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 2026-10-12, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3240 of 3528

510(k) clearances, page 3240 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K820200	IV Alert System	Allied Medical Technologies, Inc.	KPE	Class II	1982-03-18
K820174	Tampax Tampons	Tampax, Inc.	HEB	Class II	1982-03-18
K813360	Dermafile (Cat. # 38	Exco, Inc.	KKX	Class II	1982-03-18
K812049	Stockert Cardiac Pacing Electrodes	Stoeckert Instrumente	DTB	Class III	1982-03-18
K820563	Thioglycollate Enriched	American Laboratory Supply, Inc.	KZI	Class I	1982-03-16
K820558	Selenite Broth	American Laboratory Supply, Inc.	JSD	Class I	1982-03-16
K820556	Tryptic Soy Agar	American Laboratory Supply, Inc.	JSG	Class I	1982-03-16
K820555	Anaerobe Blood Agar W/kanamycin & Vanco	American Laboratory Supply, Inc.	JSJ	Class I	1982-03-16
K820554	Columbiz Cna Agar W/15% Sheep Blood	American Laboratory Supply, Inc.	JSJ	Class I	1982-03-16
K820553	Bile Esculin Azide Agar	American Laboratory Supply, Inc.	JSI	Class I	1982-03-16
K820552	Eosin Methylene Blue Agar	American Laboratory Supply, Inc.	JSI	Class I	1982-03-16
K820549	Thioglycollate W/indicator	American Laboratory Supply, Inc.	JSG	Class I	1982-03-16
K820534	Coat-a-Count Progesterone Kia Kit	Siemens Healthcare Diagnostics Inc.	JLS	Class I	1982-03-16
K820490	IV Start Tray	Seamless Hospital Products Co.	LRS	Class II	1982-03-16
K820422	Platelet Aggregometers	Chrono-Log Corp.	GHR	Class II	1982-03-16
K820376	Micromedic Systems Isoflex	Micromedic Systems	JJJ	Class I	1982-03-16
K820591	Mechanical Chair	Kaye Products, Inc.	LBE	Class I	1982-03-15
K820548	Powered Treadmill	Ogden Health Products	IOL	Class I	1982-03-15
K820539	Relieved Reinforced Cup	Zimmer GmbH	DXQ	Class II	1982-03-15
K820525	Raichem Gpt (Alt) Reagent	Reagents Applications, Inc.	CKA	Class I	1982-03-15
K820523	Chorio-Quant	Nuclear Medical Laboratories, Inc.	JHI	Class II	1982-03-15
K820502	Siloam Save-a-Needle	Siloam, Inc.	GAA	Class I	1982-03-15
K820496	TENS Model 8201	Medical Scientific Instruments	GZJ	Class II	1982-03-15
K820483	Ida Rapid O2a System	Innovative Diagnostic Systems, Inc.	JSP	Class I	1982-03-15
K820472	William Harvey H-625 Arterial Filter	C.R. Bard Inc	DTM	Class II	1982-03-15
K820455	Centrifree Micropartition System	Amicon, Inc.	JRL	Class I	1982-03-15
K820440	Emit-Amd Amikacin Contr. (Enzyme Immuno	Syva Co.	LDN	Class II	1982-03-15
K820401	Ortho* Hematology Contr. 8 Abn. Hi/low	Orhto Diagnostic Systems, Inc.	JPK	Class II	1982-03-15
K820400	Ortho* Hematology Control 8 Normal	Ortho Diagnostic Systems, Inc.	JPK	Class II	1982-03-15
K820334	Nemectrodyn Models 8,7,5 (Vols. I-IV	Nemectron Medical, Inc.			1982-03-15
K820299	Prompt Inoculation System	3M Company	LIE	Class II	1982-03-15
K820231	Command Ultra I	Cardiac Pacemakers, Inc.	DXY	Class III	1982-03-15
K820230	Pacemaker Programmer 2030	Cardiac Pacemakers, Inc.	KRG	Class III	1982-03-15
K820161	Axiom Lig-a-Boots	Axiom Medical, Inc.	KDC	Class I	1982-03-15
K813521	Transluminal Bipolar Pacing Probe	American Edwards Laboratories	LDF	Class II	1982-03-15
K813374	Nutricath	Exco, Inc.	FOZ	Class II	1982-03-15
K812225	Metec Helarium Lounge & Sky Units	Klafs Sunlight Corp.	FTC	Class II	1982-03-15
K820457	Medi-Trace Physiological Pressure Trans	Graphic Controls Corp.	DRS	Class II	1982-03-12
K820449	Pharmaceuticals Mod. 1Cc-1,2,3 Thru 50Cc	Abek Corp.	FMF	Class II	1982-03-12
K820444	Heart-Alert	Medical Equipment Devices, Inc.	KHX	Class I	1982-03-12
K820424	Impact, Model 310	ZOLL Medical Corporation	GCX	Class II	1982-03-12
K820413	Aegis Non-Adherent Dressing	Professional Medical Products, Inc.	NAB	Class I	1982-03-12
K820402	Patient Follow-Up Computer (Pfc	Medical Systems Corp.	DXN	Class II	1982-03-12
K820393	Anesthesia Ventilator	Medtronic, Inc.	CBK	Class II	1982-03-12
K820353	Monitron Model Jl-7	Florida Medical Equipment Repair, Inc.	CAP	Class II	1982-03-12
K820297	Wm. Harvey Overpressure Safety Valve	C.R. Bard Inc	DTL	Class II	1982-03-12
K820272	Cliniflow II, #701, Electromagn. Bld. Sy	Carolina Medical Electronics	DPW	Class II	1982-03-12
K820262	Permanent & Temporary Pacemaker Electr.	Diag Corp.	DTB	Class III	1982-03-12
K813547	Thermascan	Bcd Products, Inc.	KXZ	Class III	1982-03-12
K813317	Disp. Hyperinflation Bag System	Intec Medical, Inc.	NHK	Class II	1982-03-12