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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3175 of 3528

510(k) clearances, page 3175 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K823886	Profile 750 Blood Cell Counter	Mallinckrodt Critical Care	GKL	Class II	1983-03-01
K823850	Bac-T-Screen Bacteriuria Detection Dev	Marion Laboratories, Inc.	JXA	Class I	1983-03-01
K823845	Port-Lock	Norfolk Medical Products, Inc.	FPA	Class II	1983-03-01
K823569	Abbott Laboratories Strep a Eia	Abbott Medical	GTZ	Class I	1983-03-01
K823512	Mr 600 Microplate Reader	Laboratory and Medical Products Group	JJQ	Class I	1983-03-01
K830463	Lifeline Unipolar J-Lead #483-05	Intermedics, Inc.	DTB	Class III	1983-02-28
K830420	Polyethylene Monitoring Connectors	Vertex Medical Corp.	DQO	Class II	1983-02-28
K830326	Negative Pressure Arterial Blood Line	Erika, Inc.	KDC	Class I	1983-02-28
K830323	Lysostaphin Reagent Set	Remel Co.	JTO	Class I	1983-02-28
K830309	Ultra Chem Enzymatic Cholesterol Oxidase	EMD Millipore Corporation	CHH	Class I	1983-02-28
K830308	Ultra Zyme Plus Gamma Gt #65055 & 56	EMD Millipore Corporation	JQB	Class I	1983-02-28
K830283	Lithium Diluent	Shaban Mfg. Co.	JIS	Class II	1983-02-28
K830273	Countway Sys. Soiled Sponges-Blood Los	Ritmed, Inc.	FQA	Class I	1983-02-28
K830251	Campy Blood Agar Plate	Granite Diagnostics, Inc.	JSI	Class I	1983-02-28
K830250	Cvt Viral Transports	Immulok, Inc.	JTW	Class I	1983-02-28
K830233	Non-Sterile,single/souble Lumen-Cath	Evermed, Inc.	LJS	Class II	1983-02-28
K830186	Lysis +	Hematology Marketing Assoc.	GGK	Class I	1983-02-28
K830181	Referee Blood Gas Analyzer Controls	Analytical Products, Inc.	JJS	Class I	1983-02-28
K830153	Richards Intra-Articular Shaver Blades	Richard'S Medical Equip., Inc.	GEY	Class I	1983-02-28
K830150	Veinprep Vein Graft Prep. Kit A277723	Atrium Medical Corporation	DWD	Class II	1983-02-28
K830149	Il Video 22,21 & II Atomic Spectrophoto-	Instrumentation Laboratory Co.	DWD	Class II	1983-02-28
K830102	Harvard Apparatus Intermittent Infusion	C.R. Bard Inc	FRN	Class II	1983-02-28
K830013	Epi Cardia Sys. - Ambulatory Monitor	Medicomp, Inc.	DSI	Class II	1983-02-28
K823590	Manualisa Microtitration Plate Reader	Ortho Diagnostic Systems, Inc.	JJQ	Class I	1983-02-28
K823493	Check Mate #1850 Elec. Digital Thermo	Bristoline, Inc.	FLL	Class II	1983-02-28
K830448	Secura Set Volume Limiting Set	Diatek, Inc.	FPA	Class II	1983-02-25
K830301	Stratus Fluorometric Enzyme Immun0-	American Hospital Supply	JJE	Class I	1983-02-25
K830288	Triglyceride Diagnostic Kit	Sclavo, Inc.	CDT	Class I	1983-02-25
K830118	Alkaline Phosphates Isoenzyme Substrate	Corning Medical & Scientific	CIN	Class II	1983-02-25
K823871	Tandem-E -Fer Immunoenzymetric Kit	Hybritech, Inc.	DBF	Class II	1983-02-25
K823593	Inhalant Profile-Allergen-Specific Ige	Mast Immunosystems	DHB	Class II	1983-02-25
K830408	Freeman/samuelson Total Knee	Depuy, Inc.	MBV	Class II	1983-02-24
K830257	Non-Sterile Peritoneal Access Cathet-	Evermed, Inc.	FKX	Class II	1983-02-24
K823937	Seminal Collection Device	Health Development Corp.	HIS	Class II	1983-02-24
K823922	Computerized Spirometry System	Ohio Medical Products	BZK	Class II	1983-02-24
K823825	Nosite UV Interim Spectacles	Patton, Boggs & Blow	HQG	Class I	1983-02-24
K822991	Ao Docustar(mmiro) Fundus Camera	Warner-Lambert Co.	HKI	Class II	1983-02-24
K822584	Multi-Prong Fetal Scalp Electrode	Kontron Instruments, Inc.	HGP	Class II	1983-02-24
K830235	Franzen Needle Guide	Precision Dynamics Corporation	GDM	Class I	1983-02-23
K830202	Cotton Balls, X-Ray Opaqued Strung & Non	American Medical Disposable, Inc.	GDY	Class I	1983-02-23
K830201	Polyester X-Ray Detectable Strung-Sponge	American Medical Disposable, Inc.	GDY	Class I	1983-02-23
K830039	Sdc Rectal Temp. Probe Product #1020	Science Development Corp.	FLL	Class II	1983-02-23
K823832	Esa Arthroscopy Cannula Tray	Concept, Inc.	HRX	Class II	1983-02-23
K823758	Central Vein Catherization Kit	Access Devices, Inc.	DQO	Class II	1983-02-23
K823681	Model Icpm & Accessories	Electromedics, Inc.	JFC	Class I	1983-02-23
K823457	Non-Pressure Autoclave for Sterilization	Interdent, Inc.	FLE	Class II	1983-02-23
K830299	Solution Transfer Container	The Healthcare Group Laboratories, Inc.	KPE	Class II	1983-02-19
K830246	Cast Shoe, Cast Boot	Warm & Form, Orthopedic Materials	JQB	Class I	1983-02-18
K830240	Ultrazyme Plus Gamma Gt-Mca #65055-65056	EMD Millipore Corporation	JQB	Class I	1983-02-18
K830238	Ultra Chem Cresolcaversachem #65082	EMD Millipore Corporation	CIC	Class II	1983-02-18