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 2570 of 3530

510(k) clearances, page 2570 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K896363	Non-Sterile Latex Examination Gloves	Contemporary Medical Technology, Inc.	LYY	Class I	1990-02-13
K896316	Eos Ionized Calcium Test Card	Eos Technology Corp.	JFP	Class II	1990-02-13
K896303	Biopsy Punch	Premier Medical	LRY	Class I	1990-02-13
K896258	CO2 Reagent (340 Nm)	Sigma Chemical Co.	KHS	Class II	1990-02-13
K896215	Mercy Hip/knee Pack	Westmark, Sterile Packing Systems, Inc. (Sps)	KKX	Class II	1990-02-13
K896055	Erbotom Acc 450	Erbe Electromedizin GmbH	GEI	Class II	1990-02-13
K895902	Latex Patient Examination Glove	Rfb Latex Pvt., Ltd.	LYY	Class I	1990-02-13
K895793	Micropotential Analyzer/spectrocardiography Option	Del Mar Avionics	DSH	Class II	1990-02-13
K895021	Medicare Gloves	Shangrila Latex Industries Pvt., Ltd.	LYY	Class I	1990-02-13
K894595	Bonefit R Screw Implants	Straumann USA, LLC	DZE	Class II	1990-02-13
K894594	Bonefit Hollow Screw Implants	Straumann USA, LLC	DZE	Class II	1990-02-13
K894593	Bonefit Hollow Cylinder Implants	Straumann USA, LLC	DZE	Class II	1990-02-13
K894450	Latex Patient Examination Gloves	Kannex Gloves, Div. of Kanoi Plantations Private	LYY	Class I	1990-02-13
K893123	Adhesive Bandages & Pads for Minor Cuts/scrapes	Les Laboratorires Brothier, S.A.	QSY	Unclassified	1990-02-13
K893093	Flouroshield Radiation Reduction Glove	Acufex Microsurgical, Inc.	LZC	Class I	1990-02-13
K892664	Cardiopulmonary Support (Cps) System	Bard Cardiosurgery Div	DTZ	Class II	1990-02-13
K892085	Patient Examination Gloves (Latex)	Howard Associates, Inc.	LYY	Class I	1990-02-13
K891663	Leedar (Patient Examination Gloves - Latex)	Darchet (USA), Inc.	LYY	Class I	1990-02-13
K900227	Mvp (Multi-Vendor Protocol Convertor)	Merge Technologies, Inc.	LMD	Class I	1990-02-12
K896844	Babe-Ease Neonatal Cloth ECG Electrode	Labeltape Meditect, Inc.	GXY	Class II	1990-02-12
K896696	(Heart) Nebulizer	Vortran Medical Technology 1, Inc	CAF	Class II	1990-02-12
K896691	Bite Block	Endoscopix	MNK	Class I	1990-02-12
K896629	Nellcor Model N-2500 Anesthesia Safety Monitor	Nellcor, Inc.	CBS	Class II	1990-02-12
K896612	Dobbhoff(r) Papillotome	Biosearch Medical Products, Inc.	KNS	Class II	1990-02-12
K896597	The Sidewinder 40Cc Dl Intra-Aortic Balloon Cath.	Boston Scientific Corporation	DSP	Class II	1990-02-12
K896532	Dental Delivery System	Dentech Corp.	EIA	Class I	1990-02-12
K896381	Mvp-10 MRI Infant Ventilator	Bio-Med Devices, Inc.	CBK	Class II	1990-02-12
K896380	Ic-2A MRI Adult/pediatric Ventilator	Bio-Med Devices, Inc.	CBK	Class II	1990-02-12
K896223	Photophone	Image Data Corp.	LMA	Class II	1990-02-12
K896053	All Silicone Foley Catheter	Rochester Medical Corp.	KOD	Class II	1990-02-12
K895852	Buzzy Bear Enuresis Alarm	Med-Design, Inc.	KPN	Class II	1990-02-12
K895414	Multimed (Tm) Pulmonary Function Testing System	Integrated Medical Systems Inc	BZG	Class II	1990-02-12
K895244	Modified Labeling to Model 9608 Arterial Hemo Bld.	National Medical Care, Medical Products Div., Inc.	KOC	Class II	1990-02-12
K894179	Coulter Clone(r) My4 Monoclonal Antibody	Coulter Immunology	GKZ	Class II	1990-02-12
K900487	Modified Auto Suture Surgiport Trocar & Sleeve	United States Surgical, A Division of Tyco Healthc	GDH	Class I	1990-02-09
K900455	Zefazone Susceptibility Powder	The Upjohn Co.	LOP	Class II	1990-02-09
K900401	Nas&p Grasping Forceps & Assoc. Devices	North American Sterilization & Packaging Co.	KOQ	Class I	1990-02-09
K900279	Oculinum Injection Amplifier	Oculinum, Inc.	HLW	Class II	1990-02-09
K900144	Quartz Fiber Catheters and Surgical Tips	Pfizer Laser Systems	GEX	Class II	1990-02-09
K900098	Monopolar Needle Electrode	Oculinum, Inc.	HLW	Class II	1990-02-09
K900055	Modified Pss & Pfs Powered Skin & Fascia Staplers	United States Surgical, A Division of Tyco Healthc	GDW	Class II	1990-02-09
K900043	Modified Powered Disposable Lds Surgical Stapler	United States Surgical, A Division of Tyco Healthc	GDW	Class II	1990-02-09
K896891	Leukosilk(tm) Surgical Tape	Beiersdorf, Inc.	KGX	Class I	1990-02-09
K896821	Olympus Uretero. & Circon Acmi Uretero. Guide	North American Sterilization & Packaging Co.	KOQ	Class I	1990-02-09
K896566	Modified Fox Extra Gram Negative and Positive	Medical Specialties Inc.	JWY	Class II	1990-02-09
K896564	Dental Core Material	Dentsply Intl.	EBF	Class II	1990-02-09
K896539	Permadyne Garant Low Viscosity	Espe GmbH (US)	ELW	Class II	1990-02-09
K896517	Illumina Models 30, 40 & 55 CO2, Milliwatt Power	Heraeus Lasersonics, Inc.	GEX	Class II	1990-02-09
K896501	Tech Star Dental Casting Alloys (Non-Precious)	Leach and Dillon Co., Inc.	EJH	Class II	1990-02-09
K896473	H200 Hanna Suction Trephine System for Corneal Sur	Emory University School of Medicine	HPN	Class I	1990-02-09