	Bioharness	Zephyr Technology Corporation	MHX	Class II	2012-08-14
K112362	C100 Wrinkle Reduction Device	Silver Bay, LLC	OHS	Class II	2012-08-14
K122246	Mist 360 Single Use Applicator Kit, Mist 360 Single Use Applicator Kit, Case of 12	Celleration, Inc.	NRB	Class II	2012-08-13
K121819	Surgiclear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and Silver	Covalontechnologies, Inc.	FRO	Unclassified	2012-08-13
K121667	Nc Quantum Apex Ptca Dilatation Catheter (Monorail)	Boston Scientific Corporation	LOX	Class II	2012-08-13
K121443	Journey II Cr Knee System	Smith & Nephew, Inc.	JWH	Class II	2012-08-13
K120469	Erisma-Lp	Clariance, Inc.	NKB	Class II	2012-08-13
K120446	Fujinon/fujifilm Ultrasonic Endoscope Eg-530Ur2 and Eg-530Ut2	FUJIFILM Healthcare Americas Corporation	FDS	Class II	2012-08-13
K120152	Cerasorb Plus	Riemser Arzneimittel AG	NPM	Class II	2012-08-13
K121997	Imris Oncology Package	Imris, Inc.	LNH	Class II	2012-08-10
K121785	Scepter C Occlusion Balloon Catheter	Terumo Cardiovascular Systems Corporation	MJN	Class II	2012-08-10
K121632	Comfort Ez	Simple Diagnostics	FMI	Class II	2012-08-10
K121513	Multix Fusion	Siemens Medical Solution	KPR	Class II	2012-08-10
K121429	Aimago Easyldi Microcirculation Camera	Aimago SA	DPT	Class II	2012-08-10
K121390	Lube Jelly Suringe	Nurse Assist, LLC	KMJ	Class I	2012-08-10
K121368	Nitrile Examination Glove, Powder Free (Blue, Black or White)	Matang Mfg. Sdn. Bhd.	LZA	Class I	2012-08-10
K121320	C7 Anterior Cervical Intervertebral Fusion Cage	Medyssey Co., Ltd.	ODP	Class II	2012-08-10
K121197	Bodyguardian System Bodyguardian Control Unit Bodyguardian Connect	Preventice	DSI	Class II	2012-08-10
K120847	Et/ss Implant System	OSSTEM Implant Co., Ltd.	DZE	Class II	2012-08-10
K120715	Zimmer Natural Nail System Cephalomedullary Femoral Nail - Asia Short	Zimmer GmbH	HSB	Class II	2012-08-10
K120554	Arm-Type Fully Automatic Digital Blood Pressure Monitor, Wrist-Type Fully Automatic Digital Blood Pressure Monitor	Sejoy Electronics & Instruments Co., Ltd.	DXN	Class II	2012-08-10
K120278	Wireless Image Transmitter Unit	Olympus Medical Systems Corp.	GCJ	Class II	2012-08-10
K113685	Powder Free Latex Examination Gloves	Khai Hoan Joint Stock Company	LYY	Class I	2012-08-10
K113607	Biopsy Digit S Biopsy Sl	Giotto USA, LLC	IZH	Class II	2012-08-10
K113389	Ace Ck Reagent,ace Bun/urea Reagent,ace Uric Acid Reagent,ace Creatinine Reagent	Alfa Wassermann Diagnostic Technologies, Inc.	CDN	Class II	2012-08-10
K113338	Medical Air Compressor	Oricare Inc.	BTI	Class II	2012-08-10
K113210	Advantage-Strand/advantage-Load Brachytherapy Kit	Isoaid, L.L.C.	KXK	Class II	2012-08-10
K112534	Lifecell Tissue Expander	LifeCell Corp	LCJ	Unclassified	2012-08-10
K111246	Spirale Drug Delivery System	Armstrong Medical Ltd.	CAF	Class II	2012-08-10
K121524	Insignia	Ormco Corp.	DYW	Class II	2012-08-09
K121221	Profemur Z Revision Hip Stem	Wrightmedicaltechnologyinc	LZO	Class II	2012-08-09
K121142	Crawford Biocanaliculus Intubation	Fci SAS (France Chirurgie Instrumentation)	OKS	Unclassified	2012-08-09
K121136	Renoir Posterior Cervial Fixation System	Accel Spine	KWP	Class II	2012-08-09
K120781	Cello Balloon Guide Catheter (6F), 950 Mm and 1020 Mm Length	Fuji Systems Corp.	DQY	Class II	2012-08-09
K120714	Picasso Mis Spinal Fixation System	Accel Spine	NKB	Class II	2012-08-09
K120553	Espin	Nlt Spine, Ltd.	HRX	Class II	2012-08-09
K113692	Xenx	Xenolith Medical	OCY	Class II	2012-08-09