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 259 of 3528

510(k) clearances, page 259 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K212649	Disposable Surgical Face Mask	Lyncmed Medical Technology (Beijing) Co., Ltd.	FXX	Class II	2022-10-25
K222127	Soft Palate Elevator	The Tmj Clinic PC	LRK	Class II	2022-10-24
K221783	SafetiCET Safety Lancet	NSP Tech Pte Ltd	FMK	Class II	2022-10-24
K221563	Neurosteer EEG Recorder	Neurosteer, Inc.	OMC	Class II	2022-10-24
K221545	MectaLIF Anterior Extension	Medacta International SA	OVD	Class II	2022-10-24
K220190	The GIRO Growth Modulation System	Orthopediatrics Canada ULC	OBT	Class II	2022-10-24
K212493	KODEX – EPD™ System 1.5.0	Philips Medical Systems Nederland, B.V. (Pmsn)	DQK	Class II	2022-10-24
K222058	Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant	WRP Asia Pacific Sdn Bhd	KGO	Class I	2022-10-22
K213804	cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems	Roche Molecular Systems Inc	QQX	Class II	2022-10-22
K223042	Viz LVO ContaCT	Viz. Ai, Inc.	QAS	Class II	2022-10-21
K222632	UHR Bipolar Implants, Restoration GAP II Implants	Howmedica Osteonics Corp., dba Stryker Orthopaedics	KWL	Class II	2022-10-21
K222349	JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple)	JR Engineering and Medical Technologies (M) Sdn Bhd	LZA	Class I	2022-10-21
K222270	HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments	Globus Medical, Inc.	ODP	Class II	2022-10-21
K222215	IPD Dental Implant Abutments	Implant Protesis Dental 2004, S.L.	NHA	Class II	2022-10-21
K222201	Biological Feedback and Stimulation System	Medlander Medical Technology, Inc.	IPF	Class II	2022-10-21
K222199	Collagen P.I.N. (Percutaneous Induction Needling)	Induction Therapies, LLC	QAI	Class II	2022-10-21
K222141	Safety Blood Collection Needle (Without Needle Holder)	Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.	JKA	Class II	2022-10-21
K221992	Electronic Pulse Stimulator	Beijing Choice Electronic Technology Co., Ltd.	NUH	Class II	2022-10-21
K221958	Flex-MI	Emsi, Inc.	IPF	Class II	2022-10-21
K221751	NuVasive Cohere ALIF System Intervertebral Body Fusion Device	Nu Vasive, Incorporated	OVD	Class II	2022-10-21
K221643	Hair Removal Device (Model: IPL-D26, IPL-D19)	Shenzhen Desida Technology Co., Ltd.	OHT	Class II	2022-10-21
K221462	DePuy Reclaim Monobloc Revision Femoral Stem	Depuy Ireland UC	LZO	Class II	2022-10-21
K221443	PureLift Pro Plus	Xtreem Pulse	NFO	Class II	2022-10-21
K221022	NextDent Ortho Flex	Vertex-Dental B.V.	MQC	Unclassified	2022-10-21
K220273	Onetouch Non-paraben Lubricant Gel	Thai Nippon Rubber Industry Public Company Limited	NUC	Class II	2022-10-21
K220165	Enteral Transition Adaptor	Gbuk Group Limited	PIO	Class II	2022-10-21
K213128	IntraOp VSP Software Device	Xironetic, LLC	LLZ	Class II	2022-10-21
K212391	MCI-Neuro Fixation System	Mci Medical Concept Innovation Inc.	GWO	Class II	2022-10-21
K210414	CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown	Medtecs (Taiwan) Corp.	FYC	Class II	2022-10-21
K222886	Mercu 1717V	Iray Technology Taicang, Ltd.	MQB	Class II	2022-10-20
K222842	V-Patch Cardiac Monitor	Shandong Corecare Technology Limited	DXH	Class II	2022-10-20
K222827	da Vinci Firefly Imaging System	Intuitive Surgical, Inc.	NAY	Class II	2022-10-20
K222547	Electric nasal aspirator	Shenzhen Xinlianfeng Technology Co.,Ltd	BTA	Class II	2022-10-20
K222404	Evo® sEEG System	Neuroone Medical Technologies Corp.	GZL	Class II	2022-10-20
K222361	AI-Rad Companion (Musculoskeletal)	Siemens Medical Solutions USA, Inc.	JAK	Class II	2022-10-20
K221977	Disposable Surgical Gown (G4003)	Xiantao Topmed Nonwoven Protective Products Co., Ltd	FYA	Class II	2022-10-20
K221947	Tyber Medical Staple Fixation System (various)	Tyber Medical	JDR	Class II	2022-10-20
K221740	Smith & Nephew Intellio 4K Camera Control Unit, Network Enabled (72205447), Smith & Nephew Intellio 4K Camera Control Unit, Non-Network Enabled (72205448)	Smith & Nephew, Inc.	GCJ	Class II	2022-10-20
K220870	BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel	BioFire Defense, LLC	QMV	Class II	2022-10-20
K220527	PADnet Xpress	Collaborative Care Diagnostics LLC dba BioMedix	JOM	Class II	2022-10-20
K220099	eClinic Stethopod	Homediagnostic, LLC	DQD	Class II	2022-10-20
K214073	eWave Monitor	Wearlinq	DSH	Class II	2022-10-20
K213466	Houdini Cross Support Catheter	Cruzar Medsystems, Inc.	DQY	Class II	2022-10-20
K213429	AccuSert Needle Inserter	Emed Technologies Corporation	KZH	Class II	2022-10-20
K213106	BTI Interna Dental Implant System UnicCa - Prosthetic Components	B.T.I. Biotechnology Institute, S.L.	NHA	Class II	2022-10-20
K222890	Radiance Ultra 32 4K Zerowire Duo	NDS Surgical Imaging, LLC	GCJ	Class II	2022-10-19
K222856	SOMAVAC 100 Sustained Vacuum System	Somavac Medical Solutions, Inc.	BTA	Class II	2022-10-19
K222643	Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit	Sirius Medical Systems B.V.	PBY	Class II	2022-10-19
K221795	STERN FIX Sternal Stabilization System	Neos Surgery S.L.	JDQ	Class II	2022-10-19
K221728	Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior Cervical Plating (ACP) System, Reflex™ Hybrid ACP System, UniVise™ Spinous Process Fixation Plate	Stryker Corp.	KWQ	Class II	2022-10-19