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 1300 of 3531

510(k) clearances, page 1300 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K052121	Gem Premier 3000	Instrumentation Laboratory Co.	CGA	Class II	2005-10-21
K052104	Ultraclean Handcontrolled Suction Coagulator, Model 130182, 130183, 130184, 130185; Ultraclean Footcontrolled Suction	ConMed Corporation	GEI	Class II	2005-10-21
K052079	Pinnacle Constrained Acetabular Liners	Depuy Orthopaedics Inc.	KWZ	Class II	2005-10-21
K052061	Modus Imf Screws 2.0	Medartis AG	DZE	Class II	2005-10-21
K051948	Avon Patello-Femoral Joint Prosthesis	Howmedica Osteonics Corp	KRR	Class II	2005-10-21
K051909	Diagnodent	Kavo America	NBL	Class II	2005-10-21
K051812	Tgo Spray	Laboratoires Carilene S.A.S.	LFD	Unclassified	2005-10-21
K051800	In6 Safety Syringe, Model 3Ml	In6 Incuvestor, Inc.	MEG	Class II	2005-10-21
K051579	Immunalysis Amphetamine Elisa for Oral Fluids	Immunalysis Corporation	DKZ	Class II	2005-10-21
K051456	Sentinel Ceruloplasmin	Sentinel CH SpA	JFR	Class II	2005-10-21
K043520	EMG Cta01-Xxx Series Puro Oxygen Concentrator	EMG Technology Co., Ltd.	CAW	Class II	2005-10-21
K052778	Thermage Thermacool Skin Marketing	Solta Medical, Inc.	GEI	Class II	2005-10-20
K052720	Medline Iodoform Packing Strips	MEDLINE INDUSTRIES, LP - Northfield	FRO	Unclassified	2005-10-20
K052717	D732 Micro 27 Ph.i.s.i.o. Adult Arterial Filter	Dideco S.p.A.	DTM	Class II	2005-10-20
K052707	M3046b Compact Portable Patient Monitors	Philips North America LLC	MHX	Class II	2005-10-20
K052648	Modification to 3I Patient-Specific Dental Abutments and Overdenture Bars	ZimVie US Corp LLC	NHA	Class II	2005-10-20
K052581	Lunar Idxa	GE Medical Systems Ultrasound and Primary Care Dia	KGI	Class II	2005-10-20
K052462	G-Coat	GC America Inc.	EBD	Class II	2005-10-20
K052409	Silgimix Alginate Replacement Impression Material	Sultan Chemists, Inc.	ELW	Class II	2005-10-20
K052203	Aura 70 Watt Bipolar Electrosurgical Coagulators, Models 28-2000 and 28-2600	Kirwan Surgical Products, LLC	GEI	Class II	2005-10-20
K052155	Bard Large Pore Soft Mesh and Soft Mesh Preshaped	C.R. Bard Inc	FTL	Class II	2005-10-20
K052110	M-Series Pro CPAP Sytem	Respironics, Inc.	BZD	Class II	2005-10-20
K051992	Powered Pd-Io Intraosseous Infusion System	Teleflex Medical	FMI	Class II	2005-10-20
K051991	Powerpicc, Poly per-Q-Cath, 6 Fr Tl Poly per-Q-Cath, Power Hohn and Power Line	C.R. Bard Inc	LJS	Class II	2005-10-20
K051641	Alaris System Pc Unit, Model 8001	Cardinal Health, Alaris Products	FRN	Class II	2005-10-20
K051562	Nuzone Syngard Powder Free Polymer Coated Polyisoprene Sterile Surgical Glove - Aloe Vera Coated Green Colour	Terang Nusa (Malaysia) Sdn. Bhd.	KGO	Class I	2005-10-20
K051056	Verify Self-Contained Biological Indicator	Sybron Dental Specialties, Inc.	FRC	Class II	2005-10-20
K050425	Aura-Psg	Astro-Med, Inc.	OLV	Class II	2005-10-20
K050192	Brc Software Product	Brc Operations Pty Limited	OLU	Class II	2005-10-20
K052514	Clirpath Turbo Plus Excimer Laser Catheters, Models 314-151, 314-159, 317-152, 317-156, 320-006, 320-159, 323-001	Spectranetics Corp.	PDU	Class II	2005-10-19
K052240	Cardionet Ambulatory ECG Monitor with Arrhythmia Detection, Model 1002	Cardionet, LLC	QYX	Class II	2005-10-19
K052173	Vitagel Surgical Hemostat Spray Set	DSM Biomedical, Inc.	FMF	Class II	2005-10-19
K052103	Exel Secure Touch II Safety Syringe	Exelint Intl. Co.	MEG	Class II	2005-10-19
K052046	Blood Pressure Meter, Model Ch-432	Citizen Watch Co., Ltd.	DXN	Class II	2005-10-19
K051501	Zirace	Acucera, Inc.	NHA	Class II	2005-10-19
K052433	Pixarray 100 Digital Specimen Radiography (Dsr) System	Bioptics, Inc.	MWP	Class II	2005-10-18
K052040	Quicksmile	Cosmetic Dental Materials, Inc.	EEG	Class I	2005-10-18
K051888	Total Intact Pth Immunoradiometric Assay (Coated Tube Version), Model 3Kg013	Scantibodies Laboratory Inc.	CEW	Class II	2005-10-18
K033405	Longfei Lfy-I-5 Oxygen Concentrator	Zhejiang Longfei Industrial Co., Ltd.	CAW	Class II	2005-10-18
K052806	Burane	Wavelight Laser Technologie AG	GEX	Class II	2005-10-17
K052805	Mylab30, 50 and 70 Systems Upgrade, Models 7300, 7350, 6150	Esaote S.p.A.	IYN	Class II	2005-10-17
K052740	Nurse's Assistant 1.7 o.r. Control System	Conmed Integrated Systems (Cmis)	GCJ	Class II	2005-10-17
K052673	King I Powered Scooter, Model Ctl-11	King I Tech Corporation	INI	Class II	2005-10-17
K052660	Model 672-Bd, Home Uvb Light Source (Jordan Light); Model 2400, 4 (6 Foot) Ho UV Light Source; Model 2600, 6 (6 Foot) Ho	The Richmond Light Co.	FTC	Class II	2005-10-17
K052633	Dual Shot - Contrast Delivery System	Nemoto Kyorindo Co., Ltd.	DXT	Class II	2005-10-17
K052630	Rotator Cuff Quickanchor Plus (with Orthocord Suture)	DePuy Mitek, Inc.	HWC	Class II	2005-10-17
K052571	Mindstate Functional Data Acquisition Device (Fdad), Version 1.0	Neurognostics, Inc.	LNH	Class II	2005-10-17
K052500	Dar-8000F	Shimadzu Medical Systems	IZI	Class II	2005-10-17
K052498	Fragment Specific Fixator	David J. Slutsky MD	KTT	Class II	2005-10-17
K052482	Artelon Surgical Suture	Artimplant AB	GAR	Class II	2005-10-17