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 1218 of 3531

510(k) clearances, page 1218 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K063126	Dana Diabecare Iis	Sooil Development Co., Ltd.	LZG	Class II	2007-02-02
K063122	Mirage Quattro Full Face Mask	ResMed Corp	BZD	Class II	2007-02-02
K063011	Mirage Liberty Full Face Mask	ResMed Corp	BZD	Class II	2007-02-02
K062250	Delta Xtend Reverse Shoulder System	Depuy Orthopaedics Inc.	PHX	Class II	2007-02-02
K061108	Stryker Auto Irrigation System	Stryker Corp.	FRN	Class II	2007-02-02
K070157	Omniguide Beam Path CO2 Mark III Waveguide Fiber	Omni-Guide Holdings, Inc.	GEX	Class II	2007-02-01
K070144	Inhibin a Calibrators & Controls on the Access Immunoassay Systems	Siemens Healthcare Diagnostics Inc.	JIT	Class II	2007-02-01
K070025	C.t.m. Mobility Scooter, Model Hs-310	C.T.M. Homecare Product, Inc.	INI	Class II	2007-02-01
K063855	Liberty Normal Glucose Control Solution, Model 2120045/ High Glucose Control Solution, Model 2120047	Liberty Healthcare Group, Inc.	JJX	Class I	2007-02-01
K063748	Thermomed 1.8	Thermosurgery Technologies, Inc.	GEI	Class II	2007-02-01
K063652	Global Ap Porous Coated Humeral Stem	Depuy Orthopaedics Inc.	MBF	Class II	2007-02-01
K063111	Finometer Model-2 with Accessories	Finapres Medical Systems B.V.	DXN	Class II	2007-02-01
K062543	Herpeselect 1 and 2 Plexus Igg, Model Mp0900g	DiaSorin Molecular LLC	MXJ	Class II	2007-02-01
K062414	Vortex CT Port Access System and Lifeguard Safety Infusion Set	Boston Scientific Corporation	LJT	Class II	2007-02-01
K061445	Surgimesh Wn	Aspide Medical	FTL	Class II	2007-02-01
K070129	Sonotip II Ultrasound Needle System	Medi-Globe GmbH	FCG	Class II	2007-01-31
K070079	X3c Digital Radiographic Detector	Imaging Dynamics Company, Ltd.	MQB	Class II	2007-01-31
K070061	36Mm Cocr Femoral Head and 36Mm Acetabular Insert	Hayes Medical, Inc.	LWJ	Class II	2007-01-31
K070017	Pts Panels Metabolic Chemistry Panel Test Strips	Polymer Technology Systems	NBW	Class II	2007-01-31
K063773	Volumetric Tomography	Palodex Group Oy	OAS	Class II	2007-01-31
K063730	Dextroscope, Model Mk10; Dextrobeam, Model Mk3, Mk4; Radiodexter, Model 1.0	Volume Interactions Pte, Ltd.	LLZ	Class II	2007-01-31
K063714	Axcel Flow	Tri Dental Innovators	EBF	Class II	2007-01-31
K063691	Neutron Therapy System	Northern Illinois Univ. Outreach	IWL	Class II	2007-01-31
K063654	Endoguide	Kms Medical, LLC	FDF	Class II	2007-01-31
K063589	Gso Bone Fixation Fasteners	Gold Standard Orthopaedics, LLC	HWC	Class II	2007-01-31
K063585	Karl Storz Video Lower G.i. Endoscope System	Karl Storz Endoscopy-America, Inc.	FDF	Class II	2007-01-31
K063472	Ultrasonic Biometer/ Pachymeter for Ophthalmology, Model Odm 2100, 2200	Meda, Ltd.	IYO	Class II	2007-01-31
K063326	Conmed Linvatec 24K Irrigation System	Conmed Linvatec	HRX	Class II	2007-01-31
K062933	Synthes Oracle Spacer	Synthes Spine Co.Lp	MQP	Class II	2007-01-31
K062604	Rapidteg Teg-Act Test	Haemoscope Corp.	JBP	Class II	2007-01-31
K062511	Aero Tracheobronchial Stent System, Model 90129-2Xx	Alveolus, Inc.	JCT	Class II	2007-01-31
K062497	Reprocessed Trocars	Stryker Sustainability Solutions	NLM	Class II	2007-01-31
K062379	Cobas Integra Ceruloplasmin	Roche Diagnostics GmbH	JJY	Class I	2007-01-31
K062368	Wako Lba Dcp Test System, Model 993-05301; Dcp Control Set, Model 995-0551; Dcp Calibrator Set, Libasys, Model 999-05401	FUJIFILM Healthcare Americas Corporation	OAU	Class II	2007-01-31
K062303	Fraxel II Sr Laser System	Reliant Technologies, Inc.	GEX	Class II	2007-01-31
K062114	Ceruloplasmin, Model 2055953	Roche Diagnostics GmbH	CHN	Class II	2007-01-31
K061931	Solaris Compatible Reusable Adult Spo2 Finger Sensors, Models S100a-090103 and 300103, S200a-090101 and 300101	Solaris Medical Technology, Inc.	DQA	Class II	2007-01-31
K061720	Cosmelight	Penntack Enterprises, Inc.	GEX	Class II	2007-01-31
K061571	Astra 300	Sdi Diagnostics, Inc.	BZG	Class II	2007-01-31
K070063	Yag Mir II Laser	Cynosure, LLC	GEX	Class II	2007-01-30
K063290	Gambro Quickset Bloodlines	Gambro Renal Products	FJK	Class II	2007-01-30
K063238	Ultraclip II Wing and Ultraclip II Coil	Inrad	NEU	Class II	2007-01-30
K063192	Harmonic Focus Curved Shears and Torque Wrench, Harmonic Blue Hand Piece and Test Tip	Ethicon Endo-Surgery Inc	LFL	Unclassified	2007-01-30
DEN060006	Computerized Labor Monitoring System	Barnev, Ltd.	NPB	Class II	2007-01-30
K070165	Enseal Ptc Trio	Surgrx, Inc.	GEI	Class II	2007-01-29
K070044	Powder Free (Yellow) Vinyl Patient Examination	Shijiazhuang Lianhe Shunda Plastic Products Co., L	LYZ	Class I	2007-01-29
K063823	Coaguchek Xs Pt Controls	Roche Diagnostics GmbH	GGN	Class II	2007-01-29
K063574	Luminex Ll Laser System	Medical Laser Systems, Inc.	NHN	Class II	2007-01-29
K063536	Polysorb* Synthetic Absorbable Suture with Modified Packaging	Tyco Healthcare Group LP	GAM	Class II	2007-01-29
K063433	Ultrasonic Biometer/pachymeter for Opthalmology Odm 2100 and Odm 2200	Meda, Ltd.	IYO	Class II	2007-01-29