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 2930 of 3529

510(k) clearances, page 2930 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K853409	Screenmate	Erich Jaeger, Inc.	BZG	Class II	1986-02-05
K853390	Infant Body Test	Erich Jaeger, Inc.	CCM	Class II	1986-02-05
K853030	Technicon H*1 System (Hdw)	Technicon Instruments Corp.	GKL	Class II	1986-02-05
K853027	Technicon H*1 System (Mpxi)	Technicon Instruments Corp.	GKZ	Class II	1986-02-05
K852955	Hemod Conce of Var Formu & Lipuid Hemod Conce Add	Renalchem, Inc.	KPO	Class II	1986-02-05
K860201	Parenteral Administration Set	Simplivia Healthcare Ltd.	FPA	Class II	1986-02-04
K860001	Barraquer-Krumeich Refractive Set	American Medical Optics	HNO	Class I	1986-02-04
K855251	Modification Asahi New Pan-Series Hemofilters	Advocacy International, Ltd.	KDI	Class II	1986-02-04
K855224	Acromed Nested Bone Plate	Buckman Co., Inc.	JEY	Class II	1986-02-04
K855018	Durahesive Wafer with Flange	Convatec, A Division of E.R. Squibb & Sons	EXB	Class I	1986-02-04
K854994	Bartell Small Incision Lens Glide	Microtech	KYB	Class I	1986-02-04
K854983	Optronics Contrast Acuity Tester	Optronics, Inc.	HOX	Class I	1986-02-04
K854949	Model 9500 Argon, Krypton & Dye Surgical Laser Sys	CooperVision, Inc.	HQF	Class II	1986-02-04
K854937	Carrom Carelife Series 40000 Modular Bes System	Carrom Healthcare, Inc.	FNL	Class II	1986-02-04
K854879	Sunglasses	Jarnger Trading Co., Ltd.	HQY	Class I	1986-02-04
K854873	Intraocular Pressure Reducer	Mira, Inc.	LCR	Class II	1986-02-04
K854867	Everest & Jennings Tradition-Standard Bed L109684&	Carrom Healthcare, Inc.	FNL	Class II	1986-02-04
K854854	Systems of Sight Low Vision Eyeware	Int'L Eye Care, Inc.	HOI	Class I	1986-02-04
K854852	Wellcogen Bacterial Antigen Kit	Wellcome Diagnostics	GTJ	Class II	1986-02-04
K854851	Wellcogen N. Meningitidis B/e. Coli K1 Zl24	Wellcome Diagnostics	GTJ	Class II	1986-02-04
K854839	Cytomegelisa M Test Kit	Whittaker Bioproducts, Inc.	LKQ	Class II	1986-02-04
K854832	Everest & Jenning Series 5000 Modular Bed	Carrom Healthcare, Inc.	FNL	Class II	1986-02-04
K854818	Sunglasses	Jarnger Trading Co., Ltd.	HQY	Class I	1986-02-04
K854754	Patientmate Tm	Trend Medical, LLC	FPA	Class II	1986-02-04
K854593	Norfolk Medical Peritoneal-Access Port	Norfolk Medical Products, Inc.	LMQ	Class III	1986-02-04
K854588	Insta-Glaze	George Taub Products & Fusion Co., Inc.	EJR	Class I	1986-02-04
K854587	Storz Mvs Disposable Fiberoptic Lightpipe	Storz Instrument Co.	HBI	Class II	1986-02-04
K854549	Monoject Sterile M400 Plastic&sterile M401 Aluminu	Sherwood Medical Co.	FMI	Class II	1986-02-04
K854548	Monoject Sterile M216 Blood Collection Needles	Sherwood Medical Co.	FMI	Class II	1986-02-04
K854547	Monoject Sterile M200 Aluminum/m250 Polypropylene	Sherwood Medical Co.	FMI	Class II	1986-02-04
K854539	Urostat	Urologics, Inc.	KPN	Class II	1986-02-04
K854508	Storz Daisy	Storz Instrument Co.	HQE	Class II	1986-02-04
K854505	Cardimax Fx-406U	Brentwood Instruments, Inc.	DRS	Class II	1986-02-04
K854488	Ortho Hsv Antigen Elisa Test	Ortho Diagnostic Systems, Inc.	GQN	Class II	1986-02-04
K854466	Biomagnetic Technologies Neuromagneometer	Biomagnetic Technologies, Inc.	OLY	Class II	1986-02-04
K854384	Asserachrom Fpa Kit	American Bioproducts Co.	DAN	Class II	1986-02-04
K854361	CO2 Laser Laparoscope System	Richard Wolf Medical Instruments Corp.	HHR	Class II	1986-02-04
K854312	Asserachrom Ix:ag	American Bioproducts Co.	GGP	Class II	1986-02-04
K854227	Fascilulated Nail	The Deca Co.	HSB	Class II	1986-02-04
K853841	Harmo Sonic	U.S. Shizai Corp.	ELC	Class II	1986-02-04
K853540	Fiax Test Kit for Varicella Antibody Serology	Idt, A Division of Whittaker M.A. Bioproducts	GQX	Class II	1986-02-04
K854252	Transtracheal System-Scoop-Insertion Tray-Catheter	Transtracheal Systems	BTO	Class II	1986-02-03
K854077	Mix Evac II	Stryker Corp.	JDZ	Class I	1986-01-31
K860254	Healthdyne's Event Recorder System	Healthdyne, Inc.	BZQ	Class II	1986-01-30
K860203	Txr 325 X-Ray Control with High Voltage Generator	Tingle X-Ray Products, Inc.	IZO	Class I	1986-01-30
K860193	Portalcast	Diacor, Inc.	IXI	Class II	1986-01-30
K860117	Kryptosol (Sun Lamp)	Trademark Imports	FTC	Class II	1986-01-30
K855070	Spirometer Model Ts-200 Slz 7541	Teledyne Avionics Div. of Teledyne	BZC	Class II	1986-01-30
K855069	Spirometer Ts-400 Slz 7547	Teledyne Avionics Div. of Teledyne	BTY	Class II	1986-01-30
K855063	Universal Patient Chair Uni 2000X	Siemens Medical Solutions USA, Inc.	JAI	Class II	1986-01-30