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 2026-10-21, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 3014 of 3529

510(k) clearances, page 3014 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K850512	Dmem-Dulbecco's Minimum Essential Medium	Mediatech, Inc.	KIT	Class I	1985-02-27
K850511	Emem-Earle's Minimum Essential Med. W/glutamine-Ea	Mediatech, Inc.	KIT	Class I	1985-02-27
K850396	Roche Standards for Chloride & CO2	Roche Diagnostic Systems, Inc.	JIX	Class II	1985-02-27
K850356	Pruitt-Vascular Shunts	Ideas for Medicine, Inc.	DWF	Class II	1985-02-27
K850333	Pump Tube Sets for Hema-Tek I & II Slide Stainers	Shaban Mfg. Co.	KPA	Class I	1985-02-27
K850267	Sparco Piggy-Back Pole-Intravenous Transport Pole	Sparco, Inc.			1985-02-27
K850260	Gleman Acd-2020 Automatic Computing Densitometer	Gelman Sciences, Inc.	JQT	Class I	1985-02-27
K850209	Quick-Lyte	Seragen Diagnostics, Inc.	JGS	Class II	1985-02-27
K850157	Cannulas for Hema-Tek I & Kk Slide Stainers	Shaban Mfg. Co.	KPA	Class I	1985-02-27
K850092	Dulbecco's Modified Eagle's Med. (Dme) W/glucose a	Sigma Chemical Co.	KIT	Class I	1985-02-27
K850091	Basal Med. Eagle(bme) W/earle's Salts, L-Glutamine	Sigma Chemical Co.	KIT	Class I	1985-02-27
K850090	Dulbecco's Modified Eagle's Med. (Dme) W/1000 Mg/l	Sigma Chemical Co.	KIT	Class I	1985-02-27
K850089	Minimum Essential Med. (Mem) W/earle's Sals L-Glut	Sigma Chemical Co.	KIT	Class I	1985-02-27
K850085	Disposable ECG Electrodes Easatrace	Medical Device Marketing	DRX	Class II	1985-02-27
K845014	Med. 199 W/earle's Salts, L-Glutamine & 25Mm Hepes	Sigma Chemical Co.	KIT	Class I	1985-02-27
K845013	Rpmi-1640 Med. W/l-Glutamine & 25Mm Hepes & W/o So	Sigma Chemical Co.	KIT	Class I	1985-02-27
K845012	Nutrient Mixture F-10 -Ham, N 1387, W/l-Glutamine	Sigma Chemical Co.	KIT	Class I	1985-02-27
K844933	Bile Esculin Agar	American Laboratory Supply, Inc.	JSI	Class I	1985-02-27
K844932	Malt Agar	American Laboratory Supply, Inc.	JSJ	Class I	1985-02-27
K844931	Mycological Agar W/antibiotics	American Laboratory Supply, Inc.	JSJ	Class I	1985-02-27
K844930	Brillant Green Agar	American Laboratory Supply, Inc.	JSI	Class I	1985-02-27
K844929	Inhibitory Mold Agar	American Laboratory Supply, Inc.	JSJ	Class I	1985-02-27
K844771	Infraview/infrasion-Telethermographic System	Image Systems, Inc.	LHQ	Class I	1985-02-27
K844497	Austenal a-79 Crown & Bridge Casting Alloy	Austenal Dental, Inc.	EJH	Class II	1985-02-27
K844423	Coat-a-Count Free Testosterone Kit & Components	Siemens Healthcare Diagnostics Inc.	CDZ	Class I	1985-02-27
K844413	Ultroser G	Lkb Instruments, Inc.	JJY	Class I	1985-02-27
K844087	Xanar Model Xse-300 Smoke Evaculater	Xanar, Inc.	FYD	Class II	1985-02-27
K833679	Laser Protective Eyeshield	Stefanovsky & Assoc.			1985-02-27
K850611	Attends Incontinent Undergarment	Procter & Gamble Mfg. Co.	EYQ	Class I	1985-02-26
K850462	Concept Camera Drape	Concept, Inc.			1985-02-26
K850438	Renal Biopsy Tray	Packaging Technologies, Inc.	KNW	Class II	1985-02-26
K850436	Stat Blue Dispos. Manual Resuscitator	Vital Signs, Inc.	BTM	Class II	1985-02-26
K850327	Pall Gas Line Guardian Filter	Pall Biomedical Products Co.	CAH	Class II	1985-02-26
K850326	Sterile Film Drape Fenestrated W/adhesive Patch	Excel Health Care Products	KKX	Class II	1985-02-26
K850325	Sterile Suture Removal Kit	Excel Health Care Products	KDD	Class I	1985-02-26
K845030	Cronex Sr342-Quanta Fast Detail-Intensi-Screens	E.I. Dupont de Nemours & Co., Inc.	EAM	Class I	1985-02-26
K844961	Incus Prosthesis	Richards Medical Co., Inc.	ETB	Class II	1985-02-26
K844960	Canal Wall Prosthesis	Richards Medical Co., Inc.	FZD	Class II	1985-02-26
K844714	Selectron Ldr Selectron Low Dose Rate	Radiochemical Co.	JAQ	Class II	1985-02-26
K844681	EMG Report Generator	Microsystem Controls	JXE	Class II	1985-02-26
K844622	Sav-a-Life	Southern Medical Products, Inc.	CAN	Class I	1985-02-26
K844317	Dmi Console	Dimensional Medicine, Inc.	LLZ	Class II	1985-02-26
K843974	Variable Temperature Cautery Device	National Patent Development Corp.	GEI	Class II	1985-02-26
K843696	Ophthalmic a-Scan a-2000 Sonome	Sonomed Technology, Inc.	IYO	Class II	1985-02-26
K843423	Physio Gas Analyzer	Research Medical, Inc.	LLL	Class II	1985-02-26
K842887	Herpes Virus Agglutination Test	Scientific Research	GQO	Class II	1985-02-26
K850341	Cardiovascular Set Up	Marwood Medical, Inc.	DQO	Class II	1985-02-25
K850337	Cardiac Catheterization Pack	Marwood Medical, Inc.	DRE	Class II	1985-02-25
K850242	Crystal Manual Breast Pump	Crystal Medical Products, Inc.	HGY	Class I	1985-02-25
K844975	Scented Breathable Mini-Shield Private Label Brand	I.C.D. Industries, Inc.	HHL	Class II	1985-02-25