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 2026-11-02, 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 2529 of 3531

510(k) clearances, page 2529 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K902750	Visi-Swab Ophtalmic Sponge	Visitec Co.	HOZ	Class II	1990-07-26
K902545	Vaaka Baby Scale	Ferguson Medical	FRW	Class I	1990-07-26
K902470	Coherent Xa30/sp and Xa50 Surgical Lasers	Lumenis Ltd	GEX	Class II	1990-07-26
K902363	Coagulation Control, Level III	Sigma Chemical Co.	GGN	Class II	1990-07-26
K902362	Coagulation Control, Level II	Sigma Chemical Co.	GGN	Class II	1990-07-26
K902361	Coagulation Control, Level I	Sigma Chemical Co.	GGN	Class II	1990-07-26
K902350	Palatray Lc Resin Impression Tray Material	Kulzer GmbH	EBH	Class I	1990-07-26
K902253	Pathfinder(tm) Chlamydia Microplate Kit	Kallestad Diag, A Div. of Erbamont, Inc.	LJC	Class I	1990-07-26
K902092	Rateminder V Infusion Pump W/secondary Capability	Critikon Company, LLC	FRN	Class II	1990-07-26
K902042	Em-Scan Hp-2 Pediatric Body Composition Analyzer	Em-Scan, Inc.	DSB	Class II	1990-07-26
K901954	Ameda/egnell Dolphin Umbilical Cord Severing Devic	Hollister, Inc.	HFW	Class II	1990-07-26
K901928	Interpore Imz(castable)tub/scret Ret Rigid Attach	Interpore Intl.	EGG	Class I	1990-07-26
K901442	Baxter D & C Tray	Baxter Healthcare Corporation	HCY	Class I	1990-07-26
K900604	Direct Fluorescent Antibody Reagent for Giardia	Biovir Laboratories, Inc.	KHW	Class II	1990-07-26
K897006	Pharmacia Mumps Igg Elisa	Pharmacia Eni Diagnostics, Inc.	LJY	Class I	1990-07-26
K895924	Metricare Drug Reservoirs	The Metrix Company	KPE	Class II	1990-07-26
K903098	Mini-Vibrator	Frank J. Biehl	IRO	Class I	1990-07-25
K902951	Shower-a-Way	Tri-S-Sales and Mfg.	INN	Class I	1990-07-25
K902895	Infrassage Massager	Conair LLC.	IRT	Class II	1990-07-25
K902839	Liberty Hot Pack and Liberty Kold Pack	Liberty Ent.	IMD	Class I	1990-07-25
K902795	Modified Chairs (Dental, Medical, and Podiatry)	The Healthcare Group, Inc.	INO	Class II	1990-07-25
K902713	Access. Kit for the Biosurge Synchronous Autotrans	Diemolding Corp.	CAC	Class II	1990-07-25
K902707	Model 9000 at Ankle Cpm Device	Sutter Corp.	BXB	Class I	1990-07-25
K902664	Hospital/home Environmental Control Syst/hecs-1	Prentke Romich Co.	IQA	Class II	1990-07-25
K902219	Kronamax Human Performance Lab	Physicians Digital Co.	IKK	Class II	1990-07-25
K902170	Soehendra Lithotripsy Set	Wilson-Cook Medical Inc.	LQC	Class II	1990-07-25
K901998	Digital Manometer (Dm 50)	Medical Support Products, Inc.	BXR	Class II	1990-07-25
K901971	Comfortrac Table Model CT-1000	Comfortrac Systems	JFB	Class II	1990-07-25
K901772	Kodak M35a-M X-Omat Processor	Eastman Kodak Company	IXW	Class II	1990-07-25
K901643	Isoflo(tm) Amniocentesis Tray	Healthdyne Cardiovascular, Inc.	HIO	Class I	1990-07-25
K900170	Modified Exel 2400 Elite/u & Exel 2400E/u	Elscint, Inc.	JAK	Class II	1990-07-25
K902912	Thermoscan-Instant Thermometer Model Ir-4000	Thermoscan, Inc.	FLL	Class II	1990-07-24
K902792	Toxoplasma Gondii Igg	Pharmacia Diagnostics, Inc.	LGD	Class II	1990-07-24
K902751	Mitek Anchor II	Mitek Surgical Products, Inc.	JDR	Class II	1990-07-24
K902509	Saxon Ribbed Condoms	Safetex Corp.	HIS	Class II	1990-07-24
K902496	Landers Vitrectomy Lens Ring W/infusion	Ocular Instruments, Inc.	HNH	Class I	1990-07-24
K902474	Weevac 1 Portable Rescue Stretcher	W. Murphy Ent., Inc.	FPP	Class I	1990-07-24
K902457	Abnormal Glycohemoglobin Control	Analytical Control Systems	LCP	Class II	1990-07-24
K902455	Acs Normal Glycohemoglobin Control (A1c Hgb)	Analytical Control Systems	LCP	Class II	1990-07-24
K902186	Sunglasses	Creative Paper Products, Inc.	HQY	Class I	1990-07-24
K902117	Fesan Sunglasses	Fesan, S.A.	HQY	Class I	1990-07-24
K902059	Autowand(tm) 7Xxx Series	Boehringer Laboratories, LLC	CAC	Class II	1990-07-24
K901900	L.d.x Lipid Monitoring System	Cholestech Corp.	CHH	Class I	1990-07-24
K901829	Behring Chromotimer	Behring Diagnostics, Inc.	JJQ	Class I	1990-07-24
K900450	Biodex Lift Simulator	Biodex Corp.	IKK	Class II	1990-07-24
K900264	R-Band(tm) Respiratory Sensor	Buckman Co., Inc.	BZQ	Class II	1990-07-24
K900263	Antimicrobial Multi-Lumen Central Venous Catheter	Arrow Intl., Inc.	FOZ	Class II	1990-07-24
K896471	Tenstaple Orthopedic Stapling System	Tenstaple, Inc.	JDR	Class II	1990-07-24
K902917	Precision Medical Eliminator	Precision Medical, Inc.	BXY	Class I	1990-07-23
K902916	Precision Medical Neb Block	Precision Medical, Inc.	BXY	Class I	1990-07-23