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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2821 of 3530

510(k) clearances, page 2821 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K870934	Ims-2000R Resting Electrocardiographic System	Integrated Medical Systems Inc	DXG	Class II	1987-05-06
K870886	Lifeport Vascular Access System W/0.76 Mm Catheter	Strato Medical Corp.	LJT	Class II	1987-05-06
K870829	Sarns Membrane Oxygenator W/integral Reservoir	3M Health Care, Sarns	DTN	Class II	1987-05-06
K870803	The Keeper	The Keeper Co.	HHE	Class II	1987-05-06
K870528	Ovu-Trac Ovulation Timing Kit	Ob/Gyn Concepts, Ltd.	LHD	Unclassified	1987-05-06
K870524	Ambulatory Infusion Pump Drug Reservoir	Med Fusion Systems, Inc.	FRN	Class II	1987-05-06
K870301	Mx900-Dpt, Disposable Pressure Transducer	Medex, Inc.	DRS	Class II	1987-05-06
K870082	Bone Plate	Terray Manufacturing, Inc.	HRS	Class II	1987-05-06
K865074	Corday Coronary Sinus Infusion Catheter	Retroperfusion Systems, Inc.	DQY	Class II	1987-05-06
K864730	Invivo Pulse Oximeter, Model 4500	Invivo Research Labs, Inc.	DQA	Class II	1987-05-06
K864690	Additional Use for ECG Disposable Electrode V-Pad	Multi Biosensors, Inc.	DRX	Class II	1987-05-06
K864456	Cyclosporin a (Whole Blood) Control - Levels 1,2,3	Cala Diagnostics	LAS	Class I	1987-05-06
K863803	Vasopulse(tm)/model 5000	Sonicaid, Inc.	JOM	Class II	1987-05-06
K871403	Modified c.p.r. Microshield	Westmark Enterprises, Inc.	CAE	Class I	1987-05-04
K871051	Fiad Explor-X; Model 70 Kvp	United States Dental	EHD	Class II	1987-05-04
K870895	No. 1552, Valved Venti-Comp	Hudson Oxygen Therapy Sales Co.	CBP	Class II	1987-05-04
K870830	Warsaw Orthopedic Tsr Cross Link System	Warsaw Orthopedic, Inc.	KWP	Class II	1987-05-04
K870692	Perinatal Computers 2015/2025/2040/2045/2080/2085	Peritronics Research and Development, Inc.	HGM	Class II	1987-05-04
K864590	Am1000	Bear Medical Systems, Inc.	BSZ	Class II	1987-05-04
K871480	Std-228 Spectral Trend Display	Grass-Telefactor Product Group	GWS	Class I	1987-05-01
K871368	Schell C.a.p.p. Bed Model Nrs. 1268 + 1269	Schell B.V.	IOQ	Class II	1987-05-01
K871323	Arthroscopic Meniscal Suture System	Mizuho Orthopedic Systems Inc	HWT	Class I	1987-05-01
K871127	Dtv-4112 Fluoroscopic Television Camera	Philips North America LLC	JAA	Class II	1987-05-01
K871120	M10 EEG Monitor Scope	Telediagnostic Systems, Inc.	GYE	Class II	1987-05-01
K870869	Dtv-411Op	Philips North America LLC	JAA	Class II	1987-05-01
K870797	Prophy Champ Cordless Electronic Handpiece	Safco Dental Supply LLC	EKX	Class I	1987-05-01
K870793	Self Regulation Sys Prof Series Biofeedback Device	Self Regulation Systems, Inc.	HCC	Class II	1987-05-01
K870725	Fresenius Hemoflow F6 and F8	Seratronics, Inc.	FJI	Class II	1987-05-01
K870699	Standard Porocoat Modified Medial Aspect Aml Hip	Depuy, Inc.	JDI	Class II	1987-05-01
K870660	H-H External Ventricular Drain (Evd) Comp./systems	Holter-Hausner Intl.	JXG	Class II	1987-05-01
K870625	Ivt Southwest Allergy Screen	In Vitro Technologies, Inc.	DHB	Class II	1987-05-01
K870403	Cavafix(r) Central Venous Catheter Kit W/suture	Burron Medical Products, Inc.	FOZ	Class II	1987-05-01
K864226	Johnson & Johnson Staining Removing Compound	Johnson & Johnson Professionals, Inc.	EJR	Class I	1987-05-01
K871556	Merivaara Emergency Patient Trolley #436	Global Medical Prods, Inc.	FPO	Class II	1987-04-30
K871540	Swivel Connectors #014452/#014453/#014459-120	Clinical Connections, Inc.	FPK	Class II	1987-04-30
K871464	Medgroup Enterprises Cotton Gauze Sponges-Non Ster	Medgroup Enterprises, Inc.	EFN	Class I	1987-04-30
K871291	Am Cath Eswl Stent	Inter-Med, Inc.	FAD	Class II	1987-04-30
K871218	Monitral S Gs Hemodialysis Single Patient Unit	Hospal Medical Corp.	FKP	Class II	1987-04-30
K871154	Delflex Safe Lock Capd Patient Assist Device	Delmed, Inc.	KDJ	Class II	1987-04-30
K871007	Anti Needle Strike Anti Drug Abuse Hypo. Syringe	Habley Medical Technology Corp.	FMF	Class II	1987-04-30
K870383	Alginate Wool Fiber	Adri	KHR	Class I	1987-04-30
K871545	New Fuchsin Solution	Sigma Diagnostics, Inc.	IDF	Class I	1987-04-29
K871544	Methyl Green Solution	Sigma Diagnostics, Inc.	HZA	Class I	1987-04-29
K871541	Martin-Lewis Agar W/reduced Vancomycin C0226	Gibco Laboratories Life Technologies, Inc.	JTY	Class II	1987-04-29
K871533	Tomtec Gram Stainer Decolorizer	Remel Inc	PPM	Class I	1987-04-29
K871532	Tomtec Gram Stainer Crystal Violet	Remel Inc	JTS	Class I	1987-04-29
K871498	Titan Gel Immunofix Controls	Helena Laboratories, Corp.	DFT	Class II	1987-04-29
K871483	Tissue Culture/bacteriological Petri Dishes	Isratech Marketing Corp.	KIZ	Class I	1987-04-29
K871477	Neutral Red	Sigma Chemical Co.	KFE	Class I	1987-04-29
K871456	Ultra-Violet Glucose Reagent Kit	Biochemical Trade, Inc.	CFR	Class II	1987-04-29