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 274 of 3528

510(k) clearances, page 274 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K212181	ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed	Phadia AB	DHB	Class II	2022-08-03
K191131	Solidence Multipockets	Solidence Surgical Corporation	FRG	Class II	2022-08-03
K220816	BruxZir NOW	Prismatik Dentalcraft, Inc.	EIH	Class II	2022-08-02
K220032	iStent infinite Trabecular Micro-Bypass System, Model iS3	Glaukos Corporation	KYF	Class II	2022-08-02
K210179	QOCA Portable ECG Monitoring Device	Quanta Computer Inc	DSH	Class II	2022-08-02
K221671	CellFX® System	Pulse Biosciences, Inc.	GEI	Class II	2022-08-01
K221616	Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17	Caf Medical Solutions Inc	MHX	Class II	2022-08-01
K221549	X-ray Flat Panel Detectors (CareView 1800 RF)	Careray Digital Medical Technology Co., Ltd.	MQB	Class II	2022-08-01
K221451	IPL hair removal	Shenzhen Lizbella Technology Co.,Ltd	OHT	Class II	2022-08-01
K220736	Consolidated HC Steam Sterilizer	Consolidated Machine Corp.	FLE	Class II	2022-08-01
K220237	Disposable Medical Nitrile Examination Gloves	Fujian Jixiang Medical Technology Co.,Ltd	LZA	Class I	2022-08-01
K213929	Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid	O&M Halyard, Inc.	LZA	Class I	2022-08-01
K221773	Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With the Opioid Fentanyl Citrate, Simulated Gastric Acid, and Fentanyl In Gastric Acid	Onetexx Sdn Bhd	LZA	Class I	2022-07-30
K221914	Catapult Guide Sheath	Contract Medical International GmbH	DYB	Class II	2022-07-29
K221907	RhinAer® Stylus (FG1393)	Aerin Medical, Inc.	GEI	Class II	2022-07-29
K221901	EleGARD	Advancedcpr Solutions, LLC	FOA	Class I	2022-07-29
K221259	Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, Dexcom G6 Professional Continuous Glucose Monitoring (CGM) System	Dexcom, Inc.	QBJ	Class II	2022-07-29
K221251	Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)	Guangzhou Huakai Electronic Technology Co., Ltd.	NUH	Class II	2022-07-29
K221242	Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank	Hunan Vsmile Biotechnology Co.,Ltd	EIH	Class II	2022-07-29
K220989	Next Generation NetKonnect	Nihon Kohden Digital Health Solutions, LLC.	MHX	Class II	2022-07-29
K220961	Deep Learning Image Reconstruction	GE Healthcare Japan Corporation	JAK	Class II	2022-07-29
K220901	S-Core Implant System	Subchondral Solutions	MBI	Class II	2022-07-29
K220733	OptiVu ROSA MxR	Orthosoft Inc (D/B/A Zimmer Cas)	SBF	Class II	2022-07-29
K220577	Dental Handpiece, Model CA160, CA160L, and CA500L	Micro-NX Co., Ltd.	EGS	Class I	2022-07-29
K220566	Vascette HP (hemostatic pad)	Koag, LLC	QSY	Unclassified	2022-07-29
K220331	091 Balloon Guide Catheter	Inneuroco, Inc.	DQY	Class II	2022-07-29
K220048	NobelProcera Zirconia N1 Base	Nobel Biocare Services AG	NHA	Class II	2022-07-29
K213914	Injection Needle	Jiangsu Vedkang Medical Science and Technology Co.,Ltd.	FBK	Class II	2022-07-29
K213911	Microstream CO2 NanoPod	Medtronic, Inc.	CCK	Class II	2022-07-29
K213760	ABMD Software	Heartlung Corporation	KGI	Class II	2022-07-29
K213104	Auxilock Titanium Screw-In Suture Anchor	Auxein medical Private Limited	MBI	Class II	2022-07-29
K212982	Medispine - Spinal Needle, Glospine - Spinal Needle	Global Medikit Limited	BSP	Class II	2022-07-29
K211585	Bodyport Cardiac Scale	Bodyport Inc.	DSB	Class II	2022-07-29
K211370	Tablo Hemodialysis System	Outset Medical, Inc.	KDI	Class II	2022-07-29
K202852	DiviTum TKa	Biovica International AB	QTE	Class II	2022-07-29
K222017	Biotres	Biotricity	MWJ	Class II	2022-07-28
K222014	EXALT Model B Single-Use Bronchoscope	Boston Scientific Corporation	EOQ	Class II	2022-07-28
K221945	Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8mm x 160 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8 mm X 320 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 mm X 230 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 mm x 320 cm, Beamer AVEO FILTER INTEGRATED ARGON SIDEFIRE PROBE 2.3 mm x 230 cm	ConMed Corporation	GEI	Class II	2022-07-28
K221923	Swoop Portable MR Imaging System	Hyperfine, Inc	LNH	Class II	2022-07-28
K221922	Trinias	Shimadzu Corporation Medical Systems Division	OWB	Class II	2022-07-28
K221905	INERTIA CONNEXX Modular Pedicle Screw System	Nexxt Spine LLC	NKB	Class II	2022-07-28
K221898	Gastrointestinal Boundary Identifier (GIBI HD)	Reshape Lifesciences	KNT	Class II	2022-07-28
K221332	OsteoCentric Spine MIS Pedicle Fastener System	OsteoCentric Technologies,Inc	NKB	Class II	2022-07-28
K221235	neXus Ultrasonic Surgical Aspirator System	Misonix, LLC	LFL	Unclassified	2022-07-28
K221230	Tron	Xoran Technologies, LLC	OWB	Class II	2022-07-28
K220063	Single Use Cytology Brush	Zhejiang Chuangxiang Medical Technology Co., Ltd.	FDX	Class II	2022-07-28
K214122	BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel	Becton Dickinson & Co	PCI	Class II	2022-07-28
K213998	cvi42 Auto Imaging Software Application	Circle Cardiovascular Imaging Inc	QIH	Class II	2022-07-28
K212113	MagXtract Collection Tube	Magbio Genomics Inc.	QBD	Class II	2022-07-28
K221856	BIOMONITOR IIIm, BIOMONITOR III	BIOTRONIK AG	MXD	Class II	2022-07-27