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 916 of 3530

510(k) clearances, page 916 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K110623	Pillar Palatal Implant System	Medtronic Xomed, Inc.	LRK	Class II	2012-02-10
K110078	Extricare	Devon Medical Products	OMP	Class II	2012-02-10
K103044	Ap-1010 and Ap-1020 Blood Glucose Monitoring System, Major Glucose Control Solution	Bestgen Biotech Corp.	NBW	Class II	2012-02-10
K120212	Afx Introducer System	Endologix LLC	DYB	Class II	2012-02-09
K113774	Hpr Plus Emollient Foam	Prugen IP Holdings, Inc.	FRO	Unclassified	2012-02-09
K113772	Hpr Emollient Foam	Prugen IP Holdings, Inc.	FRO	Unclassified	2012-02-09
K113529	Cd Horizon Voyager Spinal System	Medtronic Sofamor Danek	NKB	Class II	2012-02-09
K113250	Dynatron Tri-Wave Light Pad Dynatron Tri-Wave Light Probe	Dynatronics Corp.	ILY	Class II	2012-02-09
K113183	Pms8210a (Iris) Multi-Parameter Patient Monitor, Model Code 500	Shanghai 3f Electronics Co, Ltd.	MWI	Class II	2012-02-09
K113104	Integra Wound Matrix (Thin)	Integra LifeSciences Corporation	KGN	Unclassified	2012-02-09
K112709	Stimulation/dissection Instruments	Nu Vasive, Incorporated	ETN	Class II	2012-02-09
K112407	Smith Medical Peel-Away Sheath Introducers	Abbott Medical	DYB	Class II	2012-02-09
K112006	Hamilton-Tc1	Hamilton Medical AG	CBK	Class II	2012-02-09
K111467	Flexi-Q Dv and Dvr Auto-Injectors	Elcam Medical A.C.A.L.	KZH	Class II	2012-02-09
K120178	Wingman Extendable Tip Support Catheter	ReFlow Medical, Inc	DQY	Class II	2012-02-08
K120156	Pureimage Ultrasound Transmission Gel	Medline	ITX	Class II	2012-02-08
K120083	Set Screw for Ti Trochanteric Fixation Nail(tfn)	Synthes (USA) Products LLC	HSB	Class II	2012-02-08
K113600	Im Band	Synexmed(Shenzhen)Company Limited	DXC	Class II	2012-02-08
K113426	Veracia Sa	Shofu Dental Corp.	ELM	Class II	2012-02-08
K113396	Depuy Pulse Thoracolumbar Screw System	Medos International SARL	NKB	Class II	2012-02-08
K113343	Diacheck Smart/superior Blood Glucose Monitoring System	Delbio Incorporation	NBW	Class II	2012-02-08
K112723	Epigray	Dosisoft	MUJ	Class II	2012-02-08
K112542	Yomura Safety i.v. Catheter	Yomura Technologies Inc.	FOZ	Class II	2012-02-08
K111937	Clearflash Ac2100 Cosmetic System	Clearflash Technologies, Inc.	OLP	Class II	2012-02-08
K111249	Orthoslenderizer	Orthomatics, Inc.	EFB	Class I	2012-02-08
K103726	Jarit Take-Apart Endoscopic Instruments	Integra LifeSciences Corporation	KNF	Class II	2012-02-08
K113401	Ortho-1(Not Finalized)	Bisco Inc	DYH	Class II	2012-02-07
K113360	Medical Image Processing Unit	Humanray Co,Ltd	EAP	Class II	2012-02-07
K113214	Tlink Data Management System (Dms)	Terumo Cardiovascular Systems Corporation	DXJ	Class II	2012-02-07
K113021	Trufreeze System, Trufreeze Spray Kit	CSA Medical	GEH	Class II	2012-02-07
K112673	Prophy-Mate Neo	Nakanishi Inc.	EFB	Class I	2012-02-07
K112591	Safe Secure Sterilization Pounch with Steam and Ethylene Oxide Process Indicators	Safe Secure Packaging Co., Ltd.	FRG	Class II	2012-02-07
K112541	Z Flex-270Tm Steerable Sheath	Great Batch Medical	DRA	Class II	2012-02-07
K112383	Callos Promodel Bone Void Filler, Skaffold Mp (Macro Porous) Bone Void Filler	Skeletal Kinetics, LLC	MQV	Class II	2012-02-07
K111678	Ortho Solutions Extremity Fixation Implants for Osteosysnthesis	Ortho Solutions Inc	HRS	Class II	2012-02-07
K120029	Hemi Phalangeal Implant Surgical Instrument Set	Solana Surgical, LLC	KWD	Class II	2012-02-06
K113862	Zio Patch	iRhythm Technologies, Inc.	DSH	Class II	2012-02-06
K113762	Checkmate Metatarso-Phalangeal (Mtp) Arthrodesis System	Arthrosurface, Inc.	HRS	Class II	2012-02-06
K113752	Metatarsal Decompression Implant Surgical Instrument Set	Solana Surgical, LLC	KWD	Class II	2012-02-06
K113716	Asahi Chikai V Peripheral Vascular Guide Wire	Asahi Intecc Co., Ltd.	DQX	Class II	2012-02-06
K113653	Patient Monitor	Edan Instruments, Inc.	MHX	Class II	2012-02-06
K113642	Perimeter Interbody Fusion Device	Medtronic Sofamor Danek USA Inc	MAX	Class II	2012-02-06
K113323	Artus Infl A/b Rg Rt-PCR Kit	Qiagen	OCC	Class II	2012-02-06
K113319	Rotor-Gene Q Mdx	Qiagen	OOI	Class II	2012-02-06
K113196	Vascular Sono	Pajunk GmbH Medizintechnologie	DYB	Class II	2012-02-06
K113100	Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs	Maxter Glove Manufacturing Sdn Bhd	LZA	Class I	2012-02-06
K112642	Aquilex Fluid Control System H112	Novanta Medical GmbH	HIG	Class II	2012-02-06
K112106	Naviaid Icvi-F,s,b,r Device	Smart Medical Systems Ltd.	ODC	Class II	2012-02-06
K111959	Aesculap Histoacryl and Histoacryl Blue Topical Skin Adhesive	Aesculap Inc	MPN	Class II	2012-02-06
K111890	Fora Diamond Prima Blood Glucose Monitoring System, Fora Diamond Mini Blood Glucose Monitoring System	Taidoc Technology Corporation	NBW	Class II	2012-02-06