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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 2117 of 3531

510(k) clearances, page 2117 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K945359	Aqua+i-F, I-H, I-Fh, II-H, II-Fh, III-H	Artema Medical AB	BYD	Class I	1995-02-21
K944861	Karl Storz Monopolar Coagulation Ball Electrodes, Cutting Wire Electrodes, Bipolar Suction Coagulator, Electrode, Probe	Karl Storz Endoscopy-America, Inc.	EOB	Class II	1995-02-21
K944585	Scanning Director	Prentke Romich Co.	IQA	Class II	1995-02-21
K944487	Electro-Mesh Sock, Wrap, and Sleeve Electrodes	Prizm Medical, Inc.	GXY	Class II	1995-02-21
K943869	Ultimax (Green Powder Free Examination)	Wembley Rubber Products (M) Sdn Bhd	LYY	Class I	1995-02-21
K943583	Kerrison Rongeurs	Enterprise Medical Corp.	HAE	Class II	1995-02-21
K943386	CPR Micromask	Plasco, Inc.	CBP	Class II	1995-02-21
K943362	Pacifier-Thermometer	Questech Intl., Inc.	FLL	Class II	1995-02-21
K943310	Model 6100 Ambulatory Infusion System	Pharmacia Deltec, Inc.	MEA	Class II	1995-02-21
K943009	Smd Electrodes	Scientific Medical Devices, Inc.	GXY	Class II	1995-02-21
K942849	Capnosat	Spegas Industries, Ltd.	CCK	Class II	1995-02-21
K942495	Sinojet Maxillary Sinus Puncture & Irrigation System	Atos Medical AB	KAM	Class I	1995-02-21
K941986	Cutaneous Electrode	Maxxim Medical	GXY	Class II	1995-02-21
K940630	503 Maxi Compressor	Medical Industries America, Inc.	BTI	Class II	1995-02-21
K934154	Disposable Aspiration/irrigation Catheter	Neuro Navigational Corp.	GWG	Class II	1995-02-21
K933954	Phototherapeutix Model 2400B	Avex Industries, Ltd.	FTC	Class II	1995-02-21
K933953	Phototherapeutix Model 1650B	Avex Industries, Ltd.	FTC	Class II	1995-02-21
K933952	Phototherapeutix Model 800B	Avex Industries, Ltd.	FTC	Class II	1995-02-21
K933522	Introducer Needle (Several Sizes)	Mediziv Medical Products 1987, Ltd.	DYB	Class II	1995-02-21
K924679	Oxycare(tm) Oxygen Controller/monitor	Air-Shields Vickers, Inc.	KLK	Class II	1995-02-21
K950428	Vivaglass Base	Ivoclar North America, Inc.	EMA	Class II	1995-02-17
K950024	Expandacell Nasal Pack with Airway	Summit Medical, LLC	EMX	Class I	1995-02-17
K946011	Argus Sinus Endoscopy Instrument System	Argus Medical Co., Inc.	EOB	Class II	1995-02-17
K945890	Karl Storz Take-Apart(r) Suture Forceps, Karl Storz Knot Tier	Karl Storz Endoscopy-America, Inc.	GCJ	Class II	1995-02-17
K945694	Nezhat-Dorsey Bipolar Electrosurgical Forceps, Surface Electrodes, and Cords	American Hydro-Surgical Instruments, Inc.	GEI	Class II	1995-02-17
K945654	Nicom Digital Image Manager	Camtronics, Ltd.	LMB	Class I	1995-02-17
K945554	Epistaxis Balloon Catheter with Packing	Ultracell Medical Technologies, Inc.	EMX	Class I	1995-02-17
K945163	Echocardiography	Tri W-G, Inc.	LGX	Class I	1995-02-17
K945121	A3 Ankle Cpm Unit	Toronto Medical Corp.	BXB	Class I	1995-02-17
K944963	Branemark System Smiline II	Nobelpharma USA, Inc.	DZE	Class II	1995-02-17
K944952	Angiographic System	Acoma Medical Imaging, Inc.	IZI	Class II	1995-02-17
K944594	Bact/alert Fan Culture Bottle	bioMerieux, Inc.	MDB	Class I	1995-02-17
K944529	Cable-Ease Plate and Cable System	Intermedics Orthopedics	JDQ	Class II	1995-02-17
K943756	Microdilution Device for Determining Gentamicin & Strrptomycin for Detection of High Level Aminoglycoside Resistance	Alamar Biosciences, Inc.	JWY	Class II	1995-02-17
K942446	i.v. Roller Guard Clamp	Plastic Manufacturing and Marketing Group, Inc.	FPA	Class II	1995-02-17
K942026	The Hill Adjustable Ha90e	Hill Laboratories	INQ	Class I	1995-02-17
K941922	Medsat Oxygen Saturation System	Medtronic Bio-Medicus, Inc.	DRY	Class II	1995-02-17
K941267	Non-Prescription Sunglasses	Topstar Trading, Ltd.	HQY	Class I	1995-02-17
K941266	Non-Prescription Sunglasses	Gbs Corp.	HQY	Class I	1995-02-17
K940768	Ad Perfect	Chimera Research & Chemical, Inc.	IFT	Class I	1995-02-17
K935526	Phototherapeutix Model 1600B	Avex Industries, Ltd.	FTC	Class II	1995-02-17
K935524	Phototherapeutix Model 3200A	Avex Industries, Ltd.	FTC	Class II	1995-02-17
K935380	Vascular Access Catheter Accessories	Bard Access Systems, Inc.	LJS	Class II	1995-02-17
K934754	The Hill Hi-Lo Table	Hill Laboratories	INQ	Class I	1995-02-17
K934151	Magnatherm Model 1000 Ss	Intl. Medical Electronics, Ltd.	IMJ	Class II	1995-02-17
K932810	The Hill Adjustable Air-Flex Model	Hill Laboratories	JFB	Class II	1995-02-17
K950559	Diener Retrieval Devices	Mill-Rose Laboratory	FCL	Class I	1995-02-16
K950310	Endure	Aalba Dent, Inc.	EJT	Class II	1995-02-16
K950309	Eagle	Aalba Dent, Inc.	EJI	Class II	1995-02-16
K946317	Harry J. Bosworth Resin I.	Harry J. Bosworth Co.	EBI	Class II	1995-02-16