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 2026-11-02, 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 990 of 3531

510(k) clearances, page 990 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K093298	Pulsair Intellipuff, Pulsair Desktop Model 2414-P-2001, 2417-P-2000	Keeler Instruments, Inc.	HKX	Class II	2010-12-10
K102989	Opus Diagnostic Ultrasound System & Transducers	Chang Gung Medical Technology Co., Ltd. Linkou Fac	IYN	Class II	2010-12-09
K102723	Model 950-12L Holter Recorder without Analysis	Memtec Corp.	MWJ	Class II	2010-12-09
K102694	2.4Mm Va-Lcp Dorsal Distal Radius Plates	Synthes (USA) Products LLC	HRS	Class II	2010-12-09
K102609	Kd-5966 Series Fully Automatic Electronic Blood Pressure Monitor	Andon Medical co., Ltd	DXN	Class II	2010-12-09
K102473	Mullins-X Ptv Catheter	Numed Inc	OMZ	Class II	2010-12-09
K102436	Nobel Active 3.0	Nobel Biocare AB	DZE	Class II	2010-12-09
K102424	Prevision Hip System with Recon Ring	Aesculap Inc	MEH	Class II	2010-12-09
K101609	Self Retaining Soft Tissue Retractor	Koros USA, Inc.	LXH	Class I	2010-12-09
K101319	Immulisa Dsdna Antibody Elisa	Immco Diagnostics, Inc.	LRM	Class II	2010-12-09
K101046	Stockert S5 System and Gas Blender and Sorin C5 System	LivaNova Deutschland GmbH	DTX	Class II	2010-12-09
K100854	Premium Plus Disposable Prophy Angle Model 3399	Premium Plus International Limited	EGS	Class I	2010-12-09
K093491	Hip Sextant Instrument System	Surgical Planning Associates	OSF	Class II	2010-12-09
K103367	Seeker Crossing Support Catheter	Bard Peripheral Vascular Inc	DQY	Class II	2010-12-08
K103356	Pruitt Carotid Kit	LeMaitre Vascular Inc.	MJN	Class II	2010-12-08
K102984	Aura	Sdi Ltd.	EBF	Class II	2010-12-08
K102965	Celox Trauma Gauze Ag, Celox Hemostatic Antibacterial Trauma Gauze, Omni-Stat Trauma Gauze Ag, Omni-Stat Hemostatic Anti	Medtrade Products Ltd.	QSY	Unclassified	2010-12-08
K102739	Hydrocolor 5	Cascades Device Consulting Associates	ELW	Class II	2010-12-08
K102659	Manukahd, Manukahd Rope, Manukahd Border	Manuka Medical Limited	FRO	Unclassified	2010-12-08
K102367	Optigen Total Knee System	CG MedTech Co., Ltd.	JWH	Class II	2010-12-08
K102143	Suspension Acromioclavicular (Ac) Repair System	Suspension Orthopaedic Solutions, LLC	JDR	Class II	2010-12-08
K101910	3M Attest Rapid Readout Steam Process Challenge Device, Model 1296V, 3M Attest Rapid Readout Steam-Plus	3M Company	FRC	Class II	2010-12-08
K101153	Quadrox-Id Adult Diffusion Membrane Oxygenator with Softline Coating, Model: Be-Hmod 70000-USA, Beq-Hmod 70000-USA, Hmod	MAQUET CARDIOPULMONARY GmbH	DTZ	Class II	2010-12-08
K100668	Nema-St, Model V1.0.2	Nervomatrix, Ltd.	GZJ	Class II	2010-12-08
K093641	Tango3 Water Storage Tank with Ozone Disinfection System	Tango3, LLC	FIN	Class II	2010-12-08
K102765	Pronex	Direx Systems Corp.	IYE	Class II	2010-12-07
K102705	Armada 14 Pta Catheter	Abbott Vascular	LIT	Class II	2010-12-07
K102422	Spacelabs Medical Patient Monitors	GE Healthcare	MHX	Class II	2010-12-07
K102376	Nihon Kohden Cns-6200 Series Central Nurse Station, Model Cns-6201	Nihon Kohden Corp.	MHX	Class II	2010-12-07
K102282	The Varia Fibula Locked Plating System Line Extension Addition of Straight Plates	Howmedica Osteonics Corp., dba Stryker Orthopaedics	HRS	Class II	2010-12-07
K102111	Medical Magnetic Tape Recorder	Wpr Medical AS	DSI	Class II	2010-12-07
K102103	Skeletal Dynamics Sterilization Trays	Skeletal Dynamics, Inc	KCT	Class II	2010-12-07
K102095	Suspension Clavicle Fracture Fixation System	Suspension Orthopaedic Solutions, LLC	HRS	Class II	2010-12-07
K101993	Viper System, Expedium System	DePuy Spine, Inc.	NKB	Class II	2010-12-07
K101806	Aidera Diasend System	Aidera AB	MRZ	Class II	2010-12-07
K101682	S 100 Pedicle Screw System	Renovis Surgical Technologies, LLC	MNI	Class II	2010-12-07
K101401	Neumovent Graphnet Model 3179L1v	Tecme S.A.	CBK	Class II	2010-12-07
K100739	Volumeview System, Models Vlv520ft6r, Vlv520ft8r, Vlv520ft6r5	Edwards Lifesciences LLC	KRB	Class II	2010-12-07
K100709	Ev1000 Platform Model: Ev1000a, Ev1000db, Ev1000m	Edwards Lifesciences LLC	DXG	Class II	2010-12-07
K100469	Arcos Interlocking Distal Stems	Biomet Manufacturing Corp	KWA	Class III	2010-12-07
K103340	Smartprep2 Bmac System, Smartprep Platelet Concentration System	Terumo BCT, Ltd	JQC	Class I	2010-12-06
K103322	Evercross 0.035 Otw Pta Dilation Catheter	Medtronic, Inc.	LIT	Class II	2010-12-06
K103099	Precicontrol Hba1c Norm; Precicontrol Hba1c Path	Roche Diagnostics GmbH	JJX	Class I	2010-12-06
K100916	Medicon Mogen Clamp	Medicon, E.G.	HFX	Class II	2010-12-06
K100596	Cryopette	Mid-Atlantic Diagnostics, Inc.	MQK	Class II	2010-12-06
K093749	Gc Aadva Implant System	GC America Inc.	DZE	Class II	2010-12-06
K103314	Clotrac Heparinase Test Cartidge (Htc) Coagulation Control	Medtronic, Inc.	GGN	Class II	2010-12-03
K103283	Physioflow Enduro	Vasocom, Inc.	DSB	Class II	2010-12-03
K102952	Prodesse Proadeno	Gen-Probe Prodesse, Inc.	OCC	Class II	2010-12-03
K102867	Iroot Fs	Innovative BioCeramix, Inc	KIF	Class II	2010-12-03