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 899 of 3530

510(k) clearances, page 899 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K113510	Evolution Colonic Stent System	Cook Ireland Ltd.	MQR	Class II	2012-05-17
K113281	MRI Sytems	Shenzhen Anke High-Tech Co., Ltd.	LNH	Class II	2012-05-17
K113253	Ace Axcel Clinical Chemistry System,ace Albumin Reagent,ace Total Protein Reagent,ace Bun/ureanitrogen Reagent	Alfa Wassermann Diagnostic Technologies, Inc.	JJE	Class I	2012-05-17
K112322	Restorelle Polypropylene Y Mesh	MEDLINE INDUSTRIES, LP - Northfield	OTO	Class II	2012-05-17
K121186	Radial Jaw 4 Pulmonary Biopsy Forceps	Boston Scientific Corporation	BWH	Class II	2012-05-16
K121149	Vanguard Ssk 360 Revision Knee System	Biomet Manufacturing Corp	JWH	Class II	2012-05-16
K121124	Arthrex Mixing and Delivery System	Arthrex GmbH	FMF	Class II	2012-05-16
K120287	Trojan Magnum Condom with Fire & Ice Lubricant	Church & Dwight Co., Inc.	HIS	Class II	2012-05-16
K120216	Genosyl Mv-1000	Geno, LLC	MRN	Class II	2012-05-16
K120173	Patient Monitor	Edan Instruments, Inc.	MHX	Class II	2012-05-16
K120035	Apex Medical Ich CPAP Series (9S-007Xxx)	Apex Medical, Inc.	BZD	Class II	2012-05-16
K113166	Clearpath Upper Gi	Easyglide, Ltd.	FDS	Class II	2012-05-16
K113050	Clearpath Lower Gi	Easyglide, Ltd.	FDF	Class II	2012-05-16
K112921	Medicalgorithmics Unified Arrhythmia Diagnostic System	Medicalgorithmics S.A.	DSI	Class II	2012-05-16
K112494	Varaya Ar , Varaya Sport	Varaya Photoceuticals, LLC	ILY	Class II	2012-05-16
K112127	Pico Single Use Negative Pressure Wound Therapy System	Smith & Nephew, Inc.	OMP	Class II	2012-05-16
K103658	Flextip Plus Closed Tip Epidural Catherter	Teleflex Medical	CAZ	Class II	2012-05-16
K121223	Qlab with Fhn and Vpq Plug-in	Philips North America LLC	LLZ	Class II	2012-05-15
K121141	Tl-200 T-Line Non-Invasive Blood Pressure Monitoring System	Tensys Medical Systems, Inc.	DXN	Class II	2012-05-15
K120707	Switch-It Catheter	Vascular Solutions LLC	DQY	Class II	2012-05-15
K120681	Advia Chemistry Gluh_3 Reagents	Siemens Healthcare Diagnostics Inc.	CFR	Class II	2012-05-15
K120267	Filmarray Rp Panel	Idaho Technology, Inc.	OCC	Class II	2012-05-15
K111940	S 100 Pedicle Screw System	Renovis Surgical Technologies, LLC	MNH	Class II	2012-05-15
K120798	Disposable Power Free Vinyl Exam Glove, Pink Color	Canopus Medical Supply Co., Ltd.	LYZ	Class I	2012-05-14
K120736	Sr Phonares II	Ivoclar Vivadent, Inc.	ELM	Class II	2012-05-14
K120692	Latex Examination Gloves (Powder Free)	Top Calibre Sdn Bhd	LYY	Class I	2012-05-14
K120571	Synthes Uss Connector	Synthes GmbH	NKB	Class II	2012-05-14
K120497	Easyra Hbalc Regent Easycal Hblc Calibrator Easyqc Hbalc Material	Medica Corp.	LCP	Class II	2012-05-14
K120257	Mls, Zerona-Ad	Erchonia Medical, Inc.	OLI	Class II	2012-05-14
K120166	Compressible Limb and Circulation Therapy System	Won Industrial Co.	IRP	Class II	2012-05-14
K120160	Rocamed Rocaus Platinum	Promepla S.A.M	KNY	Class II	2012-05-14
K120077	Comed K-Series Manual Wheelchair	Danyang Comed Healthcare Co., Ltd.	IOR	Class I	2012-05-14
K113266	Gel-Block Embolization Pledgets	Vascular Solutions LLC	KRD	Class II	2012-05-14
K113215	Model 7600 Regional Oximeter System with Equanox Technology	Nonin Medical, Inc	MUD	Class II	2012-05-14
K113194	Powder Free Vinyl Patient Examination Gloves, White Color	Suqian Ruijang Medical Supplies Co., Ltd.	LYZ	Class I	2012-05-14
K113072	Tina-Quant Albumin Gen.2	Roche Diagnostics GmbH	DCF	Class II	2012-05-14
K111188	Cobas B 123 Poc System, Cobas B 123 Autoqc Pack Tri-Level, Cobas B 123 Autocvc Pack, Roche Combitrol Plus B	Roche Diagnostics GmbH	CHL	Class II	2012-05-14
K121127	Sidelaze Laser Beam Delivery Accessory for Cynosure 1440Nm Wavelength Lasers	Cynosure, LLC	GEX	Class II	2012-05-13
K120821	Llics(tm) Laparascopic Lens Internal Cleaning System	Misder, LLC	OCT	Class II	2012-05-11
K120449	Healix Advance Peek Anchor	DePuy Mitek, Inc.	HWC	Class II	2012-05-11
K120296	Cps Direct Mediguide Enabled Outer Catheter	St. Jude Medical, Cardiac Rhythm Management Divisi	DQY	Class II	2012-05-11
K120249	Trojan Magnum Condom with Warming Lubricant	Church & Dwight Virginia Co., Inc.	HIS	Class II	2012-05-11
K120185	Inspire 6F Hollow Fiber Oxygenator with Integrated Arterial Filter and Hardshell Venous/cardiotomy Reservior	Corcym Inc.	DTZ	Class II	2012-05-11
K120183	Advocate Redi-Code+bmb-Ea001s Blood Glucose Monitoring System	Broadmaster Biotech Corperation	NBW	Class II	2012-05-11
K120119	Sunmed Guide Wire	Sunny Medical Device (Shenzhen) Co., Ltd.	DQX	Class II	2012-05-11
K120057	Envisu Spectral Domain Ophthalmic Imaging System (Sdois)	Bioptigen, Inc.	HLI	Class II	2012-05-11
K113333	Kimberly-Clark Kim Vent Microcuff Endotracheal Tube for Adults	Kimberly-Clark Corporation	BTR	Class II	2012-05-11
K112669	Tattoostar Effect Y	Asclepion Laser Technologies GmbH	GEX	Class II	2012-05-11
K112511	Dobbhoff Dual Port Feeding Tube	Covidien Lp, Formerly Registered AS Kendall	KNT	Class II	2012-05-11
K121279	Elecsys Lh Calcheck 5	Roche Diagnostics GmbH	JJX	Class I	2012-05-10