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 1011 of 3531

510(k) clearances, page 1011 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K090346	Advia 2120/2120I Body Fluids	Siemens Healthcare Diagnostics Inc.	GKZ	Class II	2010-07-28
K101664	Powdered Vinyl Patient Examination Gloves	Hebei Excellent Plastic Co., Ltd.	LYZ	Class I	2010-07-27
K101663	Powder-Free Vinyl Patient Examination Gloves	Hebei Excellent Plastic Co., Ltd.	LYZ	Class I	2010-07-27
K101191	Naviaid Icvi Device	Smart Medical Systems Ltd.	FDF	Class II	2010-07-27
K101172	Rdt3 Handpiece Head Model Rdt3	Redent Nova, Ltd.	EFA	Class I	2010-07-27
K101076	Prowess Panther Proarc, Model Version 5.0	Prowess, Inc.	MUJ	Class II	2010-07-27
K101026	Powered Pd-Io Infusion System, Ez-Io Humeral Head, Powered Ph-Io	Teleflex Medical	FMI	Class II	2010-07-27
K100536	Transbond Idb Pre-Mix Chemical Care Adhesive	3M UNITEK Corporation	DYH	Class II	2010-07-27
K093493	Aesculap Sterilcontainer S	Aesculap Inc	FRG	Class II	2010-07-27
K093266	Mam Cooler	Mam International AG	KKO	Class II	2010-07-27
K101662	Synapse 3D Basic Tools	FUJIFILM Healthcare Americas Corporation	LLZ	Class II	2010-07-26
K100420	Philips Obtracevue Model Sw Rev. G.00	Philips Medizin Systeme Boeblingen GmbH	HGM	Class II	2010-07-26
K092982	The Panpac Suction Curette	Panpac Medical Corporation	HHK	Class II	2010-07-26
K092328	Med-Seg, Model Btms 1000	Bartron Medical Imaging, Inc.	LLZ	Class II	2010-07-26
K101866	Cryopatch Sg Pulmonary Human Cardiac Patch	Artivion, Inc.	DXZ	Class II	2010-07-23
K101855	Profast+ Assay	Gen-Probe Prodesse, Inc.	OQW	Class II	2010-07-23
K101833	Infistitch for I5 Digital X-Ray Imaging System, Model I5	Infimed, Inc.	OWB	Class II	2010-07-23
K101786	Advanix Double Pigtail Biliary Stent	Boston Scientific Corporation	FGE	Class II	2010-07-23
K101777	Pioneer Plus Catheter, Model Plus 120	Medtronic, Inc.	PDU	Class II	2010-07-23
K101776	Scoutpro Acs	BIOTRONIK AG	DQY	Class II	2010-07-23
K101314	Advanix Biliary Stent with Naviflex Rx Delivery System	Boston Scientific Corporation	FGE	Class II	2010-07-23
K101240	Closed Fusion Plate, Mtp Plate, Talus Plate, Model 824077021, 22; 824677021, 22, 824071001, 824071101, 824671001, 82467	Depuy Orthopaedics Inc.	HRS	Class II	2010-07-23
K101214	Guardian Connection	Maulin Medical, LLC	FPD	Class II	2010-07-23
K101206	Tgs Unicompartmental Knee Arthroplasty (Tgs Uka) Modular Tibia System	Alexandria Research Technologies, LLC	HSX	Class II	2010-07-23
K101165	Pro-Toe Vo Hammertow Implant System	Wrightmedicaltechnologyinc	HWC	Class II	2010-07-23
K101101	Mini-Tong	Mini Lap Technologies, Inc.	OCW	Class II	2010-07-23
K100958	Modification to: Microblade Shaver and Accessories	Baxano, Inc.	HAE	Class II	2010-07-23
K100909	Reprocessed Compression Sleeves	Stryker Sustainability Solutions	JOW	Class II	2010-07-23
K100813	Qrs Card S-T Segment Analysis Patient Monitoring System Model: Qrs Card Usb	Pulse Biomedical, Inc.	DPS	Class II	2010-07-23
K100682	Gsp Neonatal 17A-Oh-Progesterone Kit Model: 3305-001U	Wallac Oy	JLX	Class I	2010-07-23
K100543	Medississ Reprocessedent Ablation Wands (Coblators), Model#eic8872-01	Medisiss	GEI	Class II	2010-07-23
K100247	Detax Implantlink Semi	Detax GmbH & Co. KG	EMA	Class II	2010-07-23
K100147	S4 Cervical Occipital Plate Spinal System	Aesculap Implant System, Inc.	NKB	Class II	2010-07-23
K100133	Airstrip Remote Patient Monitoring (Rpm) Remote Data Viewing Software, Version 3.1	AirStrip Technologies, Inc.	MWI	Class II	2010-07-23
K092261	Defcon Tsa/tsh Dental Implant System	Impladent, S.L.	DZE	Class II	2010-07-23
K091939	Thermedx Prodigy Fluid Management System, Models P1000, P2000	Thermedx LLC	HIG	Class II	2010-07-23
K101972	Solaris Reusable and Disposable Blood Pressure Cuffs	Solaris Medical Technology, Inc.	DXQ	Class II	2010-07-22
K101857	Rtc-24 Vp Metered Dose Inhaler Adapter, Model Rtc 24-V	Instrumentation Industries, Incorporated	CAF	Class II	2010-07-22
K101576	Centerridge Diagnostic ECG Electrode, Centerridge Monitoring ECG Electrodes	Team Innovations, Inc.	DRX	Class II	2010-07-22
K101434	Audit Microcv Procalcitonin Linearity	Aalto Scientific Ltd.	MJX	Class I	2010-07-22
K101302	Aleutian Ibf System	K2M, Inc	ODP	Class II	2010-07-22
K100706	Venus Basic Spinal Fixation System	L&K Biomed Co.,Ltd.	MNH	Class II	2010-07-22
K100640	20 Mmvial Fluid Transfer Adapter, Model 7E2500	B.Braun Medical, Inc.	LHI	Class II	2010-07-22
K100558	Quanta Diode Laser System	Quanta System Inc.	GEX	Class II	2010-07-22
K100544	Impix Lumbar Interbody Device	Medicrea Technologies	MAX	Class II	2010-07-22
K100488	Ir Ear/forehead Thermometer Mode Dx6635, Dx6637, Dth1081	Shenzhen Dongdixin Technology Co., Ltd.	FLL	Class II	2010-07-22
K093981	Yrnsortip Oximanometer	Cnoga Medical, Ltd.	DXN	Class II	2010-07-22
K092981	Panpac Vaginal Pessary	Panpac Medical Corporation	HHW	Class II	2010-07-22
K083418	CPR Mask	Firstar Healthcare Co., Ltd.	CBP	Class II	2010-07-22
K102008	Glidesheath	Terumo Medical Corp.	DYB	Class II	2010-07-21