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 2026-11-02, 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 949 of 3531

510(k) clearances, page 949 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K102330	Amsco V-Pro Max Low Temperature Sterilization System	STERIS Corporation	MLR	Class II	2011-08-12
K102120	Nippv Silicone Face Mask, Nippv Economy Face Mask, Nippv Silicone Nasal Mask Model 10212, 10222, 10202	Hsiner Co., Ltd.	CBK	Class II	2011-08-12
K111991	Nio Color 2Mp	Barco N.V.	LLZ	Class II	2011-08-11
K111852	Anodized Healing Collar	ZimVie US Corp LLC	NHA	Class II	2011-08-11
K111715	Embryoscope	Unisense Fertilitech A/S	MQG	Class II	2011-08-11
K111632	Infill Graft Delivery System	Pinnacle Spine Group, LLC	FMF	Class II	2011-08-11
K111338	Wildcat Catheter	Avinger, Inc.	PDU	Class II	2011-08-11
K111282	Disposable Temperature Probes / Sensors and Interconnect Instrument Cables	Starboard Medical, Inc.	FLL	Class II	2011-08-11
K111127	Romeo Posterior Osteosynthesis System	Spineart SA	MNI	Class II	2011-08-11
K111108	Pascal Streamline 577 (with Accessories)	Iridex Corporation	HQF	Class II	2011-08-11
K110719	Origin Zirconia	B&D Dental Technologies	EIH	Class II	2011-08-11
K110663	Pairetex Optimized Composite Mesh (Pco-Fx Refrences)	Sofradim Production	FTL	Class II	2011-08-11
K110348	Universal Clamp Spinal Fixation System	Zimmer Spine, Inc.	OWI	Class II	2011-08-11
K103028	Eevatm Petri Dish	Auxogyn, Inc.	MQK	Class II	2011-08-11
K102516	Lucina Model Melodi	Genadyne Biotechnologies, Inc.	HGX	Class II	2011-08-11
K112180	I5 Digital X-Ray Imaging System (with Sdx-4336Cp)	Infimed, Inc.	OWB	Class II	2011-08-10
K111963	Bridgepoint Medical Mantaray(tm) Catheter	Boston Scientific Corporation	DQY	Class II	2011-08-10
K111437	Synthes Ria System (Expanded Indications)	Synthes (USA) Products LLC	HTO	Class I	2011-08-10
K111201	C7 Xr Imaging System	Lightlab Imaging, Inc.	NQQ	Class II	2011-08-10
K111158	Latex Examination Gloves Powder-Free (Black Color) with Protein Labeling Claim (50 Micrograms or Less)	Innovative Gloves Co;, Ltd.	LYY	Class I	2011-08-10
K110856	Ralco	Ralco S.r.l.	IZX	Class II	2011-08-10
K110137	Abx Pentra Enzymatic Creatinine Cp, Abx Pentra Multical, Abx Pentra N Control, Abx Pentra P Control, and Abx Pentra Urin	Horiba Abx SAS	JFY	Class II	2011-08-10
K103619	Synthetic Exam Glove Powder Free Coated with Allogel (Green/ Blue / White / Magenta / Clear - Non Colored)	Shandong Blue Sail Innovation Co Ltd	LYZ	Class I	2011-08-10
K102078	Radiological Image Processing System	Vatech Co., Ltd.	LLZ	Class II	2011-08-10
K101533	Ex-Tem. Fib-Tem, and Ap-Tem for Rotem Delta Thromboelastometry System	TEM Innovations GmbH	JPA	Class II	2011-08-10
K111760	Naviaid(tm) Bgc Device	Smart Medical Systems Ltd.	ODC	Class II	2011-08-09
K111265	Metasurg Subtalar Implant	Metasurg	HWC	Class II	2011-08-09
K111044	Speedlock Knotless Fixation Device; 3.0Mm Drill; Sharp Tipped Obturator; Low Profile Drill Guidde	ArthroCare Corporation	MBI	Class II	2011-08-09
K110543	Crescent (R) Spinal System Titanium	Medtronic Sofamor Danek USA Inc	MAX	Class II	2011-08-09
K110388	Collacare Dental	Innocoll Pharmaceuticals	KGN	Unclassified	2011-08-09
K110293	Optichamber Diamond Valved Holding Chamber	Respironics New Jersey, Inc.	NVP	Class II	2011-08-09
K103657	Sapphire	Orbusneich Medical, Inc.	LOX	Class II	2011-08-09
K102188	Cybow Reader, Models 300 & 720	DFI Co., Ltd.	KQO	Class I	2011-08-09
K101307	Blood Glucose Monitoring System, Models Ag-6081 and Ag-6951	Andon Medical co., Ltd	NBW	Class II	2011-08-09
K100015	Vysis Cll Fish Probe Kit (Vysis Lsi Tp53 Spectrumorange/atm Spectrumgreen) and Lsi D135319 Spectrumorange/13q34	Abbott Molecular, Inc.	OVQ	Class II	2011-08-09
K112059	T2 Femoral Nail Model 1825-Xxxxcp, 1828-Xxxxcp	Stryker Corp.	HSB	Class II	2011-08-08
K111779	Y-Knot All-Suture Anchor Model Hf13	Conmed Linvatec	MBI	Class II	2011-08-08
K111590	Rog Suture Anchor, Rog Knotless Suture Anchor	Rog Sports Medicine, Inc.	MBI	Class II	2011-08-08
K111540	Synthes 3.5Mm Lcp Clavicle Plate System	Synthes (USA) Products LLC	HRS	Class II	2011-08-08
K111333	Antlia III Wound Treatment System	Innovative Therapies, Inc.	OMP	Class II	2011-08-08
K111199	Intra-Lock Dental Implants with Blossom 3.4Mm Implant Angled Abutments	Intra-Lock International	NHA	Class II	2011-08-08
K111047	Cellvizio 100 Series System with Confocal Miniprobes	Mauna Kea Technologies	OWN	Class II	2011-08-08
K112135	ECG-6 Series Electrocardiograph	Advanced Instrumentations, Inc.	DPS	Class II	2011-08-05
K112054	Infinix Cf-I/sp and Infinix Vf-I/sp Model Infx-8000V	Toshiba Medical Systems Corporation, Japan	JAA	Class II	2011-08-05
K111945	Impax Next Generation	AGFA Healthcare Corp.	LLZ	Class II	2011-08-05
K111931	Gliasite Rts	Isoray Medical, Inc.	KXK	Class II	2011-08-05
K111762	St Aia-Pack Dhea-S Calibrator Set	Tosoh Bioscience Inc	JIT	Class II	2011-08-05
K111319	Ibis Explorer and Markup Software	Medqia, LLC	LLZ	Class II	2011-08-05
K110959	Orthopediatrics Blade Plate System	Orthopediatrics Corp	HRS	Class II	2011-08-05
K110813	Headway 27 Microcatheter	Terumo Cardiovascular Systems Corporation	DQY	Class II	2011-08-05