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 871 of 3530

510(k) clearances, page 871 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K122292	Reliance Posterior Cervical- Thoracic System	Reliance Medical Systems, LLC	KWP	Class II	2012-10-24
K122289	Image-Com 5.0	TOMTEC Imaging Systems GmbH	LLZ	Class II	2012-10-24
K122284	Hoffmann 3	Stryker Corp.	KTT	Class II	2012-10-24
K122241	Imagen3d	Cardiovascular Imaging Technologies, LLC	KPS	Class II	2012-10-24
K122053	Shapematch Cutting Guide	Stryker Corp.	MBH	Class II	2012-10-24
K121636	Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular Insert	Tgm Medical, Inc.	LPH	Class II	2012-10-24
K121312	Intramedullary Nail System	Weigao Orthopaedic Device Co., Ltd.	HSB	Class II	2012-10-24
K120765	Vitros Chemistry Products Eco2 Slides	Ortho-Clinical Diagnostics, Inc.	KHS	Class II	2012-10-24
K123109	Absorbatack 5Mm Single Use Absorbable Fixation Device	Medtronic, Inc.	GDW	Class II	2012-10-23
K122533	Osseoflex Sb Inflatable Bone Tamp	Osseon Therapeutics, Inc.	NDN	Class II	2012-10-23
K122523	Carestream Vue Pacs	Eastman Kodak Company	LLZ	Class II	2012-10-23
K122280	Ipulse Smoothskin Hair Removal System	Cyden Limited	OHT	Class II	2012-10-23
K122092	Medrange Electrosurgical Expansion System	Medrange Corporation	GEI	Class II	2012-10-23
K122028	Aurical Hit	Natus Medical Denmark ApS	ETW	Class II	2012-10-23
K121815	Nuvasive Sage Lateral Plate System	NuVasive Inc	KWQ	Class II	2012-10-23
K121705	Geo	ResMed Corp	BZD	Class II	2012-10-23
K121657	Proton Radiation Therapy Beam-Shaping Aperture Proton Radiaion Therapy Beam-Shping Range Compensator	Proton Systems	IYE	Class II	2012-10-23
K121551	Resolute Facet Screw System	Neurostructures, Inc.	MRW	Unclassified	2012-10-23
K120832	Fortex Pedicle Screw System	Xtant Medical Holdings, Inc.	MNH	Class II	2012-10-23
K120545	Hx-461	Seers Technology Co., Ltd.	DXN	Class II	2012-10-23
K123019	Longevity It Highly Crosslinked Polyethyene Liners	Zimmer GmbH	LPH	Class II	2012-10-22
K122984	Atlas Gold Pta Dilatation Catheter	C.R. Bard Inc	LIT	Class II	2012-10-22
K122898	Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design	Surgical Specialties Corp. dba Angiotech	GAM	Class II	2012-10-22
K122482	Transtek Wrist Blood Pressure Monitor	Zhongshan Transtek Electronics Co., Ltd	DXN	Class II	2012-10-22
K122382	Dynasty Biofoam Shell	Wrightmedicaltechnologyinc	MBL	Class II	2012-10-22
K122277	Oxford Fixed Lateral Bearing Partial Knee Replacement (Oxford Tibial Trays a-F) Ixford Partial Knee Replacement System	Biomet Manufacturing Corp	HRY	Class II	2012-10-22
K122050	Cprmeter CPR Feedback Device	Laerdal Medical a/S	LIX	Class II	2012-10-22
K120747	Xn Cal Pf	Streck LLC	KRX	Class II	2012-10-22
K120728	Phasix Plug and Patch	C.R. Bard Inc	OWT	Class II	2012-10-22
K122916	Jetstream Navitus L System Jeystream Navitus System Jetstream G3 Sf System Jetstream Sf 1.6 System	Medrad, Inc.	MCW	Class II	2012-10-19
K122913	Affinity Fusion Recirculation Line Model Rcl841	Medtronic, Inc.	DWF	Class II	2012-10-19
K122911	Versafitcup Cc Trio Extension	Medacta International SA	LZO	Class II	2012-10-19
K122173	Digital Flat Planel X-Ray Detector / 1717Scc	Rayence Co., Ltd.	MQB	Class II	2012-10-19
K122170	Smith & Nephew, Inc. Intramedullary Nail System Instrumentation	Smith & Nephew, Inc.	HSB	Class II	2012-10-19
K121980	Zirprime	Kuraray Noritake Dental, Inc.	EIH	Class II	2012-10-19
K121962	Practical Compression Device (Pcd) 901A&901b	MEGO AFEK AC Ltd.	JOW	Class II	2012-10-19
K121931	Nondisposable Stimulating Instruments	Neurovision Medical Products Inc	ETN	Class II	2012-10-19
K121876	Vertecem II Cement Kit	Aap Biomaterials GmbH	NDN	Class II	2012-10-19
K121845	Sdx System	Dyn'R SAS	IYE	Class II	2012-10-19
K121709	Zfx Dental Cad System	ZimVie US Corp LLC	NHA	Class II	2012-10-19
K121484	3M Attest(tm) Super Rapid Readout Biological Indicator, 3M Attest(tm) Auto-Reader	3M Company	FRC	Class II	2012-10-19
K120745	Xn Cal	Streck LLC	KRX	Class II	2012-10-19
K120744	Xn Check Bf	Streck LLC	JPK	Class II	2012-10-19
K120742	Xn Check	Streck LLC	JPK	Class II	2012-10-19
K120340	Venus Facet Screw System	Apollo Spine, Inc.	MRW	Unclassified	2012-10-19
K113867	Lacricath Lacrimal Duct Catheter	Quest Medical, Inc	OKS	Unclassified	2012-10-19
K113219	Ellipse Precice Intramedullary Limb Lengthening System	Ellipse Technologies, Inc.	HSB	Class II	2012-10-19
K112605	Sysmex Xn-Series	Sysmex America, Inc.	GKZ	Class II	2012-10-19
K122896	Cougar Ls 15 Lateral Cage System	Medos International SARL	MAX	Class II	2012-10-18
K122882	Nmi Hpicc III	Boston Scientific Corporation	LJS	Class II	2012-10-18