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 1835 of 3531

510(k) clearances, page 1835 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K974556	Osteonics Scorpio Posterior Cruciate Retaining Total Knee System	Osteonics Corp.	JWH	Class II	1998-02-27
K974506	Lsf Ha Coated Triad Total Hip System	Osteoimplant Technology, Inc.	LPH	Class II	1998-02-27
K974504	Eps	E for M Imaging Systems Div., Marquette Electronic	LLZ	Class II	1998-02-27
K974082	The Performance Plus Confidence Rings, the Performance Plus Erection Inducer Device	Performance Plus, Inc.	LKY	Class II	1998-02-27
K974067	Fountain Infusion Catheter and Occluding Guide Wire	Merit Medical Systems, Inc.	QEY	Class II	1998-02-27
K973909	Ksea Endotip System	Karl Storz Endoscopy-America, Inc.	GCJ	Class II	1998-02-27
K973758	Bioscrew Absorbable Interference Srew	Linvatec Corporation	HWC	Class II	1998-02-27
K973425	The Mehdian Lumbo-Sacral Pedicle Screw System	Corin USA	MNH	Class II	1998-02-27
K973409	Kangaroo Enteral Feeding Extension Set for Syringe Pumps	Davis & Geck, Inc.	KNT	Class II	1998-02-27
K973197	Fire Stick	H.S. Intl. Co., Inc.	GEI	Class II	1998-02-27
K972775	Fastdam	Interdent, Inc.	EIE	Class I	1998-02-27
K972321	S3 Mast Pump	Stoeckert Instrumente	DWB	Class II	1998-02-27
K972244	Nt2000	Bio-Medical Research, Ltd.	GZJ	Class II	1998-02-27
K971710	Ultracon Ultrafiltrator	Quantic Biomedical, Inc.	FJI	Class II	1998-02-27
K971619	Microfuse Membrane Infusion Catheter	E-Med Corp.	KRA	Class II	1998-02-27
K971348	Fasttrach Single-Pass Tracheal/esophageal Airway System	Green Field Medical Sourcing, Inc.	CAO	Class II	1998-02-27
K980509	Deroyal Industries, Inc. Infant Transport Mattress	DeRoyal Industries, Inc.	IMD	Class I	1998-02-26
K980183	Promax Surgical Drapes and Covers	Standard Textile Co., Inc.	KKX	Class II	1998-02-26
K974764	Introsyte Catheter	Becton Dickinson Infusion Therapy Systems Inc.	FOZ	Class II	1998-02-26
K974498	Stratis II	FUJIFILM Healthcare Americas Corporation	LNH	Class II	1998-02-26
K974495	Neuroamp EEG Amplifier	Neurocorp, Ltd.	GWQ	Class II	1998-02-26
K974492	Siemens Sc6000/sc6000p Bedside Monitoring System Enhanced with St Segment Analysis	Siemens Medical Solutions USA, Inc.	MLD	Class II	1998-02-26
K973373	Prevent I	The Buzzz Corp.	INO	Class II	1998-02-26
K973000	Alimenterics Lara (Tm) Breath Test System	Alimenterics, Inc.	MSQ	Class I	1998-02-26
K972900	Ultrasafe Model T200 Injector	Safety Syringes, Inc.	FMF	Class II	1998-02-26
K972883	Isosafe Earloop Procedure Mask (Blue, Yellow)	Cypress Medical Products LLC	FXX	Class II	1998-02-26
K972877	Ultrasafe Injection System Model C200 Injector with Needle Guard	Safety Syringes, Inc.	FMF	Class II	1998-02-26
K971593	Silcraft Access 3700 Whirlpool System, Silcraft Model 1800 Lift, Silcraft Disinfectant	The Silcraft Corp.	ILJ	Class II	1998-02-26
K971592	Xtank2 Mobile Extremity Whirlpool System	The Silcraft Corp.	ILJ	Class II	1998-02-26
K980556	Liquichek Cardiac Markers Control Lt	Bio-Rad	JJT	Class I	1998-02-25
K980283	Vitros Chemistry Products Crbm Slides	Johnson & Johnson Clinical Diagnostics, Inc.	KLT	Class II	1998-02-25
K980060	Echolink	Mpacs, LLC	LLZ	Class II	1998-02-25
K980012	Creatine Kinase Reagent	Ac Biochemicals, Inc.	JHX	Class II	1998-02-25
K974710	Nitrile Exam Glove, Powder-Free/white and Blue	Sinochem Ningbo Latex Gloves Factory	LZA	Class I	1998-02-25
K974658	Infrared Group Amplification System, Infrared Emitter, Infrared Body Worn Receiver, Infrared Headset Receiver-Stereo, It	Phonic Ear, Inc.	EPF	Class II	1998-02-25
K974619	Scanaray/cd-Dent Advanced Computerized X-Ray System	Afp Imaging Corp.	LMA	Class II	1998-02-25
K974522	3D I-Scan	Ophthalmic Technologies, Inc.	IYO	Class II	1998-02-25
K974256	Ecat Pet Scanners	Siemens Medical Solutions USA, Inc.	KPS	Class II	1998-02-25
K974253	Cpd Commander	Scieran Technologies, Inc.	MRH	Class II	1998-02-25
K974173	Erecaid System/stay Erec System	Imagyn Medical Technologies, Inc.	LKY	Class II	1998-02-25
K974132	Voice Master Prosthesis	E. Benson Hood Lab, Inc.	EWL	Class II	1998-02-25
K973285	D/sense-T	Centrix, Inc.	KLE	Class II	1998-02-25
K973269	Quikstrip One Step Benzodiazepine Test	Drial Consultants, Inc.	JXM	Class II	1998-02-25
K973120	Readycath Catheter	Medical Technologies of Georgia	GBM	Class II	1998-02-25
K973011	Bpx80 Bio-Pump (Bpx80)	Medtronic Bio-Medicus, Inc.	KFM	Class II	1998-02-25
K980490	Sage Products Inc, Sharps Disposal Containers with Screw Top Caps	Sage Products LLC	MMK	Class II	1998-02-24
K980466	Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula	Abbott Medical	JOH	Class II	1998-02-24
K980332	Mta Material	Dentsply Intl.	KIF	Class II	1998-02-24
K980232	Clearfil Dc Cement	Kuraray Co.	EMA	Class II	1998-02-24
K980085	Phaco Commander	Scieran Technologies, Inc.	HQC	Class II	1998-02-24