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 326 of 3528

510(k) clearances, page 326 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K201456	Scan Monitor	Withings	DPS	Class II	2021-10-05
K201394	CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System	I-SENS, Inc.	NBW	Class II	2021-10-05
K212135	Dry DBM- A Putty	Seaspine, Inc.	MQV	Class II	2021-10-04
K211899	Surgical Face Mask	Hubei Yi-Ya Protective Products Co., Ltd.	FXX	Class II	2021-10-04
K211795	EzDent-i/ E2/ Prora View/ Smart M Viewer	Ewoosoft Co., Ltd	LLZ	Class II	2021-10-04
K211745	RecoveryAir PRO	Theragun, Inc.	IRP	Class II	2021-10-04
K211425	Private Stock Labs Surgical Face Mask	J.K. Private Stock, Inc.	FXX	Class II	2021-10-04
K211405	Prelude Guide Sheath	Merit Medical Systems, Inc.	DYB	Class II	2021-10-04
K211368	IPL Hair Remover, Model: G993, G996, G998 and G885	Shenzhen Mywin Technology Co., Ltd.	ONF	Class II	2021-10-04
K211308	Inni-Cera	Aon Co., Ltd.	EIH	Class II	2021-10-04
K201312	VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack	Ortho-Clinical Diagnostics, Inc.	NBC	Class II	2021-10-04
K200558	Smart Neck Stimulator	Guandong Skg Intelligent Technology Co., Ltd.	NUH	Class II	2021-10-04
K202927	Eye-Sync	Syncthink, Inc.	QEA	Class II	2021-10-02
K201931	Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)	Dixi Medical	GYC	Class II	2021-10-02
K212828	BRIUS Planner Software	BRIUS Technologies Inc.	PNN	Class II	2021-10-01
K212813	Zenition 70	Philips Medical Systems Nederland B.V.	OWB	Class II	2021-10-01
K212433	Anthem Fracture System	Globus Medical, Inc.	HRS	Class II	2021-10-01
K212414	OSSDSIGN Cranial PSI	Ossdsign	PJN	Class II	2021-10-01
K212201	PENTAX Medical Auto Leakage Tester SHA-P6	PENTAX of America, Inc.	PCV	Class II	2021-10-01
K212114	Elekta Unity	Elekta Solutions AB	IYE	Class II	2021-10-01
K211332	D Camera Controller	Richard Wolf Medical Instruments Corp.	FET	Class II	2021-10-01
K211221	Porous Patella and Porous Tibia Baseplate	Smith & Nephew, Inc.	MBH	Class II	2021-10-01
K210562	HRSpheres Narrow-Size Embolic Microspheres	Suzhou Hengrui Hongyuan Medical Co., Ltd.	KRD	Class II	2021-10-01
K210270	Medical Endoscope Image Processing System	Jiangsu Jiyuan Medical Technology Co., Ltd.	HIH	Class II	2021-10-01
K210140	electrocardiograph: SE-1202	Edan Instruments, Inc.	DPS	Class II	2021-10-01
K210139	Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09	Edan Instruments, Inc.	DXN	Class II	2021-10-01
K210002	Stella Bio	Egzotech Sp. Z O. O.	IPF	Class II	2021-10-01
K201934	Surgimatix Absorbable Fixation System	Surgimatix, Inc.	GDW	Class II	2021-10-01
K200011	E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS	Microport Orthopedics Inc.	LPH	Class II	2021-10-01
DEN190055	iotaSOFT Insertion System - Drive Unit, Controller and Accessories	Iotamotion Inc	QQH	Class II	2021-10-01
K212805	SteriCap Mini Needle and Standard Needles	Ocuject, LLC	FMI	Class II	2021-09-30
K212794	Accuray Precision Treatment Planning System	Accuray Incorporated	IYE	Class II	2021-09-30
K212757	Jada System	Alydia Health	OQY	Class II	2021-09-30
K212405	EMERGE™ Anterior Cervical Plate System	Evolution Spine, LLC	KWQ	Class II	2021-09-30
K212386	AngioVac F18 85	Boston Scientific Corporation	DWF	Class II	2021-09-30
K212227	Philips MR Patient Care Portal	Invivo Corporation	MWI	Class II	2021-09-30
K212208	Philips IntelliVue GuardianSoftware (Rev. E.0X)	Philips Medizin Systeme Boeblingen GmbH	DXJ	Class II	2021-09-30
K211935	ORIO-Ti Intervertebral Body Fusion Cage System	Spinecraft LLC	ODP	Class II	2021-09-30
K211593	Enteral Pump Syringe	Jiangsu Caina Medical Co., Ltd	PNR	Class II	2021-09-30
K211591	NAEOTOM Alpha, Scan&GO	Siemens Medical Solutions USA, Inc.	JAK	Class II	2021-09-30
K211450	Playboy 3 Contour Condom	Thai Nippon Rubber Industry Public Company Limited	HIS	Class II	2021-09-30
K211439	Small Bone Nailing System	Skeletal Dynamics, Inc	HTY	Class II	2021-09-30
K210523	Implanova	Dental Evolutions, Inc	DZE	Class II	2021-09-30
K203609	Intravascular Administration Sets	Baxter Healthcare Corporation	FPA	Class II	2021-09-30
K191288	Acuitas AMR Gene Panel	Opgen, Inc.	PMY	Class II	2021-09-30
K212747	Da Vinci SP Surgical System	Intuitive Surgical, Inc.	NAY	Class II	2021-09-29
K212238	TheraFace Microcurrent	Theragun, Inc.	NFO	Class II	2021-09-29
K212226	DR Safety Syringe, Sterile Hypodermic needle for Single use	Zhuhai Dr Medical Instruments Co., Ltd.	MEG	Class II	2021-09-29
K212136	Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App	Cochlear Americas	LXB	Class II	2021-09-29
K211781	Disposable Nitrile Gloves	Jiangsu Jinke Protective Equipment Co., Ltd.	LZA	Class I	2021-09-29