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 834 of 3530

510(k) clearances, page 834 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K122020	Photon Photon Plus	Zolar Technology & Mfg Co Inc	GEX	Class II	2013-06-05
K120954	Nobelprocera Peek Abutments	Nobel Biocare AB	NHA	Class II	2013-06-05
K130640	Atlantis Anterior Cervical Plate System	Medtronic Sofamor Danek USA Inc	KWQ	Class II	2013-06-04
K130290	Modification to Intel-Ge Care Iinovations Guide	Intel-Ge Care Innovations, LLC	DRG	Class II	2013-06-04
K124012	Infill Oblique Tlif Device	Pinnacle Spine Group, LLC	MAX	Class II	2013-06-04
K122979	Vidas Lyme Igm	bioMerieux, Inc.	LSR	Class II	2013-06-04
K122791	Lyoplant Onlay	Aesculap Inc	GXQ	Class II	2013-06-04
K122365	Ultracheck Curve Blood Pressure Cuffs	Statcorp Medical	OED	Class II	2013-06-04
K130507	Footprint Medical Polyurethane Picc Catheter	Footprint Medical Inc.	LJS	Class II	2013-06-03
K124046	Valved Tearaway Introducer Generation II	Medical Components, Inc.	DYB	Class II	2013-06-03
K123885	Osteomed Smartflex Cranial Spring Distractor	Osteomed	PBJ	Class II	2013-06-03
K123653	Seal Block Pro (Not Finalized), Seal Block OTC (Not Finalized)	Bisco Inc	LBH	Class II	2013-06-03
K122965	Human Caeruloplasmin Kit	The Binding Site Group Ltd.	DDB	Class II	2013-06-03
K122473	Totalcare Spot Totalcare Bariatric Totalcare Duo Toatalcare Bed System Totalcare Duo2	Hill-Rom Inc.	IOQ	Class II	2013-06-03
K131324	Maxtorque Screw System	TORNIER Inc.	HWC	Class II	2013-05-31
K131232	Wondfo Methadone Urine Test (Mtd 200), Wondofo Morphine Urine Test (Mop 100)	Guangzhou Wondfo Biotech Co., Ltd.	DJR	Class II	2013-05-31
K131136	Glucose Meter-Check Solution for Taidoc	Bionostics, Inc.	JJX	Class I	2013-05-31
K131132	Pelvis II Implant System	Stryker Trauma GmbH	HRS	Class II	2013-05-31
K130954	Ars Screw; Slant Screw	Advanced Interventional Technology, LLC	HWC	Class II	2013-05-31
K130547	Endoform Reconstructive Template	Mesynthe, Ltd.	FTM	Class II	2013-05-31
K130498	Osteoselect Demineralized Bone Matrix Putty	Xtant Medical Holdings, Inc.	MBP	Class II	2013-05-31
K130474	Surgiseal Topical Skin Adhesive	Adhezion Biomedical, LLC	MPN	Class II	2013-05-31
K130432	Pht-6500, Pht-60Cfo	Vatech Co., Ltd.	OAS	Class II	2013-05-31
K130412	Osteomed Extremifuse System	Osteomed	HWC	Class II	2013-05-31
K130338	Impedimed - Bis Extra Cellular Fluid Analysis	Impedimed, Inc.	OBH	Class II	2013-05-31
K130332	Vitros Chemistry Products Trig Slides	Ortho-Clinical Diagnostics, Inc.	CDT	Class I	2013-05-31
K130319	Medline Cannulated Screw	MEDLINE INDUSTRIES, LP - Northfield	HWC	Class II	2013-05-31
K130293	Advance 18Lp Low Profile Pta Balloon Dilatation Catheter	Cook Inc.	LIT	Class II	2013-05-31
K130277	Single Energy (Se) Femur Exams	Hologic, Inc.	KGI	Class II	2013-05-31
K130267	Romeo Posterior Osteosynthesis System	Spineart SA	MNH	Class II	2013-05-31
K130129	Univers Revers Shoulder Prosthesis System	Arthrex GmbH	KWS	Class II	2013-05-31
K123823	Interlig	Angelus Industria de Productos Odontologicos	EBF	Class II	2013-05-31
K123380	Stride Unicondylar Knee	Blue Belt Technologies, Inc.	HSX	Class II	2013-05-31
K122700	Prosben Contact Lens Cases Model Ca66-02, Ca66-03Wb, Ca66-04T Series	Prosben, Inc.	LRX	Class II	2013-05-31
K120900	I-Stat Pt Control Leviel 1 I-Stat Pt Control Level 2	Cliniqa Corporation	GGN	Class II	2013-05-31
K131404	Flash Ar Penta / Flash Ar Penta Quick	3M Deutschland GmbH	ELW	Class II	2013-05-30
K131216	Rampart O	Spineology, Inc.	MAX	Class II	2013-05-30
K131199	Ultraverse Rx Pta Balloon Dilatation Catheter	Bard Peripheral Vascular Inc	LIT	Class II	2013-05-30
K131027	Memory Pump Model Y4947	TOMY International	HGX	Class II	2013-05-30
K130869	Take 1 Advance	Sybron Dental Specialties, Inc.	ELW	Class II	2013-05-30
K130699	Aleutian Spinal System	K2M, Inc	MAX	Class II	2013-05-30
K130532	Idrive Ultra Sterilization Tray	Covidien, Formerly US Surgical A Divison of Tyco H	KCT	Class II	2013-05-30
K130311	Transtek Body Fat Analyzer	Guangdong Transtek Medical Electronics Co.,Ltd	MNW	Class II	2013-05-30
K130287	Mr Conditional Cup Electrode, Mr Conditional Webb Electrode	Rhythmlink International, LLC	GXY	Class II	2013-05-30
K123844	Chemtrue Hcg Pregnancy Urine Dipstick, Hcg Pregnancy Urine Cassette Test, and Hcg Combo Serum/urine Cassette Test	Chemtron Biotech, Inc.	JHI	Class II	2013-05-30
K123491	Biodenta Dental Implant System - Multi-Use Abutment	Biodenta Swiss AG	NHA	Class II	2013-05-30
K123202	Proclear (Omafilcon a) Soft Hydrophilic) Contact Lens	CooperVision, Inc.	LPL	Class II	2013-05-30
K122663	Oramoist	Quantum Co., Ltd.	LFD	Unclassified	2013-05-30
K120901	Human Iga Csf Kit for Use on Spaplus	The Binding Site Group Ltd.	CFN	Class II	2013-05-30
K131392	Etiam Pacs Components	Etiam S.A.S.U.	LLZ	Class II	2013-05-29