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 1478 of 3531

510(k) clearances, page 1478 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K024345	B.07 Stairway Chairlift	Services Industriels Savaria, Inc.	ILK	Class II	2003-02-26
K024340	Smith & Nephew Femoral Heads	Smith & Nephew, Inc.	JDI	Class II	2003-02-26
K024049	Verte-Span Spinal System	Medtronic Sofamor Danek	MQP	Class II	2003-02-26
K023989	Contaflex 55 (Methafilcon) Spherical Soft Contact Lens for Daily Wear (Clear and Tinted, Lathe-Cut)	Contamac Ltd.	LPL	Class II	2003-02-26
K023987	Contaflex 38 (Polymacon) Spherical Soft Contact Lens for Daily Wear (Clear and Tinted, Lathe-Cut)	Contamac Ltd.	LPL	Class II	2003-02-26
K023917	Winged Needle Sets with an Antineedle Stick Protector	Kawasumi Laboratories Co., Ltd.	FPA	Class II	2003-02-26
K023637	Tytan Electronic Stethoscopes (Model #600)	Tytan Medical Corp.	DQD	Class II	2003-02-26
K023013	Stryker Xcel Anchor System	Stryker Corp.	HWC	Class II	2003-02-26
K022251	Palabond	Heraeus Kulzer GmbH & Co. KG	LOD	Class II	2003-02-26
K022214	Msi I2010 Dual Place Hyperbaric Chamber	Mechidyne Systems, Inc.	CBF	Class II	2003-02-26
K022186	Scleral Plugs, 19 and 20 Gauge	Microvision, Inc.	LXP	Class II	2003-02-26
K022011	V.a.c. Abdominal Dressing	KCI USA, Inc.	FTL	Class II	2003-02-26
K030301	Unicondylar Femoral Component	Smith & Nephew, Inc.	JWH	Class II	2003-02-25
K030299	Tempteller Infared Ear Thermometers, Model CT-31/31Dx/32/32dx	Oriental System Technology, Inc.	FLL	Class II	2003-02-25
K030285	Modification to Tsrh Spinal System	Medtronic Sofamor Danek	NKB	Class II	2003-02-25
K030258	First Response Pregnancy Test	Armkel, LLC	LCX	Class II	2003-02-25
K024304	Microsurgical Bipolar Handpiece	Neomedix Corp.	GEI	Class II	2003-02-25
K024100	If Series True Sine Interferential Stimulator/model: Wl-2206, Well If, Life If and the Customer Private Brand	Theratech, Inc.	LIH	Class II	2003-02-25
K023949	Navigus II Trajectory Guide with Verification Reticules	Image-Guided Neurologics, Inc.	HAW	Class II	2003-02-25
K022520	U2 Acetabular Cup	United Orthopedic Corp.	LPH	Class II	2003-02-25
K010555	Jax	Smith & Nephew, Inc.	MQV	Class II	2003-02-25
K030215	Biorapid Mononucleosis	Instrumentation Laboratory Co.	KTN	Class II	2003-02-24
K030182	Liquichek D-Dimer Control, Model 356, 357	Bio-Rad	GGN	Class II	2003-02-24
K030042	Premier III Phased Array Ctl Spine Coil	GE Healthcare Coils	MOS	Class II	2003-02-24
K024281	Wako L-Type Glucose 2	FUJIFILM Healthcare Americas Corporation	CFR	Class II	2003-02-24
K024210	Immage Systems Total Immunoglobulin E (Ige) Reagent Immage Ige Calibrator	Siemens Healthcare Diagnostics Inc.	DGC	Class II	2003-02-24
K023942	Clockmini, Model Df301; Clocknavi, Model Df311	Yamato Corp.	MNW	Class II	2003-02-24
K023931	Philips Avalon Cts Cordless Fetal Transducer System, Models M2720a, M2725a, M2726a, M2727a	Philips North America LLC	HGM	Class II	2003-02-24
K023456	Oxybox System	Oxyfast Corporation	KPJ	Class II	2003-02-24
K022678	Medcomp Sc4	Medcomp	MSD	Class II	2003-02-24
K030361	Jasun, Models Dt-01F and Dt-11F	Hangzhou Hua'an Medical & Health Instruments Co.	FLL	Class II	2003-02-21
K030286	Triage Cardio Profiler/triage Cardiac Panel	Biosite Incorporated	NBC	Class II	2003-02-21
K030253	Oria Spinal Clip System, Lengthened Lateral Connector, Model Al06	Ortho Tec, LLC	KWP	Class II	2003-02-21
K030252	Oria Spinal Clip System Extended Omniaxial Connectors (Co05 & Co07)	Ortho Tec, LLC	KWP	Class II	2003-02-21
K030241	Modification to Blackstone Spinal Fixation System	Blackstone Medical, Inc.	KWP	Class II	2003-02-21
K030240	Modification to Hermes Operating Room Control Center	Computer Motion, Inc.	GCJ	Class II	2003-02-21
K030190	Carbo/optimed Brand Acupuncture Needles	Suzhou Sen Sen Medical Supplies, Ltd.	MQX	Class II	2003-02-21
K030045	Olympus Cholinesterase Reagent (Catalog Number Osr6114)	OLYMPUS Corporation of the Americas	DIH	Class I	2003-02-21
K024309	The Vest Airway Clearance System, Model 104	Advanced Respiratory	BYI	Class II	2003-02-21
K024249	Terumo Surguard Safety Syringe	Terumo Medical Corp.	MEG	Class II	2003-02-21
K024193	Modification to Vitros Immundodiagnostic Products Troponin I Reagent Pack/calibrators	Ortho-Clinical Diagnostics, Inc.	MMI	Class II	2003-02-21
K024149	Primelung	Accuimage Diagnostics Corp.	JAK	Class II	2003-02-21
K024052	Merit Medical 1-Ml Syringe	Merit Medical Systems, Inc.	FMF	Class II	2003-02-21
K024044	Saber Tech Implants System	Imtec Corp.	DZE	Class II	2003-02-21
K023982	Leo III Tx/rx Quadrature Knee Coil; Alpha III Tx/rx Quadrature Wrist Coil	GE Healthcare Coils	MOS	Class II	2003-02-21
K023959	Jerome Glass Ring	The Jerome Group, Inc.	HAX	Class II	2003-02-21
K023929	Magnetic Resonance Diagnostic Device	Advanced Imaging Research, Inc.	MOS	Class II	2003-02-21
K023924	Autocon II 200 Electrosurgical Generator	Karl Storz Endoscopy-America, Inc.	GEI	Class II	2003-02-21
K023914	Coaxia Flocontrol Catheter	Coaxia, Inc.	MJN	Class II	2003-02-21
K023664	Syntra + Dialyzer, Model 200	Baxter Healthcare Corporation	KDI	Class II	2003-02-21