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 897 of 3530

510(k) clearances, page 897 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K120587	Amt T-Fastener Anchor Kit	Applied Medical Technology Inc	KGC	Class II	2012-05-25
K120333	Prismasate Dialysis Solutions for Continuius Renal Replacement Therapy	Gambro Renal Products	KPO	Class II	2012-05-25
K120275	Synthes Acis/vertebral Spacer Cr	Synthes (USA) Products LLC	ODP	Class II	2012-05-25
K120080	Shaser Hrs2 Hair Removal System	Shaser, Inc.	ONF	Class II	2012-05-25
K113801	Vpap Adapt	ResMed Corp	BZD	Class II	2012-05-25
K113714	Vpap Tx	ResMed Corp	MNS	Class II	2012-05-25
K113696	Optos Advance	Optos PLC.	NFJ	Class II	2012-05-25
K113006	I-Fuse Hammer Toe Systems	Orthopro, LLC	HWC	Class II	2012-05-25
K112915	Spirtius Cuff Inflation Syringe	Spiritus Technologies, LLC	BSK	Class II	2012-05-25
K112550	Capillarys Hemoglobin, Capillarys Flex Piercing System	Sebia, Inc.	GKA	Class II	2012-05-25
K111941	Choyang Thermal Massager	Choyang Medical Instrument Co., Ltd.	JFB	Class II	2012-05-25
K111049	Mobile Versa Light	Medtek Lighting	FTC	Class II	2012-05-25
K110074	Hl 568 Self Monitoring Blood Glucose System, Hl 568Ba Self-Moniroting Blood Glucose System	Health & Life Corporation	NBW	Class II	2012-05-25
K121239	MRI Multi-Channel Optical Communication (Moc) System Imroc/imroc Ir Wirless Optoactive	Optoacoustics Ltd.	LNH	Class II	2012-05-24
K121236	Pax-Duo3d Plus, Pct-5000	Vatech Co., Ltd.	OAS	Class II	2012-05-24
K121232	K-Assay (R) Ferritin Reagent, K-Assay (R) Ferritin Calibrator	Kamiya Biomedical Company, LLC	DBF	Class II	2012-05-24
K120895	Remote Presence System	Intouch Health, Inc.	DRG	Class II	2012-05-24
K120840	Lexus Cervical Intervertebral Body Fusion Cage System	L&K Biomed Co.,Ltd.	ODP	Class II	2012-05-24
K120811	Leksell Gamma Knife Perfexion	Elekta Instrument AB	IWB	Class II	2012-05-24
K120767	Es Bond	Spident Co., Ltd.	KLE	Class II	2012-05-24
K120633	Mayfield Skull Clamp	Integra LifeSciences Corporation	HBL	Class II	2012-05-24
K120601	Geistlich Bio-Oss Pen (0.25 G, 0.25-1.0Mm Granules), Geistlich Bio-Oss Pen (0.5 G, 0.25-1.0Mm Granules), Geistlich Bio-O	Geistlich Pharma AG	NPM	Class II	2012-05-24
K120559	Aesculap-Meithke Prosa Adjustable Shunt System	Aesculap Inc	JXG	Class II	2012-05-24
K120425	Pentaray Nav High-Density Mapping Catheter	Biosense Webster Inc	MTD	Class II	2012-05-24
K120150	Dual Spike Transfer Device	B.Braun Medical, Inc.	LHI	Class II	2012-05-24
K120118	Ventlab Pressurechek Disosable Column Manometer	Salter Labs	CAP	Class II	2012-05-24
K120079	Primed Tracheostomy Tubes (Multiple)	Primed Halberstadt Medizintechnik GmbH	BTO	Class II	2012-05-24
K112905	Compress(r) Segmental Humeral Replacement System	Biomet Orthopedics, Inc.	MBF	Class II	2012-05-24
K112585	Touareg Closefit Dental Impant System	Adin Dental Implants System, Ltd.	DZE	Class II	2012-05-24
K112491	Sebia Capillarys Hemoglobin(e) with Capillarys 2	Sebia	GKA	Class II	2012-05-24
K112165	Rhea Cup	Apex Medical Technologies, Inc.	HHE	Class II	2012-05-24
K110644	Praezis Plus	Tatramed Spol. s.r.o.	HAW	Class II	2012-05-24
DEN120012	Cdc Denv-1-4 Real Time Rt-Pct Assay	Centers for Disease Control and Prevention	OZB	Class II	2012-05-24
K121384	Mylabsogno	Esaote S.p.A.	IYN	Class II	2012-05-23
K121227	Manuka Fill	Links Medical Products, Inc.	FRO	Unclassified	2012-05-23
K121109	Aerodr X70	Konica Minolta Medical & Graphic, Inc.	KPR	Class II	2012-05-23
K120976	Manuka Ig	Links Medical Products, Inc.	FRO	Unclassified	2012-05-23
K120934	Protexis Latex Basic Sterile Latex Powder-Free Surgical Glove with Protein Content Label Claim of 50 Ug/dm or Less	Medtronic, Inc.	KGO	Class I	2012-05-23
K120879	Lexus Cervical Fixation System	L&K Biomed Co.,Ltd.	MNI	Class II	2012-05-23
K120622	Palomar Vectus Laser	Palomar Medical Technologies, Inc.	GEX	Class II	2012-05-23
K120579	Somatom Definition Edge	Siemens Medical Solutions USA, Inc.	JAK	Class II	2012-05-23
K120556	Vilet Vilet Quick	Riverpoint Medical, LLC	GAM	Class II	2012-05-23
K120515	Tempus Cervical Plate System	Neurostructures, Inc.	KWQ	Class II	2012-05-23
K120487	Vantage Titan 3T	Toshibamedical Systems Corporation	LNH	Class II	2012-05-23
K120284	Digitex Suture Delivery System, Digitexpolypropylene Suture Cartridge Size 0, with Needle and without Needle, Digitex	MEDLINE INDUSTRIES, LP - Northfield	NEW	Class II	2012-05-23
K120191	Push-on Needle 30Gx8mm	Scandinavian Health Ltd.	FMI	Class II	2012-05-23
K120179	Reach Surgical Staplers	Reach Surgical, Inc.	GDW	Class II	2012-05-23
K113440	High Five	Central Medicare Sdn Bhd	LZA	Class I	2012-05-23
K113287	Somatom Perspective	Siemens Medical Solutions USA, Inc.	JAK	Class II	2012-05-23
K112800	Suntouch Topical Hemostatic Dressing	HuiZhou Foryou Medical Devices Co., Ltd.	QSY	Unclassified	2012-05-23