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 1770 of 3531

510(k) clearances, page 1770 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K984575	Multi-Purpose Disinfecting Solution Id 90746	Alcon Laboratories	LPN	Class II	1999-01-14
K984553	Talking Digital Thermometer, Model Kv-171	K-Jump Health Co., Ltd.	FLL	Class II	1999-01-14
K984541	Global Fx Humeral Stem, Global Advantage Humeral Head	Depuy Orthopaedics Inc.	KWT	Class II	1999-01-14
K984524	Aztech 70	Villa Sistemi Medicali S.p.A.	EHD	Class II	1999-01-14
K984172	Modification of Puresperm	Nidacon International AB	MQL	Class II	1999-01-14
K984094	Vinyl Examination Gloves, Prepowdered Usp	Trans Ancient Products Co., Ltd.	LYZ	Class I	1999-01-14
K983889	Hys-Surgiflator 150P	Novanta Medical GmbH	HIG	Class II	1999-01-14
K983827	Maxikleen-Latex Examination Glove Powder Free	Sinetimed Latex Sdn Bhd	LYY	Class I	1999-01-14
K983815	Pacscache	Dome Imaging Systems, Inc.	LLZ	Class II	1999-01-14
K983814	Gotfried Percutaneous Compression Plating System	Efratgo, Ltd. HI Tech Bio-Surgical	JDO	Class II	1999-01-14
K983683	Unik Tongue Cleaner	Unik Products, Inc.	LCN	Class I	1999-01-14
K983670	Stealthstation System	Surgical Navigation Technologies, Inc.	HAW	Class II	1999-01-14
K983570	Glove Seal D'pro Latex Examination Glove	Glove Seal Sdn Bhd	LYY	Class I	1999-01-14
K983223	Dental Sterlization Tray/cassette	Brasseler USA I, L.P.	FRG	Class II	1999-01-14
K982805	Introcan Safety IV Catheter	B.Braun Medical, Inc.	FOZ	Class II	1999-01-14
K982630	Medworks Visualization Insemination Catheter	Medworks Corp.	MFD	Class II	1999-01-14
K982518	Aqua Purator-Biotherm, Wisap Model # 1608	Wisap Gesellschaft Fur Wissenschaftl. App. Bau mbH	HET	Class II	1999-01-14
K982334	Airzone Peak Flowmeter	Clement Clarke Intl., Ltd.	BZH	Class II	1999-01-14
K982329	Visions 8.2F Pv Ultrasonic Imaging Catheter (Model 88900)	Endosonics Corp.	ITX	Class II	1999-01-14
K982228	Fm Demodulator-4 Lead Model #8500-05 and Fm Demodulator-12 Lead Model # 8500-25	TZ Medical Inc.	DXH	Class II	1999-01-14
K982058	Rotecno Fr (Fluid Resistant) Surgical Gown	Encompass Group LLC	FYA	Class II	1999-01-14
K990024	Careside Alkaline Phosphatase	Careside, Inc.	CJE	Class II	1999-01-13
K984485	Microstat 2	Chemlink Laboratories, LLC.	LRJ	Class I	1999-01-13
K984387	R-30 Aesthetic Restorative	Dentsply Intl.	EBF	Class II	1999-01-13
K984361	Oral-Eze Oral Fluid Collection System	Osborn Laboratories, Inc.	PJD	Class II	1999-01-13
K984184	Wako L-Type Amylase	FUJIFILM Healthcare Americas Corporation	JFJ	Class II	1999-01-13
K984140	Mainbond a	J.F. Jelenko & Co., Inc.	EJT	Class II	1999-01-13
K984067	Stratus (R) Cs Stat Fluorometric Analyzer, Stratus (R) Cs Ckmb Test Pak	Siemens Healthcare Diagnostics Inc.	JHX	Class II	1999-01-13
K984066	Omnigrip, Latex Surgical Glove, Powder-Free with Protein Labeling Claim	Omni Intl., Inc.	KGO	Class I	1999-01-13
K984040	Blossom Powdered Latex Examination Gloves	Mexpo Intl., Inc.	LYY	Class I	1999-01-13
K984036	Netilmicin Antimicrobial Susceptibility Test Disc	Oxoid, Ltd.	JTN	Class II	1999-01-13
K983772	Mb/bact Blood Culture Bottle	bioMerieux, Inc.	MDB	Class I	1999-01-13
K983544	Vygon Double Lumen Picc-Catheters (4Fr. and 5Fr.)	Vygon Corp.	LJS	Class II	1999-01-13
K982957	Sensiflex Powderfree Surgeon's Glove	Terang Nusa (Malaysia) Sdn. Bhd.	KGO	Class I	1999-01-13
K982570	Snn Scout	I.S.G. Technologies, Inc.	HAW	Class II	1999-01-13
K982485	Seraquest Cmv Igm	Quest Intl., Inc.	LFZ	Class II	1999-01-13
K982419	Heart-Lift Balloon Positioner	Cardiothoracic Systems, Inc.	MWS	Class I	1999-01-13
K982115	Lenserver Automatic Contact Lens Cleaning Accessory	Rim-Wide Companies, Inc.	LYL	Class II	1999-01-13
K982062	Cryo-Check Pnp Platelet Lysate, Model Pnp-10	Precision Biologicals, Inc.	GGW	Class II	1999-01-13
K981174	Cryo Check Factor XII Deficient Plasma Model Fdp12-10 (1.0Ml) and Fdp12-15 (1.5Ml)	Precision Biologicals, Inc.	GJT	Class II	1999-01-13
K981173	Cryo Check Factor XI Deficient Plasma, Model Fdp11-10 (1.Oml) and Fdp11-15 (1.5Ml)	Precision Biologicals, Inc.	GJT	Class II	1999-01-13
K984307	Modification of: Rheo Dopplex II	Huntleigh Healthcare Ltd.	IYN	Class II	1999-01-12
K984255	Olympus Hx-20 Series Ligating Device	Olympus Corp of America	MND	Class II	1999-01-12
K984167	Sage 7	GE Healthcare	LNI	Class II	1999-01-12
K984159	Medrad Quadrature Ctl Array Coil	Medrad, Inc.	MOS	Class II	1999-01-12
K984000	Stealthserver Image Storage and Communication System	Surgical Navigation Technologies, Inc.	LMD	Class I	1999-01-12
K983712	Amplaid A311 Series	Amplifon	EWO	Class II	1999-01-12
K983661	Belmont Unit, Model 6000 Series and 7500 Series	Belmont Equipment Corp.	EIA	Class I	1999-01-12
K983654	Cyber-Lase 2000 Curing and Whitening Laser	Ics of North America, Inc.	GEX	Class II	1999-01-12
K982159	Abbott Plum a+ Infusion Pump	Abbott Medical	FRN	Class II	1999-01-12