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 322 of 3528

510(k) clearances, page 322 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K213351	ds Head 32ch 3.0T	Invivo Corporation (Business Trade Name: Philips)	MOS	Class II	2021-10-29
K213264	CARTO 3 EP Navigation System Version 7.2	Biosense Webster Inc	DQK	Class II	2021-10-29
K213195	Balloon BS-3	FUJIFILM Corporation	FDA	Class II	2021-10-29
K213163	VersaWrap	Alafair Biosciences, Inc.	FTM	Class II	2021-10-29
K212831	MectaLIF Extension	Medacta International SA	MAX	Class II	2021-10-29
K212389	Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF	Intelivation, LLC	MAX	Class II	2021-10-29
K212308	SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue Nitrile Examination Gloves Powder Free	Srirungruang Global Co., Ltd.	LZA	Class I	2021-10-29
K211987	ATEC Alignment App	Alphatec Spine, Inc.	LLZ	Class II	2021-10-29
K211161	Critical Care Suite with Endotracheal Tube Positing AI algorithm	GE Healthcare	QIH	Class II	2021-10-29
K211064	nView s1 with nav option	Nview Medical	OWB	Class II	2021-10-29
K210570	TraumaGuard Intra-abdominal Pressure Sensing System	Sentinel Medical Technologies, LLC	PHU	Unclassified	2021-10-29
K210279	Enbio S	Enbio Group AG	FLE	Class II	2021-10-29
K201496	N Latex FLC kappa, N Latex FLC lambda	Siemens Healthcare Diagnostics Products Limited	DFH	Class II	2021-10-29
K201032	Phoenix Digital Thermometer	Phoenix Innovative Healthcare Manufacturers Pvt., Ltd.	FLL	Class II	2021-10-29
K212489	BonOs Inject Bone Cement; NEO Pedicle Screw System	Neo Medical, Inc.	PML	Class II	2021-10-28
K212424	AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers	STERIS Corporation	FLE	Class II	2021-10-28
K212290	Examination gloves -Type C (Nitrile gloves)	Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.	LZA	Class I	2021-10-28
K211797	TRACKER Plus Kyphoplasty System	GS Medical Co., Ltd.	NDN	Class II	2021-10-28
K211581	Disposable Nitrile Examination Gloves (Powder free, Blue)	Leping Shengde Medical Technology Company Limited	LZA	Class I	2021-10-28
K211160	EndoTool SubQ 2.1	Monarch Medical Technologies	NDC	Class II	2021-10-28
K211019	Disposable Monopolar Laparoscopic Tips and Reusable Handles	Dannik	GEI	Class II	2021-10-28
K210287	VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL)	bioMerieux, Inc.	LON	Class II	2021-10-28
K200839	APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module	Clever Culture Systems Limited	QQY	Class II	2021-10-28
K213153	SPIWay Endonasal Access Guide	SPIWay, LLC	LYA	Class I	2021-10-27
K213125	PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology	Synovis Life Technologies. Inc. (A Subsidiary of Baxter	FTM	Class II	2021-10-27
K211604	Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs	Shanxi Hongjin Plastic Technology Co., Ltd	LZA	Class I	2021-10-27
K210873	Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20	Oxoid Limited (Part of Thermo Fisher Scientific)	JTN	Class II	2021-10-27
K203316	V.A.C.ULTA Negative Pressure Wound Therapy System	Kci, A Part of 3M Health Care Business Group	OMP	Class II	2021-10-27
K201520	The Alma Opus System, Colibri Applicator and Tips	Alma Lasers Ltd.	GEI	Class II	2021-10-27
K213166	Thrombuster II Aspiration Catheter	Kaneka Medical America LLC	QEZ	Class II	2021-10-26
K213164	Avaira Vitality	CooperVision, Inc.	LPL	Class II	2021-10-26
K213124	Tomier Perform™ Reversed Glenoid Cannulated Glenospheres	TORNIER Inc.	PHX	Class II	2021-10-26
K213081	CLISIS SYSTEMS, Discovery RF180	General Medical Merate S.p.A.	IZF	Class II	2021-10-26
K212363	Disposable Medical Nitrile Examination Gloves	Lanhuo Medical Technology (Jiangsu) Co.,Ltd	LZA	Class I	2021-10-26
K211977	Medical Diode Laser Systems	Wuhan DIMED LASER TECHNOLOGY CO., Ltd.	GEX	Class II	2021-10-26
K211537	QuickAligners	Oral Image, Inc.	NXC	Class II	2021-10-26
K211069	EndSnorZ Sleep Appliance	Prismatik Dentalcraft, Inc.	LRK	Class II	2021-10-26
K202998	Vydence Zye and Vydence One	Vydence Medical Industria e Comercio Ltda	GEX	Class II	2021-10-26
K213386	Titan Manufacturing Bipolar Forceps	Titan Manufacturing Inc.	GEI	Class II	2021-10-25
K213085	Introcan Safety 3 Closed IV Catheter	B.Braun Medical, Inc.	FOZ	Class II	2021-10-25
K212793	Laser Treatment System, Model: Hera, Armo	Canadian Pioneer Medical Technology Corporation	GEX	Class II	2021-10-25
K212401	Disposable Nitrile Examination Glove	Inner Mongolia Cureguard Medical Technology Co., Ltd.	LZA	Class I	2021-10-25
K212293	Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A)	Jiangmen Ningrui Medical Supplies Co., Ltd.	FXX	Class II	2021-10-25
K212218	Advanced Algorithms for Treatment Management Applications (AATMA)	Elekta Solutions AB	QKB	Class II	2021-10-25
K212146	Arthrex LoopLoc Knotless Suture	Arthrex GmbH	GAT	Class II	2021-10-25
K210488	Ultrasonic Surgical & Electrosurgical Generator	Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.	GEI	Class II	2021-10-25
K210249	Best Glove-Nitrile Powder Free Examination Glove	Bestsafe Glove Co., Ltd.	LZA	Class I	2021-10-25
K212368	Surgical Face Mask	Anhui Tiankang Medical Technology Co., Ltd.	FXX	Class II	2021-10-24
K211698	Vinyl Examination Gloves(Yellow)	Liuping Trading Co., Ltd.	LYZ	Class I	2021-10-24
K211509	Surgical Gown	Hubei Wanli Protective Products Co.,Ltd	FYA	Class II	2021-10-24