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 1866 of 3531

510(k) clearances, page 1866 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K973112	Elecsys Digoxin	Boehringer Mannheim Corp.	KXT	Class II	1997-10-10
K972977	Insulator Wire Guide	Cook Incorporated	KNY	Class II	1997-10-10
K972964	Atrion Medical Balloon Catheter Inflation Device	Atrion Medical Products, Inc.	KOE	Class II	1997-10-10
K972823	Mini-Embryon Intra Uterine Insemination Catheter	A & A Medical, Inc.	MFD	Class II	1997-10-10
K972799	Dried Gram-Positive Mic/combo Panels	Dade Microscan, Inc.	LTT	Class II	1997-10-10
K972796	Sigma Diagnostics Thrombomax with Calcium	Sigma Diagnostics, Inc.	GJS	Class II	1997-10-10
K972727	Cbalk-1000 Blade	Howard Instruments, Inc.	HNO	Class I	1997-10-10
K972684	Innerdyne Radially Expanding Vascular Access System	Innerdyne, Inc.	DYB	Class II	1997-10-10
K972664	Storz Millennium Viscous Fluid System	Storz Instrument Co.	MRH	Class II	1997-10-10
K972607	Platalloy	Aalba Dent, Inc.	EJH	Class II	1997-10-10
K972495	Accumeter Theophylline Test	Chemtrak, Inc.	KLS	Class II	1997-10-10
K971896	Galileo High Resolution Micro Coupler	Netoptix Corp.	HET	Class II	1997-10-10
K971628	Somanetics Invos 3100A Cerebral Oximeter (Invos)	Somanetics Corp.	DQA	Class II	1997-10-10
K965112	Medline Catheterization Laboratory Trays/kits/packs	MEDLINE INDUSTRIES, LP - Northfield	DQO	Class II	1997-10-10
K964056	Rusch Ultra Tracheoflex Fenestrated Kit Cuffed,uncuffed/ Rusch Tracheoflex Tracheostomy Kit Uncuffed Sterile	Rusch Intl.	JOH	Class II	1997-10-10
K963136	Pacer Model 100 Infusion Controller	Health Watch, Inc.	LDR	Class II	1997-10-10
K962774	Osteomed Quickfix	Osteomed	DZL	Class II	1997-10-10
K961008	Automix 3+3/As Compounder System	Baxter Healthcare Corporation	LHI	Class II	1997-10-10
K973418	Universal/1000 Series(101s101sdu1100)/rolls 2000(2000E)/transport(m4)	Assembly Required Dist., Inc.	IOR	Class I	1997-10-09
K973177	Mago Automated Eia Processor	Diamedix Corp.	JJF	Class I	1997-10-09
K973075	Ontrak Teststik for Amphetamines, Ontrak Teststik for Cocaine, Ontrak Teststik for Morphine, Ontrak Teststik for Pcp, on	Roche Diagnostic Systems, Inc.	DKZ	Class II	1997-10-09
K973062	Twist Reciprocating Disposable Prophy Angle	Medidenta Intl., Inc.	EFA	Class I	1997-10-09
K973015	Multitak Ss Suture System	Bonutti Research, Inc.	MBI	Class II	1997-10-09
K972876	Glucotrend Basic System	Boehringer Mannheim Corp.	LFR	Class II	1997-10-09
K972813	Gamma Locking Nail System	Howmedica Corp.	HSB	Class II	1997-10-09
K972641	Dual Offset Perfecta Imc Hip Stem	Wrightmedicaltechnologyinc	JDI	Class II	1997-10-09
K972629	Depuy Ae Tk2 Hip Screw System	Depuy, Inc.	KTT	Class II	1997-10-09
K972622	Straight-in Bone Screw Fixation System	Influence, Inc.	MBI	Class II	1997-10-09
K972130	Disposable Camera Cover, Enclosed: Disposable Camera Cover, Perforated: Disposable Microscope Cover (Various):x-Ray Covr	Fairmontmedical	IZJ	Class II	1997-10-09
K971858	Sigma Diagnostics Fibrinogen Kit (886A/887a)	Sigma Diagnostics, Inc.	KQJ	Class II	1997-10-09
K971320	Cre Balloon Dilatation Catheter	Boston Scientific Corporation	KNQ	Class II	1997-10-09
K971281	Raulerson One-Step Guidewire Insertion Bulb Needle	Medcomp	DQX	Class II	1997-10-09
K964434	Sd-970Ems Electrical Muscular Stimulator	Skylark Device Co., Ltd.	IPF	Class II	1997-10-09
K962977	MRI Compatible Biopsy Needles	Argon Medical Devices, Inc	KNW	Class II	1997-10-09
K973589	Liquid Ldh-L Reagent Set	Horiba Instruments Incorporated	CFJ	Class II	1997-10-08
K973342	Dar-3000B	Shimadzu Corp.	IZI	Class II	1997-10-08
K973329	Shimadzu Whole Body X-Ray Computed Tomography Scanner Sct-6800Tx	Shimadzu Medical Systems	JAK	Class II	1997-10-08
K973327	Shimadzu Whole Body X-Ray Computed Tomography Scanner Sct-6800Th	Shimadzu Medical Systems	JAK	Class II	1997-10-08
K973219	Amber Du	Oldelft Corp. of America	KPR	Class II	1997-10-08
K973125	Mammoloader by C.m.a. Srl	C.M.A.	IXW	Class II	1997-10-08
K973073	Drts Image Intensifier Drape	Minrad, Inc.	JAA	Class II	1997-10-08
K972986	Accurun 140 Rubella Igg Positive Control	Boston Biomedica, Inc.	MJX	Class I	1997-10-08
K972968	Rotograph Plus	Chicago X-Ray Systems, Inc.	EHD	Class II	1997-10-08
K972926	Mvm 7.5 French Flexible Choledochoscope	Karl Storz Endoscopy-America, Inc.	FBN	Class II	1997-10-08
K972922	Vyker Silicone Epistaxis Catheter V-27030, Vyker Silicone Epistaxis Catheter Kit V-2703K	Interview Medical Technology Corp.	EMX	Class I	1997-10-08
K972815	Partial/total/porous Polyethylene Ossicular Replacement	Grace Medical, Inc.	ETB	Class II	1997-10-08
K972778	Dey Vial Sodium Chloride 3%	Dey Laboratories, Inc.	CAF	Class II	1997-10-08
K972726	Snap Swab Culture Collection and Transport System	Medical Packaging Corporation	JSM	Class I	1997-10-08
K972654	Manifold	Medical Specialties Intl., Inc.	DTL	Class II	1997-10-08
K972612	Dissectron Portable Unit	Satelec	LBK	Unclassified	1997-10-08