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 925 of 3530

510(k) clearances, page 925 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K113541	Clearstart Svm System	Intio, Inc.	LLZ	Class II	2011-12-16
K113476	Anspach Dissection Tools	The Anspach Effort, Inc.	HBE	Class II	2011-12-16
K113457	Hydrocoil Embolic System (Hes)	Terumo Cardiovascular Systems Corporation	HCG	Class II	2011-12-16
K113400	Fixate Tissue Band	Anulex Technologies, Inc.	GZB	Class II	2011-12-16
K113270	Instinct Java System	Zimmer Spine, Inc.	NKB	Class II	2011-12-16
K113193	Patient Examination Glove	Suqian Ruijang Medical Supplies Co., Ltd.	LYZ	Class I	2011-12-16
K113121	Comprehensive Reverse Shoulder	Biomet Manufacturing Corp	PHX	Class II	2011-12-16
K113068	Remstar Auto a-Flex Ht	Respironics, Inc.	BZD	Class II	2011-12-16
K112987	Twister Side Fire Optical Fiber Delivery System	Biolitec Medical Devices, Inc.	GEX	Class II	2011-12-16
K112913	Spotlight Access System	Johnson & Johnson	GZT	Class II	2011-12-16
K112869	Easyprophy Series Air Polish Devices, Models Easyprophy 200 and Easyprophy 400	Beyes Dental Canada, Inc.	EFB	Class I	2011-12-16
K112819	Reconstruction Locking Plate and 3.5Mm Locking Screw	Xiamen Double Engline Medical Material Co., Ltd.	HRS	Class II	2011-12-16
K112770	Nvision Vle Imaging System, Nvision Vle Catheter	Ninepoint Medical, Inc.	NQQ	Class II	2011-12-16
K112752	Tinnitus Therapy System Anm T30 Cr	Anm Adaptive Neuromodulation GmbH	KLW	Class II	2011-12-16
K112743	Same/various Distributors/we May Private Label	Clean Medical Manfacturing Co;Ltd	LYZ	Class I	2011-12-16
K112733	Er35 Ero-Scan Pro Hearing Test System	Etymotic Research, Inc.	EWO	Class II	2011-12-16
K112722	Ge Datex-Ohmeda Avance	GE Healthcare	BSZ	Class II	2011-12-16
K112623	Airlight Dental Handpiece	Beyes Dental Canada, Inc.	EFB	Class I	2011-12-16
K112613	Integrity(tm)	Elekta Limited	IYE	Class II	2011-12-16
K112428	Novabone Dental Morsels - Bioactive Synthetic Bone Graft	Novabone Products, LLC	LYC	Class II	2011-12-16
K112424	Verigene Staphylococcus Blood Culture Nucleic Acid Test (Bc-S)	Luminex Corporation	NQX	Class II	2011-12-16
K112388	Lanx Cervical Sa	Lanx, Inc.	OVE	Class II	2011-12-16
K112289	Disposable Thermometer Covers and Sheaths	Kang ZE Industrial Co., Ltd.	FLL	Class II	2011-12-16
K112055	Amsco Chimeron Medium Steam Sterilizer	STERIS Corporation	FLE	Class II	2011-12-16
K112048	Immunocard C. Difficile Gdh	Meridian Bioscience Inc	MCB	Class I	2011-12-16
K111514	Sbv2, Multicharger Model Mc10v2	Sleep Performance D.B.A. Fatigue Science	LEL	Class II	2011-12-16
K110881	Ultrasonic Surgical Unit	Dong IL Technology, Ltd.	DZI	Class II	2011-12-16
K110793	Amecath and Amecath Uniqath Soft Short Term Dual Hemodialysis Catheterization Kits	Ameco Medical Industries	MPB	Class II	2011-12-16
K110603	Hypertension Management Software Claient Server (Hms-Cs)	I.E.M. GmbH	DXN	Class II	2011-12-16
K110360	Prophecy Inbone Pre-Operative Navigation Alignment Guides	Wrightmedicaltechnologyinc	HSN	Class II	2011-12-16
K110184	Liquiband Flow Control	Medlogic Global Limited	MPN	Class II	2011-12-16
K102712	Med Gravity Set, Imed Pump Set	Imed Technology, Inc.	KNT	Class II	2011-12-16
K100919	Pro Focus 2202, Pro Focus 2202 UV Model: Type 2202	BK Medical ApS	IYN	Class II	2011-12-16
K113564	Exsalt T7 Wound Dressing	Exciton Technologies Inc.	FRO	Unclassified	2011-12-15
K113299	Rog Suture Anchor	Rog Sports Medicine, Inc.	MBI	Class II	2011-12-15
K113133	Medrad Mark 7 Arterion (Pedestal System), (Table Mount System), Medrad Mark 7 Arterion Arterion Syringe	Medrad, Inc.	DXT	Class II	2011-12-15
K113107	Msa Hip System	Global Manufacturing Technology	MEH	Class II	2011-12-15
K113105	Tempusic Patient Monitor	Remote Diagnostic Technologies Ltd.	MWI	Class II	2011-12-15
K112876	Cufflink(tm) Knotless Anchor with Inserter, 4.5Mm/5.5mm - Peek Only, Cufflink Sp(tm) Knotless Anchor with Inserter, 4.5	Cayenne Medical Inc.	MBI	Class II	2011-12-15
K112780	Conformis Itotal Cruciate Retaining (Cr) Knee Replacement System	ConforMIS, Inc.	JWH	Class II	2011-12-15
K112562	Bal Cath Bronchial Aspirate Sampling Catheter	Kimberly-Clark Corporation	OYI	Class I	2011-12-15
K112560	Aptus(r) Distal Humerus System	Medartis AG	HRS	Class II	2011-12-15
K112490	Quidel Molecular Hmpv Assay	Ortho-Clinical Diagnostics, Inc.	OEM	Class II	2011-12-15
K112275	Fora Premium V10 Blood Glucose Monitoring System	Taidoc Technology Corporation	NBW	Class II	2011-12-15
K112218	Ace-Fischer(r), Tempfix(r), Hoffman Classic(tm) External Fixators	Depuy Orthopaedics Inc.	KTT	Class II	2011-12-15
K112040	Arthrex Biocomposite Transfix	Arthrex GmbH	MAI	Class II	2011-12-15
K111746	Comprehensive Segmental Revision System (Srs)	Zimmer GmbH	KWT	Class II	2011-12-15
K111669	Freestyle Glucose Meter Incorporated into the Omnipod Insulin Management Systems	Insulet Corporation	LZG	Class II	2011-12-15
K111170	Pico	Smith & Nephew, Inc.	OMP	Class II	2011-12-15
K110633	Lancer Pedicle Screw System	Spinal Solutions, LLC	MNH	Class II	2011-12-15