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 2871 of 3529

510(k) clearances, page 2871 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K862955	Methods for the Dimension Clinical Chem. System	E.I. Dupont de Nemours & Co., Inc.	KLS	Class II	1986-09-25
K862952	Charter Wetting Solution for Hard Contact Lenses	Paco Pharmaceutical Services, Inc.	HPX	Unclassified	1986-09-25
K862932	The Bio-Tek Uw-II	Bio-Tek Instruments, Inc.	IMJ	Class II	1986-09-25
K862879	New Light-Curing Impression Material	Dentsply Intl.	ELW	Class II	1986-09-25
K862635	Rabinowitz Gum Massager	Arnell, Inc.	JEW	Class I	1986-09-25
K862492	Exel Three-Way Stopcock	Exel Intl.	FMG	Class II	1986-09-25
K862444	Fiberlase 100 Medical Laser Sys/nd:yag Menorrhagia	Laser Media	HHR	Class II	1986-09-25
K862336	Pancoat Cortisol Coated Tube Radioimmunoassay Kit	Pantex, Div. Bio-Analysis, Inc.	CGR	Class II	1986-09-25
K862204	Rsl (125I) Aldosterone Kit	Radioassay Systems Laboratories, Inc.	CJM	Class II	1986-09-25
K863538	Respicentral(tm)	Dickstein, Shapiro & Morin	BZK	Class II	1986-09-24
K863474	Kasey Eye Shield	Kasey Enterprises, Inc.	HOY	Class I	1986-09-24
K863418	Model 352-01 Silicone Rubber Isolation Sleeve	Intermedics, Inc.	DXY	Class III	1986-09-24
K863416	Raylor Mini-Probe	Cedar Surgical, Inc.	HAO	Class I	1986-09-24
K863415	Raylor Bone Impactors	Cedar Surgical, Inc.	HAO	Class I	1986-09-24
K863233	Stc 909Zx Power Base	The Stc Companies, Inc.	ITI	Class II	1986-09-24
K863217	Digilab Modular One-Applanation Tonometer	Bio-Rad	HKX	Class II	1986-09-24
K863008	-Om West 2000 Gnatus Chair	Sds Dental, Inc.	HME	Class I	1986-09-24
K862987	Model 1000 Ophthalmic Laser System	CooperVision, Inc.	HQF	Class II	1986-09-24
K862937	Buchbinder(tm) Multiflex(tm) Guidewire	Versaflex Delivery Systems, Inc.	DQX	Class II	1986-09-24
K862455	Modified Cardiocap Monitor	Datex Division Instrumentarium Corp.	DSK	Class II	1986-09-24
K863561	Uresil Thoracic Vent	Uresil, LLC	KDQ	Class II	1986-09-23
K863496	Mediflex Transducer Protector	Mediflex Intl.	FIB	Class II	1986-09-23
K863480	Biotronik Permanent Pacemaker Electrode	Biotronik Sales, Inc.	DTB	Class III	1986-09-23
K863446	Angiomed High Pressure Connectors	Angiomed U.S., Inc.	GCD	Class I	1986-09-23
K863407	Graf Corello, Powered Wheelchair	Graf Products, Inc.	ITI	Class II	1986-09-23
K863307	Tenzcare Snap Electrode, No. 6865	3M Company	GXY	Class II	1986-09-23
K863152	Medsentry Flotation System	Medsentry Corp.	FNM	Class II	1986-09-23
K863037	Usci (R) Disposable Inflation Device	C.R. Bard Inc	DXT	Class II	1986-09-23
K862975	Modified Ptca Guiding Catheters	Cordis US Corp.	DQY	Class II	1986-09-23
K862972	Disposable Mirror	Quali-Med, Inc.			1986-09-23
K862951	Spacelabs Series 90700 Patient Monitors	Spacelabs, Inc.	DPS	Class II	1986-09-23
K862923	Mr620 Dual Servo Heated Anaesthesia Humidifier	Fisher & Paykel Allied Products, Ltd.	BTT	Class II	1986-09-23
K862918	Scimed II-Sm25 Membrane Oxygenator System	Scimed Life Systems, Inc.	DTZ	Class II	1986-09-23
K862581	Nephrostomy Connecting Tube (a-50)	Advanced Clinical Products, Inc.	KNX	Class II	1986-09-23
K862580	Nephrostomy Drainage Kit (a-150)	Advanced Clinical Products, Inc.	KNX	Class II	1986-09-23
K862573	Hollister Drain Tube Attachment	Hollister, Inc.	KNT	Class II	1986-09-23
K862489	Enteral Feeding Sets for Gravity and Pump Use	Knight Medical, Inc.	KNT	Class II	1986-09-23
K862295	Model Pc-2 Volumetric Infusion Pump/controller	Imed Corp.	FRN	Class II	1986-09-23
K862289	Korean Green Cross Scalp Vein Set	Sturbridge Medical	FPA	Class II	1986-09-23
K861959	Bmri Soft Tissue Biopsy Needle	Bio-Medical Resources, Inc.	KNW	Class II	1986-09-23
K861681	Dentimedic Dental Emergency Kit	Dentimedic	EMB	Class I	1986-09-23
K861304	Fagan Test Machine for Infant Intelligence	Infantest Corp.	LQD	Unclassified	1986-09-23
K861156	Hospal Dialysate for Cavhd	Hospal Medical Corp.	KPO	Class II	1986-09-23
K863500	Stainless Steel Den. Crown Remover & Ama./comp.car	Pacific Union Dental, Inc.	EIS	Class I	1986-09-22
K863315	Multifil(r) Vs	Kulzer GmbH	EBF	Class II	1986-09-22
K863314	Estilux(r) Posterior C	Kulzer GmbH	EBF	Class II	1986-09-22
K863284	i.v. Start Kit	Welmed Systems, Inc.			1986-09-22
K863163	Uls 8-86	American Instrument Manufacturer'S, Inc.	DYN	Class I	1986-09-22
K863031	Twin-Core	Scientific Pharmaceuticals, Inc.	EBF	Class II	1986-09-22
K862424	Steerable Catheter System	Endovations	GCP	Class II	1986-09-22