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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 829 of 3530

510(k) clearances, page 829 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K131125	Clickfine Pen Needle	Ypsomed AG	FMI	Class II	2013-07-05
K131123	Clickfine Autoprotect Pen Needle	Ypsomed AG	FMI	Class II	2013-07-05
K131078	System 1E Liquid Chemical Sterilant Processing System	STERIS Corporation	MED	Class II	2013-07-05
K130473	Nitrile Powder Free Examination Glove (Ablu)	Hartalega Sdn Bhd	LZA	Class I	2013-07-05
K130404	Tiburon Surgical Drape	Cardinal Health200, LLC	KKX	Class II	2013-07-05
K130211	Airview Bowie Dick; Test Pack, Indicator Sheets	Spsmedical Supply Corp.	JOJ	Class II	2013-07-05
K123471	Etii Sa Fixture System	Hiossen, Inc.	DZE	Class II	2013-07-05
K123234	Ermis Sterilization Container System	Ermis Medizintechnik	KCT	Class II	2013-07-05
K122424	Isus Implant Suprastructures	Dentsply International, Inc.	NHA	Class II	2013-07-05
K121178	Transcorp Acif System	Transcorp	ODP	Class II	2013-07-05
K131786	Airstrip Remote Patient Monitoring Philips Adapter	AirStrip Technologies, Inc.	MWI	Class II	2013-07-03
K131670	Lapidus Plate, 3.5Mm Inline Fusion Plate, 3.5Mm Mtp Plate (Left and Right)	Zimmer GmbH	HRS	Class II	2013-07-03
K131575	Exactech Equinox Superior/posterior Augment Reverse Shoulder Glenoid Baseplate - Left & Right	Exactech, Inc.	PHX	Class II	2013-07-03
K131573	Cp150 Electrocardiograph	Welch Allyn Inc	DPS	Class II	2013-07-03
K131480	Emerge Medical Locking One-Third Tubular Plate System	Emerge Medical	HRS	Class II	2013-07-03
K131474	Arthrex Distal Radius Plate System	Arthrex GmbH	HRS	Class II	2013-07-03
K131106	Digital Radiography Cxdi-701C Wireless, Digital Radiography Cxdi-70Ig Wireless, Digital Radiography Cxdi-801C Wireless,	Canon, Inc.	MQB	Class II	2013-07-03
K131090	2Mp Color Lcd Monitor, Radiforce Mx215	Eizo Corporation	LLZ	Class II	2013-07-03
K131081	Cyber Tm Family	Quanta System Inc.	GEX	Class II	2013-07-03
K130805	Menicon Unique Ph Multi-Purpose Solution	Menicon Co. Ltd.	MRC	Class II	2013-07-03
K130656	Ifusion	Optovue Inc.	HKI	Class II	2013-07-03
K130553	Absoclear	Pharmaplast S.A.E.	FRO	Unclassified	2013-07-03
K130442	Newtom Vgi and Newtom 5G	Qr S.r.l.	OAS	Class II	2013-07-03
K130376	Dynasty Acetabular System with Ceramic	Wrightmedicaltechnologyinc	LZO	Class II	2013-07-03
K124035	2008K@home Hemodialysis Machine	Fresenius Medical Care Renal Therapies Group, LLC	ONW	Class II	2013-07-03
K123983	Fastpack Vitamin D; Immunoassay, Calibrators, Controls, Verifiers	Qualigen Inc	MRG	Class II	2013-07-03
K123641	Culture Dish 40 Mm, Culture Dish 60 Mm, Micro Droplet Culture Dish, 5 Well Culture Dish, Centre Well Dish, Icsi Dish	Hertart	MQK	Class II	2013-07-03
K123256	Human Alpha-1 Antitrypsin Kit Spaplus	The Binding Site Group Ltd.	DEM	Class II	2013-07-03
K123177	Stimlase 2000 Low Level Laser Therapy System	Laserstim, Inc.	ILY	Class II	2013-07-03
K123171	Abx Pentra Calcium as Cp, Abx Pentra Urine Control L/h, Abx Pentra Multical, Abx Pentra N Control, and Abx Pentra P Cont	Horiba Abx SAS	CJY	Class II	2013-07-03
K123074	Imec, Ipm and Beneview T1 Patient Monitors	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	MHX	Class II	2013-07-03
K120977	Directcheck Control for Hemochron Jr. Microcoagulation Systems Act-Lr Cuvette Directcheck Controls for Hemochron Jr. Mic	Accriva Diagnostics, Inc.	GGN	Class II	2013-07-03
K131401	Blowfish Transbronchial Micro-Infusion Catheter	Mercator Medsystems, Inc.	EOQ	Class II	2013-07-02
K131372	Mobis II	Signus Medizintechnik GmbH	MAX	Class II	2013-07-02
K131238	Affix Spinous Process Plate System	NuVasive Inc	PEK	Class II	2013-07-02
K131035	Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) Hi-Fi Sutures, 1.8Mm	Linvatec Corporation D/B/A Conmed Linvatec	MBI	Class II	2013-07-02
K131002	Vida Ptv Dilataton Catheter	C.R. Bard Inc	OMZ	Class II	2013-07-02
K130935	Digital Flat Panel X-Ray Detector/1417wca	Rayence Co., Ltd.	MQB	Class II	2013-07-02
K130920	Correct Plus 1	Pentron Clinical	ELW	Class II	2013-07-02
K130919	Sensus	Neurometrix, Inc.	GZJ	Class II	2013-07-02
K130350	Procellera	Vomaris Innovations, Inc.	FRO	Unclassified	2013-07-02
K130256	Mdk Multi-Applications Platform	Quanta System Inc.	GEX	Class II	2013-07-02
K123803	Reverse Medical Micro Vascular Plug (Mvp) System	Reverse Medical Corporation	KRD	Class II	2013-07-02
K122652	Arthrocare Turbinator Wand	ArthroCare Corporation	GEI	Class II	2013-07-02
K131743	Cirona Dvt Foot Garment	Devon Medical, Inc.	JOW	Class II	2013-07-01
K131705	Endo Gia Radial Reload with Tri-Staple Technology	Covidien, Formerly US Surgical A Divison of Tyco H	GDW	Class II	2013-07-01
K130408	Era Micro 23 Female Abutment, Era Micro 30 Female Abutment	Sterngold Dental LLC	NHA	Class II	2013-07-01
K130353	Pipeline Total Hip System (Line Extension)	Pipeline Orthopedics	LPH	Class II	2013-07-01
K130300	Heater-Cooler Unit Hcu 40	MAQUET CARDIOPULMONARY GmbH	DWC	Class II	2013-07-01
K124030	Cook Holmium Laser Fiber	Cook Incorporated	GEX	Class II	2013-07-01