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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2926 of 3529

510(k) clearances, page 2926 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K854535	Insertion Gain Optimizer Igo-1000	Madsen Electronics (Canada), Ltd.	ETW	Class II	1986-02-20
K854475	Ghajar Intraventricular Catheter Guide	Sparta Instrument Corp.	HAW	Class II	1986-02-20
K853966	Acuson L312 Transducer	Acuson Computed Sonography	ITX	Class II	1986-02-20
K853864	Intracranial Pressure Monitoring Kit 070	Camino Laboratories, Inc.	GWM	Class II	1986-02-20
K860519	Reliance Model 200 Podiatry Chair	F. & F. Koenigkramer	LGX	Class I	1986-02-19
K860492	Nordisk Infuser System with Pre-Filled Cartridge	Nordisk Infuser System	FRN	Class II	1986-02-19
K860453	Ace Controls, Normal & Elevated, No. A6040 & A7040	Sigma Diagnostics, Inc.	JJX	Class I	1986-02-19
K860447	Stanguard o.r. Towel Pack-4Towel Pack #278220400	Standard Textile Co., Inc.	KKX	Class II	1986-02-19
K860340	Serum Albumin (Bcg) Reagent Set	Sterling Diagnostics, Inc.	CIX	Class II	1986-02-19
K860323	Reese Arthrodesis Screw	Osteotomy Guide Co.	HWC	Class II	1986-02-19
K860248	100% Cotton Absorbent Towel	Devon Industries, Inc.	KKX	Class II	1986-02-19
K860236	Phakosystems CT-100 Cautery Module	Phakosystems, Inc.	GEI	Class II	1986-02-19
K860168	Umi (Franseen,westcott,greene,menghini)bio. Needle	Universal Medical Instrument Corp.			1986-02-19
K860130	Testosterone Coated Tubes Radioimmunoassay Kit	Cambridge Medical Technology	CDZ	Class I	1986-02-19
K860120	Nursery Ambient Light Meter	Rocky Mountain Medical Corp.	FMS	Class II	1986-02-19
K860111	Uric Acid Reagent Set	Technostics Intl.	LFQ	Class I	1986-02-19
K860066	Reflective Blanket	O.R. Concepts, Inc.	KME	Class I	1986-02-19
K855199	Paramax Comprehensive Calibrator	American Dade	JIX	Class II	1986-02-19
K855164	Enzynatic Triglycerides Reagent Set	Sterling Diagnostics, Inc.	CDT	Class I	1986-02-19
K855151	Fritch Ophthalmic Endoscope	Regtec	GDB	Class II	1986-02-19
K855078	Angio Med Disposable Pressure Connectors	Angiomed U.S., Inc.	KGZ	Class I	1986-02-19
K854877	Acu-Syringe W/wo Needles	Acuderm, Inc.	FMF	Class II	1986-02-19
K854870	Intraocular Electromagnet	Mira, Inc.	HPO	Class II	1986-02-19
K854442	Uvasorb-400	Optatint, Inc.	HPX	Unclassified	1986-02-19
K853901	Endo-Lase Cd 40 for Dermatology	Endo Lase, Inc.	GEX	Class II	1986-02-19
K853877	Endo-Lase Cd-100 CO2 Laser for Dermatology	Endo Lase, Inc.	GEX	Class II	1986-02-19
K860261	Cannula Band	T. G. & E. Medical	CAT	Class I	1986-02-18
K860198	Model 7500/000 Kettler Holiday Solar Sun Tanning	Mottek Intl. Corp.	FTC	Class II	1986-02-18
K860077	Sg-066 Oxygen Enrichment Kit	Instrumentation Industries, Incorporated	BTL	Class II	1986-02-18
K855190	Magnesium Reagent Set	Technostics Intl.	JGJ	Class I	1986-02-18
K855148	Tharies Fiber	Zimmer GmbH			1986-02-18
K855103	Ciribart Gyudubg Catgeter	Mansfield Scientific, Inc.	DQO	Class II	1986-02-18
K855095	S.l.t. Contact Laser Nd:yag Use in Pulmonary Airwa	Surgical Laser Technologies, Inc.	LLO	Class II	1986-02-18
K855089	Percutaneous Guidewire Placement Syringe 50505	Dlp, Inc.	DQX	Class II	1986-02-18
K854883	Omknee System	Orthomet, Inc.	JWH	Class II	1986-02-18
K854793	Monopolar Injection Needle Electrode	Oculinum, Inc.	HLW	Class II	1986-02-18
K853730	Freeman-Samuelson Mark II Press-Fit Total Knee Rep	Protek, Inc.	MBV	Class II	1986-02-18
K850861	Roentgenography Set & Pressure Monitoring Line	Medical Components, Inc.	DXT	Class II	1986-02-18
K860155	Peritoneal Lavage Cath Plc-8,Set Pls-8, Kit Plk-8	Medical Components, Inc.	FKO	Class II	1986-02-14
K854853	Ni-Pacer 1	Associated Medical Devices, Inc.	DRO	Class II	1986-02-14
K854761	Minipac Personal Touch (Tm)	Medical Devices Inc.	GZJ	Class II	1986-02-14
K854750	Top Sun	Werner Schott Elektrogerate	FTC	Class II	1986-02-14
K854070	Modification 7200 Microprocessor Ventilator System	Medtronic, Inc.	CBK	Class II	1986-02-14
K853708	Laryngascopes, Forceps, Micro Suction Tube & Refle	Downs Surgical, Ltd.	KAE	Class I	1986-02-14
K860332	Diamond Blade Micrometer Knife	Med-Tech Develoment Corp.	HNN	Class I	1986-02-13
K860242	Jms Infusion Set	Sturbridge Medical	FPA	Class II	1986-02-13
K854939	Phadebas Rast/phadezym Rast Allertubes	Pharmacia, Inc.	DHB	Class II	1986-02-13
K854872	Vfi/vfe System II	Mira, Inc.			1986-02-13
K854823	Cbc-Cal/multiple	R & D Systems, Inc.	KSA	Class II	1986-02-13
K854670	Terumo Sensibead Eig Hcg Kit	Terumo Medical Corp.	JHJ	Class II	1986-02-13