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 881 of 3530

510(k) clearances, page 881 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K121091	Catalys Precision Laser System	OptiMedica Corp.	OOE	Class II	2012-08-28
K120629	Fdr Go Flex	FUJIFILM Healthcare Americas Corporation	MQB	Class II	2012-08-28
K120246	Kodak Directview Cr Mammography System (Using Carestream Cr Mammography Cassette with Snp-M1 Screen)	Eastman Kodak Company	MUE	Class II	2012-08-28
K113666	Xia 3 Spinal System	Howmedica Osteonics Corp	NKB	Class II	2012-08-28
K112967	Pmma Cad/cam Disc	POLIDENT d.o.o., Dental products industry	EBG	Class II	2012-08-28
K112255	Aixplorer	Supersonic Imagine	IYN	Class II	2012-08-28
K122302	Ace Magnesium Regent	Alfa Wassermann Diagnostics Technologies, LLC	JGJ	Class I	2012-08-27
K121542	Picis Weight Based Dose Converter	Picis, Inc.	NDC	Class II	2012-08-27
K121264	Triton Electric High Torque Handpiece and Software Module	Medtronic Surgical Technologies	HBE	Class II	2012-08-27
K120997	Barostat Software Option	Crospon, Ltd.	FFX	Class II	2012-08-27
K122254	Inspire 8 Hollow Fiber Oxygenator with Integrated Hardshell Venous/cardiotomy Reservoir	Corcym Inc.	DTZ	Class II	2012-08-24
K121895	Elecsys Hsv-2 Igg Immunoassay	Roche Diagnostics GmbH	JJX	Class I	2012-08-24
K121892	Phantom Plus Ceramic Cage System	Amedica Corp.	MAX	Class II	2012-08-24
K121820	Inwave	Altivera Medical, Inc.	KPI	Class II	2012-08-24
K121619	Nuvasive Polyaxial Spinal Screws	NuVasive Inc	NKB	Class II	2012-08-24
K121329	Aixplorer	Supersonic Imagine	IYN	Class II	2012-08-24
K121103	Ldr Spine USA Spine Tune, Tl Spinal System, Ldr Spine USA Easyspine, Posterior Spinal System, Ldr Spine USA Mc Implant S	Ldr Spine USA	NKB	Class II	2012-08-24
K120906	Zimmer Trabecular Metal Total Ankle	Zimmer GmbH	HSN	Class II	2012-08-24
K120239	Elevance	Midmark Corp	EIA	Class I	2012-08-24
K120169	Interlab Ife Test Using G 26 Ver. 2.0 Instrument	Grifols USA, LLC.	CFF	Class II	2012-08-24
K113747	Randox Opiates Assay	Randox Laboratories, Limited	DJG	Class II	2012-08-24
K110954	Arjorad Sterile Wrap	Arjo Wiggins Medical, Inc.	FRG	Class II	2012-08-24
K122244	Polarcup Dual Mobility System	Smith & Nephew, Inc.	LPH	Class II	2012-08-23
K122086	Thermal Ligating Shears	Microline Surgical, Inc	GEI	Class II	2012-08-23
K121824	Alginor Alginelle Type 1 and 2 Millenium Kromopan 1 and 2	La.sc.od. SpA	ELW	Class II	2012-08-23
K121695	Erchonia Zerona	Erchonia Corporation	OLI	Class II	2012-08-23
K121690	Etchonia Zerona Arms	Erchonia Corporation	OLI	Class II	2012-08-23
K121611	Amplatzer Torqvue Fx	Abbott Medical	DQY	Class II	2012-08-23
K121502	Synthes Curvilinear Distraction System	Synthes GmbH	MQN	Class II	2012-08-23
K121324	Avt Naturasoft	Advanced Vision Technologies	LPL	Class II	2012-08-23
K121089	Nmi Picc III	Boston Scientific Corporation	LJS	Class II	2012-08-23
K120991	Trans1 Interbody Fusion System	Trans1 Incorporated	MAX	Class II	2012-08-23
K120004	(Multiple) Digital Thermometer	China (Shenyang) Med-Land Imp/EXP Corp., Ltd.	FLL	Class II	2012-08-23
K113552	Freedom Inguinal Hernia Implant	Insightra Medical Inc	FTL	Class II	2012-08-23
K111603	Linebacker(tm) Transseptal Introducer, 53Cm / 62Cm / 72Cm	Ep Dynamics, Inc.	DYB	Class II	2012-08-23
K122083	Elitech Clinical Systems Ck Nac Sl	ELITechGroup Inc	JHW	Class II	2012-08-22
K121943	Xpress Multi-Sinus Dilation Tool	Entellus Medical, Inc.	LRC	Class I	2012-08-22
K121890	Genesys Pressft Suture Anchor	Linvatec Corporation D/B/A Conmed Linvatec	MAI	Class II	2012-08-22
K121854	System, X-Ray, Stationary	Beijing Sinopharm Hundric Mediline Info. Tech. Co.	KPR	Class II	2012-08-22
K121550	Harmonic Ace Laparoscopic 5Mm Diameter Shears 36Cm Length + Adaptive Tissue Technology	Ethicon Endo-Surgery Inc	LFL	Unclassified	2012-08-22
K121536	Inspire 8F Oxygenator with Integrated Arterial Filter & Hardshell Reservoir	Corcym Inc.	DTZ	Class II	2012-08-22
K121304	Osteomed Cranial Distraction System	Osteomed	PBJ	Class II	2012-08-22
K121185	Edwards Percutaneous Sheath Introducer	Edwards Lifesciences LLC	DYB	Class II	2012-08-22
K121181	Swannshidi Bone Marrow Aspiration Needle	Alliance Partners, LLC	KNW	Class II	2012-08-22
K121140	Prolyte Electrolyte Analyzer	DIAMOND DIAGNOSTICS Inc	JGS	Class II	2012-08-22
K120626	Eon Calcium Regent	Vital Diagnostics (Manufacturing) Ptyltd	CJY	Class II	2012-08-22
K122240	Bone Plus Bcp Eagle Eye	Megagen Implant Co., Ltd.	LYC	Class II	2012-08-21
K121764	Cd Horizon Spinal System	Medtronic Sofamor Danek	NKB	Class II	2012-08-21
K121485	Guardiva Antimicrobial Haemstatic IV Dressing	Hemcon Medical Technologies Europe, Ltd.	QSY	Unclassified	2012-08-21
K121063	Vivid S5 Diagnostic Ultrasound System, Vivid S6 Diagnostic Ultrasound System	GE Medical System Israel, Ltd.	IYN	Class II	2012-08-21