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 536 of 3529

510(k) clearances, page 536 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K172648	Drive DeVilbiss iGo 2 Portable Oxygen Concentrator	Sunrise Medical, Inc.	CAW	Class II	2018-03-23
K172496	Supercath 5 (26G)	Togo Medikit Co., Ltd.	FOZ	Class II	2018-03-23
K172461	AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin	Aesku.Diagnostics GmbH & Co. KG	MOB	Class II	2018-03-23
K170753	Acculoc Total Knee System	Rootloc Co., Ltd.	JWH	Class II	2018-03-23
K170410	Longeviti PMMA Static Cranial Implant	Longeviti Neuro Solutions	GXN	Class II	2018-03-23
K180486	HemosIL Factor XII Deficient Plasma	Instrumentation Laboratory Co.	GJT	Class II	2018-03-22
K180456	Bio-Medicus Adult Cannulae Kit	Medtronic, Inc.	DWF	Class II	2018-03-22
K180453	Bio-Medicus Adult Cannulae and Introducer	Medtronic, Inc.	DWF	Class II	2018-03-22
K180443	Tumark Vision	SOMATEX Medical Technologies GmbH	NEU	Class II	2018-03-22
K180431	Cortina [MAX] Lumbar Cage System	Neurostructures, Inc.	MAX	Class II	2018-03-22
K180074	Diazyme Lipoprotein (a) Assay	Diazyme Laboratories, Inc.	DFC	Class II	2018-03-22
K173915	Test of Variables of Attention (T.O.V.A.)	The Tova Company	LQD	Unclassified	2018-03-22
K173903	Granada Medium	Hardy Diagnostics	PQZ	Class I	2018-03-22
K173760	Monarch Endoscopy Platform (Monarch Platform)	Auris Surgical Robotics, Inc.	EOQ	Class II	2018-03-22
K173134	SENTIO MMG Pedicle Access Needles	Medos International SARL	PDQ	Class II	2018-03-22
K173128	Alamo® C	Alliance Partners, LLC	ODP	Class II	2018-03-22
K173105	Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter	Cook Incorporated	ODC	Class II	2018-03-22
K172371	Arthrex UNIVERS REVERS COATED BASEPLATE	Arthrex GmbH	PHX	Class II	2018-03-22
K180274	Ventix Link Knotless Anchor with Inserter	Cayenne Medical Inc.	MBI	Class II	2018-03-21
K180211	Freezpoint	Apyx Medical Corporation	GEH	Class II	2018-03-21
K180192	Emprint Ablation Visualization Application	Medtronic, Inc.	LLZ	Class II	2018-03-21
K180148	ATS Thermal Imaging Probe, ATS Patient Interface Unit	Securus Medical Group, Inc.	FLL	Class II	2018-03-21
K180023	Wirion	Gardia Medical	NTE	Class II	2018-03-21
K173887	cobas CT/NG for use on cobas 6800/8800 systems	Roche Molecular Systems Inc	LSL	Class II	2018-03-21
K173846	DermaScalp Laser Cap	Dermascalp, LLC	OAP	Class II	2018-03-21
K173619	Mimics inPrint	Materialise N.V.	LLZ	Class II	2018-03-21
K173607	SOMATOM Edge Plus	Siemens Medical Solutions USA, Inc.	JAK	Class II	2018-03-21
K173571	Element System with IBT Electrodes	Infinite Biomedical Technologies, LLC	GXY	Class II	2018-03-21
K173408	Mammomat Revelation	Siemens Medi Cal Solutions, Inc.	MUE	Class II	2018-03-21
K172611	Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Sets, odd lengths and even lengths, Universal Titanium Cervix Probe Sets, odd lengths and even lengths	Varian Medical Systems, Inc.	JAQ	Class II	2018-03-21
K172168	WillCeph	HDX Will	LLZ	Class II	2018-03-21
K171982	Droplet Pen Needle	HTL-Strefa S.A.	FMI	Class II	2018-03-21
K171973	Captura® Disposable Hot Biopsy Forceps	Wilson-Cook Medical Inc.	KGE	Class II	2018-03-21
K163661	P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil	Rapid Biomedical GmbH	MOS	Class II	2018-03-21
K180438	BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit	BD	PSZ	Class II	2018-03-20
K180165	Habib EndoHPB	Emcision, Ltd.	KNS	Class II	2018-03-20
K180016	Home Use IPL Beauty Device	Shenzhen Mismon Technology Co., Ltd.	OHT	Class II	2018-03-20
K180015	Philips Incisive CT	Philips Healthcare (Suzhou) Co., Ltd.	JAK	Class II	2018-03-20
K173919	HX Device	Human Extension, Ltd.	GCJ	Class II	2018-03-20
K173451	Ingenia Elition S and Ingenia Elition X	Philips Medical Systems Nederland B.V.	LNH	Class II	2018-03-20
K172762	Single Use Hemoclip	Zhejiang Chuangxiang Medical Technology Co., Ltd.	PKL	Class II	2018-03-20
K171989	Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon Angled, Glo-Tip ERCP Catheter, Glo-Tip II Double Lumen ERCP Catheter & w/ Radiopaque Bands, Fusion ERCP Catheter with DomeTip and Fusion OMNI ERCP Catheter with DomeTip, Haber RAMP Catheter, Soehendra Universal Catheter	Wilson-Cook Medical Inc.	ODD	Class II	2018-03-20
K170957	ReConnex Pre-Sutured Tendon	Allosource	GAT	Class II	2018-03-20
K180579	Ezee Retrieval	Genicon, Inc.	GCJ	Class II	2018-03-19
K180475	CapLOX II® / TowerLOX® MIS Pedicle Screw System	CAPTIVA SPINE, Inc.	NKB	Class II	2018-03-19
K173930	PYTHON Plate Trial Instruments	Treace Medical Concepts, Inc.	HRS	Class II	2018-03-19
K173740	Reprocessed DePuy Mitek Ablation Wand	ReNovo, Inc.	NUJ	Class II	2018-03-19
K173499	Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads	Stryker Orthopaedics	JDG	Class II	2018-03-19
K173437	3M Attest Super Rapid Readout Biological Indicator 1492V, 3M Attest Auto-reader 490, 3M Attest Auto-reader 490H	3M Company	FRC	Class II	2018-03-19
K173237	Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist	Syendgen, Inc.	LFD	Unclassified	2018-03-19