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 198 of 3528

510(k) clearances, page 198 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K232167	VySpan™ PCT System	VY Spine, LLC	NKG	Class II	2023-09-27
K231538	FreedomFlow Orbital Circumferential Atherectomy System	Cardio Flow, Inc.	MCW	Class II	2023-09-27
K231363	Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)	Hantech Medical Device Co., Ltd.	NGT	Class II	2023-09-27
K231108	Talon Transseptal Sheath	Inari Medical, Inc.	DYB	Class II	2023-09-27
K231076	VariLift®-C Interbody Fusion System	Wenzel Spine	ODP	Class II	2023-09-27
K231007	CEDIA Heroin Metabolite (6-AM) Assay	Microgenics Corporation	DJG	Class II	2023-09-27
K230925	Disposable Injection Needle AF series	Alton Shanghai Medical Instruments Co Ltd	FBK	Class II	2023-09-27
K230563	EVOLUTION® Hinge Knee System	Microport Orthopedics Inc.	KRO	Class II	2023-09-27
K222638	Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems	Cepheid	NJR	Class I	2023-09-27
K214117	Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer	Abbott Diagnostics Technologies AS	LCP	Class II	2023-09-27
K232617	ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	IYN	Class II	2023-09-26
K232336	ES Series V2	E-Scopics	IYN	Class II	2023-09-26
K232233	Invisalign System with Mandibular Advancement Featuring Occlusal Blocks	Align Technology, Inc.	NXC	Class II	2023-09-26
K231971	Deka Physiq 360	El.En S.p.A.	PKT	Class II	2023-09-26
K230884	AVVIGO'+ Multi-Modality Guidance System	Boston Scientific Corporation	DQK	Class II	2023-09-26
K230513	Arthrex Univers Apex OptiFit Humeral Stem	Arthrex GmbH	KWS	Class II	2023-09-26
K230398	MedCAD® AccuPlate® 3DTi Patient-Specific Plating System	MedCAD	JEY	Class II	2023-09-26
K230252	OFIX MIS App	Orthofix SRL	LLZ	Class II	2023-09-26
K223496	Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1 Implant Systems	Prismatik Dentalcraft, Inc.	NHA	Class II	2023-09-26
K220396	EasyStat 300	Medica Corp.	CEM	Class II	2023-09-26
K213517	Access Thyroglobulin Antibody II	Siemens Healthcare Diagnostics Inc.	JZO	Class II	2023-09-26
DEN220026	VasQ	Laminate Medical Technologies	QVQ	Class II	2023-09-26
K232097	IdentiTi ALIF Interbody Systems	Alphatec Spine, Inc.	OVD	Class II	2023-09-25
K231977	PEACH 2, PEACH 2 Duo, PEACH 2 go	Foreo Inc	OHT	Class II	2023-09-25
K231928	EFAI RTSUITE CT HCAP-Segmentation System	Ever Fortune.Ai, Co., Ltd.	QKB	Class II	2023-09-25
K231891	Virtue Male Sling System with Alexis Wound Retractor Convenience Kit	MEDLINE INDUSTRIES, LP - Northfield	OTM	Class II	2023-09-25
K231888	BD Texium™ Needle-Free Syringe	Care Fusion	FMF	Class II	2023-09-25
K231739	Cervical Spine Truss System (CSTS)	4Web Medical, Inc.	OVE	Class II	2023-09-25
K230857	TiLink-P SI Joint Fusion System	Surgentec LLC	OUR	Class II	2023-09-25
K230825	Smileyscope System (Therapy Mode)	Smileyscope Holding, Inc.	QRA	Class II	2023-09-25
K230778	EndoCore	Praxis Medical LLC	KTI	Class II	2023-09-25
K230184	Holter ECG and ABP System	Edan Instruments, Inc.	DSH	Class II	2023-09-25
K223933	Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws	Exactech, Inc.	HRS	Class II	2023-09-25
K221052	Self-Fitting hearing aids	Huizhou Jinghao Medical Technology Co., Ltd	QUH	Class II	2023-09-25
K220265	ADVIA Centaur® NT-proBNPII (PBNPII)	Siemens Healthcare Diagnostics Inc.	NBC	Class II	2023-09-24
K223919	B.Light Clear Evo and B.Light Restore Evo	BEMER Int. AG	OHS	Class II	2023-09-23
K222778	Osstem Implant System	OSSTEM Implant Co., Ltd.	DZE	Class II	2023-09-23
K232978	DX. Bond V Dental Bonding Adhesive	Sino-Dentex Co.,Ltd	KLE	Class II	2023-09-22
K232594	CATHTONG™ II PICC Catheter	L & z US, Inc.	LJS	Class II	2023-09-22
K232571	CATHTONG™ II PICC Catheter	L & z US, Inc.	LJS	Class II	2023-09-22
K232558	UroLift 2 ATC Advanced Tissue Control System	Neotract Inc	PEW	Class II	2023-09-22
K232224	iLet® Dosing Decision Software	Beta Bionics, Inc.	QJI	Class II	2023-09-22
K232193	Electrically Power Wheelchairs (Models:YLB-W-0812-A01, YLB-W-0812-A02, YLB-W-0812-A03)	Yurob Rehabilitation Medical Co.,Ltd	ITI	Class II	2023-09-22
K232183	IPL Hair Removal Device, Model(s): T1, T2, T3, T7, T10	Shenzhen Koli Technology Co.,Ltd	OHT	Class II	2023-09-22
K231767	Annalise Enterprise CTB Triage Trauma	Annalise-Ai Pty, Ltd.	QAS	Class II	2023-09-22
K231730	FemaSeed Intratubal Insemination	Femasys Inc.	MQF	Class II	2023-09-22
K231479	TriALTIS Spine System	Medos International SARL	NKB	Class II	2023-09-22
K231446	Single-Use Latex Sterile Surgical Gloves (SG100)	Fitone Latex Products Co., Ltd. Guangdong	KGO	Class I	2023-09-22
K231384	Annalise Enterprise CTB Triage Trauma	Annalise-Ai Pty, Ltd.	QAS	Class II	2023-09-22
K231239	Nexiva™ Closed IV Catheter System with NearPort™ IV Access	Becton Dickinson Infusion Therapy Systems Inc.	FOZ	Class II	2023-09-22