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 316 of 3528

510(k) clearances, page 316 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K211448	Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses	Pegavision Corporation	LPL	Class II	2021-12-06
K211561	INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor)	Medtronic, Inc.	MUD	Class II	2021-12-05
K212535	Nitrile Powder Free Blue Examination Gloves, Non-Sterile	Mah Sing Healthcare Sdn Bhd	LZA	Class I	2021-12-04
K213580	Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length	Total Joint Othopedics, Inc.	LZO	Class II	2021-12-03
K213266	Inspan ScrewLES Fusion System	Lespine Innovations, LLC	PEK	Class II	2021-12-03
K213116	Everyway Incontinence Stimulation System	Everyway Medical Instruments Co., Ltd.	KPI	Class II	2021-12-03
K213067	Solero Microwave Tissue Ablation (MTA) System and Accessories	Boston Scientific Corporation	NEY	Class II	2021-12-03
K212807	Surgical Masks	Weihai Hongyu Nonwoven Fabric Products Co.,Ltd	FXX	Class II	2021-12-03
K212500	ArtiSential Trocar	LivsMed Inc.	GCJ	Class II	2021-12-03
K212442	Cydar EV (Series B) and Cydar EV Maps	Cydar, Ltd.	OWB	Class II	2021-12-03
K212295	21Hq513d	LG Electronics.Inc	PGY	Class II	2021-12-03
K212258	Medline Cardiovascular Procedure Kit	MEDLINE INDUSTRIES, LP - Northfield	LRO	Class II	2021-12-03
K212219	AHI System	Fifth Eye, Inc.	QNV	Class II	2021-12-03
K211786	Independent Corneal Viewing Chamber (IVC-21)	Bausch + Lomb, Incorporated	LYX	Unclassified	2021-12-03
K210916	PVmed Contouring Software	Perception Vision Medical Technologies Ltd.Co.	LLZ	Class II	2021-12-03
K210241	ImplaStation	Prodigident, Inc.	LLZ	Class II	2021-12-03
K210126	Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10%	The Ritedose Corporation	CAF	Class II	2021-12-03
K201435	Molecular Flow Simulations	Therataxis, LLC	HAW	Class II	2021-12-03
DEN200005	Klox Biophotonic LumiHeal System	Klox Technlogies, Inc.	QPE	Class II	2021-12-03
K212950	FUJIFILM Video Laparoscope EL-R740M30	Fujifilm Corporaton	GCJ	Class II	2021-12-02
K212907	Aimanfun Lumea Comfort, A-2789/A-3588	Kam Yuen Plastic Products Ltd.	ONF	Class II	2021-12-02
K212802	powder free nitrile examination glove - white, non-sterile	Hong Seng Gloves Sdn Bhd	LZA	Class I	2021-12-02
K212740	Puravita Medical Fold Flat Surgical Mask	Puravita M, LLC	FXX	Class II	2021-12-02
K212578	Nitrile disposable examination gloves	Xingyu Medical Tech Co.,Ltd	LZA	Class I	2021-12-02
K211886	Clivia series Diagnostic Ultrasound System	Shenzhen Wisonic Medical Technology Co., Ltd.	IYN	Class II	2021-12-02
K211773	Single-use Surgical Mask	Taiwan Seafood and Fish Corporation	FXX	Class II	2021-12-02
K211721	PS System	Inter-Med, Inc.	NYL	Class I	2021-12-02
K211452	Encevis	Austrian Institute of Technology GmbH	OMB	Class II	2021-12-02
K203745	AURORA Evacuator +Coag	Rebound Therapeutics, Corporation	GEI	Class II	2021-12-02
K202175	OxyLight 2.0	Raja Trading Company, Inc.	GEX	Class II	2021-12-02
K213305	Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR	Canon Medical Systems Corporation	LNH	Class II	2021-12-01
K212864	dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T	Philips Healthcare (Suzhou) Co., Ltd.	MOS	Class II	2021-12-01
K212804	Powder free nitrile examination glove- blue, non-sterile	Hong Seng Gloves Sdn Bhd	LZA	Class I	2021-12-01
K212789	Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)	5r Med Instruments (Chengdu) Co., Ltd.	LZA	Class I	2021-12-01
K212326	AC Cream - Conductive paste	Spes Medica S.P.A	GYB	Class II	2021-12-01
K212050	NGM WAVE PLIF Cage	Ngmedical GmbH	MAX	Class II	2021-12-01
K211959	Milli Vaginal Dilator	Materna Medical	HDX	Class II	2021-12-01
K211755	Electric Breast Pump	Zhejiang Carebao Co., Ltd.	HGX	Class II	2021-12-01
K210934	Sphincterotome / short-wire compatible, Sterile Sphincterotome	Micro-Tech (Nanjing) Co., Ltd.	KNS	Class II	2021-12-01
K212664	Sherlock	Open Implants	NHA	Class II	2021-11-30
K211696	Disposable Surgical Face Mask	Anhui Cleanpro Pharmpack Co., Ltd.	FXX	Class II	2021-11-30
K211668	KardiaMobile Card	AliveCor	DXH	Class II	2021-11-30
K210836	InstruSafe Instrument Protection System	Summitt Medical, LLC	KCT	Class II	2021-11-30
K210117	Paltop Narrow Implant	Paltop Advanced Dental Solutions Ltd	DZE	Class II	2021-11-30
K202024	ARROW Short Stem Humeral System	FH Industrie	PHX	Class II	2021-11-30
K213226	Rct700	Ray Co., Ltd.	OAS	Class II	2021-11-29
K212814	C2 CryoBalloon Ablation System	PENTAX of America, Inc.	GEH	Class II	2021-11-29
K212762	geko W-2	Firstkind Ltd	IPF	Class II	2021-11-29
K212237	3D-Cut	3D-Side	PBF	Class II	2021-11-29
K210930	ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A)	Johnson & Johnson Vision Care, Inc.	LPL	Class II	2021-11-29