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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 640 of 3529

510(k) clearances, page 640 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K160863	PBS(-), Phosphate Buffered Saline	Kitazato Biopharma Co., Ltd.	MQL	Class II	2016-07-28
K160747	Angel Catheter	Bio2 Medical, Inc.	PNS	Class II	2016-07-28
K160465	Spinal Elements' Spinous Process Plate System	Spinal Elements, Inc	PEK	Class II	2016-07-28
K160339	Cardinal Health Isolation Gown	Cardinal Health200, LLC	FYC	Class II	2016-07-28
K160192	Atteris Antimicrobial Skin & Wound Cleanser	Rochal Industries, LLC	FRO	Unclassified	2016-07-28
K153117	AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM	Aesku Systems GmbH&Co.Kg	DHN	Class II	2016-07-28
K152099	Genesys Spine Apache® Anchored Cervical Interbody Fusion System	Genesys Spine	OVE	Class II	2016-07-28
K161817	Tina-quant Cystatin C Gen.2	Roche Diagnostics Operations (Rdo)	NDY	Class II	2016-07-27
K160893	HANAROCare ReJu	M.I.Tech Co Ltd	NUH	Class II	2016-07-27
K160755	Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap	Ahlstrom Nonwovens LLC	FRG	Class II	2016-07-27
K160596	Beautifil II Ls	Shofu Dental Corp.	EBF	Class II	2016-07-27
K160385	Precision Screw	Cryptych Pty, Ltd.	OLO	Class II	2016-07-27
K160367	Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank	Nissin-Metec China Co., Ltd.	EIH	Class II	2016-07-27
K160101	SinuBand	Bioinspire Technologies, Incorporated	QJL	Class I	2016-07-27
K153484	Dillard Airway Dilatation System	Intuit Medical Products, LLC	KTI	Class II	2016-07-27
K153067	Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress	Sybron Dental Specialties, Inc.	KIF	Class II	2016-07-27
K152385	Zeramex P6 Dental Implant System	Dentalpoint AG	DZE	Class II	2016-07-27
K151424	The Progressive Orthopaedic Total Hip System	The Progressive Orthopaedic Company, LLC	LPH	Class II	2016-07-27
DEN150029	Permaseal	Micro Interventional Devices,Inc.	PNQ	Class II	2016-07-27
K161722	Vitruvian Ultimate Aspirator	Black & Black Surgical, Inc.	QPB	Class II	2016-07-26
K161557	truFreeze System	CSA Medical	GEH	Class II	2016-07-26
K161198	Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3	USA Laser Biotech, Inc.	ILY	Class II	2016-07-26
K161048	Conventus Orthopaedics Ulna Fixation System	Conventus Orthopaedics, Inc.	HRS	Class II	2016-07-26
K160887	Cook Intraosseous Infusion Needles	Cook Incorporated	FMI	Class II	2016-07-26
K160813	EasyStep	Stryker Corp.	JDR	Class II	2016-07-26
K160757	ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)	Axis-Shield Diagnostics, Ltd.	CDD	Class II	2016-07-26
K160684	Atteris No-Sting Skin Protectant	Rochal Industries, LLC	KMF	Class I	2016-07-26
K160629	InPen	Companion Medical, Inc.	FMF	Class II	2016-07-26
K153363	Red2Green Reusable Sharps Container	Triumvirate Environmental, LLC	MMK	Class II	2016-07-26
K153124	DuraLazeTM HoLEP Laser Fiber	Medkey, LLC	GEX	Class II	2016-07-26
K153070	Watch-PAT200U	Itamar Medical	MNR	Class II	2016-07-26
K153010	Hudson RCI AquaPak Sterile Prefilled Nebulizers	Teleflexmedical, Inc.	CAF	Class II	2016-07-26
K161461	BostonSight PD Prosthetic Device	Bostonsight	HQD	Class II	2016-07-25
K160577	PacEndo Chlorhexidine	Pac-Dent International, Inc.	KJJ	Unclassified	2016-07-25
K160411	Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating	Medtronic, Inc.	LYZ	Class I	2016-07-25
K160399	Skyn Original Polyisoprene Lubricated Male Condom	Ansell Healthcare Products LLC	MOL	Class II	2016-07-25
K160158	NobelProcera HT ML FCZ Implant Bridge and Framework	Nobel Biocare AB	NHA	Class II	2016-07-25
K160056	t:slim Insulin Delivery System	Tandem Diabetes Care, Inc.	LZG	Class II	2016-07-25
K153544	cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System	Iquum, Inc.	OCC	Class II	2016-07-25
K161154	Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs	SPR Therapeutics, Inc	NHI	Class II	2016-07-23
K161951	KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay	Kronus, Inc.	PNI	Class II	2016-07-22
K161218	Gianturco-Roehm Bird’s Nest Vena Cava Filter	Cook Incorporated	DTK	Class II	2016-07-22
K161139	LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set	Diasorin Inc.	LYR	Class I	2016-07-22
K161028	K2M Growing Spine System	K2M, Inc	PGM	Class II	2016-07-22
K161009	Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4	Toshibamedical Systems Corporation	JAK	Class II	2016-07-22
K160987	ReWalk(TM)	Rewalk Robotics, Inc.	PHL	Class II	2016-07-22
K160908	Vis-U-All Low Temperature Sterilization Pouch/Tubing	STERIS Corporation	FRG	Class II	2016-07-22
K160372	Uritek Tc-201 Urine Chemistry Test System	Teco Diagnostics	JIL	Class II	2016-07-22
K153473	Braemar Telemetry Patch System	Braemar Manufacturing, LLC	DSI	Class II	2016-07-22
K153267	ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash	CooperSurgical, Inc.	MQL	Class II	2016-07-22