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 2026-10-29, 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 2673 of 3530

510(k) clearances, page 2673 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K883661	Modified Universal Acetabular Cup System (Uacs)	Depuy, Inc.	LWJ	Class II	1989-02-08
K883660	Dermastrip	BD Becton Dickinson Vacutainer Systems Preanalytic	KGX	Class I	1989-02-08
K883412	The Carpentier Trans-Mitral Ventricular Vent(tm)	Promedica Products, Inc.	DWF	Class II	1989-02-08
K883274	Surgitek (R) Uroflow System	Medical Engineering Corp.	FFG	Class II	1989-02-08
K883111	Heomdialysis Single Patient System (Sps) Model 650	Baxter Healthcare Corporation	FKP	Class II	1989-02-08
K883102	Virgo (R) Cmv-Igg Elisa	Electro-Nucleonics, Inc.	GQI	Class II	1989-02-08
K882933	Daca-100	Visual Cybernetics	LLZ	Class II	1989-02-08
K882322	Continuum Knee System (Cks)	Buckman Co., Inc.	JWH	Class II	1989-02-08
K890399	Modified D-Di-Test Kit	American Bioproducts Co.	GHH	Class II	1989-02-07
K890339	Difco Director Inoculation System	Difco Laboratories, Inc.	LIE	Class II	1989-02-07
K890279	Modified Model 1000 Optilase(tm) Nd:yag Laser	Trimedyne, Inc.	GEX	Class II	1989-02-07
K890184	Modified Intended Use of Cleaning Reagent Kit	Hichem Diagnostics	JJE	Class I	1989-02-07
K890183	Modified Intended Use on Cleaning Neutralizer Sol.	Hichem Diagnostics	JJE	Class I	1989-02-07
K890154	Modified Labysystems' Toxoplasma Gondii Igg Eia	Labsystems, Inc.	LGD	Class II	1989-02-07
K885289	Kodak Ektachem 700 Analyzer Family, Soft V5.0	Eastman Kodak Company	JJE	Class I	1989-02-07
K885288	High Volume Profiler & Data Enhancement Package	Eastman Kodak Company	JJE	Class I	1989-02-07
K885269	Addit. Allergens to Include Foods for Allerg*ens	Dexall Biomedical Labs, Inc.	DHB	Class II	1989-02-07
K885266	Olympus Triglycerides Reagents #Sr1021	Em Diagnostic Systems, Inc.	CDT	Class I	1989-02-07
K885138	Capillary Tube, Blood Collection	Coeur Laboratories, Inc.	GIO	Class I	1989-02-07
K885004	Bactigen(r) N. Meningitidis	Armkel, LLC	GTJ	Class II	1989-02-07
K885003	Bactigen(r) Group B Streptococcus Test	Armkel, LLC	GTZ	Class I	1989-02-07
K884967	Bactigen(r) H. Influenzae Type B	Armkel, LLC	GRP	Class II	1989-02-07
K884966	Bactigen(r) S. Pneumoniae	Armkel, LLC	GWC	Class I	1989-02-07
K884965	Bactigen(r) Meningitidis Panel	Armkel, LLC	GWC	Class I	1989-02-07
K884358	Cedia Theophylline Assay	Microgenics Corporation	KLS	Class II	1989-02-07
K883937	Ortho* Toxoplasma-G Antibody Elisa Test	Ortho Diagnostic Systems, Inc.	LGD	Class II	1989-02-07
K883170	Stanbio Magnesium Test Set, Cat. No 0130	Stanbio Laboratory	JGJ	Class I	1989-02-07
K874389	Crack-It Chap Screen	Sakers, Inc.	DMN	Class II	1989-02-07
K890191	Handling & Cutting Device for Iridium-192 Wire Pin	Amersham Corp.	IWJ	Class I	1989-02-06
K890142	A10 Ultrascope Recorder	Ems Medical, Inc.	DSF	Class I	1989-02-06
K890059	Sharplan Combined Co2/nd:yag Laser Micro. #749	Sharplan Lasers, Inc.	GEX	Class II	1989-02-06
K890033	Model 8700 Pulse Oximeter	Nonin Medical, Inc	DQA	Class II	1989-02-06
K885188	Modified Rt. Artrial and 13.5X11.5f Cath. Tray	Quinton, Inc.	DWF	Class II	1989-02-06
K885136	Graft Guard	Sorex Medical	LZM	Class I	1989-02-06
K885095	Supreme Toning Systems	Supreme Toning Systems	BXB	Class I	1989-02-06
K884946	Jehle Coronary Perfusion Catheters	Pilling Co.	KRA	Class II	1989-02-06
K884895	Acs 0.010 Hi-Torque Floppy Gold Guide Wire	Advanced Cardiovascular Systems, Inc.	DQX	Class II	1989-02-06
K884887	Model 499 Ssr Analysis System	Del Mar Avionics	DSI	Class II	1989-02-06
K884775	Arbo Pink H82p	Arbo Medical, Inc.	DRX	Class II	1989-02-06
K884536	Al-800Pa Pulse Oximeter Module	Nihon Kohden America Inc	DQA	Class II	1989-02-06
K884425	Glove, Surgical	Med-Pak Corp.	KGO	Class I	1989-02-06
K890381	Parametrium Clamp	Kinetic Medical Products	HXD	Class I	1989-02-03
K890374	Abdominal Spatula	Kinetic Medical Products	GAF	Class I	1989-02-03
K890373	Hemorrhoidal Forceps	Kinetic Medical Products	HTD	Class I	1989-02-03
K890372	Intestinal Clamp	Kinetic Medical Products	HXD	Class I	1989-02-03
K890371	Intestinal Crushing Clamp	Kinetic Medical Products	HXD	Class I	1989-02-03
K890369	Gall Stone Forceps	Kinetic Medical Products	HTD	Class I	1989-02-03
K890368	Kidney Clamp	Kinetic Medical Products	HXD	Class I	1989-02-03
K890366	Adenoid Curette	Kinetic Medical Products	FZS	Class I	1989-02-03
K890365	Septum Elevator	Kinetic Medical Products	GEG	Class I	1989-02-03