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 1486 of 3531

510(k) clearances, page 1486 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K023490	Dermagrip-X Powder Free Latex Examination Gloves with Skin-Care Ingredients (Vitamin a, Vitamin B, Oc-Lipoic Acid, Eucal	WRP Asia Pacific Sdn Bhd	LYY	Class I	2003-01-16
K023356	Klock Watch Style Digital Blood Pressure Monitor	Card Guard Scientific Survival, Ltd.	DXQ	Class II	2003-01-16
K023213	Rdh-2000	Anodia Systems	EIA	Class I	2003-01-16
K023141	Modification to Standard Human Plasma	Siemens Healthcare Diagnostics Inc.	JPA	Class II	2003-01-16
K022976	Stratus Cs D-Dimer (Ddmr) Method (Testpak & Dilpak), Models Cddmr & Cddmr-D	Siemens Healthcare Diagnostics Inc.	DAP	Class II	2003-01-16
K013582	Maybe?mom Mini Ovulation Microscope	Maybe?Mom	CEP	Class I	2003-01-16
K024365	Tm2005 Personal Medical Phone Center	Card Guard Scientific Survival, Ltd.	DXH	Class II	2003-01-15
K024230	Liquichek Ana Control Set, Positive: Homogeneous, Speckled, Centromere and Nucleolar Patterns, Catalog #131	Bio-Rad	DHN	Class II	2003-01-15
K024229	Liquichek Ana Control, Nucleolar Pattern, Positive, Catalog #111	Bio-Rad	DHN	Class II	2003-01-15
K024227	Liquichek Anti-Mitochondrial Control, Positive, Catalog #127	Bio-Rad	DHN	Class II	2003-01-15
K024225	Liquichek Anti-Ndna Control, Positive, Catalog #119	Bio-Rad	DHN	Class II	2003-01-15
K024224	Liquichek Anti-Smooth Muscle Control, Positive, Catalog #129	Bio-Rad	DHN	Class II	2003-01-15
K024222	Liquichek Ana Control Centromere Pattern, Positive, Catalog #112	Bio-Rad	DHN	Class II	2003-01-15
K024221	Liquichek Ana Control Homogeneous Pattern Control, Posotive, Catalog #118	Bio-Rad	DHN	Class II	2003-01-15
K024219	Liquichek Anti-Sm Control, Positive, Catalog #115	Bio-Rad	LKP	Class II	2003-01-15
K024217	Liquichek Ana Control, Speckled Pattern, Positive, Catalog #108	Bio-Rad	DHN	Class II	2003-01-15
K024161	Nexgen Complete Knee Solution - Trabecular Metal Augments	Implex Corp.	JWH	Class II	2003-01-15
K024137	Jupiter Processing and Review Workstation	GE Healthcare	LLZ	Class II	2003-01-15
K024134	Uni Hip Stem	Plus Orthopedics	LWJ	Class II	2003-01-15
K024129	Modification to Ebi Xfix Dfs System	Ebi, LLC	KTT	Class II	2003-01-15
K024120	Modification to Temno Biopsy Needles	Medtronic, Inc.	FCG	Class II	2003-01-15
K024067	Rheumatoid Factor (RF)	Abbott Medical	DHR	Class II	2003-01-15
K023536	Nuamps	Neuroscan	OLT	Class II	2003-01-15
K023482	Aura 20 Bipolar Electrosurgical Coagulator, Model 26-2500	Kirwan Surgical Products, LLC	GEI	Class II	2003-01-15
K023289	Option Niv, Model 8414115, Upgrade Kit Niv, Model 8414072	Drager Medizintechnik GmbH	CBK	Class II	2003-01-15
K021555	Stereotaxis Niobe Magnetic Navigation System	Stereotaxis Inc	DXX	Class II	2003-01-15
K024184	Powder-Free Coated Nitrile Examination Glove, Blue Colored	Perusahaan Getah Asas Sdn. Bhd.	LZA	Class I	2003-01-14
K024173	Cds 3-Pd Hematology Controls	Clinical Diagnostic Solutions, Inc.	JPK	Class II	2003-01-14
K024156	Pacing Lead Extensions, Bipolar, Pacing Lead Adaptors, Unipolar/bipolar,pacing Lead Adaptors, Unipolar/bipolar	Oscor Inc.	DTD	Class II	2003-01-14
K024126	Clear or Braided Contrast Media Injection Line or without Rotator, Cath Lab Kit	Abbott Medical	DQO	Class II	2003-01-14
K023839	Hemosil Factor V Deficient Plasma	Instrumentation Laboratory Co.	GJT	Class II	2003-01-14
K023834	Hl888	Health & Life Corporation	DXN	Class II	2003-01-14
K023779	Rsv Oia	Thermo Biostar, Inc.	GQG	Class I	2003-01-14
K023706	Ultroid Hemorrhoid Management System	Ultroid, LLC	KNS	Class II	2003-01-14
K023468	Endoscopic Light Source Xl180/l3	World of Medicine Lemke GmbH	GCT	Class II	2003-01-14
K022145	Over the Wire Embolectomy Catheter, Model 2302	LeMaitre Vascular Inc.	DXE	Class II	2003-01-14
K021992	Dhs Disposable Hood System	Zimmer GmbH	FYA	Class II	2003-01-14
K024239	Chemo Dispensing Pin, Model 12495	Abbott Medical	LHI	Class II	2003-01-13
K024231	Liquichek Anti-Mitotic Spindle Pattern Control, Positive, Catalog #118	Bio-Rad	DHN	Class II	2003-01-13
K024223	Liquichek Anti-Rnp Control, Positive, Catalog #116	Bio-Rad	LKJ	Class II	2003-01-13
K023763	Randox Fructosamine, Fructosamine Calibrator, Fructosamine Controls	Randox Laboratories, Limited	LCP	Class II	2003-01-13
K023572	Loma Linda University Medical Center (Llumc) Cranial Remolding Helmet	Rehabilitation Institute,Loma Linda University Med	MVA	Class II	2003-01-13
K023499	Gold Core Plus	Pentron Laboratory Technologies	EJH	Class II	2003-01-13
K023464	Viridis Twin Ophthalmic Photocoagulator	Quantel Medical	GEX	Class II	2003-01-13
K023462	Impulse-Adjusting Instrument, Cbp Adjusting Instrument, Neuromechanical Adjusting Instrument, Models 2003	Neuromechanical Innovations, LLC	LXM	Unclassified	2003-01-13
K023459	Datex-Ohmeda S/5 Entropy Module, M-Entropy and Accessories	GE Healthcare	OLW	Class II	2003-01-13
K023449	Non-Invasive Patient Fixation System	Stryker Leibinger	IYE	Class II	2003-01-13
K023446	Meds-3 Neuromuscular Stimulator	Medical Equipment Device Specialists	IPF	Class II	2003-01-13
K023443	Meds-3 Neuromuscular Stimulator	Medical Equipment Device Specialists	GZJ	Class II	2003-01-13
K023439	Meds-4 Neuromuscular Stimulator	Medical Equipment Device Specialists	IPF	Class II	2003-01-13