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 2026-10-12, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 282 of 3528

510(k) clearances, page 282 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K220878	Straumann TLX Variobase C	Straumann USA, LLC	NHA	Class II	2022-06-16
K220469	Disposable Vinyl Examination Glove	Chifeng Huawei Medical Science&Technology Co., Ltd.	LYZ	Class I	2022-06-16
K220440	Dentis s-Clean Abutment Mini	Dentis Co.,Ltd	NHA	Class II	2022-06-16
K220399	WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System	OTU Medical Inc	EOQ	Class II	2022-06-16
K220299	Ion Endoluminal System (IF1000)	Intuitive Surgical, Inc.	EOQ	Class II	2022-06-16
K213504	Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A	Canon Medical Systems Corporation	JAK	Class II	2022-06-16
K212870	TLC Unicompartmental Knee System	Signature Orthopaedics Pty Limited	HSX	Class II	2022-06-16
K212788	Seer Home	Seer Medical Pty, Ltd.	GWQ	Class II	2022-06-16
K212426	Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA])	Donnevie Medical Technology (Shanghai) Co., Ltd.	MQL	Class II	2022-06-16
K203624	Custom-made Invisible Aligners	Zhejiang Yinchili Medical Technology Co.,Ltd	NXC	Class II	2022-06-16
K201348	DePuy 3D Additive TriFlange Acetabular Cup	Depuy International, Ltd.	LPH	Class II	2022-06-16
K201037	FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System	Taidoc Technology Corporation	NBW	Class II	2022-06-16
K221448	ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8)	Varian Medical Systems, Inc.	IYE	Class II	2022-06-15
K220804	Dia-X Bond Universal	Diadent Group International	KLE	Class II	2022-06-15
K220614	MEDOJECT fine Pen Needles	Chirana T. Injecta	FMI	Class II	2022-06-15
K220106	QardioArm 2	Qardio, Inc.	DXN	Class II	2022-06-15
K213684	SurgiCase Viewer	Materialise N.V.	LLZ	Class II	2022-06-15
K213626	Vitros Afp	Ortho-Clinical Diagnostics, Inc.	LOJ	Class II	2022-06-15
K213088	ZQuiet Advance	Sleeping Well, LLC	LRK	Class II	2022-06-15
K212325	EEG-acp	Somnomedics AG	GYB	Class II	2022-06-15
K221620	Digital Radiography CXDI-Elite, Digital Radiography E1	Canon, Inc.	MQB	Class II	2022-06-14
K221500	ACUSON Sequoia Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	IYN	Class II	2022-06-14
K221387	BEL-GEN Cold Storage Solution	Institut Georges Lopez	KDL	Class II	2022-06-14
K221386	PERF-GEN Pulsatile Perfusion Solution	Institut Georges Lopez	KDL	Class II	2022-06-14
K220550	Disposable Surgical Face Mask (M663BE, M663BT)	Makrite Industries, Inc.	FXX	Class II	2022-06-14
K220004	Zsquare ENT-Flex Endoscope	Zsquare Ltd	EOB	Class II	2022-06-14
K213467	EVA NEXUS Ophthalmic Surgical System	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	HQC	Class II	2022-06-14
K212808	Logic Hd camera head green, System green	Richard Wolf Medical Instruments Corp.	FET	Class II	2022-06-14
K211466	Yomi Robotic System with YomiPlan Go	Neocis Inc.	PLV	Class II	2022-06-14
K221695	3M Filtek Supreme Flowable Restorative	3M Company Espe Dental Products	EBF	Class II	2022-06-13
K221081	iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System	First Source Inc	IZL	Class II	2022-06-13
K220157	Disposable Hemostatic Closure Clip Device	Micro-Tech (Nanjing) Co., Ltd.	PKL	Class II	2022-06-13
DEN220006	ProdiGI	Medtronic, Inc.	QSW	Class II	2022-06-13
K203208	Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System	Taiwan Aulisa Medical Devices Technologies, Inc.	DQA	Class II	2022-06-12
K221384	Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2	Hivox Biotek Inc.	NUH	Class II	2022-06-11
K221658	Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set	Centers for Disease Control and Prevention	PBK	Class II	2022-06-10
K221393	Swoop Portable MR Imaging System	Hyperfine, Inc	LNH	Class II	2022-06-10
K221376	Nalu Neurostimulation System	Boston Scientific Neuromodulation Corporation	GZB	Class II	2022-06-10
K221362	Omni Foot and Ankle Plating System	Exremity Medical, LLC	HRS	Class II	2022-06-10
K221087	Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4	Medtronic Navigation, Inc	HAW	Class II	2022-06-10
K221065	MediLab	Sigma Scientific Services, LLC	LLZ	Class II	2022-06-10
K220894	SmileGuard	Envisiontec GmbH	MQC	Unclassified	2022-06-10
K220796	IntellaMap Orion High Resolution Mapping Catheter	Boston Scientific Corporation	DRF	Class II	2022-06-10
K220528	Surgical Isolation Cover Gown	Wuhan Dymex Healthcare Co., Ltd.	FYC	Class II	2022-06-10
K220420	Saffron Fixation System	MEDLINE INDUSTRIES, LP - Northfield	PBQ	Class II	2022-06-10
K220319	Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System	Stryker Corp.	HWC	Class II	2022-06-10
K213667	iFuse-TORQ® Implant System	SI-Bone, Inc.	OUR	Class II	2022-06-10
K213519	Rune Labs Tremor Transducer System	Rune Labs Inc.	GYD	Class II	2022-06-10
K213515	WesperO2	Wesper, Inc.	DQA	Class II	2022-06-10
K213442	Extroducer Infusion Catheter System	SmartWise Sweden AB	KRA	Class II	2022-06-10