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 1182 of 3531

510(k) clearances, page 1182 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K070361	Mrsaselect	Bio-Rad	JSO	Class II	2007-09-13
K072418	Optichamber Advantage Anti-Static Valved Holding Chamber	Respironics New Jersey, Inc.	CAF	Class II	2007-09-12
K072394	Portrait Stand-Off	Rhytec Incorporated	GEI	Class II	2007-09-12
K072308	D131 Ph.i.s.i.o Dideco Kids Infant Arterial Filter with 40 Micron Screen Phosphorycholine Coated	Corcym Inc.	DTM	Class II	2007-09-12
K072297	Boomerang Catalyst/boomerang Catalyst II System	Cardiva Medical, Inc.	DXC	Class II	2007-09-12
K072038	Vitek 2 Gram Negative Levofloxacin	bioMerieux, Inc.	LON	Class II	2007-09-12
K072023	Ellipse Juvia, Model 9Eju7465	Ellipse A/S	GEX	Class II	2007-09-12
K072021	Neopip Infant Resuscitator	Neoforce Group, Inc.	BTM	Class II	2007-09-12
K071773	CPAP Nasal Mask with Pillows	Lifesource	BZD	Class II	2007-09-12
K071672	Sentec Digital Monitoring System	Sentec AG	DQA	Class II	2007-09-12
K071650	C350 Powered Wheelchair	Permobil, AB	ITI	Class II	2007-09-12
K071644	Online Phenobarbital, Model 03016757190 & 03510620	Roche Diagnostics GmbH	DLZ	Class II	2007-09-12
K071437	Megafix-C Bioabsorbable Composite Interference Screw, Model 2870719C, 2870723C, 2870823C, 2870828C, 2870928C	Karl Storz Endoscopy-America, Inc.	HWC	Class II	2007-09-12
K071321	Pocketcpr	ZOLL Medical Corporation	LIX	Class II	2007-09-12
K071272	Trojan Thintensity Brand Male Latex Condom	Church & Dwight Co., Inc.	HIS	Class II	2007-09-12
K070859	Reprocessed Ethicon Ets Endoscopic Linear Cutters	Sterilmed Inc	NLL	Class II	2007-09-12
K070653	Kendall Kerlix Antimicrobial Super Sponge Dressing for OTC Use, Model 6662	Tyco Healthcare	FRO	Unclassified	2007-09-12
K063658	Intravascular Introducer System	Applied Medical Resources Corp	DYB	Class II	2007-09-12
K063609	River- 1 Electrocardiograph (ECG) Recorder and Transmitter	SHL TeleMedicine International	DXH	Class II	2007-09-12
K072242	Cor Analyzer II, Model V1.7	Rcadia Medical Imaging, Ltd.	LLZ	Class II	2007-09-11
K072151	P.004 Rc Cares Titanium and Ceramic Abutments	Straumann USA, LLC	NHA	Class II	2007-09-11
K071980	Dimension Vista Protein 1 Calibrator, Protein1 Control L,m,h	Siemens Healthcare Diagnostics Inc.	JJY	Class I	2007-09-11
K071700	Biogel Sensor Surgeon's Glove with Non-Pyrogenic Statement	Molnlycke Health Care, US LLC	KGO	Class I	2007-09-11
K071614	Fiducial Markers	Civco	IYE	Class II	2007-09-11
K071612	Modus Trilock 2.0/2.3/2.5	Medartis AG	JEY	Class II	2007-09-11
K071465	Biogel Orthopaedic Surgical Glove with Non-Pryogenic Statement	Molnlycke Health Care, US LLC	KGO	Class I	2007-09-11
K071379	Delta Xtend Reverse Shoulder Modular Stem	Depuy Orthopaedics Inc.	PHX	Class II	2007-09-11
K071121	Tribone 80	Biomatlante	MQV	Class II	2007-09-11
K070590	Microlife Instant Digital Electronic Thermometer, Model Mt19s1r	Microlife Intellectual Property GmbH	FLL	Class II	2007-09-11
K070554	Depuy Corail Amt Dysplasia Hip Prosthesis	Depuy Orthopaedics Inc.	LZO	Class II	2007-09-11
K062644	Flexwarmer, Models Kz-1 and Kz-2	Merlyn Associates, Inc.	LGZ	Class II	2007-09-11
K072153	Quickie Qx Manual Folding Wheelchair	Sunrise Medical, Inc.	IOR	Class I	2007-09-10
K071965	I-Surge	Satelec	EFB	Class I	2007-09-10
K071575	Sandman Intro	Mallinckrodt Developpement France	BZD	Class II	2007-09-10
K071565	Biogel Indicator Underglove with Non-Pyrogenic Statement	Molnlycke Health Care, US LLC	KGO	Class I	2007-09-10
K071541	Sbi Twistofix	Small Bone Innovations, Inc.	HWC	Class II	2007-09-10
K071507	Pts Panels Chol+hdl+glu Panel Test Strips	Polymer Technology Systems	NBW	Class II	2007-09-10
K071486	Rt300-S, Rt300-Sp (Pediatric Version), Model Fa100052, Fa100053	Restorative Therapies Inc.	GZI	Class II	2007-09-10
K071471	Corin Adaptor Sleeve	Howmedica Osteonics Corp	KWL	Class II	2007-09-10
K071429	Ti2200 Transillumination Cable	Sybron Dental Specialties, Inc.	NTK	Class II	2007-09-10
K071414	Biogel Eclipse, Latex, Powder Free, Indicator Underglove with Protein Content Labeling Claim (50 Micrograms or Less)	Molnlycke Health Care, US LLC	KGO	Class I	2007-09-10
K070694	Ccro (Craniocephalic Custom Remolding Orthosis)	Mike Miner	MVA	Class II	2007-09-10
K072269	Angiojet Ultra Dvx Thrombectomy Set, Model: 106552	Possis Medical, Inc.	QEZ	Class II	2007-09-08
K072272	Honeywell Hommed Central Station 4.0	Honeywell Hommed, LLC	DXN	Class II	2007-09-07
K072232	Gambro Polyflux Hemodialyzer, Model: Hd-C4 Small	Gambro Renal Products	KDI	Class II	2007-09-07
K072222	Spy Fluorescent Imaging System	Novadaq Technologies ULC	IZI	Class II	2007-09-07
K072208	Mayfield Disposable and Reusable Titanium Skull Pins	Integra LifeSciences Corporation	HBL	Class II	2007-09-07
K072152	Juniper Cln1 Dermal Cooling Device	Juniper Medical, Inc.	ILO	Class II	2007-09-07
K071911	Cardiopulmonary Exercise Testing Option to Innocor	Innovision, Inc.	DQK	Class II	2007-09-07
K071854	Aquadex Flexflow System	Chf Solutions, Inc.	KDI	Class II	2007-09-07