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 1274 of 3531

510(k) clearances, page 1274 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K060528	Aesculap Trelon Nonabsorbable Multifilament Polyamide Surgical Suture	Aesculap Inc	GAR	Class II	2006-03-28
K060523	Neuroport Neural Signal Processing System	Cyberkinetics, Inc.	OMC	Class II	2006-03-28
K060520	Vitamesh Macroporous Pp Surgical Mesh	Proxy Biomedical Ltd.	FTL	Class II	2006-03-28
K060469	Optibond All-in-One	Sybron Dental Specialties, Inc.	KLE	Class II	2006-03-28
K060464	Coulter 5C Cell Control	Siemens Healthcare Diagnostics Inc.	JPK	Class II	2006-03-28
K060403	Pta (Progressive Tibial Alignment)	Meridian Medical Limited	LXT	Class II	2006-03-28
K053300	Syvekexcel	Marine Polymer Technologies, Inc.	DXC	Class II	2006-03-28
K053079	Assure Pro Blood Glucose Monitoring System, Model 460001	Arkray Factory USA, Inc.	CGA	Class II	2006-03-28
K053073	N Antisera to Human Alpha2-Macroglobulin	Siemens Healthcare Diagnostics Inc.	DEB	Class II	2006-03-28
K053072	N Antisera to Human Alpha1-Antitrypsin	Siemens Healthcare Diagnostics Inc.	DEM	Class II	2006-03-28
K052898	Iqmark Ez Stress	Brentwood Medical Technology Corp.	DPS	Class II	2006-03-28
K052297	Porex Electrosurgery Needle	Porex Surgical, Inc.	GEI	Class II	2006-03-28
K051197	Aculife, Model Smw-01	Inno-Health Technology Co., Ltd.	BWK	Unclassified	2006-03-28
K060306	Accell Connexus Demineralized Bone Matrix Putty	Isotis NV	NUN	Class II	2006-03-27
K060120	Teco Cx3 Reagent Set for Synchron Cx System	Teco Diagnostics	CDQ	Class II	2006-03-27
DEN050007	Healthcheck(tm) Home Test for Loss of the Sense of Smell	Fmg Innovations, Inc.	NRK	Class II	2006-03-27
K060541	The Philips Mp20,mp30,mp40,mp50,mp60,mp70,mp80 and Mp90 Intellivue Atient Monitors	Philips Medizin Systeme Boblingen GmbH	MHX	Class II	2006-03-24
K060454	Titan Guidewire	Lake Region Mfg., Inc.	DQX	Class II	2006-03-24
K060215	Albu Trol, Low, Model 108.001.002; Albu Trol, High 108.002.002	Eurotrol B.V.	JJX	Class I	2006-03-24
K060175	Isight Imaging Catheter, Model 38986	Boston Scientific Corporation	DQO	Class II	2006-03-24
K060066	Verify 3-10 Min Flash Integrator	Sybron Dental Specialties, Inc.	JOJ	Class II	2006-03-24
K053401	Spotchem II Chemistry Basic 1 and Chemistry Basic 2 Tests	Arkray, Inc.	CIC	Class II	2006-03-24
K053384	Fixature Microthread Osseospeed, a Component of the Astra Tech Implant System	Astra Tech, Inc.	DZE	Class II	2006-03-24
K060515	Depuy Pfc Sigma Knee Prosthesis	Depuy Orthopaedics Inc.	JWH	Class II	2006-03-23
K060487	Lifestent Flexstar Xl Biliary Stent System	Edwards Lifesciences LLC	FGE	Class II	2006-03-23
K060486	Cyclone, Model Maicam 180	Spectrica	KPS	Class II	2006-03-23
K060312	Microscan Synergies Plus Gram-Positive Mic/combo Panels with Vancomycin (0.25-64 Ug/ml)	Siemens Healthcare Diagnostics Inc.	LON	Class II	2006-03-23
K060301	Palomar Lux1540 Handpiece	Palomar Medical Technologies, Inc.	GEX	Class II	2006-03-23
K060230	Dopplex Centrale	Huntleigh Healthcare Ltd.	HGM	Class II	2006-03-23
K060043	Khan Kinetic Treatment Device (Kkt-M1)	Optima Health Solutions International Corp.	LXM	Unclassified	2006-03-23
K060007	Bd Autoshield Pen Needle	Becton Dickinson & Co	FMI	Class II	2006-03-23
K053494	Oil for Tissue Culture, Gradient System and Spermfreeze	Fertipro N.V.	MQL	Class II	2006-03-23
K053360	Aerolife Ultrasonic Nebulizer, Model P2c	Aerovectrx Corporation	CAF	Class II	2006-03-23
K053229	Merits Health Products Oxygen Concentrators	Merits Health Products, Inc.	CAW	Class II	2006-03-23
K053164	Iplan Flow	Brainlab, Inc.	HAW	Class II	2006-03-23
K052891	Horizon Epikeratome Disposable Microkeratome System	Hawken Industries	HNO	Class I	2006-03-23
K060451	M-Vu Viewer Station	Vucomp, Inc.	LLZ	Class II	2006-03-22
K060437	Excia Total Hip System with U-Cap	Aesculap Inc	MEH	Class II	2006-03-22
K060411	Radiancy Cleartouch Lite Acne Clearance System	Radiancy (Israel), Ltd.	GEX	Class II	2006-03-22
K060294	Diaphyseal Plate	Hand Innovations, Inc.	HRS	Class II	2006-03-22
K060239	Aleolus/enoventions,alimaxx-E Dv Esophageal Stent System	Alveolus, Inc.	ESW	Class II	2006-03-22
K053466	Hsiner Resuscitator	Hsiner Co., Ltd.	BTM	Class II	2006-03-22
K052999	Semperflo Infusion System	Ethicon, Inc	MEB	Class II	2006-03-22
K051510	Signal Medical Corporation Beacon Knee System	Whiteside Biomechanics, Inc.	MBH	Class II	2006-03-22
K060417	Modification to Quantimetrix Urine Drugs of Abuse Control	Quantimetrix Corp.	DIF	Class I	2006-03-21
K060408	Norian Srs Bone Void Filler	Synthes (USA) Products LLC	MQV	Class II	2006-03-21
K060322	Cliniqa Dry Qc Chemistry Control, Levels 1 and 2, Assayed, Cliniqa Dry Qc Chemistry Control, Level 1 and 2 Unassayed	Cliniqa Corporation	JIT	Class II	2006-03-21
K060304	Photex Diode Laser Series, Models 980, 810 and 940	Biotex, Inc.	GEX	Class II	2006-03-21
K060206	Mission Complete	DIAMOND DIAGNOSTICS Inc	JJY	Class I	2006-03-21
K060161	Aft Allograft Filler Tube	Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics	MBP	Class II	2006-03-21