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 787 of 3530

510(k) clearances, page 787 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K132959	Depuy Pinnacle Altrx Acetabular Liners	Depuy Orthopaedics Inc.	LPH	Class II	2014-03-10
K132267	Newtron P5, Newtron P5 B.led	Satelec-Acteon Group	ELC	Class II	2014-03-10
K131708	Bwcsh-1 Sharps Container	Bradford Wright Companies, Inc.	MMK	Class II	2014-03-10
K123276	Mm-Seal	Micro-Mega Societe Anonyme	KIF	Class II	2014-03-10
K121664	T4/t5 Hytrel Togas	Stryker Corp.	FYA	Class II	2014-03-10
K121123	Biofusionary Bebe	Rocky Mountain Biosystems, Inc.	IMJ	Class II	2014-03-10
K140323	Navigator Hd Ureteral Access Sheath Sets	Boston Scientific Corporation	FED	Class II	2014-03-07
K140291	Volcano Core Control Pad, Accessory to the Volcano S5/s5i Intravascular Ultrasound Imaging & Pressure Systems	Volcano Corporation	IYO	Class II	2014-03-07
K140286	Optease Vena Cava Filter and Optease Retrieval Cathteter	Cordis, A Johnson & Johnson Co.	DTK	Class II	2014-03-07
K140148	Pro-Toe Hammertoe Fixation System	Wrightmedicaltechnologyinc	HWC	Class II	2014-03-07
K140093	Table	Anatomage, Inc.	LLZ	Class II	2014-03-07
K134026	Endoscope Position Marking Probe,endoscope Position Detecting Unit	Olympus Medical Systems Corp.	PGU	Class II	2014-03-07
K133713	Charlotte (Tm) Snap-Off Screw	Wrightmedicaltechnologyinc	HWC	Class II	2014-03-07
K133527	Suflex Putty, Suflex Heavy, Suflex Mono, Suflex Light	Osstem Germany GmbH	ELW	Class II	2014-03-07
K133436	Flash Ar; Flash Ar Quick	3M Deutschland GmbH	ELW	Class II	2014-03-07
K133363	Interbridge Interspinous Posterior Fixation System	Ldr Spine USA	PEK	Class II	2014-03-07
K133214	Blackbird Spinal System	Choicespine, LP	KWP	Class II	2014-03-07
K133135	Impax Volume Viewing 3.0	AGFA Healthcare Corp.	LLZ	Class II	2014-03-07
K132945	Cfn-Cannulated Femur Nail, Ctn-Cannulated Tibia Nail, Chn-Cannulated Humeral Nail	I.T.S. GmbH	HSB	Class II	2014-03-07
K132107	Male Latex Condom	Nulatex Sdn. Bhd.	HIS	Class II	2014-03-07
K131959	Heine Mini 3000(R) Ophthalmoscope	Heine Optotechnik GmbH & Co. KG.	HLJ	Class II	2014-03-07
K140153	Ventripoint Medical System	Ventripoint, Inc.	IYN	Class II	2014-03-06
K140113	O2 Nasal Cannula with CO2 Monitoring	Flexicare Medical Ltd.	CCK	Class II	2014-03-06
K133966	Model-Based Rsa Software	Halifax Biomedical Inc.	LLZ	Class II	2014-03-06
K133836	Optiglaze Color	GC America Inc.	EBD	Class II	2014-03-06
K133754	Integra Camino Flex Ventricular Intracranial Pressure Monitoring Kit with Flex Adapter	Integra LifeSciences Corporation	GWM	Class II	2014-03-06
K133459	Elite Ibf	Innova Spinal Technologies, LLC	MAX	Class II	2014-03-06
K133400	Flash Bite	3M Espe AG	ELW	Class II	2014-03-06
K133036	Apollo Suture Anchor System and Titan Screws	Spinal Elements, Inc	MBI	Class II	2014-03-06
K133022	Zedview	Lexi Co., Ltd.	LLZ	Class II	2014-03-06
K132812	Ucp Multi-Drug Test Key Cups	Ucp Biosciences, Inc.	DKZ	Class II	2014-03-06
K132611	Microtable System	Fred Haer Company, Inc.	HAW	Class II	2014-03-06
K132244	N-Force Fixation System	Innovision, Inc.	HWC	Class II	2014-03-06
K131912	Conchatherm Neptune Heated Humidifier, Comfort Flo Humidification System, Conchasmart Column	Teleflex Medical	BTT	Class II	2014-03-06
K131750	Autosure Ht Blood Glucose Monitoring System	Apex Biotechnology Corp.	CGA	Class II	2014-03-06
K131627	Catheter Introducer Sheath	Edwards Lifesciences LLC	DYB	Class II	2014-03-06
K131562	Breathe Niov Ventilation System	Breathe Technologies, Inc.	ONZ	Class II	2014-03-06
K131506	Airway Support System / Airport	Abeon Medical Corporation	CCK	Class II	2014-03-06
K140266	Nmi Picc IV	Boston Scientific Corporation	LJS	Class II	2014-03-05
K140263	Insuflow Synergy Port, Insuflow Synergy Xl Port	Lexion Medical, LLC.	HIF	Class II	2014-03-05
K140258	Immulite 2000 Dhea-So4; Third Generation Tsh and Intact Pth Calibration Verification Material	Siemens Healthcare Diagnostics Inc.	JJX	Class I	2014-03-05
K140208	Ferm-Flex and Fem-Flex II ( Femoral Access Arterial Cannulae) Femtrak,vfem, and Fem-Flexii	Edwards Lifesciences LLC	DWF	Class II	2014-03-05
K133740	Sauflon Clariti with Tint, Sauflon Clariti Toric with Tint, Sauflon Clariti Multifocal with Tint	Sauflon Pharmaceuticals, Ltd.	LPL	Class II	2014-03-05
K133619	Digital Automatic Blood Pressure Monitor Bpm18 Series	Grandway Technology (Shenzhen) Limited	DXN	Class II	2014-03-05
K133618	Digital Automatic Wrist Blood Pressure Monitor Wbpm22 Series	Grandway Technology (Shenzhen) Limited	DXN	Class II	2014-03-05
K133445	Angiovac Cannula	Vortex Medical, Inc.	DWF	Class II	2014-03-05
K133292	Allura Xper Fd; or Table	Philips Medical Systems Nederland B.V.	OWB	Class II	2014-03-05
K133254	Revlite Q-Switched Nd:yag Laser System	Cynosure, LLC	GEX	Class II	2014-03-05
K132926	Velofixtm Interbody Fusion System	CG MedTech Co., Ltd.	ODP	Class II	2014-03-05
K132714	Isens (Polymacon) Spherical and Toric Daily Wear Soft Contact Lenses (Clear, Tinted, and Cosmetic Tinted)	Vision Science Co., Ltd.	LPL	Class II	2014-03-05