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 2888 of 3529

510(k) clearances, page 2888 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K861864	Medtron Type P-300 Ultrasonic Therapy Unit	I-Rep, Inc.	IMJ	Class II	1986-07-14
K861758	Cushion-Flex Tm Nasal CPAP Mask for Sleep Apnea	Life Design Systems, Inc.	BYE	Class II	1986-07-14
K861715	Whiteside Condylar II Total Knee Prosthesis	Dow Corning Wright	HSX	Class II	1986-07-14
K861371	Transvaginal Probe, Model Ed65m-Tv	Elscint, Inc.	HGL	Class II	1986-07-14
K861369	Incus/stapes Prosthesis	Richards Medical Co., Inc.	ETB	Class II	1986-07-14
K861237	Vasoview Duplex Imaging System	Sonicaid, Inc.	ITX	Class II	1986-07-14
K860813	Micromedic Htsh Monoclonal Irma Kit	Micromedic Systems	JLW	Class II	1986-07-14
K860309	Hemafluor Reagent Kit	Helena Laboratories, Corp.	KHO	Class I	1986-07-14
K860145	Rubella Elisa Test System Catalog Number: 4540	Clinical Sciences, Inc.	LFX	Class II	1986-07-14
K862595	Kodak M35a X-Omat Processor	Eastman Kodak Company	IXW	Class II	1986-07-11
K862560	Precept Ceftizoxime	Austin Biological Laboratories	JWY	Class II	1986-07-11
K862538	Sentry Breakway Neck Strap	Ormco Corp.	DZB	Class II	1986-07-11
K862521	Bausch & Lomb Gr-3 Refractor	Bausch & Lomb Incorporated	HKO	Class I	1986-07-11
K862520	Bausch & Lomb Psl-3000 Slit Lamp	Bausch & Lomb Incorporated	HJO	Class II	1986-07-11
K862516	Bausch & Lomb Osl-2000 Slit Lamp	Bausch & Lomb Incorporated	HJO	Class II	1986-07-11
K862515	Bausch & Lomb Csl-1000 Slit Lamp	Bausch & Lomb Incorporated	HJO	Class II	1986-07-11
K862512	Ritch Trabeculoplasty Laser Lens	Ocular Instruments, Inc.	HKS	Class I	1986-07-11
K862503	Koeln Optik	South West Intl., Inc.	HQZ	Class I	1986-07-11
K862502	Masunaga Optical Manufacturing	South West Intl., Inc.	HQZ	Class I	1986-07-11
K862446	Precept Ceftazidime	Austin Biological Laboratories	JWY	Class II	1986-07-11
K862409	Snap-on Torquer	Advanced Cardiovascular Systems, Inc.	DQX	Class II	1986-07-11
K862403	Emds Antiepileptic Drug Calibrators Item #67630/95	Diagnostic Systems	DKB	Class II	1986-07-11
K862347	Endotracheal Tube, Accessory	Sheridan Catheter Corp.	BTR	Class II	1986-07-11
K862343	Vacuum Handle Model I/a - 1	Cutler Medical Instruments	HQE	Class II	1986-07-11
K862340	Sentec Laser Guide Line, Model Sgl-05	Sentec AG	IZW	Class II	1986-07-11
K862298	Alternate Size E-Z-Pace Electrode	Medtronic, Inc.	DRO	Class II	1986-07-11
K862250	Tdx Benzodiazepines	Abbott Medical	JXM	Class II	1986-07-11
K862225	International Total Hip System	Richards Medical Co., Inc.	JDI	Class II	1986-07-11
K862128	Digital Electronic Myo-Graph (Muscle Analyzer)	Health Products, Inc.	KQX	Class I	1986-07-11
K862057	Kirschner Universal Bipolar Endoprosthetic Head	Kirschner Medical Corp.	KWY	Class II	1986-07-11
K862044	Delfia (Tm) Hcg Kit	Lkb Instruments, Inc.	JHJ	Class II	1986-07-11
K862024	Sussman Four Mirror Hand Held Gonioprism	Ocular Instruments, Inc.	HKS	Class I	1986-07-11
K861854	Opm Slit Lamp Model P-1	Optek Medico Co., Ltd.	HJO	Class II	1986-07-11
K861831	Reflotron Uric Acid	Boehringer Mannheim Corp.	KNK	Class I	1986-07-11
K861827	Curity Central Venous Catheterization Tray	The Kendal Co.	DQY	Class II	1986-07-11
K861822	Malis Surgical Mesh for Skull /Spinal Column Repai	Valley Forge Scientific Corp.	GWO	Class II	1986-07-11
K861565	Series Ten Thousand Compact	CooperVision, Inc.	HQE	Class II	1986-07-11
K861557	Aplicare Skin Protectant Prep Pad	Aplicare, Inc.	NEC	Class I	1986-07-11
K861380	Series Ten Thousand Master	CooperVision, Inc.	HQE	Class II	1986-07-11
K861195	Delfia Digoxin	Lkb Instruments, Inc.	KXT	Class II	1986-07-11
K861115	Toray Superselective Guidewire,superselec Y-K Type	Toray Industries (America), Inc.	DQX	Class II	1986-07-11
K860815	Solid Phase Boil Dualcount (Dualcount Spb)	Siemens Healthcare Diagnostics Inc.	CDD	Class II	1986-07-11
K860460	Microtek Stainless Steel Piston	Microtek Medical LLC	ETB	Class II	1986-07-11
K854672	Candi-Kit Tm	Culture Kits, Inc.	JSI	Class I	1986-07-11
K862555	Human Epitheloid Cervix Carcinoma Cells (Hela)	Viromed Laboratories, Inc.	KIR	Class I	1986-07-10
K862469	Rich-Mar Rm 2002 Ultrasound Physical Therapy Devic	Rich-Mar Corp.	IMJ	Class II	1986-07-10
K862468	Rich-Mar Rm-2000 Ultrasound Physical Therapy Devic	Rich-Mar Corp.	IMJ	Class II	1986-07-10
K862443	Medtronic Temporary and Implantable Pacing Leads	Medtronic, Inc.	DTB	Class III	1986-07-10
K862434	Suction T Connector	Acutronic Medical Systems AG			1986-07-10
K862318	Fisher Diagnostics Hematall-C Calibrator	Fisher Scientific Company L.L.C.	JPK	Class II	1986-07-10