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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2721 of 3530

510(k) clearances, page 2721 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K882580	Mechanical Change in in-Vitro Micro Device	Precision Dynamics Corporation	JTW	Class I	1988-07-08
K882563	Radkor, Cst-18	Radkor, Inc.	IYB	Class I	1988-07-08
K882524	Universally Adjustable Armboard	Karlin Technology, Inc.	BTX	Class I	1988-07-08
K882494	Elan-E Disposalbe Drape	Dermacare Products, Inc.	KKX	Class II	1988-07-08
K882489	Revised Pneumatic Diagrams for Modulus II Plus	GE Healthcare	BSZ	Class II	1988-07-08
K882446	Alpha1antitrypsin for Technicon Dpa-1(Tm) System	Technicon Instruments Corp.	DEM	Class II	1988-07-08
K882404	Kevor-Curette	Euro-Med Intl.	PCF	Class II	1988-07-08
K882374	Wako(tm) Crp	FUJIFILM Healthcare Americas Corporation	DCN	Class II	1988-07-08
K882204	Resuscitator Valve Assembly W/filter	Intertech/Ohio	CBP	Class II	1988-07-08
K882083	Qm300 Igg Antibody Pack	Kallestad Diag, A Div. of Erbamont, Inc.	DEW	Class II	1988-07-08
K882082	Qm300 Albumin Antibody Pack	Kallestad Diag, A Div. of Erbamont, Inc.	DCF	Class II	1988-07-08
K882064	Lo-Core Needle	Device Labs, Inc.	FMI	Class II	1988-07-08
K881944	Emit Hva Control Kit	Syva Co.	DIF	Class I	1988-07-08
K881943	Emit Hva Calibrator Kit	Syva Co.	DKB	Class II	1988-07-08
K881928	Monoclonal Radial Immunodiffusion Kit	The Binding Site	CFQ	Class II	1988-07-08
K881913	Protecto-Shield	Syntech Mfg. Services	FXX	Class II	1988-07-08
K881907	Hemagel(tm) Test for Fecal Occult Blood	Enzo Biochem, Inc.	KHE	Class II	1988-07-08
K881894	Adenoclone(r)-Type 40/41 Eia Diagnostic Test (48)	Cambridge Bioscience Corp.	GOD	Class I	1988-07-08
K881852	Rep Sp Electrophoresis System Cat No. 3170	Helena Laboratories, Corp.	JJN	Class I	1988-07-08
K881846	Sceptor- New Antimicrobial Agent: Norfloxacin	BD Becton Dickinson Vacutainer Systems Preanalytic	JWY	Class II	1988-07-08
K881802	Alpine Portable Oxygen Generator	Mountain Medical Equipment, Inc.	CAW	Class II	1988-07-08
K881794	Ivory Finder Set	Ivory Instruments Co.	HCY	Class I	1988-07-08
K881761	Unsaturated Iron Binding Capacity	Data Medical Associates, Inc.	JMO	Class I	1988-07-08
K881742	Biotrol Alkaline Phosphatase	Biotrol, USA, Inc.	CJE	Class II	1988-07-08
K881709	Immunocard(tm) Hcg II Test Kit	Disease Detection International, Inc.	JHI	Class II	1988-07-08
K881692	Dideco-Shiley Fluid Collection Bag	Shiley, Inc.	CAC	Class II	1988-07-08
K881689	Lindley II Resuscitator	Lindley Resuscitator, Inc.	BYT	Class II	1988-07-08
K881679	Ciba Corning Magic Lite Digoxin Immunoassay	Ciba Corning Diagnostics Corp.	DON	Class II	1988-07-08
K881654	Acci-Guard Multi-Sample Blood Collection Needle	Medical Safety Products, Inc.	FMI	Class II	1988-07-08
K881639	Kodak Ektachem Clinical Chemistry Slides (Prot)	Eastman Kodak Company	CEK	Class II	1988-07-08
K881619	4000/4900/6000/8000/8900 Yag, & 1700 Yag/co2 Laser	Heraeus Lasersonics, Inc.	GEX	Class II	1988-07-08
K881609	Sitzmarks	Lafayette Pharmacal, Inc.	FFX	Class II	1988-07-08
K881503	Modified Dade Compre. Electrophoresis Control	Baxter Healthcare Corporation	JJY	Class I	1988-07-08
K881430	Liqui-Sera Serum Alcohol Controls	Biodiagnostic Intl	JJX	Class I	1988-07-08
K881387	X-Ray Generating System, Tf 800	Absolute X-Ray Corp.	IZO	Class I	1988-07-08
K881386	X-Ray Generating System Tf 1000	General Medical Merate S.p.A.	IZO	Class I	1988-07-08
K881188	Blood Ph Capillary Tubes, Heparin	Helps Products, Inc.	CHL	Class II	1988-07-08
K881135	Cool Eye(tm) Eye Protector	Cool Eyes, Inc.	HOY	Class I	1988-07-08
K881100	Condom	Glnic Corp.	HIS	Class II	1988-07-08
K880703	Quantai Bg(tm) Reagent Strip	Quantai Biotronics, Inc.	CGA	Class II	1988-07-08
K880702	Model Mr430 Special Purpose Humid. Heater Bases	Fisher & Paykel Allied Products, Ltd.	BTT	Class II	1988-07-08
K875204	Du Pont Vca-Igm Antibody Elisa Kit	E.I. Dupont de Nemours & Co., Inc.	LJN	Class I	1988-07-08
K872466	Adult Star	Infrasonics Corp.	CBK	Class II	1988-07-08
K871512	Sl-100 Nd:yag Laser for Gynecology Use	Medical Energy, Inc.	GEX	Class II	1988-07-08
K871143	Immunoccult Eia Test Kit	Intl. Immunoassay Laboratories, Inc.	KHE	Class II	1988-07-08
K882381	Pti Heart-Lift(tm) Cardiac Retraction Gloves-Steri	Pioneering Technologies, Inc.	KGO	Class I	1988-07-07
K881923	Ultraviolet Resources Int'l Model 2-Fs72	Ultraviolet Resources Intl.	FTC	Class II	1988-07-07
K881792	Cannula Model Ar-6551	Arthrex Arthroscopy Instruments, Inc.	HRX	Class II	1988-07-07
K864893	Anti-Cytokeratin Monoclonal Antibody	BD Becton Dickinson Vacutainer Systems Preanalytic	LYE	Class II	1988-07-07
K882637	Accu-Culshure Tm	Accu-Med Corp.	JTX	Class I	1988-07-06