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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3079 of 3528

510(k) clearances, page 3079 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K841560	Mueller-Hinton Broth	Gibco Laboratories Life Technologies, Inc.	JTZ	Class II	1984-05-07
K841492	Ab Vacuum Extractor Silc-Cup	Medela AG	HDB	Class II	1984-05-07
K841398	Variable Height Transfer Chair	Setma, Inc.	FSA	Class I	1984-05-07
K841396	Transfer Trolley	Setma, Inc.	FDA	Class II	1984-05-07
K841395	Shower Trolley	Setma, Inc.	FSA	Class I	1984-05-07
K841382	Empi Model 712, Logix, Nms	Empi	IPF	Class II	1984-05-07
K841259	Determination of Magnesium in Serum or	Sigma Chemical Co.	JGJ	Class I	1984-05-07
K841094	Human Growth Hormone Ria Kit	Siemens Healthcare Diagnostics Inc.	CFL	Class I	1984-05-07
K841081	Ventrezyme Beta-Hcg Immunoassay Hcg	Ventrex Laboratories, Inc.	JHI	Class II	1984-05-07
K841076	Ion Selective Electrode	Cooper Biomedical, Inc.	JJE	Class I	1984-05-07
K840768	Centrifuges	Heraeus-Christ GmbH	JQC	Class I	1984-05-07
K840723	Sween-a-Peel Peristomal Wafers	Sween Corp.	EXB	Class I	1984-05-07
K840549	Ck-B Ria Kit	Diagnostic Systems Laboratories, Inc.	JHX	Class II	1984-05-07
K840494	Microtrak Hsv 1 & 2 Culture	Syva Co.	GQL	Class II	1984-05-07
K840295	Ambularm	Rigi Systems, Inc.	KMI	Class I	1984-05-07
K840222	Corning Immo Phase Free T3	Corning Medical & Scientific	CDP	Class II	1984-05-07
K840088	Biodex Act-O-Kit Tsh-Ria-	Biodan Medical Systems, Ltd.	JLW	Class II	1984-05-07
K834595	Paragon Acid Hemoglobin Reagent Kit	Beckman Instruments, Inc.	GKA	Class II	1984-05-07
K833310	Fogcutter Dental Mouth Mirror	Hti, Inc.	EAX	Class I	1984-05-07
K841637	Three Port Sensor Manifold	Dryden Corp.	BZO	Class I	1984-05-02
K841608	Model 3000 Hyperbaric Chamber	Custom Craft Products, Inc.	CBF	Class II	1984-05-02
K841532	Aca Tricyclic Antidepressants Screen Tes	E.I. Dupont de Nemours & Co., Inc.	LFG	Class II	1984-05-02
K841488	Decalcifier I	Surgipath Medical Industries, Inc.	KDX	Class I	1984-05-02
K841461	Coagulation Control Plasma Level 1/2/3	Diatech, Inc.	GGP	Class II	1984-05-02
K841460	Rim Gardnerella Vaginalis Kit	Austin Biological Laboratories	JTO	Class I	1984-05-02
K841453	Differentiation Disks Spectinomycin	Difco Laboratories, Inc.	JTO	Class I	1984-05-02
K841390	Code-a-Well	Plastic Injectors, Inc.	LIB	Class I	1984-05-02
K841389	Rim-Dnase Kit	Austin Biological Laboratories	JSF	Class I	1984-05-02
K841378	Vent-Well Ventilator Tubing	Airmed Corp.	BZO	Class I	1984-05-02
K841376	Wellcogen S. Pneumoniae	Wellcome Diagnostics	GWC	Class I	1984-05-02
K841352	Nd1200 Ria Counter	Nuclear Data, Inc.	JJJ	Class I	1984-05-02
K841348	Umbrella Keel	E. Benson Hood Laboratories, Inc.			1984-05-02
K841347	Laryngeal Stent	E. Benson Hood Laboratories, Inc.	FWN	Class II	1984-05-02
K841333	Progesterone Direct Ria Kit-Radioimm	Biotecx Laboratories, Inc.	JLS	Class I	1984-05-02
K841329	Rim Onpg Kit	Austin Biological Laboratories	JTO	Class I	1984-05-02
K841328	Spc Arthroscopy Table	Surgical Products Corp.			1984-05-02
K841308	Directigen Menningitis Test Kit	BD Becton Dickinson Vacutainer Systems Preanalytic	GTI	Class II	1984-05-02
K841299	Bierman Biopsy Needle	Popper & Sons, Inc.	GDM	Class I	1984-05-02
K841288	Elvi 18	Logos Scientific, Inc.	JJN	Class I	1984-05-02
K841257	Sta-Potent System	Nu-Potent	LKY	Class II	1984-05-02
K841247	Spc Disposable Cutter	Surgical Products Corp.	FZT	Class I	1984-05-02
K841239	Assigned Value for Mean Platelet	Coulter Electronics, Inc.	JPK	Class II	1984-05-02
K841224	Uro-Male Incontinence Catheter	Gil-Med Industries C/O Kegan & Kegan, Ltd.	KNX	Class II	1984-05-02
K841162	Immpulse Gentamicin Assay Reagents	Paragon Diagnostics, Inc.	LCQ	Class II	1984-05-02
K841161	Immpulse Amikacin Assay Reagents	Paragon Diagnostics, Inc.	KLQ	Class II	1984-05-02
K841080	Technicon Ra-1000 Sys CO2	Technicon Instruments Corp.	CHS	Class II	1984-05-02
K841020	Fibrinogen Assay Kit	Helena Laboratories, Corp.	KQJ	Class II	1984-05-02
K840925	Pedia-Trake Cricothyrotomy Kit	Intl. Medical Devices, Ltd.	BTO	Class II	1984-05-02
K840752	Enterocysis Tube W/guide Wire & Connect	E-Z-EM, Inc	KNT	Class II	1984-05-02
K840701	Pacemaker 147 Vvi-the Optinia	Telectronics, Inc.	DXY	Class III	1984-05-02