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 2026-10-29, 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 799 of 3530

510(k) clearances, page 799 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K131050	Nxstage 1.6M2 Dialyzer	NxStage Medical Inc	KDI	Class II	2013-12-27
K130895	Reunion Rsa Shoulder System	Howmedica Osteonics Corp	PHX	Class II	2013-12-27
K133422	1.5T 16-Channel Flex Coil, Small 1.5T 16-Channel Flex Coil, Large	NeoCoil, LLC	MOS	Class II	2013-12-26
K133283	Candela Gentlemax Family of Laser Systems	Candela Corporation	GEX	Class II	2013-12-26
K133113	Kingtech Forehead Thermometer	Kingtech Enterprise, Ltd.	FLL	Class II	2013-12-26
K133111	Kingtech Digital Thermometer	Kingtech Enterprise, Ltd.	FLL	Class II	2013-12-26
K132095	Olea Sphere	Olea Medical	LLZ	Class II	2013-12-26
K130570	Neurovision Medical Motion Sensor	Neurovision Medical Products Inc	BZQ	Class II	2013-12-26
K133431	Venue 50	GE Healthcare	IYN	Class II	2013-12-24
K132787	Loqteq Distal Dorsolateral Humerus Plate	AAP Implantate AG	HRS	Class II	2013-12-24
K132601	Coroent Sterile Implants System	Nu Vasive, Incorporated	MAX	Class II	2013-12-24
K132511	Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring System	Abbott Medical	NBW	Class II	2013-12-24
K131724	Pioneer Maxfuse Vertebral Body Replacement Device	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	MQP	Class II	2013-12-24
K131521	Velox Anterior Cervical Plate System	Spinecraft LLC	KWQ	Class II	2013-12-24
K131447	Intuition - Tda, Tva, Parametric Mapping	Terarecon, Inc.	LLZ	Class II	2013-12-24
K131169	Mozec - Rx Ptca Balloon Dilatation Catheter	Meril Life Sciences Private Limited	LOX	Class II	2013-12-24
K131164	Acuson	Siemens Medical Solutions USA, Inc.	IYN	Class II	2013-12-24
K130977	Signify Bioactive	Globus Medical, Inc.	MQV	Class II	2013-12-24
K130975	Swabcap and Swabflush	Excelsior Medical LLC	QBP	Class II	2013-12-24
K130572	Interactive/ Swishplus2 Implant System	Implant Direct Sybron Manufacturing LLC	DZE	Class II	2013-12-24
K130519	Philips Uva (/09) and Philips Uva-1 (/10) Ultraviolet Lamps	Philips Lighting Co.	FTC	Class II	2013-12-24
K130325	Arm Automatic Blood Pressure Monitor	Shenzhen Pump Medical System Co., Ltd.	DXN	Class II	2013-12-24
K123763	Ids Isys Direct Renin Assay, Ids Isys Direct Renin Control Set, and Ids Isys Direct Renin Calibration Verifiers	Immunodiagnostic Systems Ltd.	CIB	Class II	2013-12-24
K133634	Spectrum Turbo-Ject Peripherally Inserted Central Venous Catheter Set	Cook Inc.	LJS	Class II	2013-12-23
K133627	Avaira Spheric and Toric (Enfilcon a) Soft Contact Lens	CooperVision, Inc.	LPL	Class II	2013-12-23
K133133	Laurimed Polypvac Microdebrider	Laurimed, LLC	ERL	Class II	2013-12-23
K133127	Lipiflow Thermal Pulsation System	TearScience, Inc.	ORZ	Class II	2013-12-23
K132854	Eye Secret 38 UV Aspheric (Polymacon) Soft (Hydrophilic) Contact Lens for Daily Wear	Yung Sheng Optical Co., Ltd.	LPL	Class II	2013-12-23
K132500	Cure Catheter Female, Cure Catheter Male, Cure Catheter Coude, Cure Catheter Pediatric, Cure Catheter Hydrophilic Coated	Cure Medical, LLC	EZD	Class II	2013-12-23
K132386	Totalshield Surgical Helmet System	Zimmer GmbH	FYA	Class II	2013-12-23
K132310	Ascot	Backroads Consulting, Inc.	KWQ	Class II	2013-12-23
K131901	Ivolve Nasal Mask, Ivolve Full Face Mask, Ivolve N2	3B Medical Inc	BZD	Class II	2013-12-23
K131821	Elia(tm) Cardiolipin Iga Immunoassay	Phadia AB	MID	Class II	2013-12-23
K131787	Cryomatic Mkii Console, Cryomatic Mkii Probes, Disposable Cryo Probes	Keeler Ltd.	HRN	Class II	2013-12-23
K122932	Spiro Speaking Valve with Oxygen Port Spiro Speaking Valve without Oxygen Port	Fogless International AB	JOH	Class II	2013-12-23
K133650	Capstone Spinal System	Medtronic Sofamor Danek USA Inc	MAX	Class II	2013-12-20
K133641	Core Control Pad, Core Series Sw V3.4 Installation Kit, Core, Core Mobile	Volcano Corporation	IYO	Class II	2013-12-20
K133630	Gmk Short Stem	Medacta International SA	JWH	Class II	2013-12-20
K133626	Azur Pure Peripheral Coil System, Pushable 35	Terumo Cardiovascular Systems Corporation	KRD	Class II	2013-12-20
K133605	Bd Max Mrsa Xt, Bd Max Instrument	Geneohm Sciences Canada, Inc.	NQX	Class II	2013-12-20
K133587	Pressurewire Aeris Agile Tip; Pressurewire Aeris Agile Tip 300	St. Jude Medical Systems AB	DRG	Class II	2013-12-20
K133569	True Dilatation Balloon Valvuloplasty Catheter, 20Mm X 4.5 Cm, 22Mm X 4.5Cm, 24 Mm X 4.5Cm, 26Mm X 4.5Cm	Bard Peripheral Vascular Inc	OZT	Class II	2013-12-20
K133566	Rotablator Rotational Atherectomy System with the Peripheral Rotalink Plus	Boston Scientific Corporation	MCW	Class II	2013-12-20
K133563	Pathassist Light Seeker	Entellus Medical, Inc.	LRC	Class I	2013-12-20
K133513	Multi-Stage Snare	United States Endoscopy Group, Inc.	FDI	Class II	2013-12-20
K133503	Amplivue Gbs Assay	Ortho-Clinical Diagnostics, Inc.	NJR	Class I	2013-12-20
K133423	Rest Assured Extra Comfort Nite Protector	Ranir LLC	OBR	Unclassified	2013-12-20
K133367	Orthovis Preoperative Plan	Custom Orthopaedic Solutions, Inc.	LLZ	Class II	2013-12-20
K133338	Ligasure 5 Mm Maryland Jaw Sealer/divider One-Step Sealing (Lf 17Xx)	Covidien, Formerly Valleylab, A Division of Tyco H	GEI	Class II	2013-12-20
K133281	Neotract Urolift System	Neotract Inc	PEW	Class II	2013-12-20