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 2026-10-15, 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 296 of 3528

510(k) clearances, page 296 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K220584	BD Cathena Safety IV Catheter	Becton Dickinson Infusion Therapy Systems Inc.	FOZ	Class II	2022-03-31
K220353	Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs	Niujian Technology Co., Ltd.	LZC	Class I	2022-03-31
K220291	NEXXT SPINE NAVIGATION System	Nexxt Spine LLC	OLO	Class II	2022-03-31
K220260	Hercules Syndesmosis Implant System	In2bones USA, LLC	HTN	Class II	2022-03-31
K220240	Vinyl Co-Polymer Powder-free Examination Gloves, Black	Grand Work Plastic Products Co., Ltd.	LYZ	Class I	2022-03-31
K220202	Uterine ElevatOR PRO with OccludOR Balloon	The O R Company Pty, Ltd.	LKF	Class II	2022-03-31
K220160	PediGuard Threaded	Spineguard, Inc.	PDQ	Class II	2022-03-31
K220025	ARx® Spinal System	Life Spine	NKB	Class II	2022-03-31
K214057	STATIM 6000B Vacuum Autoclave	Scican Ltd.	FLE	Class II	2022-03-31
K213843	Nitrile Examination Gloves	Dong Tai City Huayi Gloves Co., Ltd.	LZA	Class I	2022-03-31
K213745	Air Compression Therapy Device, model: ST-502	Shenzhen Future Electronic Co.,Ltd	IRP	Class II	2022-03-31
K213736	Medical Face Mask	Hangzhou Runheng Medical Co., Ltd.	FXX	Class II	2022-03-31
K212894	PhasTIPP	LeMaitre Vascular Inc.	DWQ	Class II	2022-03-31
K212888	Golnit Nylon Monofilament Suture	Antarma, LLC dba Golnit Sutures	GAR	Class II	2022-03-31
K211120	ERIC Retrieval Device	Terumo Cardiovascular Systems Corporation	NRY	Class II	2022-03-31
K211043	Alexis Contained Extraction System	Applied Medical Resources Corp	GCJ	Class II	2022-03-31
K210546	Elecsys proBNP II, Elecsys proBNP II STAT	Roche Diagnostics GmbH	NBC	Class II	2022-03-31
K220213	Empulse R90	Sunrise Medical, Inc.	ITI	Class II	2022-03-30
K220182	Aggeris™-C	Clariance, Inc.	KWQ	Class II	2022-03-30
K214093	VSP Bolus	3D Systems, Inc.	IXI	Class II	2022-03-30
K214047	EL CAPITAN Anterior Lumbar Interbody Fusion System	Astura Medical	OVD	Class II	2022-03-30
K213896	BD Trek Powered Bone Biopsy System	Bard Peripheral Vascular Inc	KNW	Class II	2022-03-30
K213699	CareTaker Monitor App	Caretaker Medical	DXN	Class II	2022-03-30
K213370	Veriqa	Ptw-Freiburg Physikalisch-Technische-Werkstaetten	IYE	Class II	2022-03-30
K212464	Dukal Corporation AAMI Level 4 Open-Back Protective Gown	Dukal LLC	QPC	Class II	2022-03-30
K212159	Shield System	Radiaction Ltd.	OWB	Class II	2022-03-30
K211681	Eon	Dominion Aesthetic Technologies, Inc.	PKT	Class II	2022-03-30
K210422	INTAI Surgical Mask (non-sterile)	Intai Technology Corp.	FXX	Class II	2022-03-30
K220255	Real Intelligence Cori	Blue Belt Technologies, Inc.	OLO	Class II	2022-03-29
K220247	Guidewire Locking Device	Micro-Tech (Nanjing) Co., Ltd.	ODC	Class II	2022-03-29
K213887	GAL-1A Plus Blood Glucose Monitoring System	Apex Biotechnology Corp.	NBW	Class II	2022-03-29
K213646	Focus HD 35 Detector	Iray Technology Taicang, Ltd.	MQB	Class II	2022-03-29
K213529	Focus HD 43 Detector	Iray Technology Taicang, Ltd.	MQB	Class II	2022-03-29
K210321	Dukal Corporation Level 1 Pediatric Face Mask	Dukal LLC	OXZ	Class II	2022-03-29
K202266	Reliance Cervical IBF System	Reliance Medical Systems, LLC	ODP	Class II	2022-03-29
DEN200042	BrainTemp Neonate System (BTNeo System)	Brain Temp, Inc.	QSL	Class II	2022-03-29
K214113	Hand-held IPL device(JOVS Graphene Hair Removal Device)	Shenzhen Qianyu Technology Co., Ltd.	OHT	Class II	2022-03-28
K213672	T3 Pro Implants	ZimVie US Corp LLC	DZE	Class II	2022-03-28
K213662	Disposable nitrile rubber protective gloves (Tested for Use with Chemotherapy Drugs)	Taishan Weibang Medical Equipment Co., Ltd.	LZA	Class I	2022-03-28
K213415	OSSIOfiber Suture Anchor	OSSIO, Ltd.	MAI	Class II	2022-03-28
K213147	CERABIEN MiLai	Kuraray Noritake Dental, Inc.	EIH	Class II	2022-03-28
K212889	Syngo.CT Dual Energy	Siemens Medical Solutions USA, Inc.	JAK	Class II	2022-03-28
K212037	SancDam Latex Oral Dam	Sanctuary Health Sdn Bhd	MSC	Class II	2022-03-28
K210352	GGM Breathing Circuit Bacterial Filter	Great Group Medical Co Ltd.	CAH	Class II	2022-03-27
K220229	Powder Free Nitrile Examination Gloves, Orange	Shanxi Hongjin Plastic Technology Co., Ltd	LZA	Class I	2022-03-26
K220215	Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with Chemotherapy Drugs, and the Opioid Fentanyl citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid (Blue)	KSG Medicare Sdn Bhd	LZA	Class I	2022-03-26
K213729	Clover Glove	Clover Glove Company Limited	LZA	Class I	2022-03-26
K220637	3 Ply Medical Grade Single Use Procedural Disposable Face Mask	Kdi Med Supply	FXX	Class II	2022-03-25
K220600	Artix Thrombectomy Device	Inari Medical, Inc.	QEW	Class II	2022-03-25
K220362	Le-12Ch	Caf Medical Solutions Inc	DPS	Class II	2022-03-25