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 2026-11-05, 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 1788 of 3531

510(k) clearances, page 1788 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K982892	3M Tegasorb Thin Hydrocolloid Dressing	3M Company	KMF	Class I	1998-10-26
K982890	Advanced Uroscience Injection Needle	Advanced Uroscience, Inc.	FBK	Class II	1998-10-26
K982636	Patient Warmer- Model Pw810	Fisher & Paykel Healthcare, Inc.	ILY	Class II	1998-10-26
K982624	Moldcare Head & Neck Cushion, Model # Mt-Acl-14242	Medtec LLC	IYE	Class II	1998-10-26
K981613	Cobe Smarxt Tubing and Connectors	LivaNova USA, Inc.	DWE	Class II	1998-10-26
K983639	Zippie Gs, Model # Eizgs	Sunrise Medical, Inc.	IOR	Class I	1998-10-25
K983079	Platinlloyd 100	Bego U.S.A.	EJT	Class II	1998-10-23
K983078	Begopal	Bego U.S.A.	EJS	Class II	1998-10-23
K983077	Bio Pontostar	Bego U.S.A.	EJT	Class II	1998-10-23
K982725	Olympus Mh-246R Balloon Sheath, for Female Reproductive Tract Use	OLYMPUS Corporation of the Americas	ITX	Class II	1998-10-23
K982689	Winstation Retinal Imager	Ophthalmic Imaging Systems	HKI	Class II	1998-10-23
K982604	Lorenz Maxilla (Le Fort) Distraction System	Biomet Microfixation	MQN	Class II	1998-10-23
K982128	Shikani-French Speaking Valve	Pilling Weck Surgical	JOH	Class II	1998-10-23
K981791	Mg	Abbott Medical	JGJ	Class I	1998-10-23
K983107	Vfe	Ramco Laboratories, Inc.	GGP	Class II	1998-10-22
K983057	Orthophos 5/Plus/cd	Sirona Dental Systems GmbH	MUH	Class II	1998-10-22
K983018	Zinc Phosphate Cement	Medental Intl.	EMA	Class II	1998-10-22
K982761	Joint Motion Device Package Pn 1032,Kneel Cervical Pn 1026, Lumbar 1027, Wrist 1028, Ankle 1029, Shoulder 1030, Hip 1031	Chamco, Inc.	LNH	Class II	1998-10-22
K982714	Bayer Immuno 1 System Ferritin Assay	Bayer Corp.	DBF	Class II	1998-10-22
K982701	Unicap Gliadin Igg Assay	Pharmacia & Upjohn Company LLC	MST	Class II	1998-10-22
K982692	Sternomega Bonding Agent, Sternomega Composite Lc, Sternomega Compomer Lc	Sterngold/Implamed	EBF	Class II	1998-10-22
K982593	Lube Free Autochuck Turbine with Vortex Air Seal for Use with Star Dental 430 Series Lube Free High Speed Dental Handpie	Dentalez Group	EFB	Class I	1998-10-22
K982580	Bird Monitor Interface	Bird Products Corp.	CBK	Class II	1998-10-22
K982576	Frialit-2 Aurobase Model Numbers 45-2446, 45-2456, 45-2466, 45-2476	Friatec AG	DZE	Class II	1998-10-22
K982533	Unicap Gliadin Iga Assay	Pharmacia & Upjohn Company LLC	MST	Class II	1998-10-22
K982255	Model 2000 Pulse Oximeter	Ivy Biomedical Systems, Inc.	DQA	Class II	1998-10-22
K982133	Olympus Endoscopic System Lumbar Hernia Discectomy and Its Ancillary Equipment	Olympus Optical Co., Ltd.	HRX	Class II	1998-10-22
K981490	Willi Geller Creation Porcelain	Jensen Industries, Inc.	EIH	Class II	1998-10-22
K981209	Monkey Oesophagus Ifa Diagnostic Test Kits	The Binding Site	MVM	Class II	1998-10-22
K980828	Exmoor Myringotomy Kit	Exmoor Plastics Limited	ETD	Class II	1998-10-22
K980590	Varisource Henschke Type Gyn Applicator for Varian Varisource Remote High Dose Rate Afterloader	Varian Medical Systems, Inc.	JAQ	Class II	1998-10-22
K980410	Sle Electrodes and Accessories	Specialized Laboratory Equipment, Ltd.	GXY	Class II	1998-10-22
K974395	Atlant's	Grad-Line Corp.	IRP	Class II	1998-10-22
K983416	Roche Diagnostics Magnesium Reagent, Cat# 1551353	Boehringer Mannheim Corp.	JGJ	Class I	1998-10-21
K983316	Ultracision 5Mm Instruments	Ethicon Endo-Surgery Inc	LFL	Unclassified	1998-10-21
K983260	Modification to Spinal Concepts Bacfix Ti Spinal Fixation System	Spinal Concepts, Inc.	MNI	Class II	1998-10-21
K983258	Modification to Spinal Concepts Bacfix Spinal Fixation System	Spinal Concepts, Inc.	MNI	Class II	1998-10-21
K983224	Xps Drill System	Xomed, Inc.	ERL	Class II	1998-10-21
K983186	Bio-Anchor, Pre-Loaded Bioabsorbable Suture Anchor	Linvatec Corporation	MAI	Class II	1998-10-21
K983058	Ceralas D Laser System, Model # Ceralas D15	Ceram Optec, Inc.	GEX	Class II	1998-10-21
K983053	Alden Classic Prosthetic (Polymacon) Tinted, Soft Daily Wear Contact Lens (Sighted and Non-Sighted Eyes)	Alden Optical Labs., Inc.	LPL	Class II	1998-10-21
K982998	Greiner Minicollect Serum Gel Blood Collection Tube	Greiner Meditech, Inc.	JKA	Class II	1998-10-21
K982991	Anspach Access Cranial Perforator	The Anspach Effort, Inc.	HBF	Class II	1998-10-21
K982990	Tsrh Spinal System	Sofamor Danek USA,Inc.	MNI	Class II	1998-10-21
K982987	Synthes Posterior Universal Spinal System	Synthes GmbH	MNI	Class II	1998-10-21
K982984	Accushear Laparoscopic Surgical Instruments	Microline Pentax, Inc.	GEI	Class II	1998-10-21
K982953	Titanium Intramedullary Nails-Various Styles	Zimmer GmbH	HSB	Class II	1998-10-21
K982936	Osteonics Extended Femoral Bearing Head	Osteonics Corp.	LWJ	Class II	1998-10-21
K982931	Threaded Fixation Pin	Sgarlato Laboratories, Inc.	JDW	Class II	1998-10-21
K982903	Sulzer Orthopedics Fluted Stems	Sulzer Orthopedics, Inc.	JWH	Class II	1998-10-21