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 2026-11-02, 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 2425 of 3531

510(k) clearances, page 2425 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K912953	Gauze Compress	Cal West Trading Co.	NAB	Class I	1991-09-30
K912905	Laryngoscope	Acorn Group, Inc.	CCW	Class I	1991-09-30
K912779	Gauze Sponge,sterile 2'S	Keilei Intl., Inc.	NAB	Class I	1991-09-30
K912430	Dental Floss	Westone Products, Ltd.	JES	Class I	1991-09-30
K911323	Flux-N-All	Precident Corp.	EJH	Class II	1991-09-30
K911229	Phoenix Digital EEG System	Dantec Medical, Inc.	GWQ	Class II	1991-09-30
K911194	Impedance Phlebograph/photoplethysmograph-Dvt-2000	Rjl Systems, Inc.	DSB	Class II	1991-09-30
K910427	Memfix Screws	W. L. Gore & Associates, Inc.	DZL	Class II	1991-09-30
K903564	Medisensor 2001	Medtest Systems, Inc.	JGS	Class II	1991-09-30
K914104	Endostat	Laserscope	GEX	Class II	1991-09-27
K914103	Lifeline(r) Personal Response System	Lifeline Systems, Inc.	ILQ	Class II	1991-09-27
K914033	Cholestech Lipid Monitor Syst, Triglycerides Test	Cholestech Corp.	JGY	Class I	1991-09-27
K913920	Abbott Quickstart Albumin Test (Albg) Item #5A37	Em Diagnostic Systems, Inc.	CIX	Class II	1991-09-27
K913706	Abbott Quickstart Uric Acid Test (Urca) Item# 5A34	Em Diagnostic Systems, Inc.	KNK	Class I	1991-09-27
K913621	Rinn Protective X-Ray Apron and Protective Collar	Rinn Dental Products	EAJ	Class I	1991-09-27
K913483	Minnilert(r) Pressure Monitor	Medivators Inc	KOC	Class II	1991-09-27
K913470	Cedia(r) Gentamicin Assay	Microgenics Corporation	LCD	Class II	1991-09-27
K913409	Latex Examination Gloves	Top Glove Sdn. Bhd.	LYY	Class I	1991-09-27
K913298	Aia-Pack Ck-Mb	Tosoh Corp.	JHX	Class II	1991-09-27
K913162	Enzymun-Test Estradiol	Boehringer Mannheim Corp.	CHP	Class I	1991-09-27
K913133	Chality Control Material (Assayed & Unassayed)	Bionostics, Inc.	JJY	Class I	1991-09-27
K913130	Stratus Iintellect Immunoassay System	Baxter Healthcare Corporation	KHO	Class I	1991-09-27
K912975	Operand Lubricating Jelly	General Medical Co.	KMJ	Class I	1991-09-27
K912973	Endoscope Suture & Carrier	United States Surgical, A Division of Tyco Healthc	GCJ	Class II	1991-09-27
K912916	Apr Collar Spacer	Intermedics Orthopedics	JDI	Class II	1991-09-27
K912891	Heidelberg Retina Tomograph	Heidelberg Engineering GmbH	HLI	Class II	1991-09-27
K912852	Stratus(r) Ultra-Sensit Htsh Fluor Enzyme Immuno	Baxter Healthcare Corporation	JLW	Class II	1991-09-27
K912838	Bartels Respiratory Syncytial Virus Enzyme Immuno	Baxter Diagnostics, Inc.	LKT	Class I	1991-09-27
K912754	Abuscreen Radioimmunoassay for Methamphetamine	Roche Diagnostic Systems, Inc.	DPJ	Class II	1991-09-27
K912615	Roche Cobas Argos 5 Diff	Roche Diagnostic Systems, Inc.	GZI	Class II	1991-09-27
K912539	Signa Advantage 0.5T Magnetic Resonance System	GE Healthcare	LNH	Class II	1991-09-27
K912499	King Diagnostics Cholesterol Reagent Strip Test	King Diagnostics, Inc.	CHH	Class I	1991-09-27
K912454	Kodak Ektascan Xlp Preliminary Dv2000 Interface	Eastman Kodak Company	JAK	Class II	1991-09-27
K912447	Series 5000 Endoscope Console Models 5100 and 5200	Medical Laser, Inc.	FET	Class II	1991-09-27
K912172	Safewedge(tm) Relief Valve Device	Sunscope Intl., Inc.	KRB	Class II	1991-09-27
K912060	Mentor Black Light Injection Stent Set	Mentor	FAD	Class II	1991-09-27
K911630	Laparoscopic Cholangiography Catheter with Balloon	Baxter Healthcare Corporation	FGE	Class II	1991-09-27
K911464	Interson Disposable Biopsy Needle	Interson Corp.	IYO	Class II	1991-09-27
K911366	Protector Disposable TENS and Nmes Electrode	Medical Design & Manufacturing Corp.	GXY	Class II	1991-09-27
K911337	Prospec T/giardia Rapid Assay	Alexon, Inc.	MHI	Class II	1991-09-27
K912322	Mega Spinal Anesthesia Kit	Mega Medical, Inc.	CAZ	Class II	1991-09-26
K914132	Wiltek Electrocautery Active Cord	Wiltek Medical, Inc.	GEI	Class II	1991-09-25
K914131	Wiltek Electrocautery Adaptor	Wiltek Medical, Inc.	GEI	Class II	1991-09-25
K913918	Heraeus Lasersonics Tactilase Sterile Dispos Fiber	Heraeus Lasersonics, Inc.	GEX	Class II	1991-09-25
K913902	B-D(r) Hypoallergeniic Non-Sterile Pat Exam Gloves	BD Becton Dickinson Vacutainer Systems Preanalytic	LYZ	Class I	1991-09-25
K913866	Urine Amphetamine Direct Ria Kit (I-125)	Immunalysis Corporation	DJP	Class II	1991-09-25
K913792	Hi Chem Low/mid/high Aqueous Glucose Control	Hichem Diagnostics	JJX	Class I	1991-09-25
K913777	Self-Contained Surgical Slush Freezer	Taylor Corp.	JRM	Class I	1991-09-25
K913677	Acs Therapeutic Drug Monit Contols, Level I,ii,iii	Analytical Control Systems	LAS	Class I	1991-09-25
K913500	Cherry Sponge	O.R. Concepts, Inc.	GCJ	Class II	1991-09-25