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 608 of 3529

510(k) clearances, page 608 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K170086	Pinnacle Radiation Therapy Planning System	Philips North America LLC	MUJ	Class II	2017-02-09
K163566	Hubble I System	Orbbo Surgical, LLC	NKB	Class II	2017-02-09
K163508	Pivo	Becton Dickinson Infusion Therapy Systems Inc.	JKA	Class II	2017-02-09
K163478	AcuNav Volume ICE Catheter	Siemens Medical Solutions USA, Inc.	OBJ	Class II	2017-02-09
K163341	syngo.CT Extended Functionality	Siemens Medical Solutions USA, Inc.	JAK	Class II	2017-02-09
K163289	syngo. CT Single Source Dual Energy (twin beam)	Siemens Medical Solutions USA, Inc., Ultrasound di	JAK	Class II	2017-02-09
K163184	cobas® CT/NG v2.0 Test	Roche Molecular Systems Inc	LSL	Class II	2017-02-09
K163046	DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long	DePuy Synthes	HRS	Class II	2017-02-09
K162918	Atlas Spine Expandable Interbody System	Atlas Spine, Inc.	MAX	Class II	2017-02-09
K162710	Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload	Tgs Medical Co., Ltd.	GDW	Class II	2017-02-09
K162611	PeriFLEX	Spiration, Inc.	EOQ	Class II	2017-02-09
K162331	Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System	Cepheid	OCC	Class II	2017-02-09
K162158	Porcine Anorganic Bone Mineral in Delivery Applicator	Collagen Matrix, Inc	NPM	Class II	2017-02-09
K161861	APTUS® Coronoid 2.0	Medartis AG	HRS	Class II	2017-02-09
K161810	BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial	Becton Dickinson & Co	MDB	Class I	2017-02-09
K161491	Scopis Hybrid Navigation System EM	Scopis GmbH	PGW	Class II	2017-02-09
K161413	Low Profile Balloon Feeding Device	Applied Medical Technology Inc	KNT	Class II	2017-02-09
K161334	RASL Repair Kit	Radicle Orthopaedics, Inc.	HWC	Class II	2017-02-09
K163703	Vivix-S 1417N	Vieworks Co., Ltd.	MQB	Class II	2017-02-08
K163173	Handheld Diode Laser for Hair Removal	Liaoning Sidey Optoelectronics Technologies Co., Ltd.	OHT	Class II	2017-02-08
K162915	Fully Automatic Electronic Blood Pressure Monitor	Andon Health Co., Ltd	DXN	Class II	2017-02-08
K162852	Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove	Lucenxia Prescience AG	KGO	Class I	2017-02-08
K162840	Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5	Roche Diagnostics GmbH	MRG	Class II	2017-02-08
K162491	Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)	Hartalega Sdn Bhd	LZA	Class I	2017-02-08
K162479	Smart Pain Reliever, Model LT5019	Shenzhen Dongdixin Technology Co., Ltd.	NUH	Class II	2017-02-08
K162039	OptosAdvance 4.0 Software	Optos PLC.	NFJ	Class II	2017-02-08
K161577	Arm-Type Fully Automatic Digital Blood Pressure Monitor	Sejoy Electronics & Instruments Co., Ltd.	DXN	Class II	2017-02-08
K161468	Transformair Indoor Air Purifier	Transformair, LLC	FRA	Class II	2017-02-08
K161432	MyNeWT Negative Pressure Wound Therapy System	Stortford Medical, LLC	OMP	Class II	2017-02-08
K160444	FB-U Hemodialyzer	Nipro Medical Corporation	KDI	Class II	2017-02-08
K170072	Fitmore® Hip Stem	Zimmer GmbH	KWY	Class II	2017-02-07
K163214	Unicare System, Unicare Manipulator	Clearpath Surgical, Inc.	LKF	Class II	2017-02-07
K163169	Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent	Cook Ireland Ltd.	FGE	Class II	2017-02-07
K162639	Proficient™ Posterior Cervical Spine System	Spine Wave Inc	NKG	Class II	2017-02-07
K161980	Fuselier Intraoral Nighttime Device (FIND)	Fuselier Enterprises, LLC	LRK	Class II	2017-02-07
K161715	EndyGel	Endymed Medical Inc.	GYB	Class II	2017-02-07
K153262	PUREtrace™	Nemo Healthcare BV	OSP	Class II	2017-02-07
K170330	3M Protemp Cement Temporary Dental Cement	3M Company	EMA	Class II	2017-02-06
K163294	syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology	Siemens Medical Solutions USA, Inc.	LLZ	Class II	2017-02-06
K163061	Altus Spine Cervical Plate System	Altus Partners	KWQ	Class II	2017-02-06
K162973	EndoWrist Suction Irrigator	Intuitive Surgical, Inc.	NAY	Class II	2017-02-06
K162923	Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Aqua Blue; Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Violet Blue; Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Dark Blue; Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Dark Violet Blue	Hartalega NGC Sdn Bhd	LZA	Class I	2017-02-06
K162283	DCM Kyphoplasty System	Dragon Crown Medical Co., Ltd.	NDN	Class II	2017-02-06
K162014	Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2 Sensor, Home Care (same sensor as above, Home Use Guide incl.), Nellcor Flexible SpO2 Sensor, Small, Home Care (same sensor as above, Home Use Guide incl.)	Bluepoint Medical GmbH & Co. KG	DQA	Class II	2017-02-06
K160934	UC-CARE NaviGo Workstation	UC-Care	LLZ	Class II	2017-02-06
DEN160016	Variola virus Real-Time PCR Assay	Centers for Disease Control and Prevention (CDC)	PRA	Class II	2017-02-06
K163551	LenSx Laser System	Alcon Laboratories	OOE	Class II	2017-02-03
K163452	PICC Maximal Barrier Nursing Kit	Boston Scientific Corporation	LJS	Class II	2017-02-03
K163155	MTM Clear Aligner	Dentsply Sirona Inc	NXC	Class II	2017-02-03
K162683	RehaStim 2	Hasomed GmbH	GZI	Class II	2017-02-03