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 2026-10-08, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3361 of 3526

510(k) clearances, page 3361 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K800052	Antimicrobial Removal Device (Ard)	Marion Laboratories, Inc.			1980-04-04
K800665	Fiberglass Cylinder Bases, #'S 65040-	B & F Medical Products, Inc.			1980-04-02
K800664	Sure Flow Tubing	B & F Medical Products, Inc.	BYX	Class I	1980-04-02
K800650	Mod. 300 Anesth. Vol. Ventilator W/alarm	Hospal Medical Corp.	CBK	Class II	1980-04-02
K800634	Ohio Disposable Tracheal Tube	Ohio Medical Products	BTR	Class II	1980-04-02
K800631	Oxymeter	Dragerwerk AG	KLK	Class II	1980-04-02
K800630	Type 4000 Transcutaneous Elec. Stim.	Frye Electronics, Inc.	GZJ	Class II	1980-04-02
K800614	Medtek #411 Portable B-P Instr.	Med-Tek Corp.	DXN	Class II	1980-04-02
K800605	Ana Latex Slide Test	Biologics Intl., Inc.	DHC	Class II	1980-04-02
K800597	Reusable Hand-Trol	Aspen Laboratories, Inc.	GEI	Class II	1980-04-02
K800593	Sirecust 311S	Siemens Corp.	DPS	Class II	1980-04-02
K800591	Contourograph M-500	Bio-Tek Instruments, Inc.	LDK	Unclassified	1980-04-02
K800585	Nsi Chloride Reagent Kit	Nobel Scientific Industries, Inc.	JFS	Class II	1980-04-02
K800584	Nsi Sodium/potassium Kit	Nobel Scientific Industries, Inc.	JGS	Class II	1980-04-02
K800583	Nsi Creatinine Kit	Nobel Scientific Industries, Inc.	CGX	Class II	1980-04-02
K800580	Percutaneous Catheter Introducer	Alva Medical, Inc.	DYB	Class II	1980-04-02
K800572	Kda Micro Chemical Analyzer	American Monitor Corp.	JJE	Class I	1980-04-02
K800550	Lipase Determination	The Dow Chemical Co.	CFG	Class I	1980-04-02
K800542	100 Ml Snyder Hemovac	Snyder Laboratories, Inc.	GCY	Class I	1980-04-02
K800540	Cinoxacin 100 Mcg Sensi Disc	BD Becton Dickinson Vacutainer Systems Preanalytic	JTN	Class II	1980-04-02
K800530	Schlein Tri-Surface Ankle	Orthopedic Equipment Co., Inc.	HSN	Class II	1980-04-02
K800524	Seralyzer Reflectance Photometer/calib.	Miles Laboratories, Inc.	CIE	Class II	1980-04-02
K800502	Additional Components Kronner Compres	Richard F. Kronner, M.D.	HRS	Class II	1980-04-02
K800452	Neurometrics Monitor	Neurometrics	GWS	Class I	1980-04-02
K800430	Oxide Anaerobic System	Oxoid U.S.A., Inc.	JTM	Class I	1980-04-02
K800251	Mt-10, Et-20	Associated Mills, Inc.	IOG	Class I	1980-04-02
K800132	Shutrak	Moore Business Forms, Inc.			1980-04-02
K800603	Implantable Programmable Unipolar Card.	Telectronics, Inc.			1980-03-25
K800582	Barnes-Hond Hard Contact Lens Stor. Case	Barnes-Hind, Inc.	HPX	Unclassified	1980-03-25
K800573	Implantable Programmable Bipolar Cardiac	Telectronics, Inc.	DXY	Class III	1980-03-25
K800563	Blom-Singer Duckbill Voice Prosthesis	Bivona Medical Technologies	EWL	Class II	1980-03-25
K800562	Disposable Hand Held Nebulizer	Intec Medical, Inc.	CAF	Class II	1980-03-25
K800559	Sertrol Product # Acs St 101	Analytical Control Systems	JJY	Class I	1980-03-25
K800558	Lipid Control Product # Acs Lc 101	Analytical Control Systems	JJY	Class I	1980-03-25
K800556	Differential Refractive Index Detector	Hewlett-Packard Co.	KIE	Class I	1980-03-25
K800551	Triglycerides Test (500Nm)	Reagents Applications, Inc.	JGY	Class I	1980-03-25
K800547	Medistor III Lung Analyzer	Cybermedic, Inc.	BZC	Class II	1980-03-25
K800546	Bunn Volumaire Respiratory Exerciser	The John Bunn Co.	BWF	Class II	1980-03-25
K800534	Model 52 Bunn Dry Air Supply	Greene & Kellogg, Inc.	BTI	Class II	1980-03-25
K800522	Micro Elisa Auto Reader	Dynatech Laboratories, Inc.	JJQ	Class I	1980-03-25
K800512	Electronic Clinical Therm. Model 811A	Y	FLL	Class II	1980-03-25
K800509	Connecting Tubes	Medi-Craft, Ltd.	BYX	Class I	1980-03-25
K800506	Oxygen Catheter	Medi-Craft, Ltd.	BZB	Class I	1980-03-25
K800499	Pediatric Anesthesia Breathing Circuits	Airlife, Inc.	CAI	Class I	1980-03-25
K800498	Adult Anesthesia Breathing Circuits . .	Airlife, Inc.	CAI	Class I	1980-03-25
K800489	Laser Backpointer Assembly, Mod. 01-2487	Atc Medical Technology, Inc.	IWE	Class I	1980-03-25
K800458	Orthodonticartide	European Orthodontic Products	EBI	Class II	1980-03-25
K800432	Helena Ristocetin	Helena Laboratories, Corp.	JOZ	Class II	1980-03-25
K800423	Adt Nerve Block Tray(disp.)	A.D.T. Lab Industries	GAA	Class I	1980-03-25
K800421	Adt Peritoneal Lavage Tray (Disp.)	A.D.T. Lab Industries	GAA	Class I	1980-03-25