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 2557 of 3530

510(k) clearances, page 2557 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K900240	Delfia Tbg Kit	Pharmacia, Inc.	CEE	Class II	1990-03-30
K900173	Hycor Accupinch Morphine Test	Hycor Biomedical	DJG	Class II	1990-03-30
K900121	Roche Reagent for Ldh	Roche Diagnostic Systems, Inc.	CFJ	Class II	1990-03-30
K897183	Synchron El-Ise(tm) Electrolyte Systems	Beckman Instruments, Inc.	JFL	Class II	1990-03-30
K897133	Model 1050 - Umbilical Cord Blood Sampling Kit	Transidyne General Corp.	CBT	Class I	1990-03-30
K897125	Atrium 2000, Chest Drain	Atrium Medical Corporation	KDQ	Class II	1990-03-30
K896873	Coulter Jt3	Coulter Corp.	GKZ	Class II	1990-03-30
K896731	Oxygen Catheters	Unoplast A/S	BZB	Class I	1990-03-30
K896730	Suction Catheter Straight/coude	Unoplast A/S	BSY	Class I	1990-03-30
K895589	Manual Resuscitator	Hudson Oxygen Therapy Sales Co.	BTM	Class II	1990-03-30
K901265	Coulter Magnesium Reagent	Coulter Corp.	JGJ	Class I	1990-03-29
K901122	Technicon Chem 1 Clinical Analyzer Urine Glucose	Technicon Instruments Corp.	CFR	Class II	1990-03-29
K901113	Matrix Plus(tm) Chemistry Reference Standard	Verichem Laboratories, Inc.	JIS	Class II	1990-03-29
K901090	Elitech Gamma Gt Test Kit	Elite Technology, Inc.	JPZ	Class I	1990-03-29
K901045	Hcg Solid Phase Component System	BD Becton Dickinson Vacutainer Systems Preanalytic	JHI	Class II	1990-03-29
K900850	Emds Cholesterol (Cho), Item Numbers 65410	Em Diagnostic Systems, Inc.	CHH	Class I	1990-03-29
K900680	Effner Arthroperiscope/arthroscope W/remov. Optics	Effner, Inc.	HRX	Class II	1990-03-29
K900060	Free T4 Immunoassay Kit	Advanced Magnetics, Inc.	CEC	Class II	1990-03-29
K900021	Percu-Set(tm)	E-Z-EM, Inc	HIO	Class I	1990-03-29
K900009	Nds Theophylline Test Kit & Nds Tdm Calibrator Set	Kallestad Diag, A Div. of Erbamont, Inc.	KLS	Class II	1990-03-29
K897162	Coulter Cholesterol Reagent	Coulter Electronics, Inc.	CHH	Class I	1990-03-29
K897072	Nds Thyroxine Test Kit & Nds Thyroxine Calibrator	Kallestad Diag, A Div. of Erbamont, Inc.	KLI	Class II	1990-03-29
K897015	Glucometer Gx Blood Glucose Meter	Kulzer GmbH	CGA	Class II	1990-03-29
K896391	Bard/angiomed Stents	C.R. Bard Inc	FGE	Class II	1990-03-29
K901279	Chatham Industries Nasopharyngeal Airway	Chatham Industries	BTQ	Class I	1990-03-28
K901255	Cuff Baro Guard or Cbg Abbreviated	Nelson Engineering, Inc.	BSK	Class II	1990-03-28
K901108	Fiberlume	Burton Corporation	HBI	Class II	1990-03-28
K901013	Radiographic Film Cassette	Infab, LLC.	IXA	Class II	1990-03-28
K901012	Radiographic Grid	Infab, LLC.	IXJ	Class I	1990-03-28
K900989	Athena-HF Mammographic X-Ray System	Fischer Imaging Corp.	IZH	Class II	1990-03-28
K900843	Oximax 100	Pace Tech, Inc.	DQA	Class II	1990-03-28
K900649	Fluorescent T12 Uva Lamp	Light Sources, Inc.	FTC	Class II	1990-03-28
K900601	Sarns Delphin Base Adapter with Mini-Battery	3M Company	KFM	Class II	1990-03-28
K900436	Protemp II	Espe GmbH (US)	EBG	Class II	1990-03-28
K900339	Hand-Held Intracardiac Suckers W/ergonomic Handles	Shiley, Inc.	DTS	Class II	1990-03-28
K900291	Mass Spectrometry Monitoring Lines and Connectors	F.L.W. Plastics, Inc.	CCK	Class II	1990-03-28
K900132	Acufex Sterile Cannulated Interference Screw;	Acufex Microsurgical, Inc.	HWC	Class II	1990-03-28
K900130	Modified Seismocardiograph	Seismed Instruments, Inc.	DSB	Class II	1990-03-28
K900113	Respironics' Remstar(tm) Sleepeasy	Respironics, Inc.	BYE	Class II	1990-03-28
K897190	Look Temporary Intracanalicular Collagen Implant	Look, Inc.	LZU	Unclassified	1990-03-28
K896308	Cordis Shuttle Catheter	Cordis US Corp.	DQO	Class II	1990-03-28
K896245	Plak Trac Powered Toothbrush	Windmere Corp.	JEQ	Class I	1990-03-28
K896118	Nezhat/dorsey Hydro Dissection Pump Ob-Gyn Use	American Surgical Instruments Corp.	HET	Class II	1990-03-28
K895791	Oxymax	Columbus Instruments Intl. Corp.	BZL	Class II	1990-03-28
K895463	Osseodent(r) Precision Dental Attachments	Collagen Corp.	DZE	Class II	1990-03-28
K894784	Modified Shiley Femoral Venous Cannula	Shiley, Inc.	DQR	Class II	1990-03-28
K894657	Polystan Heart-Lung Machine System	Polystan C/O Vitalcor, Inc.	DJQ	Class II	1990-03-28
K901112	G.s.a. Colored Condoms	Ansell, Inc.	HIS	Class II	1990-03-27
K901111	Nuda (Currently Called Ultra Sensitive)	Ansell, Inc.	HIS	Class II	1990-03-27
K900981	Intravenous Stand or IV Stand	Travl-Med Infusion Device Transport System	FOX	Class I	1990-03-27