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 1574 of 3531

510(k) clearances, page 1574 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K012498	Dynapulse 500G (Dp500g) Bllod Pressure Monitoring System	Pulse Metric, Inc.	DXN	Class II	2001-11-01
K012304	Adc 656 Electronic Stethoscope	American Diagnostic Corp.	DQD	Class II	2001-11-01
K011796	Renu Multiplus No Rub Multi-Purpose Solution	Bausch & Lomb Incorporated	LPN	Class II	2001-11-01
K011175	W.o.m. Laser U100	Novanta Medical GmbH	GEX	Class II	2001-11-01
K003957	Diaclear Ultrafilter	Gambro Renal Products	FIP	Class II	2001-11-01
K013504	Modification to: Ecat Lso Pet/ct Scanner	Siemens Medical Solutions USA, Inc.	KPS	Class II	2001-10-31
K012714	Royal Imperial Powder Free Polymer Coated Latex Examination Glove with Protein Content Labeling Claim (50 Micrograms or	Koon Seng Sdn Bhd	LYY	Class I	2001-10-31
K012495	Or Table and Headholder/magnetom Harmony, Symphony, Sonata Systems	Siemens Medical Solutions USA, Inc.	LNH	Class II	2001-10-31
K011916	Super C Hemodialysis/apheresis Chronic Catheter, Model Dc-36 Series, Dc-40 Series, Dc-45 Series	Boston Scientific Corporation	MSD	Class II	2001-10-31
K011761	Mac Two-Lumen Central Venous Kit with Arrowg Ard Blue Antimicrobial Surface and Integral Hemostasis Valve/side Port	Arrow Intl., Inc.	DYB	Class II	2001-10-31
K011221	Prisma HF 1000 Set, Prisma HF 1000 Pre-Set	Gambro Renal Products	KDI	Class II	2001-10-31
K010202	Owl Radiofrequency System, Model Urf-2A, and Associate Radiofrequency Lesion Probes	Leslie W. Organ	GXD	Class II	2001-10-31
K013422	Cardiq Function	GE Healthcare	JAK	Class II	2001-10-30
K013395	Lifejet Video Link	Ferrania S.p.A.	LMA	Class II	2001-10-30
K013257	Hemi-Arc Surgical Navigator	NuVasive Inc	HAW	Class II	2001-10-30
K013175	Tm2000 Easytrace Plus Receiving Center	Card Guard Scientific Survival, Ltd.	DXH	Class II	2001-10-30
K012895	Heamophilus/streptococcus Pneumoniae	Trek Diagnostic Systems, Ltd.	JWY	Class II	2001-10-30
K012695	Vanguard Reprocessed Arthroscopic Wands	Stryker Sustainability Solutions	GEI	Class II	2001-10-30
K012532	Sepragel Sinus	Genzyme Corporation	LYA	Class I	2001-10-30
K012497	Cryo-Hit, Models Ep6t5, Fp5t5, Fp5t3, Ep2t2, Ep1t1, and Ep2t1	Galil Medical Ltd.	GEH	Class II	2001-10-30
K011476	Sovereign	Shoprider Intl., Inc.	INI	Class II	2001-10-30
K011265	Ultrasound Transducer Cover	Advance Medical Designs Inc	ITX	Class II	2001-10-30
K010586	Palamed Bone Cement	Merck Biomaterial GmbH	LOD	Class II	2001-10-30
K013458	Cranial Helmet	Children'S Hospital	MVA	Class II	2001-10-29
K013375	Belleglass Hp Opaque 2	Kerr Dental Materials Center	EBF	Class II	2001-10-29
K013336	Xantalgin Crono	Cavex Holland B.V.	ELW	Class II	2001-10-29
K013198	Fuji VII Capsule	GC America Inc.	EMA	Class II	2001-10-29
K012868	Micromedics Fibrijet Aerosol Applicator	Micromedics, Inc.	FMF	Class II	2001-10-29
K012643	Apex Medical Lcd TENS-VII	Apex Medical, Inc.	GZJ	Class II	2001-10-29
K012465	Multitak Splinter 3.0 Mm Resorbable Anchor	Bonutti Research, Inc.	MAI	Class II	2001-10-29
K012462	Theken Large Cement Restrictor	Theken Surgical,Llc	JDK	Class II	2001-10-29
K012145	Microplex Coil System	Terumo Cardiovascular Systems Corporation	HCG	Class II	2001-10-29
K011248	Cw Disposable Acupuncture Needle	Acusupply, Inc.	MQX	Class II	2001-10-29
K013381	Advanced Lung Analysis-1	General Electric Co.	JAK	Class II	2001-10-26
K013355	Sparc Sling System	American Medical Systems, Inc.	OTN	Class II	2001-10-26
K013348	Modification to: Erbe Apc Connector Hose and Probes, Models 20132-158, 20132-155, 20132-156, 20132-157, 20132-166	Erbe USA Inc	GEI	Class II	2001-10-26
K013250	Gore-Tex Vascular Graft; Gore-Tex Stretch Vascular Graft	W. L. Gore & Associates, Inc.	DSY	Class II	2001-10-26
K012859	Nu-Spec D	Sol Weiss MD, Inc.	HIB	Class II	2001-10-26
K012809	Surgassist Right Angle Linear Cutter Dlu - 45Mm, Model Ralc45	Power Medical Interventions, Inc.	GDW	Class II	2001-10-26
K012636	Bptru Automated Non-Invasive Blood Pressure Monitor, Model Bpm-100	Vsm Technology, Inc.	DXN	Class II	2001-10-26
K012632	Tourniquet Cuff; Pneumatic Tourniquet	Medical Instruments Technology, Inc.	KCY	Class I	2001-10-26
K012628	Gynecare Tension-Free Vaginal Tape System	Gynecare Center	OTN	Class II	2001-10-26
K012450	Diamedix Is-Anti-Cardiolipin Iga Test System	Diamedix Corp.	MID	Class II	2001-10-26
K012449	Diamedix Is-Anti-Cardiolipin Igg/igm Test System	Diamedix Corp.	MID	Class II	2001-10-26
K012416	Confoscan 2 Confocal Microscope	Nidek Technologies SRL	HJO	Class II	2001-10-26
K012410	Infinity Hba Kit, Models 537-a, 537-B	Sigma Diagnostics, Inc.	LCP	Class II	2001-10-26
K011913	Sun-TENS Palm Type R5/compact Wireles M2 Ems Series	Sun-Rain System Corp.	IPF	Class II	2001-10-26
K011365	Vitalsat Pulse Oximeter, Model Ic32000	Island Critical Care Corp.	DQA	Class II	2001-10-26
K010729	Agilent Electronic Stethoscope, Models M4532a and M4533a	Andromed, Inc.	DQD	Class II	2001-10-26
K010532	Osteoset Bvf Kit	Wrightmedicaltechnologyinc	MQV	Class II	2001-10-26