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 330 of 3528

510(k) clearances, page 330 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K211270	CIV-Clear cover	CIVCO Medical Instruments Co., Inc.	ITX	Class II	2021-09-13
K210396	Harmony Referral System	Topcon Healthcare Solutions EMEA Oy	NFJ	Class II	2021-09-13
K203455	Disposable Medical Mask	Fujian Kang Chen Daily Necessities Co., Ltd.	FXX	Class II	2021-09-13
K202541	EliA RNA Pol III	Phadia AB	NYO	Class II	2021-09-13
K202540	EliA Rib-P	Phadia AB	MQA	Class II	2021-09-13
K201793	EDEN Peek Cage	Jmt Co., Ltd.	ODP	Class II	2021-09-13
K211296	Surgical face mask	Sunsmed Protective Products, Ltd.	FXX	Class II	2021-09-11
K212540	Explorer TO System	SeaSpine Orthopedics Corporation	MAX	Class II	2021-09-10
K212451	Surgical Mask	Remade USA, LLC	FXX	Class II	2021-09-10
K211856	gammaCore Sapphire	Electrocore, Inc.	PKR	Class II	2021-09-10
K211828	Aquilion Exceed LB	Canon Medical Systems Corporation	JAK	Class II	2021-09-10
K211488	Logiq E10	GE Healthcare	IYN	Class II	2021-09-10
K211375	Blazer™ Dx-20 Bidirectional Steerable Diagnostic Catheter	Boston Scientific Corporation	DRF	Class II	2021-09-10
K211334	Iovera System	Pacira Pharmaceuticals, Inc	GXH	Class II	2021-09-10
K211257	EFAI PACS Picture Archiving and Communication System	Ever Fortune.Ai, Co., Ltd.	LLZ	Class II	2021-09-10
K210625	JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve	FUJIFILM medwork GmbH	ODC	Class II	2021-09-10
K210438	Versana Premier	GE Healthcare	IYN	Class II	2021-09-10
K210410	s-Clean Pre-Milled Abutment Mini	Dentis Co.,Ltd	NHA	Class II	2021-09-10
K210227	Sterile syringe for single use with/without needle	Zhejiang Kangkang Medical-Devices Co., Ltd.	FMF	Class II	2021-09-10
K210160	AlertWatch:AC	Alertwatch, Inc.	MSX	Class II	2021-09-10
K210093	AccuFFRangio	ArteryFlow Technology Co., Ltd.	QHA	Class II	2021-09-10
K203785	ClariSIGMAM	Claripi Inc.	QIH	Class II	2021-09-10
K202056	Kinepict Medical Imaging Tool 4.0	Kinepict Health, Ltd.	LLZ	Class II	2021-09-10
K212553	DIGITAL RADIOGRAPHY CXDI-Pro, D1	Canon, Inc.	MQB	Class II	2021-09-09
K212246	Exofin Precision Pen	Chemence Medical Inc.	MPN	Class II	2021-09-09
K211824	HERA W9, HERA W10 Diagnostic Ultrasound System	Samsung Medison Co., Ltd.	IYN	Class II	2021-09-09
K211352	Electronic Thermometer (XHF2001, XHF2002)	Putian Hanjiang Huafeng Plastic Co., Ltd.	FLL	Class II	2021-09-09
K211242	Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes	Promisemed Hangzhou Meditech Co.,Ltd.	FMF	Class II	2021-09-09
K210509	Rocket Platinum Cured Cathter	Rocket Medical	DWM	Class II	2021-09-09
K210402	Curiteva Sacroiliac Joint Fusion System	Curiteva, Inc.	OUR	Class II	2021-09-09
K210385	cobas Cdiff nucleic acid test for use on the cobas Liat System	Roche Molecular Systems Inc	OZN	Class II	2021-09-09
K201785	EPIEN Dental Cleanser	Epien Medical, Inc.	KJJ	Unclassified	2021-09-09
K212495	Leva Pelvic Health System	Renovia, Inc.	HIR	Class II	2021-09-08
K212058	Longeviti ClearFit™ OTS Cranial Implants	Longeviti Neuro Solutions	GXN	Class II	2021-09-08
K211945	V8 Diagnostic Ultrasound System	Samsung Medison Co., Ltd.	IYN	Class II	2021-09-08
K211867	RayStation 11.0	RaySearch Laboratories AB (publ)	MUJ	Class II	2021-09-08
K211832	Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask	Zhejiang Lanhine Medical Products Ltd.	FXX	Class II	2021-09-08
K211597	EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System	Philips North America LLC	IYN	Class II	2021-09-08
K211235	CIRCUL8 Luxe DVT Prevention Device	Precision Medical Products	JOW	Class II	2021-09-08
K211127	Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM	Health & Life Corporation	DXN	Class II	2021-09-08
K210712	Verifine Mechanical Safety Insulin Syringe	Promisemed Hangzhou Meditech Co.,Ltd.	FMF	Class II	2021-09-08
K203555	AmCAD-UT	Amcad Biomed Corporation	QIH	Class II	2021-09-08
K203434	BlueStar Rx	Welldoc	NDC	Class II	2021-09-08
DEN200030	FEops HEARTguide	Feops NV	QQI	Class II	2021-09-08
K211769	OneLIF Intervertebral Body Replacement System	Novapproach Spine LLC	OVD	Class II	2021-09-07
K211607	SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate	STERIS Corporation	MED	Class II	2021-09-07
K211579	CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft)	Bolder Surgical, LLC	GEI	Class II	2021-09-07
K210997	PreferX Delivery System	Md3, LLC	FMF	Class II	2021-09-07
K202049	Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter	Applied Medical Resources Corp	DXE	Class II	2021-09-07
K202796	SANSIN Tubing Sets for Hemodialysis	Jiangxi Sanxin Medtec Co.,Ltd.	FJK	Class II	2021-09-06