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 1873 of 3531

510(k) clearances, page 1873 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K962422	Infimed Dental System	Infimed, Inc.	EHD	Class II	1997-09-11
K973259	K&w 2-Piece Take-Apart Instruments(various)	Medical Creative Technologies, Inc.	OCZ	Class II	1997-09-10
K973199	Amsino Suction Catheter	Amsino Intl., Inc.	BSY	Class I	1997-09-10
K972430	Extrawear, Gentlemen's Choice W/nonoxynol-9	Custom Services Intl., Inc.	LTZ	Class II	1997-09-10
K972429	Innerwear, Gentlemen's Choice W/nonoxynol-9	Custom Services Intl., Inc.	LTZ	Class II	1997-09-10
K972412	Prolene Polypropylene Mesh Hernia Device Nonabsorbable Synthetic Surgical Mesh	Ethicon, Inc	FTL	Class II	1997-09-10
K972376	Impact Air 45 Handpiece for Periodontal Use	Glenwood, LLC	EFB	Class I	1997-09-10
K972375	Impact Air 45 Handpiece for Endodontic Use	Glenwood, LLC	EFB	Class I	1997-09-10
K972323	Osteo Bos System	Osteonics Corp.	HRS	Class II	1997-09-10
K972243	2D Vog - Video-Oculography	Sensomotoric Instruments, GmbH	GWN	Class II	1997-09-10
K972223	Bone Plate with Cables	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	HRS	Class II	1997-09-10
K972212	0.015Cc Pinpoint Ionization Chamber, 0.005 Cc Pinpoint Ionization Chamber	Ptw-New York Corp.	LHN	Class II	1997-09-10
K972211	Multidos, Qc6plus	Ptw-New York Corp.	LHN	Class II	1997-09-10
K972017	Biocor Softshell Venous Reservoir (Biocor Svr)	Medivators Inc	DTN	Class II	1997-09-10
K971520	S3 Cyclic Rpm Control	Stoeckert Instrumente	DWB	Class II	1997-09-10
K971494	Virazyme Influenza Id Test for Influenza Types a and B Viruses	Zymetx, Inc.	GNX	Class I	1997-09-10
K971425	Narkomed M Anesthesia System (M)	Draeger, Inc.	BSZ	Class II	1997-09-10
K970847	Impulse Hvg	Armstrong Industries, Inc.	IPF	Class II	1997-09-10
K970197	Htp-1500 Localized Heat Therapy Pump	Adroit Medical Systems, Inc.	ILO	Class II	1997-09-10
K963725	Model Cg-2206 Personal Electrocardiogram (ECG) Transmitter Device (Modified)	Card Guard, Ltd.	DXH	Class II	1997-09-10
K963373	Cosmed K4	Cosmed S.r.l.	BZC	Class II	1997-09-10
K972733	Avl Omni Analyzer	Avl Scientific Corp.	CGA	Class II	1997-09-09
K972706	Clinitek Microalbumin Reagent Strips	Bayer Corp.	CJG	Class II	1997-09-09
K972523	Punctual Occluder	Odyssey Medical, Inc.	LZU	Unclassified	1997-09-09
K972455	Jimmy John III Rectal Nozzel, Model Cit	Colon Therapeutics	KPL	Class II	1997-09-09
K972316	Opus D-Dimer	Behring Diagnostics, Inc.	GHH	Class II	1997-09-09
K972227	Shoe Cover	American Seal Co.	FYF	Class I	1997-09-09
K972220	Rheumatoid Factor Latex-Enhanced Immunoturbidimetric Test Kit	Randox Laboratories, Limited	DHR	Class II	1997-09-09
K972187	Bouffant Cap	American Seal Co.	KKX	Class II	1997-09-09
K971640	Leadcare Blood Lead Testing System	Esa, Inc.	DOF	Class II	1997-09-09
K970591	Blood Monitor Pump	Baxter Healthcare Corporation	KDI	Class II	1997-09-09
K970585	Fukuda Denshi Dynascope Model Ds-5800 Central Station Monitor	Fukuda Denshi USA, Inc.	DSI	Class II	1997-09-09
K963196	Vygon Umbilical Cathether Insertion Tray	Vygon Corp.	FOZ	Class II	1997-09-09
K961381	Kis-III Non-Submerged Implant, Screws and Cylinders	The Emerging Technologies Group	DZE	Class II	1997-09-09
K950261	Device for Providing Quick Coupling for Dental Prostheses	Dr. Joseph E. Grasso, D.D.S.	DZE	Class II	1997-09-09
K950260	Quick Coupling Device for Dental Prostheses	Dr. Joseph E. Grasso, D.D.S.	DZE	Class II	1997-09-09
K972855	Karl Storz Contact Nasal Micro-Endoscopes	Karl Storz Endoscopy-America, Inc.	EOB	Class II	1997-09-08
K972776	Dry & Store	Ear Technology Corporation	ESD	Class I	1997-09-08
K972688	Microscan Dried Gram Positive Mic/combo Panels Levofloxacin	Dade Microscan, Inc.	JWY	Class II	1997-09-08
K972524	Dried Gram-Positive Mic/combo Panels	Dade Intl., Inc.	JWY	Class II	1997-09-08
K972519	Grasping Forceps, Right and Left Curved	Richard Wolf Medical Instruments Corp.	GEI	Class II	1997-09-08
K972509	Cequal-Quantitative Analysis for Cardiolite Executing on the Medasys Digital Systems Computer	Nuccardiac Software, Inc.	KPS	Class II	1997-09-08
K972485	Cimpat N	Arent, Fox, Kintner, Plotkin & Kahn	EMA	Class II	1997-09-08
K972275	Lantis Treatstation	Siemens Medical Solutions USA, Inc.	IYE	Class II	1997-09-08
K972221	K 15 Audiometer	American Electromedics Corp.	EWO	Class II	1997-09-08
K972191	Digitizer Director (Hsc025-01)	Howtek, Inc.	LMD	Class I	1997-09-08
K972030	Staphytect Plus/dryspot Staphytect Plus	Oxoid, Ltd.	JWX	Class I	1997-09-08
K971624	Dye Stop and Save - Quickfill	Shepherd Laboratories, Inc.	FPA	Class II	1997-09-08
K971023	Chase Thoracic Catheter	Chase Medical, Inc.	DWF	Class II	1997-09-08
K964597	Biosurgical, Corp. Multi Chamber Suction Syringe	Biosurgical Corp.	FMF	Class II	1997-09-08