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 1472 of 3531

510(k) clearances, page 1472 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K022965	Blackstone Classic Anterior Cervical Plate	Blackstone Medical, Inc.	KWQ	Class II	2003-03-28
K022446	Mucus Collection Probe, Models Bc-401C & Bc-402C	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	EOQ	Class II	2003-03-28
K012677	Reprocessed Pulse Oximeter Sensors	Sterilmed Inc	NLF	Class II	2003-03-28
K030859	Nova Ceramic Spray Glaze and Tru-Paque, Opaque Porcelain	Enamelite, LLC	EIH	Class II	2003-03-27
K030770	Oti Scan with Transducers	Ophthalmic Technologies, Inc.	IYO	Class II	2003-03-27
K030363	Org@nizer, Model Version 3.0	Ebit Sanita, S.p.A.	LLZ	Class II	2003-03-27
K030212	Monodek Synthetic Absorbable Surgical Suture	Genzyme Biosurgery	NEW	Class II	2003-03-27
K024334	Quanta Lite H.pylori Iga Elisa	Inova Diagnostics, Inc.	LYR	Class I	2003-03-27
K023556	Flu Oia A/b Test Kit	Thermo Biostar, Inc.	PSZ	Class II	2003-03-27
K020189	Exel Butterfly Scalp Vein Set	Exelint International Co.	FPA	Class II	2003-03-27
K030789	Amsco Century Steam Sterilizer	STERIS Corporation	FLE	Class II	2003-03-26
K030763	Diagnostic Ultrasound Bladdermass Bvm 6500 Ultrasound System	Diagnostic Ultrasound Corp.	IYO	Class II	2003-03-26
K030705	Cliniqa Liquid Qc Tumor Marker Control Level 1, Level 2, Level 3, and Tri Level	Cliniqa Corporation	JJY	Class I	2003-03-26
K030689	Spi Element Dental Implant O 3.5 Mm	Thommen Medical AG	DZE	Class II	2003-03-26
K030312	Porta Implant	Wieland Dental + Technik GmbH & Co. KG	EJT	Class II	2003-03-26
K030273	Glovetex Latex Examination Gloves, Powdered, Blue, Non Sterile	Pt. Wrp Buana Multicorpora	LYY	Class I	2003-03-26
K030201	Modification to Export Aspiration Catheter	Medtronic, Inc.	NFA	Class II	2003-03-26
K030018	Mhs 7000	Micro Health Systems, Inc.	LHQ	Class I	2003-03-26
K024356	Clearfil Silane Kit	Kuraray Medical, Inc.	KLE	Class II	2003-03-26
K024261	Dental Protector	Dental Concepts, LLC	MQC	Unclassified	2003-03-26
K024240	Bd Vacutainer Plus Plastic Urine C&s Preservayive Tubes and Kits	BD	JSM	Class I	2003-03-26
K023998	Theriridge Block, Bone Graft Substitute	Therics, Inc.	LYC	Class II	2003-03-26
K023819	Fiberfill Sgp	Pentron Clinical Technologies	EKM	Class I	2003-03-26
K023513	Logos Junior Dental Chair and Unit	Castellini S.p.A.	EIA	Class I	2003-03-26
K030666	Multicare Platinum System and Accessories	Hologic, Inc.	IZH	Class II	2003-03-25
K030665	Bone Wire	Stork Instrumente GmbH	HTY	Class II	2003-03-25
K030658	Standard Thermometer	Global Treasure Industries, Ltd.	FLL	Class II	2003-03-25
K030645	Boston Scientific Express Biliary Ld Unmounted Stent	Boston Scientific Corporation	FGE	Class II	2003-03-25
K030601	Verte-Stack Spinal System	Medtronic Sofamor Danek	MQP	Class II	2003-03-25
K030577	Proven Modular Tibial Tray	Globus Medical, Inc.	JWH	Class II	2003-03-25
K030317	Model 1300Ge-64: Pediatric Positioner	Midwest Rf, LLC	MOS	Class II	2003-03-25
K030284	Powder Free Nitrile Examination Gloves (Natural, Blue,purple)	Pt. Smartglove Indonesia	LZA	Class I	2003-03-25
K030134	Latex Examination Gloves Powder Free with Neoprene Lined, Sizes Xsmall, Small, Medium, Large, Xlarge	Pt.Shamrock Manufacturing Corp.	LYY	Class I	2003-03-25
K024358	20.1 Monochrome Lcd Monitor, Radiforce G21	Eizo Nanao Corporation	LLZ	Class II	2003-03-25
K024327	Setpoint Endovascular Temperature Probe	Radiant Medical	DQY	Class II	2003-03-25
K024324	Latex Condom and Latex Condom Lubricated with Nonoxynol-9	Global Protection Corp.	HIS	Class II	2003-03-25
K023969	Reactive Skin Decontamination Lotion	Dept. of the Army	MAC	Class I	2003-03-25
K023754	Vinyl Examination Gloves, Powder-Free with Vitamin E	Arista Latindo Industrial, Ltd. P.T.	LYZ	Class I	2003-03-25
K023753	Vinyl Examination Gloves, Pre-Powdered with Vitamin E	Arista Latindo Industrial, Ltd. P.T.	LYZ	Class I	2003-03-25
K023658	Sterilization Cases and Trays	Carr Metal Products, Inc.	FRG	Class II	2003-03-25
K020271	Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100	Levitronix, LLC	KFM	Class II	2003-03-25
K030611	Modification to Suzanne Portable Polysomnograph System	Nellcor Puritan Bennett (Melville), Ltd.	MNR	Class II	2003-03-24
K030567	Modification to Vascular Architects Aspire Covered Stent and Contrilled Expansion Delivery System	Vascular Architects, Inc.	JCT	Class II	2003-03-24
K030238	Bindazyme Anti-Mitochondria M2 Iggam Eia Kit	The Binding Site	DBM	Class II	2003-03-24
K030194	Xues-41 Endoscopic Electrosurgical Unit	Olympus Optical Co., Ltd.	KNS	Class II	2003-03-24
K024349	Aesulap Kopitnik Avm Microclips and Applier	Aesculap Inc	HCH	Class II	2003-03-24
K024310	Nma 1052 Console System with Nma 100 Laser Accessory	Medx Electronics, Inc.	NHN	Class II	2003-03-24
K024301	Lsi Endoscopic External Accessory Channel and Accessories Product	Lsi Solutions Inc.	ODC	Class II	2003-03-24
K023218	Modification to Plexolong Sets	Pajunk GmbH Medizintechnologie	BSP	Class II	2003-03-24
K022949	Synthes Uss, Click'x, Uss Vas, Dual-Opening Uss and Small Stature Uss	Synthes (USA) Products LLC	MNI	Class II	2003-03-24