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 2026-10-19, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 487 of 3529

510(k) clearances, page 487 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K182517	MULTIX Impact	Siemens Medi Cal Solutions, Inc.	KPR	Class II	2019-01-11
K182500	Catalyst CSR Press-Fit Humeral Components	CATALYST ORTHOSCIENCE Inc	KWT	Class II	2019-01-11
K182453	ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)	I-Tech Industries SRL	NUV	Class II	2019-01-11
K182421	Senhance Ultrasonic System	Asensus Surgical, Inc.	NAY	Class II	2019-01-11
K182409	Applied Tissue Technologies PWD™ Platform Wound Dressing	Applied Tissue Technologies, LLC	OMP	Class II	2019-01-11
K182212	Geo Staple System	Gramercy Extremity Orthopedics, LLC.	JDR	Class II	2019-01-11
K182202	Sleepapp	Comfort Acrylics, Inc.	LRK	Class II	2019-01-11
K181917	Mta2.3 Materials	Nusmile, Ltd	KIF	Class II	2019-01-11
K181805	UV Phototherapy	Xuzhou Kernel Medical Equipment Co Ltd	FTC	Class II	2019-01-11
K181649	AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)	Trudell Medical International	NVP	Class II	2019-01-11
K181377	PROSTEP MICA Screw System	Wrightmedicaltechnologyinc	HWC	Class II	2019-01-11
K180902	MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly	Medipines Corporation	CCK	Class II	2019-01-11
K180229	RESCAN 700, CALLISTO eye	Carl Zeiss Meditec Inc	OBO	Class II	2019-01-11
K180228	II-Type Intervertebral Spacer	Paonan Biotech Co., Ltd	MAX	Class II	2019-01-11
K183616	HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)	M.I.Tech Co Ltd	MQR	Class II	2019-01-10
K183097	Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream	Weihai Kangzhou Biotechnology Engineering Co., Ltd.	LCX	Class II	2019-01-10
K183071	VLIFT-s Vertebral Body Replacement System	Howmedica Osteonics Corp	PLR	Class II	2019-01-10
K183011	Additive Orthopaedics Patient Specific 3D Locking Lattice Plates	Additive Orthopaedics, LLC	HRS	Class II	2019-01-10
K182873	STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices	Ethicon, Inc	NEW	Class II	2019-01-10
K182727	Trident HD Specimen Radiography System	Hologic, Inc.	MWP	Class II	2019-01-10
K182636	DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	IYN	Class II	2019-01-10
K182635	Signal Catheter	Safe Medical Design	EZL	Class II	2019-01-10
K182367	DIASAFEplusUS	Fresenius Medical Care Renal Therapies Group, LLC	FIP	Class II	2019-01-10
K182120	Maxpower Relief	Omron Healthcare Co., Ltd.	NUH	Class II	2019-01-10
K181444	Clarus	Carl Zeiss Meditec Inc	QER	Class II	2019-01-10
K181204	RENASYS Y-Connector; RENASYS TOUCH	Smith & Nephew Medical Ltd	OMP	Class II	2019-01-10
K181180	OSSIO™ Pin Product Family	OSSIO, Ltd.	HTY	Class II	2019-01-10
K180837	CONTEC Oxygen Concentrator	Contec Medical System Co., Ltd.	CAW	Class II	2019-01-10
K180387	Infrared Ear Thermometer	Hetaida Technology Co., Ltd.	FLL	Class II	2019-01-10
K180355	Advocate Non-Contact Infrared Thermometer	Broadmaster Biotech Corporation	FLL	Class II	2019-01-10
K183713	Wireless Digital Flat Detector	Iray Technology Taicang, Ltd.	MQB	Class II	2019-01-09
K183422	Wireless Digital Flat Panel Detector	Iray Technology Taicang, Ltd.	MQB	Class II	2019-01-09
K183200	iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses	C&E GP Specialist, Inc.	MUW	Class II	2019-01-09
K183133	MRCP+ v1.0	Perspectum Diagnostics, Ltd.	LLZ	Class II	2019-01-09
K182869	Fit SA	Shofu Dental Corp.	EBF	Class II	2019-01-09
K182846	PENTAX Medical EPK-3000 Video Imaging System	PENTAX of America, Inc.	EOB	Class II	2019-01-09
K181637	DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	IYN	Class II	2019-01-09
K181282	G3A 40 Bone Cement	G21, S.r.l.	LOD	Class II	2019-01-09
K181118	Reliance Lumbar IBF System	Reliance Medical Systems, LLC	OVD	Class II	2019-01-09
K181086	Cortical Fixation Systems	Cousin Biotech SAS	MBI	Class II	2019-01-09
K181047	Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves Tested for Use with Chemotherapy Drugs	Smart Glove Corporation Sdn. Bhd.	KGO	Class I	2019-01-09
K182868	INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor	Medtronic, Inc.	MUD	Class II	2019-01-08
K182721	Choice Spine Navigation System	Choicespine, LP	OLO	Class II	2019-01-08
K182692	BD MAX CTGCTV2, BD MAX System	Becton Dickinson & Co	OUY	Class II	2019-01-08
K182632	HS30 Diagnostic Ultrasound System	Samsung Medison Co., Ltd.	IYN	Class II	2019-01-08
K182630	Omnipod Insulin Management System, Omnipod DASH Insulin Management System	Insulet Corporation	LZG	Class II	2019-01-08
K182439	TruShot with Y-Knot Shallow All-Suture Anchor	ConMed Corporation	MBI	Class II	2019-01-08
K180648	Park Dental Research Aligners	Park Dental Research Corp	NXC	Class II	2019-01-08
K183470	Precision Ideal Eyes Arthroscopes	Stryker Corp.	HRX	Class II	2019-01-07
K182305	Stryker Facial iD Plating System	Stryker Corp.	JEY	Class II	2019-01-07