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 2315 of 3531

510(k) clearances, page 2315 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K925994	Rstar Image Managment Sytem (Rstar-Ims)	Rstar, Inc.	LMD	Class I	1993-03-18
K925877	Dc-Uibc-Cal	Diagnostic Chemicals, Ltd. (USA)	JIS	Class II	1993-03-18
K925686	Thera Pulse a Electro Nerve Stimulator	BioMedical Life Systems Inc.	GZJ	Class II	1993-03-18
K925370	Triangular Jaw Microlaryngeal Forceps	Pilling Co.	ELW	Class II	1993-03-18
K925130	Nessy Surestick(tm)/standard Surestick(tm)	Laserscope	GEI	Class II	1993-03-18
K924857	Aia-Pack Cea Calibration Verification Test Set	Tosoh Medics, Inc.	DHX	Class II	1993-03-18
K924522	Medtronic Model 3080 Pisces-Quad Lead	Medtronic, Inc.	GZB	Class II	1993-03-18
K924338	Arrow-Fischell Extended Vascular Access Needle	Arrow Intl., Inc.	DRC	Class II	1993-03-18
K924297	Dewette 2 Isolette Incubator Humidifier	Air-Shields Vickers, Inc.	FMZ	Class II	1993-03-18
K924223	Mar-Med Liver Strap	MAR-MED Inc.	GDJ	Class I	1993-03-18
K924070	B-D Pen Needle	BD Becton Dickinson Vacutainer Systems Preanalytic	FMI	Class II	1993-03-18
K924032	Corneal Analysis Systems(tm)	Eyesys Laboratories, Inc.	HQY	Class I	1993-03-18
K924022	O.r. Concepts Secondary Cannula	O.R. Concepts, Inc.	GCJ	Class II	1993-03-18
K923931	Medtronic Model 3487A Pisces-Quad Lead	Medtronic, Inc.	GZB	Class II	1993-03-18
K923884	Augusta Valentini	Revue Intl.	HQZ	Class I	1993-03-18
K923725	Ophthalmic Pharco Needle	Synergetics Inc	HQC	Class II	1993-03-18
K923265	Funnel Adaptor	Southmedic Inc.	CAD	Class II	1993-03-18
K923072	Handtymp	Life-Tech Intl., Inc.	ETY	Class II	1993-03-18
K922742	Hpm 40 Heart Pacemaker Monitor	BIOTRONIK AG	KRE	Class II	1993-03-18
K922397	4 Sure Tm Nasal Oxygen Cannula	Boston Pacific Medical, Inc.	CAT	Class I	1993-03-18
K922094	Dissection Instrument	Origin Medsystems, Inc.	GCJ	Class II	1993-03-18
K921761	Shawnee Products Kit II	Absentee Shawnee Bandage Group	KGX	Class I	1993-03-18
K921757	Angeion Igital Angeflator	Angeion Corp.	MAV	Class II	1993-03-18
K921657	Vasectomy Drape	Graham Medical Products	KKX	Class II	1993-03-18
K921433	Attic Defect Plate	Smith & Nephew Richards, Inc.	ETC	Class II	1993-03-18
K921164	Model 1300 Softrace II Electrode	Medtronic, Inc.	DRX	Class II	1993-03-18
K920594	Shiley Perfusion Tubing Sets	Shiley, Inc.	DTM	Class II	1993-03-18
K920394	Merocel Epistacis Kit	Merocel Corp.	EMX	Class I	1993-03-18
K930485	Quanta Lite(tm) Thyroid M Elisa	Inova Diagnostics, Inc.	JZO	Class II	1993-03-16
K930229	Clinical Neuro Systems Cranial Drill	Clinical Neuro Systems, LLC	HBE	Class II	1993-03-16
K930215	Flexible Trocar Tubes	Olympus Corp.	EWY	Class II	1993-03-16
K926193	Arthrex Instruments (Shoulder Gp. 1)	Arthrex GmbH	HRX	Class II	1993-03-16
K926111	Arthroscopic Knee Instruments	Arthrex GmbH	HRX	Class II	1993-03-16
K926074	Pulpdent Dental Bond Enchancer	Pulpdent Corporation	EBF	Class II	1993-03-16
K926062	Arthroscopic Knee Instruments	Arthrex GmbH	HRX	Class II	1993-03-16
K925996	Arthroscopic Acl Cannulated Drills and Sleeves	Arthrex GmbH	HRX	Class II	1993-03-16
K925874	Breast Stabilizer	Bip USA, Inc.	MDM	Class I	1993-03-16
K925579	Verasoft Casting Alloy	Aalba Dent, Inc.	EJH	Class II	1993-03-16
K925376	Comfeel(r) Wound Dressing Sd	MEDLINE INDUSTRIES, LP - Northfield	KMF	Class I	1993-03-16
K925301	Oti Orthopedic Fastener System	Osteo Technology, Inc.	HTY	Class II	1993-03-16
K925162	Microdose Dentin Conditioner	Unicep	EBF	Class II	1993-03-16
K924824	Microdose Pit and Fissure Sealant-Clear or White	Unicep	EBC	Class II	1993-03-16
K924823	Microdose Silane	Unicep	ELL	Class II	1993-03-16
K924821	Microdose Porcelain Etchant	Unicep	ELL	Class II	1993-03-16
K924180	i.v. Pro	I.V. - Pro Tek, Inc.	KMK	Class I	1993-03-16
K924017	Symbiosis Disposable Arthroscopic Surgical Inst.	Boston Scientific Corporation	HRX	Class II	1993-03-16
K923984	Smt-50X/h Magnetic Resonance Imaging System	Shimadzu Medical Systems	LNH	Class II	1993-03-16
K923757	Dental Diamond Drills	Alpha Industrializacao de Metais Ltda.	DZP	Class I	1993-03-16
K923717	Jelenko Porcelain System Pvs Procelain	J.F. Jelenko & Co., Inc.	EIH	Class II	1993-03-16
K923714	Symphony	J.F. Jelenko & Co., Inc.	EJT	Class II	1993-03-16