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 604 of 3529

510(k) clearances, page 604 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K162947	Disposable End-to-end Anastomosis Circular Stapler; Universal Endoscopic Linear Cutting Stapler and Single Use Loading Unit; Linear Cutting Stapler and Single Use Loading Unit; Disposal Hemorrhoidal Circular Stapler	Chongqing Qmi Surgical Co., Ltd.	GDW	Class II	2017-03-03
K162746	Ontex and other proprietary names	Ontex Bvba	HEB	Class II	2017-03-03
K162646	Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)	Hartalega NGC Sdn Bhd	LZA	Class I	2017-03-03
K162580	Guardian Angel GA1000 Digital Vital Sign Monitoring System	Taiwan Aulisa Medical Devices Technologies, Inc.	DQA	Class II	2017-03-03
K162575	Z-LINKPC System	Zavation	NKG	Class II	2017-03-03
K162529	DigiX FDX	Allengers Medical Systems Limited	KPR	Class II	2017-03-03
K162524	AZUR CX Detachable 18 Peripheral Coil System	Terumo Cardiovascular Systems Corporation	KRD	Class II	2017-03-03
K162044	Dentca Denture Base II	Dentca, Inc.	EBI	Class II	2017-03-03
K161991	Curasite	Izun Pharmaceuticals	FRO	Unclassified	2017-03-03
K161918	SREE MRI Transport Incubator	Advanced Imaging Research dba Sree Medical Systems	FPL	Class II	2017-03-03
K160345	Glass Ionomer Cement	Shandong Huge Dental Material Corporation	EMA	Class II	2017-03-03
K170420	n!ce Glass Ceramic Blocks for Amann Girrbach	Straumann USA, LLC	EIH	Class II	2017-03-02
K170355	RayStation 6	RaySearch Laboratories AB (publ)	MUJ	Class II	2017-03-02
K170348	Signia Four-Bay Smart Charger (to be used with Signia Stapler)	Medtronic, Inc.	GDW	Class II	2017-03-02
K163497	EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Lateral Offset Proximal Body Implant, EXPRT™ Hip Capture Bolt	Encore Medical, LP	KWZ	Class II	2017-03-02
K163379	KneeAlign 2 System	OrthAlign, Inc.	OLO	Class II	2017-03-02
K162811	MR Conditional CGA 870	Essex Industries, Inc	CAN	Class I	2017-03-02
K162410	TIPCAM 1S 3D System	Karl Storz Endoscopy-America, Inc.	EOB	Class II	2017-03-02
K162364	Intellijoint HIP Generation 2A System	Intellijoint Surgical Inc.	OLO	Class II	2017-03-02
K162356	Vesair Cystoscopic Sheath	Solace Therapeutics	KNY	Class II	2017-03-02
K162199	Cascade IOMAX Intraoperative Monitor	Cadwell Industries Inc	GWF	Class II	2017-03-02
K161892	Slimming Treatment Device	Beijing Honkon Technologies Co., Ltd.	NUV	Class II	2017-03-02
K161737	RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX Undyed	Myco Medical	NEW	Class II	2017-03-02
K161633	Rexlon, Rexsil	Sm Eng Co., Ltd.	GAR	Class II	2017-03-02
K161554	Endoflator 40, Endoflator 50	Karl Storz Endoscopy-America, Inc.	HIF	Class II	2017-03-02
K161430	Myoject Luer Lock Needle Electrode	Natus Manufacturing Limited	IKT	Class II	2017-03-02
K161304	EndoPur Filter	Nephros Inc	FIP	Class II	2017-03-02
K153688	Edi Catheter ENFit	Maquet Critical Care AB	PIF	Class II	2017-03-02
K153538	Dextramer CMV Kit	Immudex, ApS	GKZ	Class II	2017-03-02
K170332	Digital Radiography Cxdi-710C Wireless, Digital Radiography Cxdi-810C Wireless	Canon, Inc.	MQB	Class II	2017-03-01
K163284	syngo. CT Neuro Perfusion	Siemens Medical Solutions USA, Inc.	JAK	Class II	2017-03-01
K162383	Cadwell Sierra Summit, Cadwell Sierra Ascent	Cadwell Industries Inc	IKN	Class II	2017-03-01
K162026	EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION Revision Modular Keels, EVOLUTION Revision Stem Adapters (offset and extension), EVOLUTION Revision Cemented Stem Extensions, Canal Filling Stem Extensions	Microport Orthopedics Inc.	JWH	Class II	2017-03-01
K170283	BD Nexiva Diffusics Closed IV Catheter System	Becton Dickinson & Co	FOZ	Class II	2017-02-28
K170105	Jac-Cell Medic testers	Jac-Cell Medic	GEI	Class II	2017-02-28
K170008	Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set	Cook Incorporated	KNW	Class II	2017-02-28
K163709	FIRMap Catheter	Abbott Electrophysiology	MTD	Class II	2017-02-28
K163543	Biomet Fusion System	Highridge Medical, LLC	OVD	Class II	2017-02-28
K163282	Apex Dental Sensors	Masterlink, LLC.	MUH	Class II	2017-02-28
K163245	Virtual Occupational Therapy Application (VOTA)	Barron Associates, Inc.	LXJ	Class II	2017-02-28
K163234	Biograph mMR with syngo MR E11P system software	Siemens Medical Solutions USA, Inc.	OUO	Class II	2017-02-28
K163038	EPIC Extremity Snap-Off Screw	Epic Extremity, LLC	HWC	Class II	2017-02-28
K163008	CareLink SmartSync Device Manager - Pacing System Analyzer	Medtronic, Inc.	DTA	Class II	2017-02-28
K162837	Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart532™ Laser System	Lumenis Ltd	GEX	Class II	2017-02-28
K162753	RTC 26-C Inline Aerosol Adapter	Instrumentation Industries, Incorporated	CAF	Class II	2017-02-28
K162018	Surface Applicator Set	Varian Medical Systems, Inc.	JAQ	Class II	2017-02-28
K161655	On1 Concept	Nobel Biocare AB	NHA	Class II	2017-02-28
K170373	Flextra Steerable Introducer	Rhythm Xience, Inc. (Rxi)	DYB	Class II	2017-02-27
K163591	BD PosiFlush Heparin Lock Flush Syringe	Becton Dickinson & Co	NZW	Class II	2017-02-27
K163191	ComfortGuard Surgical Gown, i600, Film Reinforced	Gri Medical & Electrical Technology Co., Ltd.	FYA	Class II	2017-02-27