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 911 of 3530

510(k) clearances, page 911 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K112648	Asfora Bullet Cage	Medical Designs, LLC	MAX	Class II	2012-03-13
K112561	Nuvasive Coroent No-Profile System	NuVasive Inc	OVD	Class II	2012-03-13
K112144	Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis Reversed Fracture Shoulder Prosthesis	TORNIER Inc.	PHX	Class II	2012-03-13
K111523	Osteocool (Tm) RF Ablation System	Baylis Medical Co., Inc.	GEI	Class II	2012-03-13
K103329	Diatrue Plus Blood Glucose Monitoring System; Diatrue Plus Blood Glucose Test Strip; Diatrue Glucose Control Solution	Delbio Incorporation	NBW	Class II	2012-03-13
K103116	Ap-2000, Ap-2010, and Ap-2020 Blood Glucose Monitoring System	Bestgen Biotech Corp.	CGA	Class II	2012-03-13
K113860	Visual-Ice Cryoablation System	Galil Medical Ltd.	GEH	Class II	2012-03-12
K113838	Wildcat Catheter	Avinger, Inc.	PDU	Class II	2012-03-12
K113624	Wondfo Buprenorphine Urine Test Wondfo Oxycodone Urine Test	Guangzhou Wondfo Biotech Co., Ltd.	DJG	Class II	2012-03-12
K113540	Reliance Lumbar Ibf System	Reliance Medical Systems, LLC	MAX	Class II	2012-03-12
K113429	Safetouch Psv Winged Infusion Set, and Set with Filter	Nipro Medical Corporation	FOZ	Class II	2012-03-12
K112757	Pioneer Posterior Cervico Thoracic System	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	KWP	Class II	2012-03-12
K112663	Enhatch Orthopaedics Patient/technique-Specific Humeral	Enhatch Orthopaedics, LLC	HRS	Class II	2012-03-12
K111663	Trauma Internal Fixation Systems	Depuy Orthopaedics Inc.	HRS	Class II	2012-03-12
K110662	Adaptive Wedge	Adaptive Specialty, LLC	HRS	Class II	2012-03-12
K120525	Qlab Quantification Software	Philips Healthcare Group	LLZ	Class II	2012-03-09
K120399	Lanx Spinal Fixation System	Lanx, Inc.	NKB	Class II	2012-03-09
K120380	Saturn 8000	New Medical Co., Ltd.	MQB	Class II	2012-03-09
K120233	Synchrony Respiratory Tracking System	Accuray Incorporated	IYE	Class II	2012-03-09
K113487	Hemo-Cath 10F, Hemo-Cath 12.5F	Medical Components, Inc.	MSD	Class II	2012-03-09
K113423	Kimberly Clark Purple Nitrile, and Purple Nitrile Xtra Powder Free Exam Glove	Kimberly-Clark Corporation	LZA	Class I	2012-03-09
K113413	Ascend Shoulder System	TORNIER Inc.	KWS	Class II	2012-03-09
K113260	Modified Concentirc Microcatheter	Concentric Medical, Inc.	DQO	Class II	2012-03-09
K112802	Pipeline Total Hip System	Pipeline Orthopedics	OQG	Class II	2012-03-09
K112659	Surgical Retractors	Surgical Innovations Ltd	GCJ	Class II	2012-03-09
K112638	Nova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test Strips	Nova Biomedical Corporation	NBW	Class II	2012-03-09
K112077	Hbidb - Human Brian Index Software	Corscience GmbH & Co. KG	OLU	Class II	2012-03-09
K110761	Mict Tsh	Magnabiosciences, LLC	JLW	Class II	2012-03-09
K120526	Yuyue K2 Wheelchair, Yuyue K4 Wheelchair	Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.	IOR	Class I	2012-03-08
K120434	Power Adaptor Instrument Accessory	Stryker Corp.	NKB	Class II	2012-03-08
K120044	Arthrex Universii Xl Glenoid-Pegged, Arthrex Univers II Xl Glenoid-Keeled	Arthrex GmbH	KWS	Class II	2012-03-08
K113872	The Oncontrol Bone Access and Bone Biopsy System by Vidacare	Teleflex Medical	KNW	Class II	2012-03-08
K113822	Quadrasphere 30 to 60	Biosphere Medical, S.A.	HCG	Class II	2012-03-08
K113810	Modified Alma Lasers Harmony 1064Nm (Nd:yag) Modules	Alma Lasers Ltd.	PDZ	Class II	2012-03-08
K113151	Ifs Laser System	Advanced Medical Optics, Inc.	GEX	Class II	2012-03-08
K113131	Liasys 450	Ams	CFR	Class II	2012-03-08
K113082	Sonovision	Peridot Technologies Ny, Inc.	LLZ	Class II	2012-03-08
K120355	Leucadia 4.5 Mm Pedicle Screw System	Phygen, LLC	NKB	Class II	2012-03-07
K120109	Super Seal Tooth Desensitizer	Phoenix Dental, Inc.	LBH	Class II	2012-03-07
K113807	Dexeryl Cream	Pierre Fabre Medical Devices	FRO	Unclassified	2012-03-07
K113575	Hilla Digital Transfers	Hilla Technologies, Inc.	EIH	Class II	2012-03-07
K113372	Nuvant, Mobilc Cardiac Telemetry	Corventis, Inc.	QYX	Class II	2012-03-07
K113284	Biopsy Positioner	Fuji Film Medical Systems	IZH	Class II	2012-03-07
K113255	Puregraft 850/Pure System	Cytori Therapeutics, Inc.	MUU	Class II	2012-03-07
K120505	Fresenius 2008T Hemodialysis Machine	Fresenius Medical Care North America, Design Cente	KDI	Class II	2012-03-06
K120358	Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)	Hongxin Plastic Products Co., Ltd.	LYZ	Class I	2012-03-06
K120318	Vivi Ergon-X HF	Vivi S.r.l.	MUH	Class II	2012-03-06
K120254	Therasage Heating Pad	Therasage Corporation	ILY	Class II	2012-03-06
K120124	Foresight U120 Urine Analyzer	Acon Laboratories, Inc.	JIL	Class II	2012-03-06
K113832	Soniceye Ultrasound Transducer	Blacktoe Medical Iii, Inc.	ITX	Class II	2012-03-06