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 1344 of 3531

510(k) clearances, page 1344 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K043325	Zoomcam Ld-10 Intraoral Camera and Accessories	Rolence Enteprise, Inc.	EIA	Class I	2005-02-11
K043289	E-Z Frame External Surgical Support Boot	Whiteside Biomechanics, Inc.	KTT	Class II	2005-02-11
K043282	Devilbiss Autoadjust, Model 9054 Series	Sunrise Medical, Inc.	BZD	Class II	2005-02-11
K043094	Easyspine System	Ldr Spine USA	MNI	Class II	2005-02-11
K043006	Millennium M10 Oxygen Concentrator, Model M10600; with Opi, Model M10605	Respironics, Inc.	CAW	Class II	2005-02-11
K042992	Corail Amt Hip Prosthesis	Depuy Orthopaedics Inc.	LZO	Class II	2005-02-11
K042834	Micromedics Fibrijet Air Assisted Endoscopic Applicator	Micromedics, Inc.	GCJ	Class II	2005-02-11
K042757	Vanguard Ssk Knee System	Zimmer GmbH	JWH	Class II	2005-02-11
K042571	Stryker Spine Avs Tl Peek Spacer	Howmedica Osteonics Corp	MQP	Class II	2005-02-11
K041940	Howmedica Osteonics Zirconia-Toughened-Alumina (Biolox Delta) Ceramic Femoral Heads	Howmedica Osteonics Corp	LZO	Class II	2005-02-11
K041690	Monarch Nasal Implant	Hanson Medical, Inc.	FZE	Class II	2005-02-11
K050220	Evis Exera Bronchovideoscope, Olympus Xbf-160Y3ac, Xbf-1T160y3ac,xbf-Q160y2ac	Olympus Medical Systems Corp.	EOQ	Class II	2005-02-10
K050079	Cd Horizon Spinal System	Medtronic Sofamor Danek USA Inc	KWP	Class II	2005-02-10
K050062	Gemifloxacin, 5Ug Bbl Sensi-Disc	Becton Dickinson & Co	JTN	Class II	2005-02-10
K050057	Coulter Lh 750 Hematology Analyzer	Siemens Healthcare Diagnostics Inc.	GKZ	Class II	2005-02-10
K050016	Hemochron Signature Elite	Accriva Diagnostics, Inc.	JPA	Class II	2005-02-10
K043434	Osteomed Pediatric Intraoral Mandibular Distraction System	Osteomed	MQN	Class II	2005-02-10
K043420	Osteofil, Optefil, Regenafil, Rti Allograft Paste	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	MQV	Class II	2005-02-10
K043267	Potassium Test Kit and Electrolyte Cal 1 and 2	Randox Laboratories, Limited	CEJ	Class II	2005-02-10
K043254	Pathway Ureteral Access Sheath, Pathway Expandable Ureteral Access Sheath	Onset Medical Corporation	EZN	Class II	2005-02-10
K043123	Apex Modular Ha Hip Stem	VQ Orthocare	LPH	Class II	2005-02-10
K042755	Monochrome Lcd Monitor, Radiforce G51	Eizo Nanao Corporation	LLZ	Class II	2005-02-10
K042513	Vectorvision Osteotomy	Brainlab, Inc.	HAW	Class II	2005-02-10
K040780	Electrosurgical Pencils	Hangzhou Shuyou Medical Instrument Company, Ltd.	GEI	Class II	2005-02-10
K033716	Trident Acetabular System	Howmedica Osteonics Corp	LPH	Class II	2005-02-10
K050202	Cortisol and Cortisol Calibrators on the Access Immunoassay Systems	Siemens Healthcare Diagnostics Inc.	CGR	Class II	2005-02-09
K050151	Multidiagnost Eleva	Philips North America LLC	KPR	Class II	2005-02-09
K050068	Lnopv Ad-L and Pd-L Oximetry Sensors	Masimo Corporation	DQA	Class II	2005-02-09
K050063	Prostate-63 Cancer Diagnostic Test	Asymmetrx	NTR	Class I	2005-02-09
K050013	Retractofoam	Coltene /Whaledent AG	ELW	Class II	2005-02-09
K043615	Oxytec, Model 900	Oxytec Medical Corporation	CAW	Class II	2005-02-09
K043612	Orthopantomograph Op200, Op200d, and Orthoceph Oc200, Oc200d	Instrumentarium Corp. Imaging Division	EHD	Class II	2005-02-09
K043525	Catheter Introducer	Galt Medical Corp	DYB	Class II	2005-02-09
K043505	Discovery-Mosaic Total Humerus System	Zimmer GmbH	KWT	Class II	2005-02-09
K043459	Hemosil Factor XII Deficient Plasma	Instrumentation Laboratory Co.	GJT	Class II	2005-02-09
K043414	Hl 188 & Hl 189 Body Fat Meter	Health & Life Corporation	MNW	Class II	2005-02-09
K043334	Bone Source Hac Rapid Setting Cement	Stryker Corp.	GXP	Class II	2005-02-09
K043251	Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, Sptl-1B	Candela Corporation	GEX	Class II	2005-02-09
K043189	Sonalis, Model 2000	3g Ultrasound, Inc.	IYO	Class II	2005-02-09
K043188	Alcohawk Precision	Q3 Innovations, LLC	DJZ	Class I	2005-02-09
K043122	Smd 21500 or Dsb-2103-D-5Mp-5M Pixel Grayscale Flat Panel Display	Siemens Corp.	LLZ	Class II	2005-02-09
K042343	Scorpio Nrg Knee System	Howmedica Osteonics Corp	JWH	Class II	2005-02-09
K041390	Diamond Medistim	Diamond Systems USA, Inc.	IPF	Class II	2005-02-09
K050167	Chison 600M with C60 Convex Probe, L700 Linear Probe	Chison Medical Imaging Co., Ltd.	IYO	Class II	2005-02-08
K050120	Easy Core Biopsy System II	Boston Scientific Corporation	FCG	Class II	2005-02-08
K050113	Tina-Quant Igg Gen.2	Roche Diagnostics GmbH	DEW	Class II	2005-02-08
K050088	Quantix/or Blood Flow Monitor; Flexible Probe with Optional Vessel Stabilizer	Neoprobe Corp.	DPW	Class II	2005-02-08
K043584	Liquichek Bnp Control	Bio-Rad Laboratories Inc.	JJX	Class I	2005-02-08
K043277	C&g Acupuncture Needle	Helio Medical Supplies, Inc.	MQX	Class II	2005-02-08
K043179	Select 3D Arterial Cannula	Medtronic Perfusion Systems	DWF	Class II	2005-02-08