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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 1464 of 3531

510(k) clearances, page 1464 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K031396	Advantage Workstation Pasting 1.1	GE Healthcare	LNH	Class II	2003-05-13
K031333	Philips Integris Allura Flat Detector Release 1.2	Philips North America LLC	IZI	Class II	2003-05-13
K031290	Modification to Easys Transverse Connection	Scien'Tx USA, Inc.	MNH	Class II	2003-05-13
K031037	Eopa Elongated One-Piece Arterial Cannula and Guidewire	Medtronic Perfusion Systems	DWF	Class II	2003-05-13
K030209	Mahurkar Oplus Catheter, Model 13.5 Fr	Kendall	MPB	Class II	2003-05-13
K023740	Syrex Pre-Filled Syringe	Excelsior Medical LLC	NZW	Class II	2003-05-13
K023478	Inbody Ap1 Body Composition Analyzer	Biospace Inc.	MNW	Class II	2003-05-13
K022834	Dinamap Pro 1000 Monitor with Superstat, Model 1000	GE Medical Systems Information Technologies, Inc.	MHX	Class II	2003-05-13
K031330	Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and Cables	Masimo Corporation	DQA	Class II	2003-05-12
K031299	Elecsys Lh Calset II	Roche Diagnostics GmbH	JIT	Class II	2003-05-12
K031259	Model 833Hc Vacuum/gravity Steam Sterilizer	Getinge USA, Inc.	FLE	Class II	2003-05-12
K030873	Randox Ammonia	Randox Laboratories, Limited	JIF	Class I	2003-05-12
K030775	Auto I.d. Jo-1, Scl-70 & Pcna Positive Control Serum	IMMUNO CONCEPTS, NA, Ltd.	LKJ	Class II	2003-05-12
K030513	Cell-Dyn 1800 System	Abbott Medical	GKZ	Class II	2003-05-12
K030453	Cooltouch Nd: Yag Laser System	New Star Lasers, Inc.	GEX	Class II	2003-05-12
K031358	Transvaginal Doppler Probe	Vascular Control Systems, Inc.	ITX	Class II	2003-05-09
K031347	Ultrasonic Gastrovideoscope, Type Uc160p-At8 and Uct160-At8	Olympus Optical Co., Ltd.	ODG	Class II	2003-05-09
K031293	Synthetic (White) Vinyl Patient Examination Gloves-Powder Free	Shijiazhuang Eversharp Plastic Products Co., Ltd.	LYZ	Class I	2003-05-09
K031289	Quickie Freestyle Power Wheelchair, Model G-424	Sunrise Medical, Inc.	ITI	Class II	2003-05-09
K031224	Smartxide	Cynosure, LLC	GEX	Class II	2003-05-09
K031156	Navitrack System-Fluorospine, Model 900.005	Orthosoft, Inc.	HAW	Class II	2003-05-09
K031008	Aesculap Neuro Patties, Neurosorb 4, 6, and 75 (Green & White)	Aesculap Inc	HBA	Class II	2003-05-09
K030931	C3 Patient Monitor	Analogic Corp.	MHX	Class II	2003-05-09
K030907	Stacked Abr for Navigator Pro	Bio-Logic Systems Corp.	GWJ	Class II	2003-05-09
K030776	Mega Bite Registration - Dental Bite Registration Material	Discus Dental LLC	ELW	Class II	2003-05-09
K030743	Etchant 40%	Confi-Dental Products Co.	KLE	Class II	2003-05-09
K030680	Spsmedical Gas Plasma Chemical Indicator	Spsmedical Supply Corp.	JOJ	Class II	2003-05-09
K030561	Mytech/happy Life Blood Pressure Monitor, Models Hpl-100 and Hpl-100A	Mytech Technology Co., Ltd.	DXN	Class II	2003-05-09
K030506	Depilase Yag Lase Plus Laser System	Depilase Group, Ltd.	GEX	Class II	2003-05-09
K030469	Laparoshield Conditioned Insufflation Set	Pall Medical	HIF	Class II	2003-05-09
K030448	Osteomed 2.0 Locking Plates and Screws	Osteomed	JEY	Class II	2003-05-09
K030443	Mammary Aspiration Specimen Cytology Test	Nastech Pharmaceutical Company, Inc.	KNW	Class II	2003-05-09
K030423	Powerlite 600 Ep System	Preswede AB	GEX	Class II	2003-05-09
K030417	Disposable Sterile Internal Defibrillation Paddles (Switched-Large), Disposable Sterile Internal Defibrillation Paddles	Philips North America LLC	LDD	Class II	2003-05-09
K030300	Opaque Herrick Lacrimal Plug	Lacrimedics, Inc.	LZU	Unclassified	2003-05-09
K023424	Igi-System	Denx Advanced Dental Systems	HAW	Class II	2003-05-09
K023338	Portapres Ambulatory Continuous Non Invasive Blood Pressure Monitor,model-2	Finapres Medical Systems B.V.	DXN	Class II	2003-05-09
K022978	Steritite Container with Flashtite Valve Plate(s) & Meditray Products	Case Medical, Inc.	FRG	Class II	2003-05-09
K022662	Diatek Cannon-Catheter, Model Cc5500	Arrow Intl., Inc.	MSD	Class II	2003-05-09
K021813	Hydrocision General Surgery Fluidjet System	Hydrocision, Inc.	FQH	Class II	2003-05-09
K021230	Hero	Medical Decision Networks	DPS	Class II	2003-05-09
K031089	Gore-Flex Mp8 Multipurpose Torso Array	W. L. Gore & Associates, Inc.	MOS	Class II	2003-05-08
K031056	Modification to Premier III Phased Array Ctl Spine Coil	GE Healthcare Coils	MOS	Class II	2003-05-08
K030573	Bd Vacutainer Push Button Blood Collection Set, Models 367338, 367344, 367336, 367342, 367335, 367341	BD Vacutainer Systems Preanalyical Solutions	JKA	Class II	2003-05-08
K030439	Headfix	3C-Medical Intelligence GmbH	IYE	Class II	2003-05-08
K030632	Pd Casta-H	Mountain Medico, Inc.	EJH	Class II	2003-05-07
K030588	Artegral and Polystar Selection	Merz Dental GmbH	ELM	Class II	2003-05-07
K023820	CO2 Clip	Bregas AB	CCK	Class II	2003-05-07
K031320	Ek-Pro Arrhythmia Detection Algorithm	GE Medical Systems Information Technologies, Inc.	MHX	Class II	2003-05-06
K031312	Rta Model D Retinal Thickness Analyzer	Talia Technology, Ltd.	HLI	Class II	2003-05-06