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 307 of 3528

510(k) clearances, page 307 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K213696	ETHICON Megadyne Electrosurgical Generator	Megadyne Medical Products, Inc	GEI	Class II	2022-01-21
K213673	b-ONE MOBIO Total Knee System	b-ONE Ortho Corp.	JWH	Class II	2022-01-21
K213470	PERLA® TL Posterior Osteosynthesis System	Spineart SA	NKB	Class II	2022-01-21
K213412	VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM	Steris Corparation	JOJ	Class II	2022-01-21
K213343	Saremco Print CROWNTEC	Saremco Dental AG	EBF	Class II	2022-01-21
K213044	Nitrile Examination Gloves	Jiangsu Huayuan Medical Technology Co., Ltd.	LZA	Class I	2022-01-21
K212991	Osteorevive	Bone Solutions, Inc.	MQV	Class II	2022-01-21
K212594	OSSIOfiber® Staple	OSSIO, Ltd.	MNU	Class II	2022-01-21
K211864	Powder Free Nitrile Patient Examination Gloves, Blue Color	Siyang Jaysun Medtech Co., Ltd.	LZA	Class I	2022-01-21
K211752	Infrared Thermometer	Beijing Choice Electronic Technology Co., Ltd.	FLL	Class II	2022-01-21
K203761	ParaMotion	Powerbasetec GmbH	IPL	Class II	2022-01-21
K203293	Abbott Medical Grounding Pad, model RF-DGP-IS	Abbott Medical	GXD	Class II	2022-01-21
K191105	e-Throne Folding Wheelchair, Model: ET-12F22	Golden Motor Technology Co., Ltd	ITI	Class II	2022-01-21
DEN200059	POMC/PCSK1/LEPR CDx Panel	Preventiongenetics, LLC	QRV	Class II	2022-01-21
K214084	hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS	Cefla S.C.	OAS	Class II	2022-01-20
K214019	syngo.CT Extended Functionality	Siemens Medical Solutions USA, Inc.	JAK	Class II	2022-01-20
K213709	Signa Pet/mr	GE Healthcare	OUO	Class II	2022-01-20
K213668	SIGNA Hero	GE Healthcare (GE Medical Systems, LLC)	LNH	Class II	2022-01-20
K213356	Entuit PEG, Entuit PEGJ	Wilson-Cook Medical Inc.	PIF	Class II	2022-01-20
K213075	Goody Gloves, Wincare, TBG Gloves	Thai Rubber Gloves Company Limited	LZA	Class I	2022-01-20
K212941	Porous Patella	Encore Medical, L.P. dba Djo Surgical	MBH	Class II	2022-01-20
K212884	Electric breast pump	Dongguan Rongfeng Medical Co.,Ltd	HGX	Class II	2022-01-20
K212748	Disposable Dual Action Tissue Clip	Micro-Tech (Nanjing) Co., Ltd.	PKL	Class II	2022-01-20
K212592	Gas-Chex Indicator	Propper Manufacturing Co., Inc.	JOJ	Class II	2022-01-20
K212458	Flexible Video-Uretero-Renoscope SSU System	Karl Storz Endoscopy-America, Inc.	FGB	Class II	2022-01-20
K212357	Surgical isolation gown	Wuhan Zonsen Medical Products Co., Ltd	FYC	Class II	2022-01-20
K211333	KIDNEY ASSIST-transport	Xvivo Perfusion, Inc.	KDN	Class II	2022-01-20
K210259	Parkell Self-Adhesive Cement	Parkell, Inc.	EMA	Class II	2022-01-20
K203161	Surgical Face Mask	Wuhan Raytex Protection Co., Ltd	FXX	Class II	2022-01-20
K214059	CoreLink Navigation Instruments	Corelink, LLC	OLO	Class II	2022-01-19
K213447	LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210.	Shenzhen Cosbeauty Technology Co., Ltd.	OAP	Class II	2022-01-19
K213438	3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory	Adaptiiv	MUJ	Class II	2022-01-19
K213424	Jabra Enhance Plus	GN Hearing A/S	QDD	Class II	2022-01-19
K213227	Powder free Nitrile Examination Glove-(Test for use with Chemotherapy Drugs)	Uweport, LLC	LZA	Class I	2022-01-19
K212826	Disposable Medical Mask	Jiangsu Nanfang Medical Co., Ltd.	FXX	Class II	2022-01-19
K212683	GLOBAL ICON Stemless Shoulder System	Depuy (Ireland)	PKC	Class II	2022-01-19
K212650	Celeris, Disposable Sinus Debrider	Gyrus ACMI, Inc.	ERL	Class II	2022-01-19
K212581	VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System	Stryker Corp.	HRS	Class II	2022-01-19
K212576	MDx-Chex for BCID2	Streck LLC	PMN	Class II	2022-01-19
K212012	Follicle Clarity	Cycle Clarity	QIH	Class II	2022-01-19
K211709	Biotres	Biotricity	MWJ	Class II	2022-01-19
K211613	Stern Fix Sternal Stabilization System	Neos Surgery S.L.	JDQ	Class II	2022-01-19
K211532	Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB33	Yibin Junxin Electronics Technology Co., Ltd.	DXN	Class II	2022-01-19
K211330	R3 Large Head Liners	Smith & Nephew, Inc.	LPH	Class II	2022-01-19
K211003	SHOWA(R) Blue Nitrile Powder Free Medical Examination Glove	Showa Best Glove, Inc.	LZA	Class I	2022-01-19
K210747	Caption Interpretation Automated Ejection Fraction Software	Caption Health	QIH	Class II	2022-01-19
K203072	Franz Zirconia Dental Crown	Franz Biotech, Inc.	ELL	Class II	2022-01-19
K213781	ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DP	Depuy Ireland UC	MBH	Class II	2022-01-18
K213572	JuniOrtho Plating System™	Orthofix SRL	HWC	Class II	2022-01-18
K213216	Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens	Unicon Optical Co., Ltd.	LPL	Class II	2022-01-18