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 266 of 3528

510(k) clearances, page 266 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K213598	LUOFUCON Collagen Wound Dressing	HuiZhou Foryou Medical Devices Co., Ltd.	KGN	Unclassified	2022-09-20
K213353	Aorta-CAD	Imagen Technologies, Inc.	MYN	Class II	2022-09-20
K222131	NB 1 SA Implant System	ARUM DENTISTRY Co., Ltd.	DZE	Class II	2022-09-19
K222121	C630G LCD monitor, JUSHA-C630G LCD monitor, C630 LCD monitor, JUSHA-C630 LCD monitor	Nanjing Jusha Display Technology Co., Ltd	PGY	Class II	2022-09-19
K221839	Lancet	Hebei Xinle Sci&tech Co.,Ltd	FMK	Class II	2022-09-19
K221819	35g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical Gown;43g Standard SMMS Surgical Gown;43g Reinforced SMMS Surgical Gown ;50g Standard SMMS Surgical Gown; 50g Reinforced SMMS Surgical Gown;BVB Surgical Gown	Winner Medical Co., Ltd.	FYA	Class II	2022-09-19
K221638	Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3	Olympus Medical Systems Corp.	EOB	Class II	2022-09-19
K220839	Arthrex Compression FT Pins	Arthrex GmbH	HWC	Class II	2022-09-19
K220129	Promisemed X-Safety Pen Needle	Promisemed Hangzhou Meditech Co.,Ltd.	FMI	Class II	2022-09-19
K214060	LANDMARK REBOA Catheter	Zien Medical Technologies LLC	MJN	Class II	2022-09-19
K213897	Pro M Class	Saeyang Microtech Co., Ltd.	EKX	Class I	2022-09-19
K213013	Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe	Jeil Tech Co.,Ltd	QNQ	Class II	2022-09-19
K222519	ClearPoint System	ClearPoint Neuro Inc.	HAW	Class II	2022-09-16
K221799	Electric Wheelchair, Model: 9000N	Silver Fox Corporation Limited	ITI	Class II	2022-09-16
K221676	Exsalta	DRW Medical	BTA	Class II	2022-09-16
K221534	Surgical Face Masks (Ear Loops And Tie-On)	San-M Package Co., Ltd.	FXX	Class II	2022-09-16
K221343	ECHELON ENDOPATH Staple Line Reinforcement	Ethicon Endo-Surgery Inc	OXC	Class II	2022-09-16
K221249	L1p-1F (Trios 5)	3SHAPE Trios a/S	NBL	Class II	2022-09-16
K221194	Ledex	Dentmate Technology Co., Ltd.	EBZ	Class II	2022-09-16
K221074	OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device	Stryker Corp.	GEI	Class II	2022-09-16
K220969	GelPOINT V-Path Vaginal Access System	Applied Medical Resources Corp	MOK	Class II	2022-09-16
K220553	Neuro Omega System, NeuroSmart System	Alpha Omega Engineering Ltd.	GZL	Class II	2022-09-16
K220441	CYGNUS™ MoRe Anterior Cervical Plate System	Mirus, LLC	KWQ	Class II	2022-09-16
K220339	Esthetic Abutments Nobel Biocare N1	Nobel Biocare Services AG	NHA	Class II	2022-09-16
K220297	True Tulip, True M.I.S.	Innovative Surgical Designs, Inc.	NKB	Class II	2022-09-16
K220134	cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH	Roche Diagnostics GmbH	CFR	Class II	2022-09-16
K212926	AllureTM Surgical Mask	Allure Gift Wraps Private Limited	FXX	Class II	2022-09-16
K212217	Tempo Smart Button	Eli Lilly and Company, Pharmaceutical Delivery Systems	QOG	Class II	2022-09-16
K211027	Altus Spine Pedicle Screw System	Altus Partners	NKB	Class II	2022-09-16
K202929	Nexpowder	Nextbiomedical Co., Ltd	QAU	Class II	2022-09-16
DEN220025	Phagenyx System	Phagenesis Inc.	QQG	Class II	2022-09-16
K222500	Air Optix Colors	Alcon Laboratories	LPL	Class II	2022-09-15
K222468	ArcTO Transobturator Sling System	Urocure, LLC	OTN	Class II	2022-09-15
K221968	StageOne™ Shoulder Cement Spacer Molds	Zimmer GmbH	MBB	Class II	2022-09-15
K221966	Dynamic TiBase	Talladium Espana, SL	NHA	Class II	2022-09-15
K221686	NovoSorb Matrix	Polynovo Biomaterials Pty Ltd	QSZ	Unclassified	2022-09-15
K221597	CO2 Laser System	Smedtrum Medical Technology Co. Ltd.	GEX	Class II	2022-09-15
K221553	Diamond Air+ (UI04A, UI04B, UI04C)	Ulike Co., Ltd.	OHT	Class II	2022-09-15
K221089	P12 Elite Series Digital Color Doppler Ultrasound System	Sonoscape Medical Corp.	IYN	Class II	2022-09-15
K220830	TrueBalance™ Surgical System	These Three Medical, LLC	ONN	Class II	2022-09-15
K220697	Nitrile Patient Examination Gloves, Powder Free	Lalan Rubbers (Pvt) Ltd.	LZA	Class I	2022-09-15
K220176	Elecsys AFP	Roche Diagnostics GmbH	LOJ	Class II	2022-09-15
K213856	Identity Shoulder System	Zimmer GmbH	MBF	Class II	2022-09-15
K213641	MONDRIAN ALIF Cage with Supplementary Fixation Plate	CTL Medical Corporation	MAX	Class II	2022-09-15
K211204	SafePort(TM) Manifold (or Stopcock)	Elcam Medical A.C.A.L.	FMG	Class II	2022-09-15
K203336	Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30	Oxoid Limited (Part of Thermo Fisher Scientific)	JTN	Class II	2022-09-15
K222764	LightForce Orthodontic System	LightForce Orthodontics	NJM	Class II	2022-09-14
K222503	Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip	Boston Scientific Corporation	PKL	Class II	2022-09-14
K222331	WatchPAT300 (WP300)	Itamar Medical	MNR	Class II	2022-09-14
K222091	Grappler Suture Anchor System	Paragon 28	MBI	Class II	2022-09-14