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 2026-11-05, 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 1356 of 3531

510(k) clearances, page 1356 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K042941	Dade Behring Heparin Calibrator and Controls	Siemens Healthcare Diagnostics Inc.	GIZ	Class II	2004-12-02
K042932	Bd Phoenix Automated Microbiology System-Piperacillin-Tazobactam 0.5/4-128/4 Ug/ml	Becton Dickinson & Co	LON	Class II	2004-12-02
K042576	Coatest Sp Fviii	Instrumentation Laboratory Co.	GGP	Class II	2004-12-02
K042409	Modular Arthrodesis Nail	Zimmer GmbH	HSB	Class II	2004-12-02
K041693	Wrist Digital Blood Pressure Monitor (Digital Sphygmomanometer), Mw-300 Series	Hangzhou Hua'an Medical & Health Instruments Co.	DXN	Class II	2004-12-02
K043115	Laparoscopic Compression Anastomosis Clip (Lapcac)	Niti Medical Technologies, Ltd.	FZP	Class II	2004-12-01
K043019	Vascular Solutions Sclero-Kit	Vascular Solutions LLC	FMI	Class II	2004-12-01
K043001	Mx Polyaxial Pedicle Screw	Scient'X	MNH	Class II	2004-12-01
K043000	Modification to D-Tronplus	Disetronic Medical Systems	LZG	Class II	2004-12-01
K042828	Obtura Gutta Percha Delivery System, Model 823-700	Young O/S, LLC	EKR	Class I	2004-12-01
K042823	Cosmedent Pit & Fissure Sealant	Cosmedent, Inc.	EBC	Class II	2004-12-01
K042777	Harmonic Ace Curved Shears with Hand Control, Model Ace23p, Ace36p	Ethicon Endo-Surgery Inc	LFL	Unclassified	2004-12-01
K042547	Dragon Heart Piston Syringe	Dragon Heart Medical Devices Co., Ltd.	FMF	Class II	2004-12-01
K042519	Gamma-B 1,25-Dihydroxy Vitamin D	Immunodiagnostic Systems Ltd.	MRG	Class II	2004-12-01
K042476	Vitros Chemistry Products Valp Reagent; Vitro Chemistry Products Calibrator Kit 12; Vitros Chemistry Products Tdm Perfos	Ortho-Clinical Diagnostics, Inc.	LEG	Class II	2004-12-01
K042395	Outpatient III Minor Surgery Light	Burton Medical Products Corp.	FSY	Class II	2004-12-01
K042333	Control Plasma N, Proc Control Plasma	Siemens Healthcare Diagnostics Inc.	GGN	Class II	2004-12-01
K042286	Uniester C	United Medical Industries Co. Ltd.	GAT	Class II	2004-12-01
K042283	Unipro	United Medical Industries Co. Ltd.	GAW	Class II	2004-12-01
K042282	Unisilk	United Medical Industries Co. Ltd.	GAP	Class II	2004-12-01
K041957	Evlt Kit and the D15plus and D30plus Diode Lasers	Diomed, Inc.	GEX	Class II	2004-12-01
K041913	Powderfree Colored and Flavored Chloreprene Patient Examination Gloves Tested for Chemo Use	PT. Medisafe Technologies	LZA	Class I	2004-12-01
K041063	Smartwave Ms 2000	Newwave Medical, LLC	IPF	Class II	2004-12-01
K041047	Ultradent Carbon Mask - Upi #342	Medspring Group, Incorporated	FXX	Class II	2004-12-01
K040888	Duramatrix Collagen Dura Substitute Membrane	Collagen Matrix, Inc	GXQ	Class II	2004-12-01
K033732	Medtrade Products Antiseptic Barrier Silver Foam Dressing, Model 09912450	Medtrade Products Ltd.	FRO	Unclassified	2004-12-01
K043196	Aloka Ssd-Alpha 10 Ultrasound System	Aloka Co., Ltd.	IYN	Class II	2004-11-30
K042950	Vag O Speculum, Models Vs1, Vm1, Vl1	Panatrex, Inc.	HIB	Class II	2004-11-30
K042744	Optiv Antage Dh Power Injection System	Mallinckrodt Inc., Liebel-Flarsheim Business	DXT	Class II	2004-11-30
K042520	Vitros Chemistry Products Caffn Reagent Kit and Tdm Performance Verifiers I, II and III	Ortho-Clinical Diagnostics, Inc.	KLS	Class II	2004-11-30
K042382	Dual LED Lite Engine with Illumination LED Cable Coupled to a LED Lite Head	Med-General Technologies, LLC	FSY	Class II	2004-11-30
K041708	Enpath Safety Introducer	Enpath Medical Incorporated	DYB	Class II	2004-11-30
K041501	Guangzhou Fortunique Drapes, Bags and Covers	Guangzhou Fortunique, Ltd.	MMP	Class II	2004-11-30
K041432	Astroglide Brand Warming Liquid Personal Lubricant	Biofilm, Inc.	HIS	Class II	2004-11-30
K041080	Surgical Drape Kit - D.i.r.r.a. Srl	D.I.R.R.A. S.r.l.	LRO	Class II	2004-11-30
K040985	Pump Connectivity Interface	Baxter Healthcare Corporation	FRN	Class II	2004-11-30
K040744	Atrilaze Soft Tissue Ablation System	Medical Cv, Inc.	GEX	Class II	2004-11-30
K042919	Fibrotek Fib	R2 Diagnostics, Inc.	GIS	Class II	2004-11-29
K042890	Triage D-Dimer Test, Model 98100	Biosite Incorporated	GHH	Class II	2004-11-29
K030275	Mb System, Bioenergy Light Therapy	Amest Corp.	ILY	Class II	2004-11-29
K042936	Solution Administration with Luer Access Injection Site	Baxter Healthcare Corporation	FPA	Class II	2004-11-26
K042913	Clearfil Tri-S Bond	Kuraray Medical, Inc.	KLE	Class II	2004-11-26
K042704	Reusable Finger Clip Spo2 Sensors	Elekon Industries U.S.A., Inc.	DQA	Class II	2004-11-26
K042653	Pack & Proper Pack & Proper, Ear-Thermometer Probe Cap	Pack & Proper Co., Ltd.	FLL	Class II	2004-11-26
K042645	Powder Free Latex Examination Gloves with Aloe Vera, Natural Water, Soluble Vitamin E and Vitamin C and Protein Labeling	Qingdao Bestex Rubber & Plastic Products Co., Ltd	LYY	Class I	2004-11-26
K042618	Laglove Brand Double Polymer Coated Nitrile Examination Gloves (Powder Free - Blue Color)	La Glove (M) Sdn. Bhd.	FMC	Class I	2004-11-26
K042607	Primus US	Draeger, Inc.	BSZ	Class II	2004-11-26
K041861	Nexus Intravenous Tubing Sets (Nivts)	Nexus Medical, LLC	FPA	Class II	2004-11-26
K041766	Ezy-Travel Wristband	Apothecary Products, LLC	MVV	Unclassified	2004-11-26
K030901	Medtrade Prodict's Soothing Gel Patch	Medtrade Products Ltd.	NTC	Class I	2004-11-26