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 3111 of 3528

510(k) clearances, page 3111 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K833746	Tech. Ra-1000 Sys Serum Chloride	Technicon Instruments Corp.	CHJ	Class II	1984-01-13
K833744	Alkaline Phosphatase-Rate	Seragen Diagnostics, Inc.	CJE	Class II	1984-01-13
K833712	Na/k Fluida Pack for Nova 1 Analyzer	Fisher Scientific Company L.L.C.	JGS	Class II	1984-01-13
K833701	Aca Thyroxine Analytical Test Pack	E.I. Dupont de Nemours & Co., Inc.	LBH	Class II	1984-01-13
K833699	Albumin Reagent Cs-716	Fisher Scientific Company L.L.C.	CIX	Class II	1984-01-13
K833666	Ur/rite System	Wright Laboratories, Inc.	JQW	Class I	1984-01-13
K833618	Ortho Elt-8/Ds Hematology Analyzer	Ortho Diagnostic Systems, Inc.	GKZ	Class II	1984-01-13
K833558	X-Ray Shield	Moyco Industries, Inc.	EHB	Class I	1984-01-13
K833431	Hdl Ex-Sep Precipitating Reagent	Preventive Diagnostics Corp.	LBR	Class I	1984-01-13
K833426	Doctor Vellette's Injector	Deproco, Inc.	EJI	Class II	1984-01-13
K833009	Omni-Fal I & II	American Monitor Corp.	JJY	Class I	1984-01-13
K832352	3-Day Release of Ethylene Oxide Device	Parke-Davis Co.	BSO	Class II	1984-01-13
K834326	Campy 5H	Hardy Media	JSJ	Class I	1984-01-12
K833791	Syva Advance Digoxin Assay	Syva Co.	KXT	Class II	1984-01-12
K834150	Strip Splitter II -Half Width Carrier	Larken Industries, Inc.	JJQ	Class I	1984-01-11
K833967	Cva	Remel Co.	JSJ	Class I	1984-01-11
K833949	Micro Infusion Set	Deltec Systems, Inc.	FPA	Class II	1984-01-11
K833837	American Gold Series Autoclave	Tuttnauer Ltd.	FLE	Class II	1984-01-11
K833787	Somas Chloride Assay Kit	Somas Medical Industries, Inc.			1984-01-11
K833754	Hamilton Pediatrics Scale	Befour, Inc.	FRW	Class I	1984-01-11
K833751	Porta Pulse III #D320	Medical Research Laboratories, Inc.	LDD	Class II	1984-01-11
K833608	Gold Alligator Forceps	Microtek Medical LLC	KAE	Class I	1984-01-11
K833574	Percutaneous Sheath Introducer Trays	Intermed, Inc.	DQX	Class II	1984-01-11
K833573	Central Vein Cath. Tray Cc-20-1420	Intermed, Inc.	DQY	Class II	1984-01-11
K833521	Reagent Tests Strip Combinations	Syn-Kit, Inc.	JJB	Class I	1984-01-11
K833505	Il Model 840 Microprocessor Loader	Instrumentation Laboratory Co.	JQW	Class I	1984-01-11
K833471	Adrenocor Ticotropic Hormone Radioimm	Nichols Institute Diagnostics	CKG	Class II	1984-01-11
K833416	Ceftizoxime 30 Mcg Sensitivity Discs	Difco Laboratories, Inc.	JTN	Class II	1984-01-11
K833415	Ticarcillin 75Mcg. Sensitivity Discs	Difco Laboratories, Inc.	JTN	Class II	1984-01-11
K833414	Azlocillin 75Mcg. Sensitivity Discs	Difco Laboratories, Inc.	JTN	Class II	1984-01-11
K833097	Chem Trak Liquid Bilirubin Control	Medical Analysis Systems, Inc.	JJX	Class I	1984-01-11
K832694	Diria-Progk Immunoassay	Sorin Biomedica, Fiat, USA, Inc.	JLS	Class I	1984-01-11
K832593	Hospital Lab in-Home Early Preg Test	Aicl-Pack, Inc.	LCX	Class II	1984-01-11
K831802	Life Vac #2191 & 2192	Exco, Inc.	LJS	Class II	1984-01-11
K830294	Medical Exam Table	Coe Laboratories, Inc.	LGX	Class I	1984-01-11
K823783	Respicomb	Respitrace Corp.	BZK	Class II	1984-01-11
K840105	Apo a-I Ria Kit-Human Plasma Apolip-	Iso-Tex Diagnostics			1984-01-10
K834308	Multitreat 48	Mick Radio-Nuclear Instruments, Inc.	JAQ	Class II	1984-01-10
K834287	Digital Radiography Sys-Dps7100	Philips North America LLC	JAA	Class II	1984-01-10
K834260	Recon-2 Flow Controller	Precision Metering, Inc.	CAX	Class I	1984-01-10
K834229	Bone Plugging Tool	Standard Surgical	HTW	Class I	1984-01-10
K834129	Medela Apgar Timer	Medela AG	LHB	Class I	1984-01-10
K834061	Slo-Flo 40Al Adjust-Flow Regulator	S.L.O. Health Products, Inc.	CAN	Class I	1984-01-10
K834037	Heparin Coated Balloon Thermodilu	Nova Medical Specialties	DYG	Class II	1984-01-10
K834036	Heparin Coated Balloon Thermodilu	Nova Medical Specialties	DYG	Class II	1984-01-10
K833825	Multi-Lumen Intravenous Infusion Cath	Medical Parameters, Inc.	DQY	Class II	1984-01-10
K833764	Sterilization of Gore-Tex Soft Tissu	W. L. Gore & Associates, Inc.	FTL	Class II	1984-01-10
K833716	Lp200 & Hp800 Series Vascular Prosth	Intervascular, Inc.	DSY	Class II	1984-01-10
K833671	Sterile Oil and Guidewire	CooperVision, Inc.	HNL	Class I	1984-01-10
K833610	Dental Rubberdam	Center for Marketing Services	EIE	Class I	1984-01-10