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 328 of 3528

510(k) clearances, page 328 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K212002	Synthetic Vinyl Examination Gloves	Yunnan Huazhiyuan Medical Technology Co., Ltd.	LYZ	Class I	2021-09-23
K211996	Nexta PEEK Hammertoe Correction System	Medartis AG	HWC	Class II	2021-09-23
K211974	LED PHOTIC System	MicroMed, LLC	GWE	Class II	2021-09-23
K211827	Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)	Zhejiang Lanhine Medical Products Ltd.	FXX	Class II	2021-09-23
K211747	Reusable NIBP Cuff	Shenzhen Coreray Technology Co., Ltd.	DXQ	Class II	2021-09-23
K211667	Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)	Changzhou Universal Medical Equipment Co., Ltd.	LAZ	Class I	2021-09-23
K210707	OnGuard2 Chemfort Closed Administration (CADM)	Simplivia Healthcare Ltd.	ONB	Class II	2021-09-23
K210294	One Touch Spiral Condom	Thai Nippon Rubber Industry Public Company Limited	HIS	Class II	2021-09-23
K210232	Sterile Hypodermic Needles for Single Use	Zhejiang Kangkang Medical-Devices Co., Ltd.	FMI	Class II	2021-09-23
K210152	Automatic Digital Blood Pressure Monitor	Aviche Shandong Medical Technology Co, Ltd.	DXN	Class II	2021-09-23
K203662	Infrared thermometer, Models: YRK-002A, T8, T9, T10, T11	Yibin Junxin Electronics Technology Co., Ltd.	FLL	Class II	2021-09-23
K203446	TorrentX Wound Wash	Next Science, LLC	FRO	Unclassified	2021-09-23
K202092	ABC Dental Implant System	Abracadabra Implants Ltd.	DZE	Class II	2021-09-23
K212727	FilmArray Pneumonia Panel	BioFire Diagnostics, LLC	QDP	Class II	2021-09-22
K212667	Single Use Guide Sheath Kit-401, K-402	Olympus Medical Systems Corp.	EOQ	Class II	2021-09-22
K212660	Smylio Invisible Clear Aligners	Smylio	NXC	Class II	2021-09-22
K212353	DB-EZ Bone Void Filler	Dimensional Bioceramics, LLC	MQV	Class II	2021-09-22
K212160	SimpleSENSE Platform	Nanowear, Inc.	DXH	Class II	2021-09-22
K211805	IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoTec Interbody System	Alphatec Spine, Inc.	MAX	Class II	2021-09-22
K211097	Banyan USA Surgical Mask Level 3	Banyan USA, LLC	FXX	Class II	2021-09-22
K210772	3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT)	Vr Vertical, LLC dba Xrgo	FXX	Class II	2021-09-22
K210263	Mpres Neck Preserving Stem	Medacta International SA	LZO	Class II	2021-09-22
K210045	Activa Presto Pack	Pulpdent Corporation	EBF	Class II	2021-09-22
K200423	Electric Wheelchair (XW-LY001)	Yongkang Dingchang Industry & Trade Co., Ltd.	ITI	Class II	2021-09-22
K212837	ProxiDiagnost N90	Philips Medical Systems DMC GmbH	JAA	Class II	2021-09-21
K212692	Mariner Pedicle Screw System	SeaSpine Orthopedics Corporation	NKB	Class II	2021-09-21
K212655	Flyte	Pelvital USA, Inc.	HIR	Class II	2021-09-21
K212334	GEO Extremity and Ankle Plating System	Gramercy Extremity Orthopedics, LLC.	HRS	Class II	2021-09-21
K212303	T2	OSSTEM Implant Co., Ltd.	OAS	Class II	2021-09-21
K212287	Dayspring Lite	Koya Medical, Inc.	JOW	Class II	2021-09-21
K211689	KEYSTONE PEEK Cage System	Shanghai Sanyou Medical Co. Ltd	MAX	Class II	2021-09-21
K211073	Disposable Nitrile Examination Gloves	Foshan Kangkang Biotechnology Co., Ltd.	LZA	Class I	2021-09-21
K201441	Elecsys Troponin T Gen 5	Roche Diagnostics GmbH	MMI	Class II	2021-09-21
K200898	Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin	Medicon Hellas SA	CIX	Class II	2021-09-21
DEN200080	Paige Prostate	Paige.ai, Inc	QPN	Class II	2021-09-21
K212961	Smilers	Biotech Dental Smilers, SAS	NXC	Class II	2021-09-20
K212224	TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform	Imperative Care Inc.	QJP	Class II	2021-09-20
K211931	Medline Digital Thermometer Non-Lubricated Probe Sheath	MEDLINE INDUSTRIES, LP - Northfield	FLL	Class II	2021-09-20
K211922	IPL Home Use Hair Removal Device	Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd.	OHT	Class II	2021-09-20
K211477	Latex Examination Powder Free Gloves	Aspen Glove Sdn. Bhd.	LYY	Class I	2021-09-20
K210955	Kubtec Mozart Supra (XPERT 84) Radiography System	Kub Technologies, Inc.	MWP	Class II	2021-09-20
K210440	Disposable Sampler Inactivated Transport Media, Nest ITM	Wuxi Nest Biotechnology Co., Ltd	QBD	Class II	2021-09-20
K203799	ProFlex CO2 Laser Fiber	Innovaquartz LLC	GEX	Class II	2021-09-20
K201789	CT-Stor	Energy Delivery Solutions	NDS	Class II	2021-09-20
K212272	Tempo Natural Tampon	Dong-a Pharmaceutical Co., Ltd.	HEB	Class II	2021-09-17
K212269	Intelligent NR	Canon, Inc.	MQB	Class II	2021-09-17
K212067	Deep Learning Image Reconstruction	GE Healthcare Japan Corporation	JAK	Class II	2021-09-17
K211904	Vinyl Glove	Jiangsu Dihong Industry and Trade Co., Ltd.	LYZ	Class I	2021-09-17
K211751	WELLTRUST WT-III Mask with Flat Earloop	Lonestar Meadows, LLC	FXX	Class II	2021-09-17
K211234	RedEx	Advanced Surgical Concepts	GCJ	Class II	2021-09-17