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 311 of 3528

510(k) clearances, page 311 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K213136	CPL Surgical Face Mask	Control Print Limited	FXX	Class II	2021-12-24
K212921	Nitrile Examination Golves Powder Free	Jiangsu Standard Health Co.,Ltd	LZA	Class I	2021-12-24
K202255	Skypro, SP02 Mask (3)	Skypro Medical Supplies Company	FXX	Class II	2021-12-24
K213766	dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coils for 1.5T and 3.0T	Invivo Corporation	MOS	Class II	2021-12-23
K213547	SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla	TTK Healthcare Limited	HIS	Class II	2021-12-23
K213479	D²RS and D²RS 9090	Stephanix	OWB	Class II	2021-12-23
K213219	Vy Spine™ VyWasher™ Buttress System	VY Spine, LLC	KWQ	Class II	2021-12-23
K213208	Twist Drills	Biomet Microfixation	HBE	Class II	2021-12-23
K212436	NBR Synthetic Nitrile Examination Gloves	Shandong Langtai International Trade Co., Ltd.	LYZ	Class I	2021-12-23
K212088	Integrity Implants Navigated Instruments	Integrity Implants, Inc.	OLO	Class II	2021-12-23
K210992	Altech® Exhalation Valve (Single Limb and Dual Limb)	Meditera Tibbi Malzeme San ve Tic AS	CBP	Class II	2021-12-23
K210976	Curian Campy	Meridian Bioscience Inc	LQP	Class I	2021-12-23
K203714	NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, NuVasive Attrax Putty	Nu Vasive, Incorporated	MAX	Class II	2021-12-23
K202788	Sonomed IV, Sonomed V	Carci Industria E Comercio de Aparelhos Cirurgicos E Orto	IMI	Class II	2021-12-23
K193407	Contour® next GEN Blood Glucose Monitoring System	Ascensia Diabetes Care	NBW	Class II	2021-12-23
K213691	Solas OR	Cirdan Imaging Limited	MWP	Class II	2021-12-22
K213428	EdgePro	Biolase, Inc.	NVK	Class II	2021-12-22
K213411	iSR’obot Mona Lisa 2.0	Biobot Surgical Pte. Ltd.	IYO	Class II	2021-12-22
K213225	Diode Laser System GP900A8, Diode Laser System GP900Q8	Shenzhen GSD Tech Co., Ltd	GEX	Class II	2021-12-22
K213207	Sheath, Stopcock Accessory	Olympus Winter & Ibe GmbH	HIH	Class II	2021-12-22
K213159	Encore System	Siesta Medical, Inc.	ORY	Class II	2021-12-22
K213144	Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors	Shen Wei (USA), Inc.	LYZ	Class I	2021-12-22
K213140	Claritas iPET	Claritas Healthtech Limited	LLZ	Class II	2021-12-22
K213094	ID-500 iRestore Hair Growth System	Freedom Laser Therapy Inc	OAP	Class II	2021-12-22
K213024	Oren LED Perioral Light Therapy System	Shenzhen Kaiyan Medical CO, Ltd.	OHS	Class II	2021-12-22
K212914	Glovmaster Nitrile Examination Glove Powder Free	Glovmaster Sdn. Bhd	LZA	Class I	2021-12-22
K212767	SleepRight Select-Comfort Dental Guard	Splintek Inc.	MQC	Unclassified	2021-12-22
K212603	Non Absorbable Surgical Nylon Suture	Shandong Haidike Medical Product Co., Ltd.	GAR	Class II	2021-12-22
K212397	StealthStation S8 Cranial v2.0	Medtronic Navigation, Inc	HAW	Class II	2021-12-22
K212310	EyeBOX (Model EBX-4)	Oculogica Inc.	QEA	Class II	2021-12-22
K212285	Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android)	Oriental Inspiration Limited	NUH	Class II	2021-12-22
K211691	Ultrast Gel	Ultrast, Inc.	MUI	Class II	2021-12-22
K211022	Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims.	Central Medicare Sdn Bhd	LZA	Class I	2021-12-22
K210978	BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle	Becton Dickinson & Co	BSP	Class II	2021-12-22
K210711	Neocis Guidance System (NGS) with Yomi Plan v2.0.1	Neocis Inc.	PLV	Class II	2021-12-22
K210305	Pulse Oximeter	Dongguan Lingxin Technologies Co., Ltd.	DQA	Class II	2021-12-22
K210147	Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield	Unicoglobal, Inc.	FXX	Class II	2021-12-22
K203647	SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay	Immunalysis Corporation	LAF	Class II	2021-12-22
K203564	SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay	Immunalysis Corporation	DJG	Class II	2021-12-22
K202404	BoneMRI	Mriguidance B.V.	QIH	Class II	2021-12-22
K213705	DRSplus	Centervue	MYC	Class II	2021-12-21
K213596	OSSIOfiber Compression Screw, 3.5mm	OSSIO, Ltd.	HWC	Class II	2021-12-21
K213456	Xenco Medical Multilevel CerviKit	Xenco Medical LLC	KWQ	Class II	2021-12-21
K213301	InCore Subtalar System	Medartis AG	HWC	Class II	2021-12-21
K213139	SURGmatic S15 L Pro	KaVo Dental GmbH	EGS	Class I	2021-12-21
K213129	Restoration Modular 115mm Conical Distal Stem	Howmedica Osteonics Corp., dba Stryker Orthopaedics	LZO	Class II	2021-12-21
K213045	TearCare System	Sight Sciences, Inc.	ORZ	Class II	2021-12-21
K213006	Vinyl Examination Gloves	Taian Hengchang Medical Technology Co., Ltd.	LYZ	Class I	2021-12-21
K212830	CT3000Pro	SRS Medical	FEN	Class II	2021-12-21
K212770	Vision	Softsmile, Inc.	PNN	Class II	2021-12-21