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 2026-10-26, 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 2714 of 3530

510(k) clearances, page 2714 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K882989	Dulbecco's Modified Eagle's Medium No. 210-3502	J R Scientific	KIT	Class I	1988-08-04
K882988	Dulbecco's Modified Eagle's Medium No. 210-3540	J R Scientific	KIT	Class I	1988-08-04
K882987	Dulbecco's Modified Eagle's Medium No. 200-2009	J R Scientific	KIT	Class I	1988-08-04
K882986	Mccoy's 5A Medium No. 210-3530	J R Scientific	KIT	Class I	1988-08-04
K882985	Fischer's Medium No. 200-2184	J R Scientific	KIT	Class I	1988-08-04
K882984	Medium 199, No. 200-2035	J R Scientific	KIT	Class I	1988-08-04
K882983	Medium 199, Catalog No. 210-3535	J R Scientific	KIT	Class I	1988-08-04
K882965	Krebs-Henseleit Bicarbonate Buffer No. K3753	Sigma Chemical Co.	KIT	Class I	1988-08-04
K882958	Sony Video Printers, Up Series	Sony Medical Electronics Co.	KQM	Class I	1988-08-04
K882902	Qrk 100, Qualitative Ring Keratoscope	Technitex, Inc.	HLR	Class I	1988-08-04
K882884	Storz Infusion Cannula	Storz Instrument Co.	HMX	Class I	1988-08-04
K882829	Circulating Immune Complexes Controls	Cytotech, Inc.	DAK	Class II	1988-08-04
K882822	Fiagen Ferritin	Cyberfluor, Inc.	DFL	Class II	1988-08-04
K882750	Ocu-Film Tip Cover	Oculab, Inc.	HKY	Class II	1988-08-04
K882626	Pharmacia Ige Eia Ultra	Pharmacia, Inc.	DGC	Class II	1988-08-04
K882616	Alternate Procedure, Pharmacia Ige Eia	Pharmacia, Inc.	JHR	Class II	1988-08-04
K882483	Fti 200 Medical Thermal Imager	FUJIFILM Healthcare Americas Corporation	LMC	Class II	1988-08-04
K882436	Laser - 1000	Panoramic Corp.	EHD	Class II	1988-08-04
K882314	Coronary Vein Graft Marker	Med-Edge, Inc.	DSY	Class II	1988-08-04
K882252	Phase II Lh Kit	Vitek Systems, Inc.	CEP	Class I	1988-08-04
K882194	Geminii Gamma Counter	Laboratory Technologies, Inc.	JJE	Class I	1988-08-04
K882153	Technicon Dpa-1(Tm) System	Technicon Instruments Corp.	DCF	Class II	1988-08-04
K882127	Clinical Electronic Thermometers	Sheridan Catheter Corp.	FLL	Class II	1988-08-04
K882117	Ethyl Alcohol Standard	Verichem Laboratories, Inc.	DNN	Class II	1988-08-04
K881976	Catheter, Intravascular	Primrose Medical, Inc.	FOZ	Class II	1988-08-04
K881886	Modified X-Ray Controls, Model Ed125l and Ed150l	U.S. Imaging, Inc.	IZO	Class I	1988-08-04
K881808	Emerson Chest Respirator, Model 33-Cre	J. H. Emerson Co.	BYT	Class II	1988-08-04
K881608	Merifluor(tm) Pneumocystis	Meridian Diagnostics, Inc.	LYF	Class II	1988-08-04
K881425	Captia(r) Syphilis-G	Mercia Diagnostics, Ltd.	LIP	Class II	1988-08-04
K881335	Bear 3 Ventilator	Bear Medical Systems, Inc.	CBK	Class II	1988-08-04
K880748	Ball Tip Fulgurating Electrode, 3 French	Cook Incorporated	KNS	Class II	1988-08-04
K880200	Exl-14 Medical Linear Accelerator	Mitsubishi Intl. Corp.	IYE	Class II	1988-08-04
K883060	Storz Microsurgical Bipolar Coagulator	Storz Instrument Co.	GEI	Class II	1988-08-03
K883018	Auto Suture Disp. Endoscopic Surg. Clip Applier	United States Surgical, A Division of Tyco Healthc	FZP	Class II	1988-08-03
K882956	Vital-Vue Illumination, Suction and Irrigation	Vital Metrics, Inc.	HBI	Class II	1988-08-03
K882724	Microtek Probe Drape	Microbio-Medics, Inc.	KKX	Class II	1988-08-03
K882712	Stick Sponge	Bioseal	EFQ	Unclassified	1988-08-03
K882711	Gauze Sponge 12Ply	Bioseal	EFQ	Unclassified	1988-08-03
K882710	Intestinal Sponges	Bioseal	EFQ	Unclassified	1988-08-03
K882709	Tonsil Sponge, X-Ray Detectable, W/string	Bioseal	GDY	Class I	1988-08-03
K882708	Gauze Sponge, X-Ray Detectable	Bioseal	GDY	Class I	1988-08-03
K882707	Gauze Packing, X-Ray Detectable	Bioseal	GDY	Class I	1988-08-03
K882684	Repak Surgical Packs - Gown/towel/major/drape/bas.	Standard Textile Co., Inc.	LRO	Class II	1988-08-03
K882516	Three-Component Medical Laser Gas Mixtures	Matheson Gas Products, Inc.	GEX	Class II	1988-08-03
K882470	Sterile Disposable Surgical Gowns	Bolden Products, Div. of the Transport Group	FYA	Class II	1988-08-03
K882208	Mediblend (Tm) Medical Laser Gas Mixtures	Linde Div. Union Carbide Corp.	GEX	Class II	1988-08-03
K882024	Fitc Murine Monoclonal Anti-Cmv Igg	Whittaker Bioproducts, Inc.	GQH	Class II	1988-08-03
K882023	Fiax Test Kit for Eb-Vca-G Antibody	Whittaker Bioproducts, Inc.	LSE	Class I	1988-08-03
K881897	Acs Hi-Torque Floppy/floppy Ii/inter./standard Gw	Advanced Cardiovascular Systems, Inc.	DQX	Class II	1988-08-03
K880604	Colorgene Hsv DNA Hybridization Test	Enzo Biochem, Inc.	GQN	Class II	1988-08-03