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 1470 of 3531

510(k) clearances, page 1470 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K030069	Synthes Poly (L-Lactide-Co-Glycolide) Resorbable Fixation System	Synthes (USA) Products LLC	JEY	Class II	2003-04-08
K023001	Home Care Various Models of Powered Muscle Stimulator, Ht-326L	Home Care Technology Co., Ltd.	IPF	Class II	2003-04-08
K022793	Tetris Spinal Implant	Signus Medical, LLC	MQP	Class II	2003-04-08
K022614	Invigra	Indus Medicare, Ltd.	HIS	Class II	2003-04-08
K021978	Petit Sophia	Nishitomo Co., Inc.	LHD	Unclassified	2003-04-08
K021876	Mas with or without Syringe	Marina Medical Instruments Inc.	HHK	Class II	2003-04-08
K021802	Stereotaxis Catheter Advancer System	Stereotaxis Inc	DQY	Class II	2003-04-08
K030949	Titan High Resolution Ultrasound System	FUJIFILM SonoSite,Inc.	IYN	Class II	2003-04-07
K030136	Drip Alert	Drip Alert, Inc.	FLN	Class II	2003-04-07
K030061	Ps 3000 Digatal Photospot System	Precise Optics	OWB	Class II	2003-04-07
K030059	Portable Ro+ Model Mros09	AmeriWater LLC.	FIP	Class II	2003-04-07
K024339	Cozart Eia Opiates Oral Fluid Kit	Cozart Bioscience, Ltd.	DIG	Class I	2003-04-07
K023614	Steritite Rigid Reusable Sterilization Container System	Case Medical, Inc.	FRG	Class II	2003-04-07
K023073	Seed Link	Implant Sciences Corp.	KXK	Class II	2003-04-07
K030890	Switchblade	Snowden-Pencer	GEI	Class II	2003-04-04
K030882	Rabbit Mobile Standing Frame	R82 a/S	IPL	Class II	2003-04-04
K030858	Synthes (USA) Lcp Proximal Femur Plate and Screws	Synthes (USA) Products LLC	HRS	Class II	2003-04-04
K030783	Frontier Model X5	Vestil Manufacturing Corp.	ITI	Class II	2003-04-04
K030709	Wu's Powered Wheelchair, Mambo 5	Wu's Tech Co., Ltd.	ITI	Class II	2003-04-04
K030707	Wu's Powered Wheelchair, Mambo 3	Wu's Tech Co., Ltd.	ITI	Class II	2003-04-04
K030697	Radionics Single Use Ground Pad (Dgp-Hp)	Radionics, Inc.	GEI	Class II	2003-04-04
K030673	Flexible Tip Thermometer, Model 011206	Global Treasure Industries, Ltd.	FLL	Class II	2003-04-04
K030548	Saview 55 Multifocal (Methafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear	St. Shine Optical Co., Ltd.	LPL	Class II	2003-04-04
K030459	Medley System with Medication Management System (Mms)	CareFusion 303, Inc	FRN	Class II	2003-04-04
K030245	Nitrile Examination Gloves, Powder Free, Polymer Coated, Purple Color	Arista Latindo Industrial, Ltd. P.T.	LZA	Class I	2003-04-04
K030092	Complete Brand Multi-Purpose Solution	Advanced Medical Optics, Inc.	LPN	Class II	2003-04-04
K030051	Versaboard, Model 7040	Bionix Development Corp.	IYE	Class II	2003-04-04
K024325	Ji-Ee Electric Scooter, Esthete Es 1	Ji-Ee Industry Co., Ltd.	INI	Class II	2003-04-04
K023231	Elfcare Device, Models 314A Through 314G	Mediseb, Ltd.	GZJ	Class II	2003-04-04
K030826	Preciset Dat Amphetamine	Quantimetrix Corp.	DIJ	Class II	2003-04-03
K030723	Ivs Introducer Set, Model 1003	Integrated Vascular Systems, Inc.	DYB	Class II	2003-04-03
K030562	Tuohy Epidural Needle	Epimed International, Inc.	BSP	Class II	2003-04-03
K030318	P2 Polyether	Kulzer GmbH	ELW	Class II	2003-04-03
K030172	Small High Speed Motor Drill System	Brasseler USA I, L.P.	HBE	Class II	2003-04-03
K030110	CT Hdr Tandem/ring Applicator with Rectal Retractor	Mick Radio-Nuclear Instruments, Inc.	JAQ	Class II	2003-04-03
K030062	Admiral .035 Dilatation Catheter, Models Adl0720-80,Adl0720-135,Adl0820-80, Adl0820-135,Adl0920-80,Adl0920-135,Adl1020-0	Avantec Vascular Corp.	LIT	Class II	2003-04-03
K024300	Microcap Plus/npb-75	Oridion Medical 1987 Ltd.	DQA	Class II	2003-04-03
K023818	Fiberfill Agp	Pentron Clinical Technologies	KIF	Class II	2003-04-03
K023290	Sterrad 50 & Sterrad 100S Sterilizers	Advanced Sterilization Products	FLF	Class II	2003-04-03
K022124	Galemed Peak Flow Meter, Models 3751/3752	Galemed Corp.	BZH	Class II	2003-04-03
K022112	Fortune All Silicone Stomach (Gastric) Tubes, Model 2020	Fortune Medical Instrument Corp.	KNT	Class II	2003-04-03
K030893	Levo Combi	Levo AG	IPL	Class II	2003-04-02
K030888	Eva Empty Solution Container	The Metrix Company	KPE	Class II	2003-04-02
K030818	Hemochron Response/system	Accriva Diagnostics, Inc.	JPA	Class II	2003-04-02
K030736	Verte-Stack Spinal System, Extra Small Sizes	Medtronic Sofamor Danek	MQP	Class II	2003-04-02
K030686	Optetrak Total Knee System - Molded Metal-Back Tibial Component	Exactech, Inc.	JWH	Class II	2003-04-02
K030323	MRI-Caddy	Mammendorfer Institute for Physics & Medicine GmbH	FRN	Class II	2003-04-02
K030216	Coloncare	Care Products, Inc.	KHE	Class II	2003-04-02
K030167	Mieru (Etafilcon a) Daily Wear Contact Lens Clear and Visibility Tint, with UV Blocker	Clearlab Pte, Ltd.	LPL	Class II	2003-04-02
K030009	Ksea Powershaver System S2	Karl Storz Endoscopy-America, Inc.	HRX	Class II	2003-04-02