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 348 of 3528

510(k) clearances, page 348 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K211307	GalaSTITCH Absorbable Monofilament Suture	Tepha, Inc.	NWJ	Class II	2021-05-27
K211282	Aqua Medical RF Vapor System	Aqua Medical, Inc.	KNS	Class II	2021-05-27
K211134	BIB Stent Placement Catheter	Numed Inc	NVM	Class II	2021-05-27
K211057	LigaPASS® Spinal System, CD Horizon™ Spinal System	Medtronic, Inc.	OWI	Class II	2021-05-27
K202765	ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs	Careplus (M) Sdn Bhd	KGO	Class I	2021-05-27
K201639	Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads	Beijing Biosis Healing Biolog Ical Technology Co., Ltd.	GDW	Class II	2021-05-27
K200704	ZedView	Lexi Co., Ltd.	LLZ	Class II	2021-05-27
DEN190043	SafeBreak Vascular	Site Saver, Inc. D/B/A Lineus Medical	QOI	Class II	2021-05-27
K211292	Fassier-Duval Telescopic IM System	Orthopediatrics Canada ULC	HSB	Class II	2021-05-26
K211258	Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA Interbody System, Endoskeleton TAS & TAS Hyp Interbody System, Endoskeleton TL Interbody System, Endoskeleton TL Hyp. Interbody System, Endoskeleton TO Interbody System, Endoskeleton TT Interbody System	Medtronic Sofamor Danek USA Inc	MAX	Class II	2021-05-26
K211253	PlasmaWave	Manamed LLC	JOW	Class II	2021-05-26
K211251	ViperCath XC Peripheral Exchange Catheter	Cardiovascular Systems Incorporated	DQY	Class II	2021-05-26
K211098	Breast Volume Navigator (BVN) Model G-2000	MetriTrack, Inc.	IYO	Class II	2021-05-26
K210520	Disposable Synthetic Examination Gloves	Shandong Shengshixincheng Medical Science & Technology Co.	LYZ	Class I	2021-05-26
K210051	OTE MPS 045 Multi-purpose Lens Care Solution	Ote' North America LLC.	LPN	Class II	2021-05-26
K203322	SpyGlass Discover Retrieval Basket	Boston Scientific Corporation	LQR	Class II	2021-05-26
K203196	Peak flow meter	Shanghai Sonmol Medical Equipment Co., Ltd.	BZH	Class II	2021-05-26
K202832	Implacil Implant System	Implacil de Bortoli Material Odontologico Ltda	DZE	Class II	2021-05-26
K211460	Air Relax Plus Model AR-3.0	Diode Art Engineering Doing Business AS Air Relax	IRP	Class II	2021-05-25
K211313	MAXFRAME Multi-Axial Correction System (aka MAXFRAME)	Synthes (USA) Products LLC	KTT	Class II	2021-05-25
K211275	AirMax Procedure Mask	Premiumestore, LLC	FXX	Class II	2021-05-25
K210977	E-Dent 1000	Envisiontec GmbH	EBF	Class II	2021-05-25
K210915	Pathfinder Endoscope Cap	Neptune Medical, Inc	FDS	Class II	2021-05-25
K210608	LUX-Dx Insertable Cardiac Monitor	Boston Scientific Corporation	MXD	Class II	2021-05-25
K203760	Tokuyama Universal Bond II	Tokuyama Dental Corporation	KLE	Class II	2021-05-25
K203724	HeRO Graft, HeRO Adapter	Merit Medical Systems, Inc.	DSY	Class II	2021-05-25
K203144	MicroPen EVO	Eclipse Medcorp, LLC	QAI	Class II	2021-05-25
K211246	LEGION CR Porous Plus HA Femoral Components	Smith & Nephew, Inc.	MBH	Class II	2021-05-24
K210975	Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia	Bausch & Lomb Incorporated	LPL	Class II	2021-05-24
K210535	UltraLight LED System	Rohrer Aesthetics, Inc.	GEX	Class II	2021-05-24
K210425	Catalyft PL Expandable Interbody System	Medtronic Sofamor Danek USA Inc	MAX	Class II	2021-05-24
K210214	NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System	Nu Vasive, Incorporated	MAX	Class II	2021-05-24
K190703	Neuro-IOM system with Neuro-IOM.NET software	Neurosoft Ltd	GWF	Class II	2021-05-22
K211423	Rover	Micro-X Ltd.	IZL	Class II	2021-05-21
K211312	Universal Viewer	GE Healthcare	LLZ	Class II	2021-05-21
K211273	Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray	Ethicon Endo-Surgery Inc	LFL	Unclassified	2021-05-21
K210358	Neurescue device	Neurescue ApS	MJN	Class II	2021-05-21
K210119	IPL Hair Removal Device (Model: KCA423)	Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd.	ONF	Class II	2021-05-21
K203806	JWX-1 Plus (Navigo 16/Navigo 24)	Yamaha Motor Co Ltd	ITI	Class II	2021-05-21
K202527	Zio ECG Utilization Software (ZEUS) System	iRhythm Technologies, Inc.	DQK	Class II	2021-05-21
K202359	Zio Monitor	iRhythm Technologies, Inc.	DSH	Class II	2021-05-21
K202299	Ultrasonic Surgical Aspirator System	Smtp Technology Co., Ltd.	LFL	Unclassified	2021-05-21
K201461	Manual Wheelchair, Model A011	Ningbo Shenyu Medical Equipment Co., Ltd.	IOR	Class I	2021-05-21
K201192	Impla-NX (Model: ISE-270M)	Micro-NX Co., Ltd.	EBW	Class I	2021-05-21
K211001	C-Qual M™ Breastboard; Monarch™ Overhead Arm Positioner	Medtec, Inc. dba Civco Medical Solutions and Civco	IYE	Class II	2021-05-20
K210581	Actis DuoFix Hip Prosthesis- Collarless	Depuy Ireland UC	MEH	Class II	2021-05-20
K210476	EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle	Cook Ireland Ltd.	FCG	Class II	2021-05-20
K210257	Xoran Workstation, Model 10050	Xoran Technologies, LLC	LLZ	Class II	2021-05-20
K210086	Vitals360 Multi-Vitals Mobile Monitor	Vocare, Inc.	MWI	Class II	2021-05-20
K203583	YUWELL infrared ear thermometer: YHT101, YHT200	Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.	FLL	Class II	2021-05-20