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 2026-10-26, 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 734 of 3530

510(k) clearances, page 734 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K133187	FREERIDER FR1, models FR1-13, FR1-15, FR1-17	Freerider, Corp.	INI	Class II	2015-01-08
K143486	Ufi Gel hard C	Voco GmbH	EBI	Class II	2015-01-07
K143107	DLP Vein Graft Cannula	Medtronic, Inc.	DWF	Class II	2015-01-07
K142840	Unity Network ID	GE Healthcare	MWI	Class II	2015-01-07
K142667	Stern AC 3.3x10mm, Stern AC 3.3x11.5mm, Stern AC 3.3x13mm, Stern AC 4.0x8.5mm, Stern AC 4.0x10mm	Sterngold Dental LLC	DZE	Class II	2015-01-07
K142447	PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch	Synovis Life Technologies, Inc.	DXZ	Class II	2015-01-07
K142256	Applied BioPhotonics Phototherapy System ABPT1003	Applied BioPhotonics Ltd.	ILY	Class II	2015-01-07
K141861	Hilthera 4.0	Jeisys Medical Inc.	ILY	Class II	2015-01-07
K141689	FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive Protein Calibrator Kit, FastPack High Sensitivity C-Reactive Protein Controls, FastPack High Sensitivity C-Reactive Protein Method Verification Kit	Qualigen Inc	DCK	Class II	2015-01-07
K141615	Endophys Blood Pressure Monitor	Endophys, Inc.	DSK	Class II	2015-01-07
K141515	AED Hysteroscope and Accessories	National Advanced Endoscopy Devices, Inc.	HIH	Class II	2015-01-07
K141275	Endophys Pressure Sensing Sheath Kit	Endophys, Inc.	DYB	Class II	2015-01-07
K140359	Maximis Spinal Fixation System	Valorem Surgical	MNH	Class II	2015-01-07
K142850	McKesson Radiology Mammography Plus	Change Healthcare Canada Company	LLZ	Class II	2015-01-06
K142316	IMPAX Agility	AGFA Healthcare Corp.	LLZ	Class II	2015-01-06
K141923	Inclusive Titanium Abutments, Compatible with Dentsply Implants Ankylos C/x	Prismatik Dentalcraft, Inc.	NHA	Class II	2015-01-06
K141852	Ifs Advanced Femtosecond Laser System	Advanced Medical Optics, Inc.	GEX	Class II	2015-01-06
K140722	Integra Flow Regulating Valve Systems Osv II Models and Integra Flow Regulating Valve Low Flow Models	Integra LifeSciences Corporation	JXG	Class II	2015-01-06
K140587	Mr-CT Vva	Medis Medical Imaging Systems, B.V.	LLZ	Class II	2015-01-06
K143149	Arsenal Spinal Fixation System	Alphatec Spine, Inc.	NKB	Class II	2015-01-05
K142710	S9 Portable Digital Color Doppler Ultrasound System	Sonoscape Company Limited	IYN	Class II	2015-01-05
K142233	zenostar MO, Zenostar T, Zenostar VisualiZr	Wieland Dental + Technik GmbH & Co. KG	EIH	Class II	2015-01-05
K140264	Madm	Thornhill Research Inc	BSZ	Class II	2015-01-05
K140893	Cora (Coagulation Resonance Analysis) System with Platelet Mapping Assay	Coramed Technologies, LLC	JOZ	Class II	2015-01-03
K143472	TE7 Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	IYN	Class II	2015-01-02
K143154	IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe(RFID)	Iridex Corporation	GEX	Class II	2015-01-02
K142229	Laparoscopic FMsealer	Omni-Guide Holdings, Inc.	GEI	Class II	2015-01-02
K141851	Navilas Laser System	Od-Os GmbH	GEX	Class II	2015-01-02
K141186	Firebird Spinal Fixation System	Orthofix SRL	NKB	Class II	2015-01-02
K133088	Zx-27	M&M Dental Studio, Inc.	EJX	Class I	2015-01-02
K143175	AEx Generator; PlasmaBlade T	Medtronic Navigation, Inc	GEI	Class II	2014-12-31
K142699	LITe Plate System	Stryker Corp.	KWQ	Class II	2014-12-31
K142611	TYRX Neuro Absorbable Antibacterial Envelope	Medtronic Tyrx, Inc.	FTL	Class II	2014-12-31
K142289	PK Spatula	Gyrus ACMI, Inc.	GEI	Class II	2014-12-31
K142124	Aeu-6000 Implant / Endodontic Dental System	Aseptico, Inc.	EKX	Class I	2014-12-31
K133333	Uni Npwt Foam Dressing Kit, Uni Npwt Foam Dressing Kit, Uni Npwt Foam Dressing Kit	Blue Ocean Medical Product, LLC	OMP	Class II	2014-12-31
K143188	3.Omm Biomet Cannulated Screw System	Biomet Manufacturing Corp	HWC	Class II	2014-12-30
K142173	Non-Sterile Ors-400N Scope Pillow Warmer Drape	Microtek Medical LLC	LHC	Class I	2014-12-30
K141868	Tria Fanp	Tria Beauty, Inc.	ONG	Class II	2014-12-30
K141695	Acrosspine Pedicle Screw System	Arthro-Dif	NKB	Class II	2014-12-30
K141586	Owl Cannulae	Diros Technology, Inc.	GXI	Class II	2014-12-30
K143378	AQUARIUS Gastrostomy Replacement Tube	Degania Silicone, Inc.	KNT	Class II	2014-12-29
K142746	G7 Finned Acetabular Shell	Biomet Manufactuting Corp.	LPH	Class II	2014-12-29
K141936	Microblab, Microloop	Carefusion Germany 234 GmbH	BZG	Class II	2014-12-29
K140649	Vectrix External Fixator	3D Medical Concepts, LLC	NDK	Class II	2014-12-29
K143352	IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3 Calibration Verification Material	Siemens Healthcare Diagnostics Inc.	JJX	Class I	2014-12-24
K142429	CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2 Microcoil Delivery System, EnPower Control Cable, Connector Cable	Cerenovus, Inc.	HCG	Class II	2014-12-24
K142407	Straight Stud Attachment	Sterngold Dental LLC	NHA	Class II	2014-12-24
K141878	Hongyun Powder-Free Yellow Vinyl Patient Examination Gloves	Tangshan Hongyun Plastic Products Co., Ltd.	LYZ	Class I	2014-12-24
K141046	Midi-Srs	Srmc Co., Ltd.	ONG	Class II	2014-12-24