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 2026-10-26, 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 673 of 3530

510(k) clearances, page 673 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K152993	MUSE Cardiology Information System	GE Medical Systems Information Technologies, Inc.	DQK	Class II	2016-01-12
K152880	Biograph Horizon PET/CT	Siemens Medical Solutions USA, Inc.	KPS	Class II	2016-01-12
K152696	Infx-8000V, V6.20	Toshibamedical Systems Corporation	OWB	Class II	2016-01-12
K152589	Bio2 CLM BG Bioactive Scaffold	Bio2 Technologies, Inc.	MQV	Class II	2016-01-12
K152509	CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)	Altatec GmbH	NHA	Class II	2016-01-12
K151450	Endoscope Sterilization Tray	Intuitive Surgical, Inc.	KCT	Class II	2016-01-12
K151282	core nova Complete Operating Room Endoscopy	Richard Wolf Medical Instruments Corp.	ODA	Class II	2016-01-12
K151152	ImplantMax Software	Saturn Imaging, Inc.	LLZ	Class II	2016-01-12
K150515	IQSense Flow Sensor Mouthpiece	Sdi Diagnostics, Inc.	BZG	Class II	2016-01-12
K153197	Fortress Introducer Sheath SYstem	Contract Medical International GmbH	DYB	Class II	2016-01-11
K151884	K-Y Marilyn Pleasure Gel	Reckitt Benckiser LLC	NUC	Class II	2016-01-11
K151328	PURE Ceramic Implants	Straumann USA, LLC	DZE	Class II	2016-01-11
K151051	Universa Soft Ureteral Stents and Stent Sets	Cook Incorporated	FAD	Class II	2016-01-11
K150678	Sysmex Automated Blood Coagulation Analyzer CS-5100	Siemens Healthcare Diagnostic Products GmbH	JPA	Class II	2016-01-11
K153435	Direct HDL Cholesterol (HDL)	Randox Laboratories, Limited	LBS	Class I	2016-01-08
K153039	MRI Dynamic Analysis Plus	Esaote S.p.A.	LNH	Class II	2016-01-08
K152876	Long Sheath or Ls, 70 Cm, Long Sheath or Ls, 80 Cm, Long Sheath or Ls, 90 Cm	Tni Manufacturing, Inc.	DQY	Class II	2016-01-08
K152392	Vintage Ld	Shofu Dental Corp.	EIH	Class II	2016-01-08
K152356	Sapphire	Respironics, Inc.	BZD	Class II	2016-01-08
K152245	ONLINE TDM Vancomycin Gen.3	Roche Diagnostics Operations (Rdo)	LEH	Class II	2016-01-08
K151083	BioBridge Collagen Matrix	Fibralign Corporation	OWY	Class II	2016-01-08
K151018	Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette	Cook Incorporated	MQH	Class II	2016-01-08
K150969	Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces	Karl Storz Endoscopy-America, Inc.	ERL	Class II	2016-01-08
K143169	MyGlucoHealth Wireless System	Entra Health Systems	NBW	Class II	2016-01-08
K153541	Coldplay CryoBalloon® Ablation System	PENTAX of America, Inc.	GEH	Class II	2016-01-07
K153531	Treace Medical Concepts (TMC) Plating System	Treace Medical Concepts, Inc.	HRS	Class II	2016-01-07
K153427	Volpara Imaging Software	Matakina Technology Limited	LLZ	Class II	2016-01-07
K153336	VuePoint OCT System	Nu Vasive, Incorporated	NKG	Class II	2016-01-07
K153217	ConforMIS iTotal Posterior Stabilized Knee Replacement System	ConforMIS, Inc.	JWH	Class II	2016-01-07
K153214	Full Automatic (NIBP) Blood Pressure Monitor	Health & Life Corporation	DXN	Class II	2016-01-07
K153069	Edwards Balloon Catheter	Edwards Lifesciences LLC	OMZ	Class II	2016-01-07
K152924	Tiva¿	Becton Dickinson Infusion Therapy Systems Inc.	JKA	Class II	2016-01-07
K151960	Sterile High-pressure Angiographic Syringes for Single-use	Shenzhen Baoan Medical Supplies Co., Ltd.	DXT	Class II	2016-01-07
K151084	Well Lead Ureteral Access Sheath	Well Lead Medical Co. Ltd	FED	Class II	2016-01-07
K143445	Tellos ISQ Buddy	Tellos Medical AB	EKX	Class I	2016-01-07
K153536	Piccolo Composite® Nailing System	CarboFix Orthopedics Inc.	HSB	Class II	2016-01-06
K153502	ClariVein IC	Vascular Insights, LLC	KRA	Class II	2016-01-06
K153259	VasoStat Hemostasis Device	Forge Medical, Inc.	DXC	Class II	2016-01-06
K153233	Galaxy UNYCO System	Orthofix SRL	KTT	Class II	2016-01-06
K152944	Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems	Mortara Instrument, Inc.	DPS	Class II	2016-01-06
K152604	KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set	Medtronic Sofamor Danek USA, Incorporated	PML	Class II	2016-01-06
K152313	Medline ReNewal Reprocessed Endopath Endoscopic Instruments	Surgical Instrument Services and Savings, Inc.	NUJ	Class II	2016-01-06
K151662	iRestore	Freedom Laser Therapy Inc	OAP	Class II	2016-01-06
K151310	Amendia Interbody Fusion Devices	Spinal Elements, Inc	MAX	Class II	2016-01-06
K151287	Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D	Guangdong Biolight Meditech Co., Ltd	DQA	Class II	2016-01-06
K151104	Otelo Ll	Spineart SA	GAD	Class I	2016-01-06
K153265	New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated	New Deantronics Taiwan Ltd.	GEI	Class II	2016-01-05
K153190	Zenysis Short-Term Dialysis Catheter	C.R. Bard Inc	MPB	Class II	2016-01-05
K152954	Quell	Neurometrix, Inc.	NUH	Class II	2016-01-05
K152872	K2M Fenestrated Tap System	K2M, Inc	KNW	Class II	2016-01-05