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 2572 of 3530

510(k) clearances, page 2572 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K900103	Cronex Quanta Sr300 Intensifying Screen	E.I. Dupont de Nemours & Co., Inc.	EAM	Class I	1990-02-05
K900062	U.s.i. Model 1012, Remote Fluoroscopic Control	U.S. Imaging, Inc.	IZO	Class I	1990-02-05
K897136	Protein C Antigen Rocket Eid Method No. 5357	Helena Laboratories, Corp.	GGP	Class II	1990-02-05
K897067	Modified J-Stiffener Wire Material in Lead Lines	Telectronics Pacing Systems, Inc.	DTB	Class III	1990-02-05
K896975	Cardiac Cooling Jacket, 30% Reduced, Model Cj-220	Daily Medical Products, Inc.	DWC	Class II	1990-02-05
K896974	Cardiac Cooling Jacket, 8 Cm, Model Cj-120	Daily Medical Products, Inc.	DWC	Class II	1990-02-05
K896973	Cardiac Cooling Jacket, 30% Enlarged, Model Cj-320	Daily Medical Products, Inc.	DWC	Class II	1990-02-05
K896972	Cardiac Cooling Jacket, 12 Cm, Model Cj-520	Daily Medical Products, Inc.	DWC	Class II	1990-02-05
K896971	Cardiac Cooling Jacket, 8 Cm, Model Cj-420	Daily Medical Products, Inc.	DWC	Class II	1990-02-05
K896430	Percor Stat-Dl 9.5 Fr & Stat-Sl 8.5 Fr Intra-Aorti	Datascope Corp.	DSP	Class II	1990-02-05
K896332	Supplement to Anaerobic Mic Panel	Microtech Medical Systems, Inc.	JWY	Class II	1990-02-05
K894956	Circamed Holter Version 4	Circadian, Inc.	DPS	Class II	1990-02-05
K893861	Tmi Lw-100 Pulsed Doppler System	Titronics Medical Instruments, Inc.	IYN	Class II	1990-02-05
K900241	Anti-Ssa Microassay and Anti-Ssb Microassay	Diamedix Corp.	LLL	Class II	1990-02-02
K900236	Et-Restraint Cat. # Er 4000	Salter Labs	CBH	Class I	1990-02-02
K900225	Romcheck Specimen Collection Kit	Adeza Biomedical	LIO	Class I	1990-02-02
K900210	Bone Harvester System & Osteotome System 2500	Micro-Aire Surgical Instruments, Inc.	HSZ	Class I	1990-02-02
K896839	Mf-450 Electrosurgical Unit 60-5500-001	Aspen Laboratories, Inc.	GEI	Class II	1990-02-02
K896635	Viral Respiratory Indirect Fluores. Mono. Antibody	Baxter Healthcare Corporation	GNW	Class I	1990-02-02
K896565	Dmv(r) Veneer Suction Gripper	DMV Corporation	EKJ	Class I	1990-02-02
K896518	Dobbhoff(r) Ercp Cannula	Biosearch Medical Products, Inc.	FGE	Class II	1990-02-02
K896419	Model: Gyrex Version V	Elscint, Inc.	LNH	Class II	1990-02-02
K896393	Cardiac Cooling Jacked, 16 Cm, Model Cj-620	Daily Medical, Inc.	DWC	Class II	1990-02-02
K896379	Acs Gold Series Elastinite Guide Wire	Advanced Cardiovascular Systems, Inc.	DQX	Class II	1990-02-02
K896361	Handpiece Fiber Optic System Improvement Feature	Dentalez Group	EFB	Class I	1990-02-02
K896183	Ktp/532 Surgical Laser for Percutaneous Diskectomy	Laserscope	GEX	Class II	1990-02-02
K895953	Wright Ventilometer Vm-1	Clement Clarke, Inc.	BZG	Class II	1990-02-02
K895629	Model 8100; Upper Extremity Coil	Medical Advances, Inc.	LNH	Class II	1990-02-02
K894844	Bonefit Implant System Accessories & Instruments	Straumann Institute, Ltd.	DZE	Class II	1990-02-02
K894403	Pca Modular Knee Constrained Tibial Insert	Howmedica Corp.	JWH	Class II	1990-02-02
K892642	Dade(r) Tdm Control	Baxter Healthcare Corporation	JJY	Class I	1990-02-02
K892390	Flexible Immersible Hysteroscope	Schott Fiber Optics, Inc.	HIH	Class II	1990-02-02
K891289	Flo-Gard 6300 Dual Channel Volume Infusion Pump	Baxter Healthcare Corporation	FRN	Class II	1990-02-02
K883911	Electro-Acuscope 85	Biomedical Design Instruments	GZJ	Class II	1990-02-02
K900329	Narkomed 3 Anesthesia System	Draeger, Inc.	BSZ	Class II	1990-02-01
K900328	Narkomed 2B Anesthesia System	Draeger, Inc.	BSZ	Class II	1990-02-01
K897063	Fukuda Denshi Model Ds-3300 Etr	Fukuda Denshi USA, Inc.	DSI	Class II	1990-02-01
K896859	Accuprobe Histoplasma Capsulatum Culture Conf.test	Hologic, Inc.	MBT	Class II	1990-02-01
K896846	Madin-Darby Canine Kidney Culture Cells	Baxter Healthcare Corporation	KIR	Class I	1990-02-01
K896733	Vaccon	Unoplast A/S	KGX	Class I	1990-02-01
K896633	Auto-Cuff(tm)	U.S. Medical Corp.	DXN	Class II	1990-02-01
K896590	Carbon Dioxide Reagent	Horiba Instruments Incorporated	KHS	Class II	1990-02-01
K896561	Extension Set	Westmark, Sterile Packing Systems, Inc. (Sps)	FPA	Class II	1990-02-01
K896457	Devilbiss Model Pv02 Series	Devilbiss Health Care, Inc.	CAW	Class II	1990-02-01
K896432	Rubber Latex Surgeon's Glove	Regent Hospital Products	KGO	Class I	1990-02-01
K896413	Combination 6X-Magnifier and Tweezers	James Alexander Corp.	LRR	Not classified	1990-02-01
K896412	Gas Mixtures as Device Components	Spectra Gases, Inc.	GEX	Class II	1990-02-01
K896382	Modified Gluma Bonding System	Kulzer GmbH	KLE	Class II	1990-02-01
K896358	Vari/moist Wound Dressing	Catalina Biomedical Corp.	KGX	Class I	1990-02-01
K896348	Argelite 80 + 5 Dental Alloy for Porcelain Appl.	Argen Precious Metals, Inc.	EJT	Class II	1990-02-01