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 2026-11-02, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 2515 of 3531

510(k) clearances, page 2515 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K901156	Eia for Igg Antibody to Ebv Vca in Human Serum	Granbio, Inc.	GNP	Class I	1990-09-12
K900966	Eup-V12 5.0 Mhz Convex Array Transvaginal Probe	Hitachi Medical Corp. of America	HGL	Class II	1990-09-12
K900632	Dynasty Hearing Systems Instrument	Alastair Granville-Jackson, Mfa, Ed.D.	ESD	Class I	1990-09-12
K896896	Kawasumi Small Vein Infusion Set	Kawasumi Laboratories Co., Ltd.	FPA	Class II	1990-09-12
K896895	Kawasumi i.v. Administration Set	Kawasumi Laboratories Co., Ltd.	FPA	Class II	1990-09-12
K896894	Kawasumi Blood Administration Set	Kawasumi Laboratories Co., Ltd.	FPA	Class II	1990-09-12
K896893	Kawasumi i.v. Administration Set with Burette	Kawasumi Laboratories Co., Ltd.	FPA	Class II	1990-09-12
K896892	Kawasumi Y-Type Blood Administration Set	Kawasumi Laboratories Co., Ltd.	FPA	Class II	1990-09-12
K895597	Vas-Cath Trifusion Triple Lumen Infusion Catheter	Vas-Cath, Inc.	FOZ	Class II	1990-09-12
K903647	Module 486 Variable Wavelength Tunable Uv/vis Dete	EMD Millipore Corporation	LDM	Class I	1990-09-11
K902621	Sl-Self Locking Total Hip-Femoral Component	Lima Intl. Corp.	JDI	Class II	1990-09-11
K902615	Adg Bone Plug	American Design Group, Inc.	LZN	Class II	1990-09-11
K902368	Personal 120/210 Basic Electrocardiograph	Esaote Biomedica SpA	DPS	Class II	1990-09-11
K901736	Oximetry Probe Catheters	Baxter Healthcare Corporation	DQE	Class II	1990-09-11
K896830	Optimate Hemoglobin A1c	Kulzer GmbH	LCP	Class II	1990-09-11
K903949	Frame, Spectacle	Eureka Optics, Inc.	HQZ	Class I	1990-09-10
K903764	Companion 318 Nasal CPAP System	Medtronic, Inc.	BYE	Class II	1990-09-10
K903676	Sternotomy Cable, Songer Cable System	Danek Medical, Inc.	JDQ	Class II	1990-09-10
K903616	Dsl Androstanediol Glucuronide (Dsl #6000)	Diagnostic Systems Laboratories, Inc.	JKC	Class I	1990-09-10
K903510	Mickey/minnie Mouse Batt. Operate Toothbrush	Helm Toy Corp.	JEQ	Class I	1990-09-10
K903384	Imx Free T4 Calculation	Abbott Medical	CEC	Class II	1990-09-10
K903383	Tdx Free T4 Calculation	Abbott Medical	CEC	Class II	1990-09-10
K903329	Cui Anatomical Silicone Malar	Cui Corp.	LZK	Class II	1990-09-10
K903328	Cui Premaxillary Implant	Cui Corp.	FZE	Class II	1990-09-10
K903327	Cui Articulated Silicone Chin	Cui Corp.	FWP	Class II	1990-09-10
K903188	Abbott Vision Lyte (Tm) Sodium	Abbott Medical	JGS	Class II	1990-09-10
K903028	Gyrex 2T Version 2.1U.	Elscint, Inc.	LNH	Class II	1990-09-10
K902892	Cell-Dyn Calibrator	Unipath, Ltd.	KRZ	Class II	1990-09-10
K902888	Customed Orthopedic II	Customed, Inc	LRO	Class II	1990-09-10
K902887	Customed Arthroscopy Pack	Customed, Inc	LRO	Class II	1990-09-10
K902865	Baumer Surgical Table	Sds Dental, Inc.	BWN	Class I	1990-09-10
K902864	Surgical Lighting-Centra 450	Sds Dental, Inc.	FSY	Class II	1990-09-10
K902861	Ciba Corning Acs Digoxin Immunoassay	Ciba Corning Diagnostics Corp.	DON	Class II	1990-09-10
K902851	Microscope Drape	Medical Technique Instruments, Inc.	HMW	Class II	1990-09-10
K902609	Directigen Flu a	BD Becton Dickinson Vacutainer Systems Preanalytic	GNT	Class I	1990-09-10
K902591	Cytette(tm) Cytology Brush	Birchwood Laboratories LLC	HHT	Class II	1990-09-10
K902589	Cytoset(tm)	Birchwood Laboratories LLC	HHT	Class II	1990-09-10
K902280	Rad-X Glasses	Compudrug	HQY	Class I	1990-09-10
K901559	Modification to Api Uniscept 20Gp	Analytical Products, Inc.	LQL	Class I	1990-09-10
K901315	Aeromist II Nebulizer	Inhalation Plastics, Inc.	CAF	Class II	1990-09-10
K901127	Lasercomp Model Star 10 for Knee Arthroscopy	Lasercomp	GEX	Class II	1990-09-10
K900925	Nidek, Inc. Model Adc-8000 Derm	Nidek, Inc.	GEX	Class II	1990-09-10
K900890	Nidek Model Akc-8000 Ophthalmic Laser Photocoagula	Nidek, Inc.	GEX	Class II	1990-09-10
K897070	Endobrush(tm) Device; Omnibrush	Intl. Cytobrush, Inc.	HFE	Class II	1990-09-10
K896068	Tipstop(tm)	Gambro-Hospal, Inc.	KGX	Class I	1990-09-10
K895764	Modified Lyofoam Wound Dressings	Acme United Corp.	KMF	Class I	1990-09-10
K903855	The on-Gard Cord-Caddy	On-Gard Systems, Inc.	GEI	Class II	1990-09-07
K903767	Ect (Emmission Computed Tomography) Carbon Fib Pal	Siemens Gammasonics, Inc.	IYZ	Class I	1990-09-07
K903704	Fukuda Denshi Model Fcp-2201 Modification	Fukuda Denshi USA, Inc.	DSI	Class II	1990-09-07
K903628	Aia-Pack Iri	Tosoh Corp.	CFP	Class I	1990-09-07