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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 1372 of 3531

510(k) clearances, page 1372 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K040901	Steritec Emu-Graph, Model No. Ci 131/Us	Steritec Products, Inc.	JOJ	Class II	2004-09-09
K040079	M.l. Primer	Shofu Dental Corp.	KLE	Class II	2004-09-09
K042325	Trochanteric Nail System	Depuy Orthopaedics Inc.	HSB	Class II	2004-09-08
K042309	Biosomnia-V3	Oxford Biosignals Limited	OMC	Class II	2004-09-08
K042304	Chunc Junior Model# Sm 242, Chunc Adapt Model# Sm 251	Spectris Technologies, Inc.	IOR	Class I	2004-09-08
K042293	Brilliance CT, Private Practice Cv Configuration, CT Scanner	Philips North America LLC	JAK	Class II	2004-09-08
K042292	Isite Pacs	Philips North America LLC	LLZ	Class II	2004-09-08
K042269	Leksell Gammaplan 4C with Multiview	Elekta Instrument AB	MUJ	Class II	2004-09-08
K042257	Discovery St Pet/ct Imaging System with an Alternate Detector Option	General Electric Co.	KPS	Class II	2004-09-08
K042234	Modification to: Liftloc Saftey Infusion Set	Specialty Health Products, LLC.	FPA	Class II	2004-09-08
K042199	Translux Power Blue	Kulzer GmbH	EBZ	Class II	2004-09-08
K042167	Modification to: Cd Horizon Spinal System	Medtronic Sofamor Danek	NKB	Class II	2004-09-08
K042136	Sanarus Cassi Rotational Core Biopsy System	Sanarus Medical, Inc.	KNW	Class II	2004-09-08
K042130	Aura CPAP Patient Interface	Aeiomed, Inc.	BZD	Class II	2004-09-08
K042128	Modification to Zargis Acoustic Cardioscan (Zac)	Zargis Medical Corp.	DQD	Class II	2004-09-08
K042013	Digital Clinical Thermometer, Models St-8A3c and St-8A3f	Mesure Technology Co., Ltd.	FLL	Class II	2004-09-08
K041965	Arthrex Humeral Fracture Plates and Screws	Arthrex GmbH	HRS	Class II	2004-09-08
K041936	Biopro Subtalar Implant	Biopro, Inc.	HWC	Class II	2004-09-08
K041923	Bioblanket	DSM Biomedical, Inc.	FTM	Class II	2004-09-08
K041911	Synthes (USA) Lcp Curved Plates	Synthes (USA) Products LLC	KTT	Class II	2004-09-08
K041872	Ascent Porous Open Box Ps Component/ascent Posterior Stabalized (Ps) Distal Femoral Pegs	Biomet Manufacturing Corp	MBH	Class II	2004-09-08
K041860	Synthes (USA) Lcp Proximal Humerus Plates, Long	Synthes (USA) Products LLC	HRS	Class II	2004-09-08
K041801	Expedium Mis Spine System	DePuy Spine, Inc.	NKB	Class II	2004-09-08
K041786	Calcamea Plate	New Deal, S.A.	HRS	Class II	2004-09-08
K041749	Scandius Acl Reconstruction System	Scandius Biomedical, Inc.	HWC	Class II	2004-09-08
K041709	Numelock II System	Howmedica Osteonics Corp	KTT	Class II	2004-09-08
K041706	Hoffmann II Foot Ring	Howmedica Osteonics Corp	KTT	Class II	2004-09-08
K041660	Trimedyne Holmium Laser Systems	Trimedyne, Inc.	GEX	Class II	2004-09-08
K041655	Bio Plant System (Implants and Abutments)	Cowellmedi Co., Ltd.	DZE	Class II	2004-09-08
K041625	Ltd Polyaxial Fixation System	Us Spinal Technologies, LLC	KWQ	Class II	2004-09-08
K041617	Stalif Tt	Surgicraft, Ltd.	MQP	Class II	2004-09-08
K041611	Synthes (USA) Rapid Resorbable Cranial Clamp	Synthes (USA) Products LLC	GXR	Class II	2004-09-08
K041566	Sonosurg Ultrasonic Surgical System	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	LFL	Unclassified	2004-09-08
K041516	Digital Thermometer, Models Mt-Xx8 and Mt-Xx9	Vega Technologies Inc.	FLL	Class II	2004-09-08
K041346	Synergy Ultimate	Pride Mobility Products Corp	ITI	Class II	2004-09-08
K041237	Echosampler	Gynetics Medical Products NV	HFF	Class II	2004-09-08
K040662	Vectra Genisys (Module & Transportable) and Intelect Xt (Module & Transportable) Laser Systems	Chattanooga Group, Inc.	ILY	Class II	2004-09-08
K034021	Vacuum Assisted Core Biopsy Device	Hologic, Inc.	KNW	Class II	2004-09-08
K021096	X-Sizer Catheter System	Medtronic, Inc.	MCW	Class II	2004-09-08
K042260	Phot-X II, Model 303	Takara Belmont USA, Inc.	EHD	Class II	2004-09-07
K042190	Model 6416 Temporary Pacing Lead System	Medtronic, Inc.	LDF	Class II	2004-09-07
K042170	En-Bloc Biopsy System Model#777-110,777-001,777-002,777-006,777-301,777-302,777-115,777-120	Neothermia Corp.	GEI	Class II	2004-09-07
K041904	Compass F10 System	Medcare Flaga	MNR	Class II	2004-09-07
K041883	Skintact Multifunction Electrodes, Model Df 21	Leonhard Lang GmbH	MKJ	Class III	2004-09-07
K041829	Focus Medical Naturalase Lp and Naturalight Family of Products	Focus Medical, LLC.	GEX	Class II	2004-09-07
K041754	Stryker Maestro System	Stryker Corp.	HBB	Class II	2004-09-07
K041082	Newport Nebsonic N550 Ultrasonic Nebulizer	Newport Medical Instruments, Inc.	CAF	Class II	2004-09-07
K040965	Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford Needles	Pajunk GmbH Medizintechnologie	BSP	Class II	2004-09-07
K033164	Abram's Multi-Density Polyurethane Foam Wound Dressing System	Dr. Len'S Medical Products, LLC	FRO	Unclassified	2004-09-07
K042301	Protens Electrode	Bio Protech, Inc.	GXY	Class II	2004-09-03