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 1907 of 3531

510(k) clearances, page 1907 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K964742	Ronix II Rotary Ultrasonic Surgical System	Aziz Y. Anis, M.D.	LFL	Unclassified	1997-04-22
K964596	Proselect 3 Peridontal Therapy System	Professional Dental Mfg., Inc.	ELC	Class II	1997-04-22
K964440	Eudermic Hypoallergenic Surgical Gloves/eudermic Surgical Gloves (Various)	Maxxim Medical	KGO	Class I	1997-04-22
K964365	Resectoscope Cutting Loop Electrode	Omnitech Systems, Inc.	FAS	Class II	1997-04-22
K964309	Sonos 2000, Sonos 2500 (M2406 a)	Hewlett-Packard Co.	IYN	Class II	1997-04-22
K963850	Pleur-Evac Sahara Plus Model S-1150 Continuous Reinfusion Autotransfusion System	Deknatel, Inc.	CAC	Class II	1997-04-22
K963844	Hydragel 15 Hb A1c Kit	Morax	LCP	Class II	1997-04-22
K963731	Tru-5000 Thermal Recovery Radiant Heating Unit	Enthermics Medical Systems, Inc.	DWJ	Class II	1997-04-22
K963593	Imt Loupe-Colposcope	Inventive Medical Technology	HEX	Class II	1997-04-22
K962571	Coaguchek Pst System	Boehringer Mannheim Corp.	GJS	Class II	1997-04-22
K960553	Card Guard Model Cg-900	Card Guard Scientific Survival, Ltd.	HGM	Class II	1997-04-22
K941170	Ventana Anti-Melanoma Primary Antibody	Ventana Medical Systems Inc	DEH	Class II	1997-04-22
K971363	Synchron Cx Systems Phosphorus Reagent	Carolina Liquid Chemistries	CEO	Class I	1997-04-21
K971344	Ast or Sgot	Carolina Liquid Chemistries	CIT	Class II	1997-04-21
K971323	Alt or Sgpt	Carolina Liquid Chemistries	CKA	Class I	1997-04-21
K971255	Imagyn Expandable Laparoscopic Introducer	Imagyn Medical, Inc.	HET	Class II	1997-04-21
K971005	Triglycerides	Derma Media Lab., Inc.	JGY	Class I	1997-04-21
K970985	Wako Total Bilirubin V	FUJIFILM Healthcare Americas Corporation	JFM	Class II	1997-04-21
K970897	Bti Distal Femoral Intramedullary Rod System	Biodynamic Technologies, Inc.	HSB	Class II	1997-04-21
K970867	Uric Acid Reagent	Derma Media Lab., Inc.	KNK	Class I	1997-04-21
K970781	Liquid Glucose (Oxidase) Reagent Set	Horiba Instruments Incorporated	CGA	Class II	1997-04-21
K970754	Innerdyne Step Trocar Expanable Port, Open Step	Innerdyne, Inc.	GCJ	Class II	1997-04-21
K970734	Siregragh T.o.p. 33 and Siregraph T.o.p. 40 Universal Fluoroscopic X-Ray Systems	Siemens Medical Solutions USA, Inc.	OWB	Class II	1997-04-21
K970617	CT-Modeller System	Materialise N.V.	LLZ	Class II	1997-04-21
K970616	Mini Sampler Processor	Cavro Scientific Instruments, Inc.	JQW	Class I	1997-04-21
K970608	Evt Marker Board	Guidant Cardiac and Vascular Surgery	JAA	Class II	1997-04-21
K970485	Smartsite Access Pin	Ivac Medical Systems	FPA	Class II	1997-04-21
K970422	Right Angle Laser Fibers;optilase Nd:yag Laser;optilase Pl100 Nd Laser Systems	Trimedyne, Inc.	GEX	Class II	1997-04-21
K970416	Acufex Double Armed Suture Needle	Smith & Nephew Endoscopy, Inc.	GAT	Class II	1997-04-21
K970328	Ultracell Neuro Sponges	Ultracell Medical Technologies, Inc.	HBA	Class II	1997-04-21
K970314	Synchron Lx Systems Apolipoprotein (Apoa and Apob) Reagents	Beckman Instruments, Inc.	MSJ	Class I	1997-04-21
K970284	Artos, Diplos System	Turnkey Intergration USA, Inc.	KWY	Class II	1997-04-21
K970205	Vitallium 2000 Alloy; Vitallium 2000 Plus Alloy; Cobalt Chrome Casting Alloy	Austenal, Inc.	EJH	Class II	1997-04-21
K970201	Gsi Cannula with Introducer	General Surgical Innovations	DYB	Class II	1997-04-21
K970090	Solo-Sled	Solo-Sled, LLC	IXA	Class II	1997-04-21
K965033	Immage Immunochemistry System Alpha-1-Microglobulin (Ai) Reagent	Beckman Instruments, Inc.	MGA	Class I	1997-04-21
K964898	In the Ear Hearing Aid	Keytone Hearing Laboratory	ESD	Class I	1997-04-21
K964281	Aesculap Angled Neuroendoscopes	Aesculap Inc	GWG	Class II	1997-04-21
K964254	Titanium Liberty Posterior Spinal System	Sofamor Danek USA,Inc.	KWP	Class II	1997-04-21
K963863	Janus I	3D Ultrasound, Inc.	IYO	Class II	1997-04-21
K963589	Vail 3000 Bed Enclosure	Vail Products, Inc.	FNL	Class II	1997-04-21
K951640	Human Protein S Rid Test Kit	The Binding Site	GGP	Class II	1997-04-21
K941707	Anti-Muscle Actin Primary Antibody	Ventana Medical Systems Inc	DEH	Class II	1997-04-21
K970381	Powered Toothbrush	Emjoi Action USA, Ltd.	JEQ	Class I	1997-04-18
K970209	Capnocheck Plus	Bci Intl., Inc.	CCK	Class II	1997-04-18
K963889	Qfc Umbilical Clamp	Qfc Industries	HFW	Class II	1997-04-18
K963761	Quartet Clinical System	Respironics, Inc.	BZD	Class II	1997-04-18
K961972	Model Ami Infant Central Aphea/heart Rate Monitor	Aequitron Medical, Inc.	BZQ	Class II	1997-04-18
K955487	Gambro Polyflux 14, 17, & 21 Hemodialyzers	Cobe Renal Care, Inc.	KDI	Class II	1997-04-18
K971210	Synchron Systems 10 Ng/ml & 40 Ng/ml Thc Urine Controls	Beckman Instruments, Inc.	LAS	Class I	1997-04-17