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 2026-10-21, 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 2993 of 3529

510(k) clearances, page 2993 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K851123	R-1000 ECG Receiver	Brentwood Instruments, Inc.	DXH	Class II	1985-05-15
K851105	Tooth Extracting Forceps 151(2010)-875 Pcs. Ss410/	The Huxley Instrument Corp.	EMG	Class I	1985-05-15
K851054	Lx120 Tissue Processor	Innovative Medical Systems, Inc.	IEO	Class I	1985-05-15
K850638	Laser Apo a-I Test Apolipoprotein a-I Reagents	Behring Diagnostics, Inc.	MSJ	Class I	1985-05-15
K850610	Pepsodent Denture Adhesive Cream	Lever Brothers Company, Inc.	EBD	Class II	1985-05-15
K850508	Logikal Lontophoresis Unit -Anesthesia Inotophores	Kal Life Systems	EGJ	Class II	1985-05-15
K850464	Programalith III 240 Pulse Generator	Pacesetter Systems	DXY	Class III	1985-05-15
K850424	Marc Medical Probe Cover-200	K&M Plastics	FLL	Class II	1985-05-15
K845051	Vitalog Pms-8	Vitalog Corp.	DPZ	Class II	1985-05-15
K844849	Ohmeda Mdm Electronic-Gas Machine for Analgesia	GE Healthcare	BSZ	Class II	1985-05-15
K843446	Digital Sphygmomanometer Bp-2500	Pollenex Associated Mills, Inc.	DXN	Class II	1985-05-15
K843435	Labmaster & Crsi 600	Control Resource Systems, Inc.	FRF	Class II	1985-05-15
K843390	Copal Digital Sphygmomanometer Ua-535	Takeda Medical, Inc.	DXN	Class II	1985-05-15
K851859	Facial/upper Body Unit	Tannhut	FTC	Class II	1985-05-14
K851858	Fold Away Hut	Tannhut	FTC	Class II	1985-05-14
K851837	Manan Westcott Needle	Manan Manufacturing Co., Inc.	KNW	Class II	1985-05-14
K851831	Manan Franseene Needle	Manan Manufacturing Co., Inc.	KNW	Class II	1985-05-14
K851701	Manan Zavala Needle	Manan Manufacturing Co., Inc.			1985-05-14
K851675	The Percutaneous Nephrostolithotomy Drape	Lingeman Medical Products, Inc.	EYY	Class II	1985-05-14
K851619	Gen Profiler System	Electro-Cucleonics, Inc.	JJG	Class I	1985-05-14
K851594	Sf Broth	Preferred Micro-Media	JSI	Class I	1985-05-14
K850964	Double-Swivel Connector	Sheridan Catheter Corp.	BZA	Class I	1985-05-14
K850956	Always Maxipads - Scented	Procter & Gamble Mfg. Co.	HHL	Class II	1985-05-14
K850955	Always Maxipads - Unscented	Procter & Gamble Mfg. Co.	HHD	Class I	1985-05-14
K850940	Always Super Maxipad-Unscented	Procter & Gamble Mfg. Co.	HHD	Class I	1985-05-14
K850939	Always Super Maxipad-Scented	Procter & Gamble Mfg. Co.	HHL	Class II	1985-05-14
K850771	Oster Massage Wand Stick Massager 295-07	Daito Electric Machine Industries Company, Ltd.	ISA	Class I	1985-05-14
K850697	Digital Grip/pinch Strength Metor	Chattanooga Group, Inc.	LBB	Class II	1985-05-14
K850640	Sonopuls 434 Ultrasound Therapy Equipment	Fluidotherapy Corp.	IMI	Class II	1985-05-14
K850415	Cronex Kevlar Cassette	E.I. Dupont de Nemours & Co., Inc.	IXA	Class II	1985-05-14
K850198	Floor to Wall or Floor to Ceiling Tubestand;radiog	Summit Industries, LLC	IYB	Class I	1985-05-14
K844578	Non-Magnetic Examination Table for Magnetic Resona	Engineering Dynamics Corp.	FPO	Class II	1985-05-14
K851873	Fortec Mi-305	Nam Tai, Ltd.	FLL	Class II	1985-05-13
K851742	Medical Examination Lights	Burton Medical Products Corp.	KZF	Class I	1985-05-13
K851638	Clinalyzer Model Vx-1000	Alpkem Corp.	JJE	Class I	1985-05-13
K851597	Triple Sugar Iron Agar	Preferred Micro-Media	JSH	Class I	1985-05-13
K851596	Sim Medium	Preferred Micro-Media	JSH	Class I	1985-05-13
K851595	Simmons Citrate Agar	Preferred Micro-Media	JSH	Class I	1985-05-13
K851593	Selective Streptococcus Agar	Preferred Micro-Media	JSJ	Class I	1985-05-13
K851592	Sabouraud Dextrose Agar	Preferred Micro-Media	JSJ	Class I	1985-05-13
K851591	Phenylethyl Alcohol Agar W/5%sheep Blood	Preferred Micro-Media	JSJ	Class I	1985-05-13
K851259	Human Growth Hormone Immunoradiometric Assay Kit	Nichols Institute Diagnostics	CFL	Class I	1985-05-13
K851154	Electrophoresis Apparatus, for Clinical Use 160,18	Astral Medical Systems	JQT	Class I	1985-05-13
K851001	Series 7000 End Tidal CO2 Monitoring System	Marquette Electronics, Inc.	CCK	Class II	1985-05-13
K850997	Uvp 2000 Volumed -Tentative	Sterling Medical Devices, Inc.	FRN	Class II	1985-05-13
K850755	Cbc-Plt-4/Multiple Whole Blood Hematology Control	R & D Systems, Inc.	JPK	Class II	1985-05-13
K850592	Platelet Aggregation Reagent	Chrono-Log Corp.	JBX	Class II	1985-05-13
K850171	Sysmex E-3000, Fully Automated Hematology Sys	Toa Medical Electronics USA, Inc.	GKL	Class II	1985-05-13
K850009	Evans, Vas-Cath Epidural Needle & Catheter	Vas-Cath of Canada, Ltd.	BSO	Class II	1985-05-13
K851904	Data Trac Anesthesiology Recorder	Datascope Corp.	KZD	Class I	1985-05-10