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 2026-10-29, 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 2696 of 3530

510(k) clearances, page 2696 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K883161	Himobilix 2N	Bay X-Ray, Inc.	JAA	Class II	1988-10-21
K883110	Bard Ureteroscopic Device	C.R. Bard Inc	FGB	Class II	1988-10-21
K882754	Report and Image Management System	Medical Image Processing Specialists, Inc.	LMD	Class I	1988-10-21
K881707	Introcular Fluid Injector	B&B Medical Assoc., Inc.	FIH	Class II	1988-10-21
K883974	Tangent II	Fischer Imaging Corp.	IZZ	Class II	1988-10-20
K883892	Ballet Sterile Disposable Electrolysis	Synoptic Products	KCW	Class I	1988-10-20
K883799	Base, Denture, Relining, Repairing, Rebasing,resin	Austenal Dental, Inc.	EBI	Class II	1988-10-20
K883707	Tdx Amphetamine/methamphetamine II	Abbott Medical	DKZ	Class II	1988-10-20
K883642	Codman Neurolase Laser System	I.L. Med, Inc.	GEX	Class II	1988-10-20
K883220	Extravakit for Radiological Applications	Cancer Technologies, Inc.	FMF	Class II	1988-10-20
K882671	Samuelson Screwloc Cup	Protek, Inc.	KWA	Class III	1988-10-20
K882389	Kiss of Mint(tm) Non-Lubricated Condom	Ansell, Inc.	HIS	Class II	1988-10-20
K882234	Johnson & Johnson Modular Total Knee Prosthesis	Johnson & Johnson Professionals, Inc.	JWH	Class II	1988-10-20
K884145	Floser Plus	Pacific Lin Intl., Co.	JES	Class I	1988-10-19
K884101	Du Pont Dimension C-Reactive Protein Calibrator	E.I. Dupont de Nemours & Co., Inc.	DCK	Class II	1988-10-19
K884095	Scissors, Wire Cutting	Magnatrade Corp.	LRW	Class I	1988-10-19
K884093	Sterile Disposable Surgical Packs	Bolden Surgical Products	LRO	Class II	1988-10-19
K884075	Immunochemical Determination of Transferrin	Orion Diagnostica, Inc.	DDG	Class II	1988-10-19
K884057	Elan-E Disposable Drape	Aesculap Instruments Corp.	KKX	Class II	1988-10-19
K884040	Immunochemical Determination of Immunoglobulin a	Orion Diagnostica, Inc.	CZP	Class II	1988-10-19
K883915	Autoantibody Test System (Mouse Kidney/stomach)	Immco Diagnostics, Inc.	DBL	Class II	1988-10-19
K883885	Radkor, RF-159	Radkor, Inc.	KXJ	Class II	1988-10-19
K883864	Radkor Sfr-70	Radkor, Inc.	IYB	Class I	1988-10-19
K883714	Qm300 Apolipoprotein B Antibody Pack	Kallestad Diag, A Div. of Erbamont, Inc.	MSJ	Class I	1988-10-19
K883713	Qm300 Apolipoprotein a-I Antibody Pack	Kallestad Diag, A Div. of Erbamont, Inc.	MSJ	Class I	1988-10-19
K883649	Instrumentarium Ulf Mr Imaging System Model 110H	Instrumentarium Corp.	LNH	Class II	1988-10-19
K883648	Beta 3000M Mobile Nmr Imaging System	Fonar Corp.	LNH	Class II	1988-10-19
K883540	Oxoid Infectious Mononucleosis Kit	Unipath, Ltd.	KTN	Class II	1988-10-19
K883519	Fast and Ce-Fast MRI Sequences (for Nmr 1000)	Philips North America LLC	LNH	Class II	1988-10-19
K883482	Vista Mr 2055 Hp System	Philips North America LLC	LNH	Class II	1988-10-19
K883229	Ohmeda Continuous Suction Regulator	GE Healthcare	KDP	Class II	1988-10-19
K882885	Datex Airway Monitor	Datex Division Instrumentarium Corp.	CCK	Class II	1988-10-19
K882748	Normocap 200 Capnometer	Datex Division Instrumentarium Corp.	CCK	Class II	1988-10-19
K882599	Nicolet Brainlab System	Nicolet Instrument Corp.	GWK	Class II	1988-10-19
K882566	Visio-Perl	Espe GmbH (US)	EBF	Class II	1988-10-19
K882532	Star Alloys, Lite Alloys and Brite Alloys	Five Stars Alloys, Ltd.	EJT	Class II	1988-10-19
K882358	Pulsed Fluoroscopic Control Model:pf-02	U.S. Imaging, Inc.	IZI	Class II	1988-10-19
K881793	Wilson Biomedical Coronary Guiding Catheter	Wilson Biomedical, Inc.	DQY	Class II	1988-10-19
K881305	Tct-300S Computed Tomo. (CT) X-Ray System for Exam	Toshiba Medical Systems	JAK	Class II	1988-10-19
K873772	Changes to Encor Pervenous J-Atrial Leads	Cordis Leads, Inc.	DTB	Class III	1988-10-19
K873624	Kontron Pulse Oximeter 7840	Kontron Instruments, Inc.	DQA	Class II	1988-10-19
K883957	Arterial Anchor Bandage	Guidelines, Inc.	FMK	Class II	1988-10-18
K883719	Interconn. of Ophthalas & Nanolas Laser System	Biophysic Medical, Inc.	LQJ	Class II	1988-10-18
K883666	Quidel Allergy Screen	Ortho-Clinical Diagnostics, Inc.	DHB	Class II	1988-10-18
K883633	Ultracare	Jobst Institute, Inc.	DWL	Class II	1988-10-18
K883472	Closed Wound Suction Device	Westmark, Sterile Packing Systems, Inc. (Sps)	GCY	Class I	1988-10-18
K883392	Luminbond, Bonding and Cementation System	Scientific Pharmaceuticals, Inc.	EBF	Class II	1988-10-18
K883283	Disposable Amniotome	Galenica Enterprises, Inc.	HGG	Class II	1988-10-18
K883132	Nebulizer Pump Powered Models 020 and 050	Travelneb, Inc.	BTI	Class II	1988-10-18
K882053	Nicolet Epidural Spinal Electrode	Nicolet Instrument Corp.	GYC	Class II	1988-10-18