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 2026-10-22, 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 557 of 3529

510(k) clearances, page 557 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K172685	LiverMultiScan	Perspectum Diagnostics, Ltd.	LNH	Class II	2017-11-21
K172622	Microcyn Antimicrobial Skin and Wound Cleanser	Sonoma Pharmaceuticals, Inc.	FRO	Unclassified	2017-11-21
K172253	Altus Spine Cervical Interbody Fusion System	Altus Partners	ODP	Class II	2017-11-21
K172218	MIM – Y90 Dosimetry	MIM Software Inc	LLZ	Class II	2017-11-21
K172176	Parkell Universal Adhesive	Parkell, Inc.	KLE	Class II	2017-11-21
K172050	Follicle Aspiration Set, Reduced Single Lumen	Vitrolife Sweden AB	MQE	Class II	2017-11-21
K171719	Hybrid3D	Hermes Medical Solutions AB	KPS	Class II	2017-11-21
K171681	Hermes Medical Imaging Suite v5.7	Hermes Medical Solutions AB	KPS	Class II	2017-11-21
K171650	Alere Afinion HbA1c and ACR on Afinion 2 analyzer	Abbott Rapid Diagnostics	LCP	Class II	2017-11-21
K171155	Surgical Angle Handpiece, Surgical Straight Handpiece	Nakanishi Inc.	KMW	Class II	2017-11-21
K171073	Smith & Nephew, Inc. REDAPT Augments	Smith & Nephew, Inc.	LPH	Class II	2017-11-21
K171044	Climax Personal Lubricant	Wsm Investment, LLC, dba Topco Sales	NUC	Class II	2017-11-21
K170915	TXM Hydrophilic Guidewire	Texasmedical Technologies, Inc.	DQX	Class II	2017-11-21
K170914	TXM Support Catheter	Texasmedical Technologies, Inc.	DQY	Class II	2017-11-21
K170754	3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced Securement Dressing	3M Company, 3M Healthcare	FRO	Unclassified	2017-11-21
K170545	Automatic Wrist Bluetooth Blood Pressure Monitor	Truly Instrument Limited	DXN	Class II	2017-11-21
K170398	S.I.N. Dental Implant System	S.I.N. Implant System Ltda	DZE	Class II	2017-11-21
K170236	Dental Low-speed Turbine Handpiece	Guangdong Jinme Medical Technology Co., Ltd.	EFB	Class I	2017-11-21
K163579	KLS Martin Individual Patient Solutions	KLS-Martin L.P.	JEY	Class II	2017-11-21
K163414	Ultrasonic scaler	Nanning VV Dental Co., Ltd.	ELC	Class II	2017-11-21
K173378	syngo®.via protoNeo (Version VA20)	Siemens Healthcare GmbH	LLZ	Class II	2017-11-20
K173169	Rapid Family	Sharplight Technologies Ltd.	GEX	Class II	2017-11-20
K173044	Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff	Ningbo Albert Novosino Co., Ltd.	DXQ	Class II	2017-11-20
K173018	MDR17 Mobile Direct Radiographic System	Del Medical, Inc.	IZL	Class II	2017-11-20
K172984	Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Pixie Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Cortiva BioActive Surface	Medtronic, Inc.	DTZ	Class II	2017-11-20
K172921	Stryker Self-Punching ICONIX	Stryker Corp.	MBI	Class II	2017-11-20
K172650	Materialise PKA Guide System	Materialise N.V.	HSX	Class II	2017-11-20
K172584	Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach	William Cook Europe ApS	DTK	Class II	2017-11-20
K172580	ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length	Ethicon Endo-Surgery Inc	GEI	Class II	2017-11-20
K172557	Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach	William Cook Europe ApS	DTK	Class II	2017-11-20
K172241	Tyece OTC EMS System, Model EM35	Tyece Limited	NGX	Class II	2017-11-20
K172032	Modulift Vertebral Body Replacement (VBR) System	Aesculap Implants Systems, LLC	PLR	Class II	2017-11-20
K171492	B7 2C Occlusion Balloon	Spiration, Inc.	EOQ	Class II	2017-11-20
K171136	LIA Pregnancy Test	Lia Diagnostics	LCX	Class II	2017-11-20
K173446	Contour 24	Quality Electrodynamics	MOS	Class II	2017-11-17
K173423	MR Wire Guide Wire Straight, MR Wire Guide Wire Angled	NANO4IMAGING GmbH	DQX	Class II	2017-11-17
K173365	Bausch + Lomb Boston Scleral Lens Case	Bausch & Lomb Incorporated	LRX	Class II	2017-11-17
K173355	Gastric Sizing Balloon Catheter	Cook Incorporated	KNT	Class II	2017-11-17
K173305	NeuroBlate System	Monteris Medical Corp	GEX	Class II	2017-11-17
K173068	Performer Introducer	Cook Incorporated	DYB	Class II	2017-11-17
K173023	Symbia T16, Symbia Intevo 16 and Symbia Intevo Bold	Siemens Medical Solutions USA, Inc.	KPS	Class II	2017-11-17
K172878	Vantage Titan 3T, MRT-3010/A7, M-Power GX	Toshiba Medical Systems Corporation, Japan	LNH	Class II	2017-11-17
K172850	SterilContainer with PrimeLine Pro Lid	Aesculap Inc	KCT	Class II	2017-11-17
K172761	New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded)	Shanghai New Century Dental Materials Co., Ltd.	EIH	Class II	2017-11-17
K172660	Duravess bovine pericardial vascular patch	Edwards Lifesciences LLC	PSQ	Class II	2017-11-17
K172514	Trak Plus Male Fertility Testing System	Sandstone Diagnostics, Inc.	POV	Class II	2017-11-17
K172472	Micro-MEC 1.8% Glutaraldehyde Monitor Strip	STERIS Corporation	JOJ	Class II	2017-11-17
K172451	Dr.MUSIC 3s	Smartmedicaldevice Co., Ltd.	NUH	Class II	2017-11-17
K172363	Deka Smartxide Ultraspeed	El.en. Electronic Engineering SpA	GEX	Class II	2017-11-17
K172362	Deka Smartxide Touch	El.en. Electronic Engineering SpA	GEX	Class II	2017-11-17