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 2026-10-21, 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 3018 of 3529

510(k) clearances, page 3018 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K844471	Visible Light-Cure Composite -Polishable	Dentsply Intl.	EBH	Class I	1985-02-08
K844339	Braun Dental Center Oc-3	Braun GmbH	EFS	Class I	1985-02-08
K844284	Copal Digital Sphygmomanometer Ua-540	Takeda Medical, Inc.	DXN	Class II	1985-02-08
K844221	Hmb Allergogen Skin Prick Test Needle	Aller/Guard, Inc.	SCL	Class II	1985-02-08
K842716	Mde Escort 1000 & Mde Escor 2000	Medical Data Electronics	DXH	Class II	1985-02-08
K840756	Biopatch Bovine Pericardial Patch	Meadox Medicals, Div. Boston Scientific Corp.	DQX	Class II	1985-02-08
K833828	Percor 9.5 Fr Iab on Datascope CO2	Datascope Corp.	DSP	Class II	1985-02-08
K831235	Iabp #90 System	Datascope Corp.	DSP	Class II	1985-02-08
K850258	Bcs Potassium Turbidimetric Test	Bioclinical Systems, Inc.	CEJ	Class II	1985-02-07
K850245	Brewer Heave-Duty i.v. Stand W/foot Operated Pnuem	E.F. Brewer Co.	FOX	Class I	1985-02-07
K850212	Isoenzyme Test Ck-Mb	Sclavo, Inc.	CGS	Class II	1985-02-07
K850211	Isocontrol Serum Ld-	Sclavo, Inc.	JJT	Class I	1985-02-07
K850196	Copal Digital Thermometer Uf-22B	Takeda Medical, Inc.	FLL	Class II	1985-02-07
K850195	Copal Digital Thermometer Uf-12	Takeda Medical, Inc.	FLL	Class II	1985-02-07
K850142	Ace Intramedullary Rod for Small Bones	Buckman Co., Inc.	HSB	Class II	1985-02-07
K844968	Epichrome Pap	Cetus Corp.	JFH	Class II	1985-02-07
K844936	Super Tampax Tampons	Tambrands Inc.	HEB	Class II	1985-02-07
K844935	Original Regular Tampax Tampons	Tambrands Inc.	HEB	Class II	1985-02-07
K844917	Turn Needle Intravenous Cannul, Nub, W/tubing Inte	Turn Needle Intl., Inc.	FPA	Class II	1985-02-07
K844788	Soleo Sunbed	Hapro International B.V.			1985-02-07
K844355	Synatomic Standard Tibial Plateau	Depuy, Inc.	HSX	Class II	1985-02-07
K843920	Fluoroscan/tm by Healthmate	Healthmate, Inc.	JAA	Class II	1985-02-07
K843522	Donway Splint	Australian Biomedical Corporation, Ltd.	ITH	Class II	1985-02-07
K841451	Biotronik Dy-Unipolar	Biotronik Sales, Inc.	DTD	Class II	1985-02-07
K841450	Biotronik Dnp Unipolar	Biotronik Sales, Inc.	DTD	Class II	1985-02-07
K841083	Quikpage Arrhythmia Report Generator	Agilent Technologies, Inc.	DSI	Class II	1985-02-07
K850281	Calcium	Boehringer Mannheim Corp.	CIC	Class II	1985-02-06
K850202	Gelman Triphor Control	Gelman Sciences, Inc.	JJY	Class I	1985-02-06
K850174	Tdx Ethosuximide	Abbott Medical	DLF	Class II	1985-02-06
K850141	Active Cortisol Dsl 2000-Sp	Diagnostic Systems Laboratories, Inc.	CGR	Class II	1985-02-06
K850140	Corning Magic 1-Free T3 Radioimmunoassay	Corning Medical & Scientific			1985-02-06
K850056	Leeco Progesterone-Quant Diagnostic Test Kit	Leeco Diagnostics, Inc.	JLS	Class I	1985-02-06
K844996	Paragon Tricheck Electrophoresis Control	Beckman Instruments, Inc.	JJY	Class I	1985-02-06
K844683	Imagen Chlamydia Test	Boots-Celltech Diagnostics, Inc.	IWP	Class I	1985-02-06
K844475	Specimen Collection & Transport System	Portable Medical Laboratories, Inc.	FMF	Class II	1985-02-06
K844209	Argon/krypton Laser System 8500	Cooper Lasersonics, Inc.	HQB	Class II	1985-02-06
K844115	Medtronic 3465 Se-4F Receiver/extension for Spinal	Medtronic, Inc.	GZB	Class II	1985-02-06
K843000	Micro Organism Growth Sys-M1000	Hml Inc/Biotechnology Transfer	LIO	Class I	1985-02-06
K841241	Anterior Cruciate Ligament Grasper	Surgical Products Corp.	HRX	Class II	1985-02-06
K840869	Surgical Module 7000 ECG	Marquette Electronics, Inc.	DPS	Class II	1985-02-06
K850346	Oxygen Concentrator	Inspiron Corp.	CAW	Class II	1985-02-04
K850031	Vision Triglycerides	Abbott Medical	CDT	Class I	1985-02-04
K844743	Seratest Ena(rnp/sm) Determination	Seragen Diagnostics, Inc.	LLL	Class II	1985-02-04
K844404	Irex Ps, Portable Scanner and 118	Irex Corp.	IYO	Class II	1985-02-04
K844307	Egnell-Lact B Battery-Operated Breast Pump	Egnell, Inc.	HGX	Class II	1985-02-04
K844294	Cordia Ic	Cordis US Corp.	DAK	Class II	1985-02-04
K844188	Corning Calcium Ph Analyzer 634	Corning Medical & Scientific	JFP	Class II	1985-02-04
K844183	Palmer Obstetic Brace	Mic Medical Corp.	KNC	Class II	1985-02-04
K844098	Canmed 103	Medtronic, Inc.	GXY	Class II	1985-02-04
K843515	Minuteman CO2 Microsurgical Laser Gyn	American Surgical Laser, Inc.	HHR	Class II	1985-02-04