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 2026-10-21, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 537 of 3529

510(k) clearances, page 537 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K172264	OTW Takeru PTCA Balloon Dilatation Catheter	KANEKA Corporation	LOX	Class II	2018-03-19
K172148	Anchorage Bone Plating System	Stryker Corp.	HRS	Class II	2018-03-19
K171912	Double Flexible Tip Wire Guides	Cook Incorporated	DQX	Class II	2018-03-19
K171863	Anjon Bremer Halo System	G-5 Florida LLC	JEC	Class II	2018-03-19
DEN170029	PrimeStore MTM	Longhorn Vaccines and Diagnostics LLC	QBD	Class II	2018-03-19
K173841	AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058 x 132cm; AXS Catalyst Distal Access Catheter 060 x 132cm	Stryker Corp.	NRY	Class II	2018-03-18
K180426	Empower H35	Quanta System Inc.	GEX	Class II	2018-03-16
K180411	Memo 4D	Corcym Inc.	KRH	Class II	2018-03-16
K180404	3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System	3M Healthcare	NJM	Class II	2018-03-16
K180195	Frigitronics adapter	Phakos	HRN	Class II	2018-03-16
K180172	FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 151 & Paragon HDS 100 (paflufocon D) RGP contact lenses with Tangible Hydra-PEG	Paragon Vision Sciences, Inc.	HQD	Class II	2018-03-16
K180129	Imbio Segmentation Editing Tool software	Imbio, Inc.	LLZ	Class II	2018-03-16
K173873	BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial	Becton Dickinson & Co	MDB	Class I	2018-03-16
K173840	Xpert CT/NG	Cepheid	LSL	Class II	2018-03-16
K173752	SI Screw System	Zavation Medical Products, LLC	OUR	Class II	2018-03-16
K173611	syngo Application Software	Siemens Medical Solutions USA, Inc.	LLZ	Class II	2018-03-16
K173358	ARTAS System	Venus Concept Inc.	ONA	Class II	2018-03-16
K173326	MIS CONNECT Conical Connection Abutment	MIS Implants Technologies Ltd.	NHA	Class II	2018-03-16
K173181	ExSpiron 1Xi	Respiratory Motion, Inc.	BZK	Class II	2018-03-16
K173120	CCM Abutment System	Innobiosurg Co., Ltd.	NHA	Class II	2018-03-16
K172928	Portable X-ray System	Rolence Enterprise Co., Ltd.	EHD	Class II	2018-03-16
K172593	XCelliStem Wound Powder	Stemsys	KGN	Unclassified	2018-03-16
K172516	SurgiQuest AIRSEAL iFS System	ConMed Corporation	HIF	Class II	2018-03-16
K172366	Wrist Pulse Oximeter	Beijing Choice Electronic Technology Co., Ltd.	DQA	Class II	2018-03-16
K171937	Microlife Upper Arm Automatic Digital Blood Pressure Monitor	Microlife Intellectual Property GmbH	DXN	Class II	2018-03-16
K171851	Softxil	Bistool Inc	MIB	Class II	2018-03-16
K171542	TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges	Dr. Harold Katz, LLC (dba Therabreath	LFD	Unclassified	2018-03-16
DEN160044	Acumen Hypotension Prediction Index (HPI) Feature Software	Edwards Lifesciences LLC	QAQ	Class II	2018-03-16
K180448	INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated Arterial Filter; INSPIRE 8M Hollow Fiber Oxygenator; INSPIRE 8F M Hollow Fiber Oxygenator with Integrated Arterial Filter	Corcym Inc.	DTZ	Class II	2018-03-15
K180423	Empower H65	Quanta System Inc.	GEX	Class II	2018-03-15
K180406	Ellipse Ydun	Ellipse A/S	GEX	Class II	2018-03-15
K180405	FUJIFILM Endoscope Models EC-600HL and EC-600LS	FUJIFILM Corporation	FDF	Class II	2018-03-15
K180396	miraDry System	miraDry, Inc.	NEY	Class II	2018-03-15
K180393	AIRO Computed Tomography (CT) X-ray System	Brainlab, Inc.	JAK	Class II	2018-03-15
K180330	Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/mL	Liofilchem S.r.l.	JWY	Class II	2018-03-15
K180227	Polaris Spinal Growth System	Highridge Medical, LLC	PGM	Class II	2018-03-15
K180224	Element-Tl	Elemenic Co., Ltd.	GEX	Class II	2018-03-15
K180198	NuVasive® VuePoint® II OCT System	Nu Vasive, Incorporated	NKG	Class II	2018-03-15
K180153	X-spine Cortical Bone Screw System	Xtant Medical Holdings, Inc.	NKB	Class II	2018-03-15
K173839	Tissue of Origin Test Kit-FFPE	Cancer Genetics, Inc.	OIW	Class II	2018-03-15
K173811	TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System	In2Bones SAS	HSB	Class II	2018-03-15
K173180	Mega Plus Spine System	BK Meditech Co., Ltd.	NKB	Class II	2018-03-15
K171808	TDM Plate and Screw System	Tdm Co., Ltd.	HRS	Class II	2018-03-15
K171430	Incontinence Treatment Device, Model LT2061	Shenzhen Dongdixin Technology Co., Ltd.	KPI	Class II	2018-03-15
K180429	Advincula Delineator Uterine Manipulator	CooperSurgical, Inc.	HEW	Class II	2018-03-14
K180421	Natus NeuroWorks	Natus Medical Incorporated	OMB	Class II	2018-03-14
K180104	Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant	Church & Dwight Co., Inc.	HIS	Class II	2018-03-14
K173980	Specular Microscope CEM-530	Nidek Co., Ltd.	NQE	Class II	2018-03-14
K173798	Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack	DiaSorin Molecular LLC	PGI	Class II	2018-03-14
K173794	AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared	Medacta International SA	LZO	Class II	2018-03-14