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 265 of 3528

510(k) clearances, page 265 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K221718	Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural)	Hartalega NGC Sdn Bhd	KGO	Class I	2022-09-24
K212751	Powder Free Nitrile Examination Glove	Dainam Glove Joint Stock Company	LZA	Class I	2022-09-24
K222877	FREEPRINT crown	Detax GmbH	EBF	Class II	2022-09-23
K222568	OptiCross™ 18 Peripheral Imaging Catheter	Boston Scientific Corporation	OBJ	Class II	2022-09-23
K222561	Align	Acuity Surgical Devices, LLC	OVD	Class II	2022-09-23
K222555	reepot Nd; YAG laser system	Ilooda Co,., Ltd.	GEX	Class II	2022-09-23
K222265	Diosculpt	Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd	PKT	Class II	2022-09-23
K222204	Medical Surgical Mask	Guangzhou Zhengkang Medical Equipment Co.,Ltd	FXX	Class II	2022-09-23
K222152	3M™ Attest™ Hydrogen Peroxide Indicator Tape 1228	3M Company	JOJ	Class II	2022-09-23
K221829	Wet Flavored Personal Lubricants	Trigg Laboratories, Inc.	NUC	Class II	2022-09-23
K221821	ATEC IOM Accessory Instruments	Alphatec Spine, Inc.	PDQ	Class II	2022-09-23
K221724	Conductive Gel	Tone-a-Matic International, Inc.	GYB	Class II	2022-09-23
K221481	NeutrArt	Asset Medikal Tasarim AS.	FPA	Class II	2022-09-23
K220941	HotDog Temperature Management System	Augustine Temperature Management, LLC	DWJ	Class II	2022-09-23
K220483	Platform® Acetabular System	Total Joint Orthopedics, Inc.	LZO	Class II	2022-09-23
K220369	Esthetic Colorant	Kuraray Noritake Dental, Inc.	EIH	Class II	2022-09-23
K213759	XACT Robotic System, ACE Model	Xact Robotics, Ltd.	JAK	Class II	2022-09-23
K213339	DENU Composite Resin, DENU Flow Resin	Hdi, Inc.	EBF	Class II	2022-09-23
K202144	A.B. Dental Devices Dental Implants System	A.B. Dental Device, Ltd.	NHA	Class II	2022-09-23
K222804	Irrisept Antimicrobial Wound Lavage	IrriMAX Corporation	FQH	Class II	2022-09-22
K222253	GlasIonomer FX ULTRA	Shofu Dental Corp.	EMA	Class II	2022-09-22
K222224	SurgiLance® Safety Lancet	Medipurpose Pte. Ltd.	FMK	Class II	2022-09-22
K220681	Talee, Talee PostOP	Invent Medical USA, LLC	MVA	Class II	2022-09-22
K220540	ProGrip Self-Gripping Polypropylene Mesh	Medtronic, Inc.	FTL	Class II	2022-09-22
K220089	Disposable Polyp Snare	Jiangsu Vedkang Medical Science and Technology Co.,Ltd.	FDI	Class II	2022-09-22
K214125	TRANBERG Thermoguide Therapy System	Clinical Laserthermia Systems AB	ONO	Class II	2022-09-22
K213674	CellFX System	Pulse Biosciences, Inc.	GEI	Class II	2022-09-22
K212197	WasherCap Fixation System	Abanza Tecnomed, S.L.	MBI	Class II	2022-09-22
K211605	Dual Switch	Laser Engineering, Inc.	GEX	Class II	2022-09-22
K222542	MCB UNIT Model: V10GMCBUS	Lamidey Noury Medical	KNS	Class II	2022-09-21
K222293	ArcSP Suprapubic Sling System	Urocure, LLC	OTN	Class II	2022-09-21
K222059	SpeediCath Flex Set	MEDLINE INDUSTRIES, LP - Northfield	EZD	Class II	2022-09-21
K221383	MedtFine Blood Lancet	Shanghai Carelife International Trading Co. Ltd	QRK	Class II	2022-09-21
K221214	Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100, FZ-200	Shenzhen IONKA Medical Technology Co., Ltd.	ONF	Class II	2022-09-21
K221179	SomnoMetry	Neumetry Medical, Inc.	OLZ	Class II	2022-09-21
K220607	BD MAX Enteric Viral Panel	Becton Dickinson & Co	PCH	Class II	2022-09-21
K220236	V-Print dentbase	Voco GmbH	EBI	Class II	2022-09-21
K213379	Clearblue ® Early Pregnancy Test	SPD Swiss Precision Diagnostics GmbH	LCX	Class II	2022-09-21
K212615	EpiFaith CV	Flat Medical Co., Ltd.	DQX	Class II	2022-09-21
K212359	PWD Negative Pressure Wound Therapy System	Applied Tissue Technologies, LLC	OMP	Class II	2022-09-21
K210475	Eq-M	Meta Systems Co., Ltd.	EKX	Class I	2022-09-21
K222642	Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug)	Inner Mongolia Cureguard Medical Technology Co., Ltd.	LZA	Class I	2022-09-20
K221976	Surgical Face Mask (Non-sterile)	Xiantao Junhui Plastic Products Co.,Ltd.	FXX	Class II	2022-09-20
K221908	JO CUMPLAY Personal Lubricant	CC Wellness LLC	NUC	Class II	2022-09-20
K221809	DePuy Synthes 3.5mm Intrapelvic Acetabular System	DePuy Synthes	HRS	Class II	2022-09-20
K221717	Disposable Surgical Gown UM-148	Unimax Medical Products Co., Ltd.	FYA	Class II	2022-09-20
K221227	Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120	Tuttnauer Ltd.	FLE	Class II	2022-09-20
K220359	Tandry Compression Screw System	Microware Precision Co., Ltd.	HWC	Class II	2022-09-20
K214056	Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs)	Mezorrison Medical Technology (Dongying) Co., Ltd.	LZA	Class I	2022-09-20
K214048	Millipede 088 Access Catheter	Perfuze	QJP	Class II	2022-09-20