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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2841 of 3529

510(k) clearances, page 2841 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K870064	Mobil-Air	Roman Laboratories, Inc.	CAW	Class II	1987-02-11
K865076	Syntron Bioresearch Microcheck Hcg Pregnancy Test	Syntron Bioresearch, Inc.	JHI	Class II	1987-02-11
K864927	Kodak Ektascan Image Trans Sys T1/r1 Software,1.10	Eastman Kodak Company	LLZ	Class II	1987-02-11
K864835	Takane Auto Enemator Models 1200R/g1300tr/g1300sr*	Eisai U.S.A., Inc.	FCD	Class I	1987-02-11
K864739	Kodak Ektascan Image Transmission System P1	Eastman Kodak Company	LLZ	Class II	1987-02-11
K864364	Windsor Safety-Top Enteral Feeding Bag/bag & Set	Technical Associates of New England	KNT	Class II	1987-02-11
K861988	Modified Protasul 100 (Ti-6A1-7Nb) Alloy	Protek, Inc.	JDI	Class II	1987-02-11
K870354	Immunoadsorbed Factor V Deficient Plasma (Human)	American Dade	GGP	Class II	1987-02-10
K870353	Immunoadsorbed Factor X Deficient Plasma (Human)	American Dade	GGP	Class II	1987-02-10
K870327	Back Rest, Litter, Nonadjustable	Military Engineering, Inc.	FPP	Class I	1987-02-10
K870326	Various Luer and Tubing Fittings	Clinical Connections, Inc.	FPK	Class II	1987-02-10
K870310	Vsid Medical Three-Folding Bed	China National Medicines & Health Prod. I/E Corp.	FNJ	Class I	1987-02-10
K870299	Redman Upholstery Series for Wheelchairs	Redman, Inc.	KNN	Class I	1987-02-10
K870297	Dakota Model 102C Wheelchair	Redman, Inc.	ITI	Class II	1987-02-10
K870296	Mohave Model 102W Wheelchair	Redman, Inc.	IOR	Class I	1987-02-10
K870295	Sioux Model 102Alw Wheelchair	Redman, Inc.	IOR	Class I	1987-02-10
K870294	Crow Model 106A Wheelchair	Redman, Inc.	IOR	Class I	1987-02-10
K870293	Navajo Model 103A Wheelchair	Redman, Inc.	IOR	Class I	1987-02-10
K870292	Cheyenne Model 107A Wheelchair	Redman, Inc.	IOR	Class I	1987-02-10
K870291	Cherokee Model 102A Wheelchair	Redman, Inc.	IOR	Class I	1987-02-10
K870274	Di-Mix Parenteral Nutrition & Medicine Container	Gil-Med Industries C/O Kegan & Kegan, Ltd.	KPE	Class II	1987-02-10
K870228	Permobil Hexior	Permobil of America	ITI	Class II	1987-02-10
K870227	Permobil Superior	Permobil of America	ITI	Class II	1987-02-10
K870226	Permobil Minior	Permobil of America	ITI	Class II	1987-02-10
K870225	Permobil Exterior	Permobil of America	ITI	Class II	1987-02-10
K870224	Permobil Maxior	Permobil of America	ITI	Class II	1987-02-10
K870188	Norfolk Medical Butterfly Infusion Set	Norfolk Medical Products, Inc.	FPA	Class II	1987-02-10
K870164	Summit Optics Soft Contact Lens Case	Dayton Mfg. Co.	LRX	Class II	1987-02-10
K870139	Gas, Calibration, Specified Concentration	Portland Welding Supply, Inc.	BXK	Class I	1987-02-10
K870129	Ventilation Tubes with Hydrogel Coating	Richards Medical Co., Inc.	ETD	Class II	1987-02-10
K870107	Coat-a-Count Irma Ferritin Kit and Its Components	Siemens Healthcare Diagnostics Inc.	DBF	Class II	1987-02-10
K870055	Mr590 Dual Hose Heater Power Pack	Fisher & Paykel Allied Products, Ltd.	BTT	Class II	1987-02-10
K865108	N-Doguide(tm) Endotracheal Tube Introducing Guide	Ackrad Laboratories	BSR	Class I	1987-02-10
K865077	Accu-Flo Regulator	Alum-Ox, Inc.	CAN	Class I	1987-02-10
K865051	Graseby Pcas Model No. 0124-0701, Pvs Dytinhr Pump	Panamedix, Inc.	FRN	Class II	1987-02-10
K865047	Salter Labs #4004/4104 Oxygen Mask W/c02 Samp Line	Salter Labs	BYG	Class I	1987-02-10
K865019	Aft(r) Hep Performance Evaluation Program	Behring Diagnostics, Inc.			1987-02-10
K864960	Tv-Endoscope, Upper & Lower Gastrointestinal Appl.	Cooper Lasersonics, Inc.	GCQ	Class II	1987-02-10
K864904	3F Electrode	Northgate Research, Inc.	FFK	Class II	1987-02-10
K864832	Dental Floss	Westone Products, Ltd.	JES	Class I	1987-02-10
K864826	A-Sp Alloy (Silver-Palladium Crown & Bridge Alloy)	Austenal Dental, Inc.	EJH	Class II	1987-02-10
K864821	Airway Fiberscopes, Models Ls-9, 0L-1, 0L-2 & Pl-2	Reichert-Jung, Inc.	EOB	Class II	1987-02-10
K864809	Ivac(r) Star-Flow(tm) Volumetric Pump - Model 580	Y	FRN	Class II	1987-02-10
K864757	Modified Vinylac Press Pack Denture Resin	Astron Dental Corporation	EBI	Class II	1987-02-10
K864749	Telamat	Comet Ltd. C/O Radiology Resources, Inc.	JAA	Class II	1987-02-10
K864734	Hall Oral Implant System	Hall Surgical, Division of Zimmer, Inc.	DZE	Class II	1987-02-10
K864722	Medi-Trace Infant Electrode	Graphic Controls Corp.	DRX	Class II	1987-02-10
K864710	Isosit N	Ivoclar USA, Inc.	EBF	Class II	1987-02-10
K864709	Ivocryl Heat Cure & Ivocryl Quick Denture Material	Ivoclar USA, Inc.	EBI	Class II	1987-02-10
K864707	Sr-Vivodent Anterior & Sr-Orthotyp Posterior Teeth	Ivoclar USA, Inc.	ELM	Class II	1987-02-10