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 2934 of 3529

510(k) clearances, page 2934 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K854798	T-4 Riassay	Ria Diagnostics	CDX	Class II	1986-01-15
K854788	Acuson Al538 Transducer	Acuson Computed Sonography	ITX	Class II	1986-01-15
K854786	Acuson Bl538 Transducer	Acuson Computed Sonography	ITX	Class II	1986-01-15
K854785	Acuson Al558 Transducer	Acuson Computed Sonography	ITX	Class II	1986-01-15
K854458	Cushion-Flex Tm-CPAP Face Mask	Life Design Systems, Inc.	BYE	Class II	1986-01-15
K854293	Medsurg Pott-Cournand Needle	Medsurg Industries, Inc.	DRC	Class II	1986-01-15
K854142	Stylet Introducer Funnel	Telectronics, Inc.	DTB	Class III	1986-01-15
K853625	Nova Arterial Embolectomy Catheter	Nova Medical Specialties	DXE	Class II	1986-01-15
K853568	Dnr Unipolar	Biotronik Sales, Inc.	DTB	Class III	1986-01-15
K853478	Pinpoint Needle	Regional Master Corp.	BSP	Class II	1986-01-15
K853422	The Gripper	Regional Master Corp.	BXN	Class II	1986-01-15
K853182	Diagnostic Intravascular Catheters	Mallinckrodt Critical Care	DQO	Class II	1986-01-15
K855198	Indi Kwik (Tm) Co/two Kit	Micro-Bio-Logics	JTR	Class I	1986-01-14
K855195	Direct & Total Bilirubin Set	Technostics Intl.	CIG	Class II	1986-01-14
K855194	Glucose Oxidase Reagent Set	Technostics Intl.	CGA	Class II	1986-01-14
K855193	Creatinine Reagent Set	Technostics Intl.	CGX	Class II	1986-01-14
K855192	Alkaline Phosphatase Reagent Set	Technostics Intl.	CIO	Class II	1986-01-14
K855191	Total Protein Reagent Set	Technostics Intl.	CEK	Class II	1986-01-14
K855189	Glutamic Oxaloacetic Transaminase Reagent Set	Technostics Intl.	CIQ	Class II	1986-01-14
K855187	Enzymatic Cholestrol Reagent Set	Technostics Intl.	CHH	Class I	1986-01-14
K855186	Gamma Glutamyl Transpeptidase (Kinectic)reagentset	Technostics Intl.	JPZ	Class I	1986-01-14
K855159	Lactic Dehydrogenase Reagent Set	Technostics Intl.	CFJ	Class II	1986-01-14
K855158	Albumin Reagent Set	Technostics Intl.	CIX	Class II	1986-01-14
K855156	Gamma Glutamyl Transpeptidase Reagent Set	Technostics Intl.	JPZ	Class I	1986-01-14
K855154	Inorganic Phosphorus Reagent Set	Technostics Intl.	CEO	Class I	1986-01-14
K855153	Glucose (UV Hexokiase) Reagent Set	Technostics Intl.	CFR	Class II	1986-01-14
K855047	Auto Suture Titanium Surgical Staples	United States Surgical, A Division of Tyco Healthc	GDW	Class II	1986-01-14
K854982	Vision Sgot (Ast)	Abbott Medical	CIT	Class II	1986-01-14
K854717	Nsi Astra Tm Total Protein Reagent Kit, Nsi #7928	Nobel Scientific Industries, Inc.	CEK	Class II	1986-01-14
K854403	Model 2120 Spiroscreen	Gould, Inc.	BZG	Class II	1986-01-14
K854208	The Bodylog 500 Ret Therapeutic Electromyographics	Bodylog, Inc.	HCC	Class II	1986-01-14
K853477	Nerve Finder	Regional Master Corp.	BXN	Class II	1986-01-14
K853476	T4 Monitor Stimulator Computer	Regional Master Corp.	BXN	Class II	1986-01-14
K853331	Osm-1 Oxygen Saturation Monitor	Criticare Systems, Inc.	JOM	Class II	1986-01-14
K852978	Comfort - Cuf	Dynasty Instruments, Ltd.	DXN	Class II	1986-01-14
K852641	Orion 40 Cardiac Stimulator & Pmp 200 Programmer	Sorin Biomedica, Fiat, USA, Inc.	DXY	Class III	1986-01-14
K852542	Palladium Seed Model 100	Nuclear Medicine, Inc.	IWI	Class II	1986-01-14
K852471	Confident Odor Eliminator	Hallmark Industries, Inc.	EXB	Class I	1986-01-14
K851968	Cordis Multicor St, Model 350A	Cordis US Corp.	DXY	Class III	1986-01-14
K851624	Model Tt-185 Telemetry Transmitter	Eaton Medical Group	DXH	Class II	1986-01-14
K860072	Juergens Self Reliant Wheelchair	E.H. Juergens, Inc.	IOR	Class I	1986-01-13
K855181	Comfortex Wheelchair Cushion	Comfortex, Inc.	KNN	Class I	1986-01-13
K855135	Cefaclor Sensi-Disc	BD Becton Dickinson Vacutainer Systems Preanalytic	JTN	Class II	1986-01-13
K855131	Suture Removal Kit	Dynarex Corp.	JOK	Class I	1986-01-13
K855085	Tissue Culture Media	Newport Biosystems, Inc.	KIT	Class I	1986-01-13
K854989	Canwest-Pregblue	Canwest Medictex, Inc.	JHI	Class II	1986-01-13
K854973	V-Trend Oc Cpk	V-Tech, Inc.	JJT	Class I	1986-01-13
K854850	Falkon Stretch-Sterile	G.B.F. Industries, Inc.	NAD	Class I	1986-01-13
K854846	Vision Creatinine	Abbott Medical	CGX	Class II	1986-01-13
K854837	Lee-Bead Beta Fsh (Eia)	Leeco Diagnostics, Inc.	CGJ	Class I	1986-01-13