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 783 of 3530

510(k) clearances, page 783 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K140541	Immulite 2000: C-Peptide Calibration Verification Material, Shbg Calibration Verification Material, Total Testosterone C	Siemens Healthcare Diagnostics Inc.	JJX	Class I	2014-04-01
K140420	Vado Steerable Sheath	Kalila Medical, Inc.	DYB	Class II	2014-04-01
K140414	Imbibe Needle	DSM Biomedical, Inc.	LXH	Class I	2014-04-01
K140271	Tablet Viewer Software for Image Suite	Eastman Kodak Company	LLZ	Class II	2014-04-01
K140259	Variax Clavicle Hook Plate	Stryker Trauma GmbH	HRS	Class II	2014-04-01
K140199	Vupad	Sonomed, Inc.	IYO	Class II	2014-04-01
K133939	Modified Distal Radius Plating System	Zimmer GmbH	HRS	Class II	2014-04-01
K133606	N8tive Acl Anatomic Reconstruction System, N8tive Acl Femoral Implant, N8tive Acl Tibial Implant, Various Class I Ancill	ArthroCare Corporation	MBI	Class II	2014-04-01
K131140	Omnyx Idp for Her2 Manual Application	Omnyx, LLC	OEO	Class II	2014-04-01
K140584	Icerod Cx Cryoablation Needle	Galil Medical Ltd.	GEH	Class II	2014-03-31
K140505	Advia Centaur Vitamin B12 Master Curve Material, Total Hcg Master Curve Material, and Testosterone Master Curve Material	Siemens Healthcare Diagnostics Inc.	JJX	Class I	2014-03-31
K134044	Ep-Tracer System, Ep-Tracer System, Ep-Tracer System	Cardio Tek, BV	DQK	Class II	2014-03-31
K134033	Miromatrix Biological Mesh	Miromatrix Medical, Inc.	FTM	Class II	2014-03-31
K133721	Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif Contour Oblique and the Infill 60	Pinnacle Spine Group, LLC	MAX	Class II	2014-03-31
K132850	Bovine Pericardium Suturable Dural Graft, Tutopatch Dm Graft, Tutoplast Bovine Pericardium Dm	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	GXQ	Class II	2014-03-31
K131984	Synthes Synsonic Ulna Nail	Synthes (USA) Products LLC	HSB	Class II	2014-03-31
K131848	Vashe Wound Solution (4.0 Oz), (8.5 Oz & (16.0 Oz)	Puricore, Inc.	FRO	Unclassified	2014-03-31
K140201	Axera 2 Access System	Arstasis, Inc.	DYB	Class II	2014-03-28
K134016	Arietta 70/Arietta S70/arietta V70 Diagnostic Ultrasound Scanner	Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical	IYN	Class II	2014-03-28
K133984	Coronis 5Mp	Barco N.V.	LLZ	Class II	2014-03-28
K133940	Oxford Fixed Lateral Bearing Partial Knee Replacement (Bearings / Trays)	Biomet U.K., Ltd.	HRY	Class II	2014-03-28
K133636	Extremity Medical Hammertoe Device	Extremity Medical, LLC	HWC	Class II	2014-03-28
K133560	Itotal Cruciate Retaining Knee Replacment System	ConforMIS, Inc.	JWH	Class II	2014-03-28
K133540	Flocap	Maxtec, LLC	CCK	Class II	2014-03-28
K133515	Peek Fusion Implant	Mtp Solutions, LLC	HWC	Class II	2014-03-28
K133408	Neurostar Tms Therapy System	Neuronetics Inc.	OBP	Class II	2014-03-28
K133344	Minicap Hb A1c, Minicap Flex-Piercing, Hb A1c Capillarys Controls, Hba1c Capillarys Calibrators	Sebia, Inc.	LCP	Class II	2014-03-28
K133210	B&b Bubbler	S & T Medical Technologies, Inc.	BYE	Class II	2014-03-28
K133174	Orthoscan Fd Mini C-Arm	Orthoscan, Inc.	OXO	Class II	2014-03-28
K133170	Quick Jet M	Micron Corp.	EFB	Class I	2014-03-28
K133116	Video Extended Length Tray (Plastic - Radel), Video Tray Single Level (Plastic - Radel), Video Arthroscope Tray (Plastic	ConMed Corporation	KCT	Class II	2014-03-28
K132988	Vital Cough	Lung Assist, Inc.	NHJ	Class II	2014-03-28
K132572	I-Hip Total Hip System	Iconacy Orthopedic Implants, LLC	LPH	Class II	2014-03-28
K131861	Da Vinci Surgical System, Endowrist Instruments and Accessories	Intuitive Surgical, Inc.	NAY	Class II	2014-03-28
K131075	X-Ray Tv System Sonial Vision G4	Shimadzu Corp.	JAA	Class II	2014-03-28
K130263	Sterrad 50/100S/200 Test Pack	Advanced Sterilization Products	FRC	Class II	2014-03-28
K122298	Ajex 1200 H / Ajex 240H Mobile X-Ray Generator	Ajex Meditech., Ltd.	IZL	Class II	2014-03-28
DEN130040	Iogyn System	Iogyn, Inc.	PGT	Class II	2014-03-28
K140534	Elecsys Precicontrol Ts	Roche Diagnostics GmbH	JJX	Class I	2014-03-27
K140485	Mandrel Guidewire	Lake Region Medical	DQX	Class II	2014-03-27
K140106	S128 Anterior Lumbar Interbody Fusion (Alif) System	Renovis Surgical Technologies, LLC	OVD	Class II	2014-03-27
K133930	Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating Set	FLOWER ORTHOPEDICS Corporation dba Conventus Flower	HRS	Class II	2014-03-27
K133719	Pde-Neo	Hamamatsu Photonics K.K.	IZI	Class II	2014-03-27
K133631	Lexipliant Dilator Sheath Set	Spectranetics Corp.	DRE	Class II	2014-03-27
K133493	Single Use Sterile Syringe with Needle	Jiangxi Kelun Medical Devices Manufacturing Co.,Lt	FMF	Class II	2014-03-27
K133455	Crossfuse II Coronal Taper, Crossfuse II Hyperlordotic	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	MAX	Class II	2014-03-27
K133004	Vented Millex -Gv, Cathivex -Gv	Merck Millipore Ltd.	BSN	Class II	2014-03-27
K132373	Biomet Access System	Biomet Spine (Aka Ebi, LLC)	PDQ	Class II	2014-03-27
K132002	Single Use Soft Tipped Disposable Injector, Raysert Single Use Soft Tipped Small Incision Disposable Injector	Rayner Intraocular Lenses Limited	MSS	Class I	2014-03-27
K130603	Pathfast Ctnl Calibrators	Mitsubishi Chemical Medience Corporation	JIT	Class II	2014-03-27