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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3095 of 3528

510(k) clearances, page 3095 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K840442	Sterilized Dispos. Cystotome	MicroSurgical Technology Inc	HMX	Class I	1984-03-16
K840399	Foam Nose	Mallinckrodt Critical Care	BYD	Class I	1984-03-16
K840398	Inline Foam Nose	Mallinckrodt Critical Care	BYD	Class I	1984-03-16
K840321	Endodyne Dual	Elmed, Inc.	LIH	Class II	1984-03-16
K840310	Category 6 Opthalmic Devices	Imm Enterprises, Ltd.	HOB	Class I	1984-03-16
K840297	Coltene Oralloy Magicaps	Coltene, Inc.	EJJ	Class II	1984-03-16
K840292	Urethral Cath. Tray W/bag	Corpak Co.	KNX	Class II	1984-03-16
K840275	Cehpalometric Head Positioner	Gary E. Hall, Dds	EAH	Class I	1984-03-16
K840226	Motor Tilted Exam. Table UV-56	Medicor USA, Ltd.	IXR	Class II	1984-03-16
K840191	Digital Fluorography X-Ray System	Philips North America LLC	JAA	Class II	1984-03-16
K840141	Dental Ultrasonic Scaler/endosonic	CooperVision, Inc.	ELC	Class II	1984-03-16
K840136	Linear Accelerator Multiple Exl 3-4-6	Philips North America LLC	IYE	Class II	1984-03-16
K840134	Camtex 1000	Digital Imaging Co. of America	JAA	Class II	1984-03-16
K840101	Eye Surgery Instrument	Truline Instruments, Inc.	HOB	Class I	1984-03-16
K840085	Coltene Brilliant	Bauer, Cheng & Associates, Inc.	EBF	Class II	1984-03-16
K834546	Surgical Knife	Fine-Cut Diamond Instruments	HNN	Class I	1984-03-16
K834543	Ocucare Ultrasound Tip & Freedom Pack	Intermedics Intraocular, Inc.	HQC	Class II	1984-03-16
K834537	Micro Vit Fragmentation System	Medical Instrument Development Laboratories, Inc.	HQC	Class II	1984-03-16
K834508	Corning 4000 Multi-Well Gamma Counter	Corning Medical & Scientific	JJJ	Class I	1984-03-16
K834453	Phaco Fragmentor Gt-1	Fibra Sonics, Inc.	HQC	Class II	1984-03-16
K834443	Rotavirus Bio-Enzabead Screen Kit	Litton Bionetics	LIQ	Class I	1984-03-16
K834356	Eye Sponge or Spear	JEDMED Instrument Company	HOZ	Class II	1984-03-16
K834355	Micro Forceps	JEDMED Instrument Company	HNR	Class I	1984-03-16
K834305	Argon/krypton Ion Laser Photocoagula	Nidek, Inc.	HQF	Class II	1984-03-16
K834283	Dentsply G-106 Cavitron Ultrasonic	Coopercare, Inc.	ELC	Class II	1984-03-16
K834261	Plastic Optical Lens M-110	U-Molde Systems, Inc.	HQC	Class II	1984-03-16
K834145	Ergo Diagnostic Card	American Ergo Systems	HOX	Class I	1984-03-16
K832674	Satelec Prophy Unit Pu 2000S	Spelna, Inc.	ELC	Class II	1984-03-16
K832664	Satelec Suprasson Piezomatic P2	Spelna, Inc.	ELC	Class II	1984-03-16
K840021	Operating Room Tray Set	Medi-Plast Intl., Inc.	FSM	Class I	1984-03-15
K834436	Chemonucleolysis Needle	Universal Medical Instrument Corp.	FMI	Class II	1984-03-15
K834102	Ra-1000 Sys-T4(thyroxine)serum Anal	Technicon Instruments Corp.	KLI	Class II	1984-03-15
K833832	3-Day Bioindicator Release for Respir	Shiley, Inc.	BTO	Class II	1984-03-15
K833611	Titan Gel Lipoprotein Electrophoresis	Helena Laboratories, Corp.	JHO	Class I	1984-03-15
K833465	Disposable Fiber Optic Illuminator	CooperVision, Inc.	HQC	Class II	1984-03-15
K822306	Bio-Band Bandages	Robert Hirschfield	FRO	Unclassified	1984-03-15
K842169	Fcp-11Ecg	Brentwood Instruments, Inc.			1984-03-13
K840926	Formalin Solution 10% Neutral Buffer	Sigma Chemical Co.	IFP	Class I	1984-03-12
K840849	Scavenger Tubing 19Mm	The Kendal Co.	CBN	Class II	1984-03-12
K840798	Amyloid Stain, Congo Red Ht 60	Sigma Chemical Co.	ICH	Class I	1984-03-12
K840673	Sensibead Eia Digoxin Kit	Terumo Medical Corp.	KXT	Class II	1984-03-12
K840671	Cardiac Catheterization Pack	Professional Medical Services	DRE	Class II	1984-03-12
K840664	Tracheostomy Cleaning Tray	American Pharmaseal Div. Ahsc	BSY	Class I	1984-03-12
K840651	Mole-Marker	Notation Systems, Inc.	FTY	Class I	1984-03-12
K840529	Steiger Tunneling Instrument 285	Evermed, Inc.	DRC	Class II	1984-03-12
K840489	Disposiquet a Dispos. Tourniquet	Med Lab Products	GAX	Class I	1984-03-12
K840487	T-Meter	K.J. Electronics	HCS	Class II	1984-03-12
K840485	Total Iron Uibc/tibc Assay	Somas Medical Industries, Inc.	CFM	Class I	1984-03-12
K840470	Surgiscribe Marking Pen	Surgicot, Inc.	FZZ	Class I	1984-03-12
K840464	Tissue Expander	Surgitek	LCJ	Unclassified	1984-03-12