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 1444 of 3531

510(k) clearances, page 1444 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K020875	Tso3 Ozone Sterilizer, Model 125L	Technologies of Sterilization with Oxone, Tso3, Inc.	FLF	Class II	2003-08-26
K032500	Modificarion to Wackers-Liu Cq Software	Eclipse Systems, Inc.	KPS	Class II	2003-08-25
K032474	3.0T 4-Channel Cervico-Thoracic-Lumbar (Ctl) Array Coil	GE Healthcare Coils	MOS	Class II	2003-08-25
K032415	Millennium III 4 Channel Neurovascular Coil	GE Healthcare Coils	MOS	Class II	2003-08-25
K032341	Intra Oral Camera System and Accessories, Model Claris I310	Sota Precision Optics, Inc.	EIA	Class I	2003-08-25
K032203	Hemocue Hemoglobin 201 + System Article 121704	HemoCue AB	GKR	Class II	2003-08-25
K032106	Starbond Dental Bonding Alloys	Star Refining Precious Metals South Africa	EJT	Class II	2003-08-25
K032078	Mitek Micro Quickanchor	Mitek Worldwide	NOV	Class II	2003-08-25
K032018	Easy Pulse II Oxygen Conserver	Precision Medical, Inc.	NFB	Class II	2003-08-25
K031921	Linical Chemistry Calibration Verifiers Levels a - E for Beckman Coulter Synchron Systems	Cliniqa Corporation	JJY	Class I	2003-08-25
K031883	Lyra Nasal Mask	Sensor Medics Corp.	BZD	Class II	2003-08-25
K030980	Dentaurum No-Mix One Step Bracket Adhesive	Dentaurum Inc.	DYH	Class II	2003-08-25
K030977	Dentaurum Mix Two-Paste Bracket Adhesive	Dentaurum Inc.	DYH	Class II	2003-08-25
K030374	Sonik Ldi 20 Air	Evit Labs, Inc.	CAF	Class II	2003-08-25
K024250	Match Press Pressable Ceramic	Davis Schottlander & Davis, Ltd.	EIH	Class II	2003-08-25
K023913	Neurotech Baxolve Type 294	Bio-Medical Research, Ltd.	GZJ	Class II	2003-08-25
K023856	Visualine Methadone Dipstriptest	Sun Biomedical Laboratories, Inc.	DJR	Class II	2003-08-25
K032503	Eub-5500 Diagnostic Ultrasound Scanner	FUJIFILM Healthcare Americas Corporation	IYN	Class II	2003-08-22
K032483	Viatronix V3d Explorer, Revision 1.2	Viatronix, Inc.	LLZ	Class II	2003-08-22
K032466	Spiderview	Ela Medical, Inc.	MWJ	Class II	2003-08-22
K032464	Aloetouch Powder Free Latex Surgical Gloves, Sterile, Coated with Aloe Vera and with Protein Content Labeling Claim (50	WRP Asia Pacific Sdn Bhd	KGO	Class I	2003-08-22
K032448	Altatec Ceramic Abutment	Altatec Biotechnologies	NHA	Class II	2003-08-22
K032314	Vitek 2 Gram Positive Gatifloxacin	bioMerieux, Inc.	LON	Class II	2003-08-22
K032306	Versatrek	Trek Diagnostic Systems, Ltd.	MDB	Class I	2003-08-22
K032261	Trellis Reserve Infusion System	Bacchus Vascular, Inc.	QEY	Class II	2003-08-22
K032068	Cardiovention Corx Ios-200 System, Model Ios-200	Cardiovention, Inc.	DTR	Class II	2003-08-22
K032049	Roche Online Tdm Valproic Acid	Roche Diagnostics GmbH	LEG	Class II	2003-08-22
K032005	Medtronic Minimed Paradigm Reservoir, Model Mmt-332	Medtronic, Inc.	FRN	Class II	2003-08-22
K031692	Safe-Cross Deflecting Catheter, Model C114nd1	Intra Luminal Therapeutics, Inc.	DQY	Class II	2003-08-22
K031657	Stryker Spine Oasys Bone Screw	Howmedica Osteonics Corp	MRW	Unclassified	2003-08-22
K031639	Intermed Zoom Colposcope	Intermed Group, Inc.	HEX	Class II	2003-08-22
K031637	Innova 3100	GE Healthcare	OWB	Class II	2003-08-22
K031318	Traxis Cement Restrictor	Spinal Concepts, Inc.	JDK	Class II	2003-08-22
K031155	Osteomed Subtalar Implant System	Osteomed	HWC	Class II	2003-08-22
K030860	Accubind Neonatal T4 Microplate Eia, Model 2625-300	Monobind, Inc.	KLI	Class II	2003-08-22
K023400	Fci Mesh Wrapped Bioceramic Orbital Implant	Fci Ophthalmics, Inc.	HPZ	Class II	2003-08-22
K022587	Medtrade Product's Antiseptic Barrier Hydrogel Dressings	Medtrade Products Ltd.	MGQ	Unclassified	2003-08-22
K012681	Ankylos	Dentsply Ceramco	DZE	Class II	2003-08-22
K032504	Arthrocare System	ArthroCare Corporation	GEI	Class II	2003-08-21
K032490	Toshiba Excelart Vantage Xgv/agv MRI Diagnostic System, Models Mrt-1503/P3 and Mrt-1503/P2	Toshiba America Medical Systems, In.C	LNH	Class II	2003-08-21
K032452	Modification to: Stellartech Coagulation System, Models 1100C-115 & 100C-230	Stellartech Research Corp.	GEI	Class II	2003-08-21
K032429	Qsc-127 Shoulder Array Coil Set	Mri Devices Corp.	MOS	Class II	2003-08-21
K032396	Ringloc 36Mm Line and Modular Femoral Heads	Zimmer GmbH	JDI	Class II	2003-08-21
K032377	Roche Diagnostics Hitachi Bicarbonate Liquid	Roche Diagnostics GmbH	KHS	Class II	2003-08-21
K032347	Biomarc Tissue Marker	Carbon Medical Technologies, Inc.	GDW	Class II	2003-08-21
K032301	Neogen One, Closed Wound Drain System, Part Number: Ng9900	Neogen Technologies, Inc.	OMP	Class II	2003-08-21
K032295	Genesis II Posterior Stabilized High Flexion Articular Insert	Smith & Nephew, Inc.	JWH	Class II	2003-08-21
K032285	Olympus Prealbumin Calibrator, Odr3029	OLYMPUS Corporation of the Americas	JIT	Class II	2003-08-21
K032282	Modification to Hedrocel Trabecular Metal Reconstruction System	Implex Corp.	EZX	Class II	2003-08-21
K032252	Model 120 Series Maternal/fetal Monitor	GE Medical Systems Information Technologies, Inc.	HGM	Class II	2003-08-21