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 2235 of 3531

510(k) clearances, page 2235 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K934757	Cu-Free & Lta	Jeneric/Pentron, Inc.	EJS	Class II	1994-02-04
K934404	Monoject Vertical Entry Sharps Container	Sherwood Medical Co.	FMI	Class II	1994-02-04
K934029	Sterile Laceration & Debridement Trays	Surgipro, Inc.	LRO	Class II	1994-02-04
K934002	Perio/endo Lens	New Image Industries, Inc.	EIA	Class I	1994-02-04
K933060	S-610 & 2-628 Wheeled Shower Stretchers	The Anthros Medical Group	FPO	Class II	1994-02-04
K932852	Non Invasive Vascular Program	D. E. Hokanson, Inc.	JOB	Class I	1994-02-04
K932627	Chakoff Endoscopy	Stephen Chakoff, Inc.	GCJ	Class II	1994-02-04
K931760	Carapace Packing Gauze Trays	Carapace, Inc.	LRO	Class II	1994-02-04
K931027	Bullett Peripheral Infusion Catheter	Cardio-Dynamics, Inc.	FOZ	Class II	1994-02-04
K930315	Thoracic Clamps: Sarot, Kantowitz and Lawrence	Thomasville Medical Assoc.	GDJ	Class I	1994-02-04
K926313	Computerized Testing and Exercise Systems	Henley Intl.	BXB	Class I	1994-02-04
K925861	Gimbel Puncture Resistant Surgical Glove	Gimbel Glove Co.	KGO	Class I	1994-02-04
K925459	Gs-Modular (Gold Standard - Modular)	Warren E. Collins, Inc.	BZG	Class II	1994-02-04
K924224	Owens Biopsy Forceps	Owens Precision Systems, Inc.	HFB	Class I	1994-02-04
K936210	Npac	National Healthcare Linen Service	KKX	Class II	1994-02-03
K936172	Rhesus Monkey Kidney Cells (Llc-Mk2)	Advanced Clinical Diagnostics	KIR	Class I	1994-02-03
K936171	Transformed Primary Human Embryonal Kidney	Advanced Clinical Diagnostics	KIR	Class I	1994-02-03
K936169	Rhesus Monkey Kidney Cells	Advanced Clinical Diagnostics	KIR	Class I	1994-02-03
K936100	Clearfil Liner Bond 2	Kuraray Intl. Corp.	KLE	Class II	1994-02-03
K936094	Prepare Lock	Prepare, Inc.	CBH	Class I	1994-02-03
K935930	Non Adherent Dressing and Non Adherent Drain Dressing	McNeil Healthcare LLC	EFQ	Unclassified	1994-02-03
K935883	Neurological Sponges	McNeil Healthcare LLC	GDY	Class I	1994-02-03
K935832	Chromophare	Berchtold Holding GmbH	KZF	Class I	1994-02-03
K935830	Ciba Corning 248 Ph/blood Gas Analyzer	Ciba Corning Diagnostics Corp.	CHL	Class II	1994-02-03
K935803	Cica-Care Silicone Gel Sheet	Smith & Nephew United, Inc.	MDA	Class I	1994-02-03
K935699	Colored Powder Free Patient Examination Gloves	Glove India Private, Ltd.	LYY	Class I	1994-02-03
K935687	Nil	Dentalsafe Systems Pty., Ltd.	EAX	Class I	1994-02-03
K935533	Nasal Cannula	Puritas Health Care, Inc.	CAT	Class I	1994-02-03
K935506	Multi-Sample Luer Adapter for Blood Sample Collection	Kawasumi Laboratories Co., Ltd.	FMI	Class II	1994-02-03
K935505	Winged Collection Set W/multi-Sample Luer Adapter	Kawasumi Laboratories Co., Ltd.	FMI	Class II	1994-02-03
K935440	Johnson & Johnson Fluoride Dental Floss, Mint Waxed	Johnson & Johnson Consumer Products, Inc.	JES	Class I	1994-02-03
K935156	Dentaurum Band Seater and Band Seating Instruments	Dentauraum, Inc.	ECR	Class I	1994-02-03
K935154	Dentaurum Expansion Screws	Dentauraum, Inc.	DYJ	Class I	1994-02-03
K934981	Dental Drill	Eare Consulting Service	DZP	Class I	1994-02-03
K934829	Haskon Medical Grade Sheeting	Haskon Intl., Inc.	MDA	Class I	1994-02-03
K934631	Transwarmer	Prism Technologies, Inc.	IMD	Class I	1994-02-03
K934389	Urotek Laser Catheter	Energy Life Systems Corp.	GEX	Class II	1994-02-03
K934233	Zara Zone IV Malar Implant Modification	Byron Medical	LZK	Class II	1994-02-03
K934089	Bio Quantum Technologies, Inc. Hand-Held CO2 Laser System Model Hh-550S	Bio Quantum Technologies, Inc.	GEX	Class II	1994-02-03
K934088	Auto Suture Sharps Container	United States Surgical, A Division of Tyco Healthc	FMI	Class II	1994-02-03
K934050	Topographic Brain Mapping Option	Biosound, Inc.	OLT	Class II	1994-02-03
K933951	Video EEG Option Modification	Esaote Biomedica SpA	GWQ	Class II	1994-02-03
K933587	Immunocard Rotavirus	Meridian Diagnostics, Inc.	LIQ	Class I	1994-02-03
K933121	Microbiological Culture Media,chocolate Agar	Bioclinical Systems, Inc.	JTY	Class II	1994-02-03
K933075	Laparoscopic Retractor	Origin Medsystems, Inc.	GCJ	Class II	1994-02-03
K932948	Medtronic Model 3625 Screener System	Medtronic, Inc.	GZB	Class II	1994-02-03
K932828	Centrix's Encore Solo Light Activated Resin Core	Alpha-Dent	EBF	Class II	1994-02-03
K932723	Conbio Cub-D10 Copper Laser System	Buckman Co., Inc.	GEX	Class II	1994-02-03
K932253	Arthrobot Bi-Fold Drape	Andronic Devices, Ltd.	KKX	Class II	1994-02-03
K932015	Tri-Med Inflatable Esophageal Dilator	Tri-Med Specialties, Inc.	KNQ	Class II	1994-02-03