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 1003 of 3531

510(k) clearances, page 1003 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K101688	Emm Surgical Drape-Spunlace W/pe Sides, Model 13-004	Exact Medical Manufacturing, Inc.	KKX	Class II	2010-09-20
K101589	Blanketrol III, Model 233 and Coolblue, Model 25-01 Hyper-Hypothermia Systems	Gentherm Medical, LLC	DWJ	Class II	2010-09-20
K101568	Model Sb100ii Finger Pulse Oximeter	Atlantean	DQA	Class II	2010-09-20
K101039	Shimadzu Collimator R-300	Shimadzu Corp.	IZW	Class II	2010-09-20
K100969	Wmi Dvt Wrap, Wmi Thermal Wrap Model: D-1000F, D-1000C, T-2000A, T-2000B, T-2000Kf, T-2000S, T-2000N	Wmi Enterprises, LLC	JOW	Class II	2010-09-20
K093883	Ast/got 4+1 Sl, Ast/got 4+1 Sl, Elical 2, Elitrol I, Elitrol II, Model Assl-0250, Assl-0455, Cali-0580, Cont-0080, Cont-	VitalScientific	CIT	Class II	2010-09-20
K093694	Geratherm Uniqueresc	Geratherm Medical AG	DWJ	Class II	2010-09-20
K092734	E-Light Line	Espansione Marketing SpA	GEX	Class II	2010-09-20
K102353	Fully Automatic Electronic Blood Pressure Monitor Model Kd-513	Andon Health Co., Ltd	DXN	Class II	2010-09-17
K102021	Cryo-Touch II	Myoscience, Inc.	GXH	Class II	2010-09-17
K101906	Shape to Fit Compression Wear	Tsung Hau Technology Co., Ltd.	DWL	Class II	2010-09-17
K101555	CO2 Laser System	Advanced Technology Laser Co., Ltd.	GEX	Class II	2010-09-17
K101420	Gc Fuji Temp	GC America Inc.	EMA	Class II	2010-09-17
K101366	I-Lipo, Models A00-1238 (230V), A00-1239 (120V)	Chromogenex Technologies Limited	NUV	Class II	2010-09-17
K101245	Ultraseal Id	Ultradent Products Inc.	EBC	Class II	2010-09-17
K101170	Acute Innovations Sternal Fixation System	Acute Innovations, LLC	KTT	Class II	2010-09-17
K101157	E-Basic Single Breast Pump	Mapa GmbH	HGX	Class II	2010-09-17
K100787	Renasys F/-Ab Abdominal Wound Dressing Kit	Smith & Nephew, Inc.	FTL	Class II	2010-09-17
K100657	V.a.c. Ulta Negative Pressure Wound Therapy System (V.a.c. Ulta Therapy System) Model V.a.c. Ulta Therapy Unit Model U	Kci USA, Inc. (Kinetic Concepts, Inc.)	OMP	Class II	2010-09-17
K094003	Revivator	Hersill, S.L.	BTM	Class II	2010-09-17
K091467	Baby Quasar	Silver Bay, LLC	ONE	Class II	2010-09-17
K101661	Myray Hyperion	Cefla S.C.	MUH	Class II	2010-09-16
K101587	Propatch Soft Tissue Repair Matrix	Artivion, Inc.	FTM	Class II	2010-09-16
K101129	Esprit Ventilator with Af531 Se Full Face Mask	Respironics, Inc.	CBK	Class II	2010-09-16
K094050	Itotal Cr Knee Replacement System	ConforMIS, Inc.	JWH	Class II	2010-09-16
K102291	Covidien Endo Gia Radial Reload with Tri-Staple Technology	Medtronic, Inc.	GDW	Class II	2010-09-15
K102174	Zoll Propaq M	ZOLL Medical Corporation	DRT	Class II	2010-09-15
K101968	Sjm Confirm Icm, Model Drm2100, Sjm Confirm Pa, Model Dm2100a	Abbott Medical	MXC	Class II	2010-09-15
K101536	2.7/3.5Mm Va-Lcp Anteriro Clavicle Plate System	Synthes (USA) Products LLC	HRS	Class II	2010-09-15
K101505	Rtvue Model Rtvue 100	Optovue Inc.	HLI	Class II	2010-09-15
K101435	Imix Panorad and Somarad	Imix Adr Finland Oy	KPR	Class II	2010-09-15
K101429	Eco Supergel	Ceracarta SpA	IYO	Class II	2010-09-15
K101426	Ceros Tcp Granules	Mathys Corp.	LYC	Class II	2010-09-15
K101375	Trimed X-Fix	Trimed Inc	NDK	Class II	2010-09-15
K101373	Embrace	Izi Medical Products LLC	IZH	Class II	2010-09-15
K100726	Ceralas D/ 980Nm Fiber-Coupled Diode Laser Family, Ceralas E/ 980Nm Fiber-Coupled Diode Laser Family, Ceralas Hpd/ 980Nm	Biolitec, Inc.	GEX	Class II	2010-09-15
K100029	Mepilex Border Ag Dressing	Molnlycke Health Care	FRO	Unclassified	2010-09-15
K093254	Amo Brand Multi-Purpose Disinfecting Solution	Advanced Medical Optics, Inc.	LPN	Class II	2010-09-15
K101977	Tapered Screw-Vent T Implant	ZimVie US Corp LLC	DZE	Class II	2010-09-14
K101976	Interface Acetabular System, Acetabular Insert +4 Offset	Omni Life Science, Inc.	LPH	Class II	2010-09-14
K101496	Cablecap Model: Wlf, Stz, Acm	Sensormed	FST	Class II	2010-09-14
K101064	Bredent Novo.lign a/ Bredent Novo.lign P	Bredent GmbH & Co. KG	ELM	Class II	2010-09-14
K100727	Liquid Assayed Multiqual 1, Liquid Assayed Multiqual 2, Liquid Assayed Multiqual 3, Liquid Assayed Multiqual Minipak	Bio-Rad, Diagnostics Grp.	JJY	Class I	2010-09-14
K100221	Intelliwave3	Art Optical Contact Lens, Inc.	LPL	Class II	2010-09-14
K093960	St Aia-Pack Cystatin C, Model 025217	Tosoh Bioscience Inc	NDY	Class II	2010-09-14
K092551	Smith & Nephew Instrument Trays	Smith & Nephew, Inc.	KCT	Class II	2010-09-14
K102173	Moldex-Metric Health Care N95 Particulate Respirator and Surgical Mask, Model 1712	Moldex/Metric, Inc.	MSH	Class II	2010-09-13
K101824	Amsure 3-Way Hydrophilic Latex Foley Catheter	Amsino International, Inc.	EZL	Class II	2010-09-13
K101783	Cooltouch Model Ct3pz, Cooltouch Ct3 Plus Coolbreeze	New Star Lasers, Inc.	GEX	Class II	2010-09-13
K101676	Cleararch	Ormco Corp.	DYW	Class II	2010-09-13