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 662 of 3529

510(k) clearances, page 662 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K151506	Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula	Salter Labs	NFB	Class II	2016-03-11
K151271	BellaFuse	Hans Biomed Corp.	MQV	Class II	2016-03-11
K160386	ReadeR, VieweR, QuickScan PSP	Trident SRL	MUH	Class II	2016-03-10
K160369	GuideWire	Fiagon GmbH	PGW	Class II	2016-03-10
K160078	Vivid T8	GE Medical Systems Ultrasound and Primary Care Diagnotics, L	IYN	Class II	2016-03-10
K160069	Sonoma Fibula Repair System	Sonoma Orthopedics Products, Inc.	HSB	Class II	2016-03-10
K153776	Optetrak One Logic Femoral Components	Exactech, Inc.	MBH	Class II	2016-03-10
K153485	ENROUTE Transcarotid Neuroprotection System	Silk Road Medical	NTE	Class II	2016-03-10
K153248	PEEK Customized Cranial Implant	Stryker Corp.	GWO	Class II	2016-03-10
K153090	Reprocessed Diagnostic Ultrasound Catheter	Innovative Health, LLC.	OWQ	Class II	2016-03-10
K152919	OMNI Skirted Heads	Omni Life Science, Inc.	LZO	Class II	2016-03-10
K152720	Xingda Nitrile Powder Free Patient Examination Gloves, Blue Color	Xingda Medical Products Co., Ltd.	LZA	Class I	2016-03-10
K152217	Exactech Vantage Total Ankle System	Exactech, Inc.	HSN	Class II	2016-03-10
K151984	Thommen Milling Abutment for CAD/CAM	Thommen Medical AG	NHA	Class II	2016-03-10
K151940	Thora-3Di, Model T-01	Pneumacare Limited	BZQ	Class II	2016-03-10
K151421	Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines	Salter Labs	CCK	Class II	2016-03-10
K142993	QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument	Orion Diagnostica, Inc.	DCK	Class II	2016-03-10
K160381	TE7 Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	IYN	Class II	2016-03-09
K160058	Biomet Variable Pitch Compression Screw System	Zimmer GmbH	HWC	Class II	2016-03-09
K160002	Piccolo Composite(R) Distal Volar Radius Plate System	CarboFix Orthopedics Inc.	HRS	Class II	2016-03-09
K153671	Family of CoolGlide Aesthetic Lasers	Cutera Inc	GEX	Class II	2016-03-09
K153429	SmartView 3D Option	GE Hangwei Medical System Co., Ltd.	JAK	Class II	2016-03-09
K152712	Nitrile Powder Free Patient Examination Gloves, Blue Color	Zhonghong Pulin Medical Products Co.,Ltd.	LZA	Class I	2016-03-09
K152662	S-Wire	Spinal Resources Inc	HTY	Class II	2016-03-09
K152625	MMS Guide Catheter	Micro Medical Solutions Inc	KRA	Class II	2016-03-09
K152448	da Vinci Single-Site Instrument and Accessories	Intuitive Surgical, Inc.	NAY	Class II	2016-03-09
K151694	Gammex PI Hybrid Surgical Gloves	Ansell Healthcare Products LLC	KGO	Class I	2016-03-09
K160085	Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System	Zimmer GmbH	KWS	Class II	2016-03-08
K153326	Erisma-LP Spinal Fixation System	Clariance-SAS	NKB	Class II	2016-03-08
K153270	TruGuard Custom Tongue and Jaw Positioner	Bionix Development Corp.	IYE	Class II	2016-03-08
K152882	Propeller System	Reciprocal Labs Corporation	CAF	Class II	2016-03-08
K152815	Mailuokang Self-adhesive Electrode	Shenzhen Mailuokang Technology Co., Ltd.	GXY	Class II	2016-03-08
K152766	CharmFlex	Dentkist, Inc.	ELW	Class II	2016-03-08
K152262	Ventix Knotless Anchors	Biomet Manufacturing Corp	MBI	Class II	2016-03-08
K152206	SurgiPure XD Reconstructive Tissue Matrix	Tissue Regenix Group PLC	FTM	Class II	2016-03-08
K160418	PERIMETER Interbody Fusion Device	Medtronic Sofamor Danek USA Inc	MAX	Class II	2016-03-07
K160041	Cobbra RF Tissue Dissector	Elliquence LLC	GEI	Class II	2016-03-07
K160025	iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR) Knee Replacement System	ConforMIS, Inc.	JWH	Class II	2016-03-07
K153430	Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select	Cook Incorporated	DYB	Class II	2016-03-07
K153400	ProLift Expandable System	Life Spine	MAX	Class II	2016-03-07
K153244	Cios Fusion	Siemens Medical Solutions USA, Inc.	OWB	Class II	2016-03-07
K152835	Uritek Tc-201 Urine Chemistry Test System	Teco Diagnostics	JFY	Class II	2016-03-07
K152824	Medt Pen Needle	Shandong Caremed Medical Products Co.,Ltd.	FMI	Class II	2016-03-07
K152614	Xpert Carba-R	Cepheid	PMY	Class II	2016-03-07
K150876	Bead Block	BIOCOMPATIBLES U.K. Limited, a BTG Company	KRD	Class II	2016-03-07
K150731	Medline Epidural Catheter	MEDLINE INDUSTRIES, LP - Northfield	BSO	Class II	2016-03-07
K150144	VisuCon-F Low Fibrinogen Control Plasma	Affinity Biologicals Inc.	GGN	Class II	2016-03-06
K160426	syngo.via MI Workflows	Siemens Medical Solutions USA, Inc.	LLZ	Class II	2016-03-04
K160301	Platinum dRF Imaging System	Apelem-Dms Group	JAA	Class II	2016-03-04
K160272	Endophys Pressure Sensing Sheath Kit	Endophys, Inc.	DYB	Class II	2016-03-04