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 3375 of 3526

510(k) clearances, page 3375 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K792542	Vogel-Johnson Agar	Isle Media and Sterile Products, Inc.	JSH	Class I	1979-12-31
K792511	Helena Factor VII Deficient Sub. Plasma	Helena Laboratories, Corp.	GGP	Class II	1979-12-31
K792508	Helena Factor X Deficient Substrate	Helena Laboratories, Corp.	GGP	Class II	1979-12-31
K792507	Helena Factor V Deficient Substrate	Helena Laboratories, Corp.	GGP	Class II	1979-12-31
K792503	Sandare Cyanmethemoglobin Reagent	Sandare Chemical Co., Inc.	KHG	Class II	1979-12-31
K792496	Volu-Sol Nmb Reticulocyte Stain	Volu Sol Medical Industries	KQC	Class I	1979-12-31
K792487	Seracon-Srii	Bhp Diagnostix, Inc.	JIX	Class II	1979-12-31
K792486	Seracon-Sri (Prod. # D029	Bhp Diagnostix, Inc.	JIX	Class II	1979-12-31
K792485	Seracon-Sri	Bhp Diagnostix, Inc.	JIX	Class II	1979-12-31
K792481	Culture Plates & Tubed Media	Laboratory Products, Inc.	JTZ	Class II	1979-12-31
K792476	Helena Factor XI Deficient Substrate	Helena Laboratories, Corp.	GGP	Class II	1979-12-31
K792475	Helena Factor IX Deficient Substrate	Helena Laboratories, Corp.	GGP	Class II	1979-12-31
K792467	Platelet-Chex for Blood Centers	Streck Laboratories, Inc.	JPK	Class II	1979-12-31
K792449	Centria Ferritin Ria	Union Carbide Corp.	DBF	Class II	1979-12-31
K792422	Tetrathionate Broth Base	Isle Media and Sterile Products, Inc.	JSJ	Class I	1979-12-31
K792421	Decarboxylase Broth Base with or with-	Isle Media and Sterile Products, Inc.	JSH	Class I	1979-12-31
K792420	Sim Medium	Isle Media and Sterile Products, Inc.	JSE	Class I	1979-12-31
K792360	Hansapor Sterile	Beiersdorf, Inc.	FPX	Class I	1979-12-31
K792358	Sandare Cyanmethemoglobin Standard	Sandare Chemical Co., Inc.	KRZ	Class II	1979-12-31
K792230	Avl Model 940 Automatic Ph/blood Gas	Gauntlet Technology Corp.	CHL	Class II	1979-12-31
K791507	Agglutinotest-Rheumatoid Arthritis	Volu Sol Medical Industries	DHR	Class II	1979-12-31
K791461	Agglutinotest-C-Reactive Protein	Volu Sol Medical Industries	DCK	Class II	1979-12-31
K791458	Agglutinotest-Thyroglobulin	Volu Sol Medical Industries	JZO	Class II	1979-12-31
K791455	Agglutinotest-Infectious Mononucleosis	Volu Sol Medical Industries	KTN	Class II	1979-12-31
K792185	Piasma Safe	Cry-O-Safe, Inc.	KSR	Class II	1979-12-28
K791977	Psoralite Mark I	Paul B. Elder Co.	KGL	Class II	1979-12-28
K792575	Bactec Bacterial Detection System	BD Becton Dickinson Vacutainer Systems Preanalytic	JTA	Class I	1979-12-27
K792558	Container System	Aesculap Instruments Corp.	FLE	Class II	1979-12-27
K792544	Lysine Iron Agar	Isle Media and Sterile Products, Inc.	JSH	Class I	1979-12-27
K792543	Tryptose Blood Agar Base & Tryptose	Isle Media and Sterile Products, Inc.	JSG	Class I	1979-12-27
K792530	Plaque-X Denture Cleaner	Nexell Corp.	JER	Class I	1979-12-27
K792525	Irex Cardioplan	Irex Corp.	DQK	Class II	1979-12-27
K792506	Rionet Hearing Aid Hb-68L	Rion Acoustic Instruments, Inc.	ESD	Class I	1979-12-27
K792505	Rionet Hearing Aid Hb-32T	Rion Acoustic Instruments, Inc.	ESD	Class I	1979-12-27
K792484	Tipsep-T3u Triiodothyronine Uptake	Nuclear Diagnostics, Inc.	KHQ	Class II	1979-12-27
K792480	Chem-Strate Triglyceride	General Diagnostics	CDT	Class I	1979-12-27
K792479	Chem-Strate Amylase	General Diagnostics	CIJ	Class II	1979-12-27
K792478	Chem-Strate Cholesterol	General Diagnostics	CHH	Class I	1979-12-27
K792477	Chem-Strate Ck-Nac	General Diagnostics	CGS	Class II	1979-12-27
K792472	Electro-Immuno-Quantitation (Eiq)	Icl Scientific	DAK	Class II	1979-12-27
K792468	Feeding Tube Placement Stylet	Biosearch Medical Products, Inc.	FZX	Class I	1979-12-27
K792447	Referee Bft Blood for Tonometry	Analytical Products, Inc.	JJS	Class I	1979-12-27
K792444	Norland Model 278 Bone Densitometer	Norland Corp.	KGI	Class II	1979-12-27
K792443	Tsh Radioimmunoassay	Dade, Baxter Travenol Diagnostics, Inc.	JLW	Class II	1979-12-27
K792431	Vaginal Packing	American Medical Disposable, Inc.	EFQ	Unclassified	1979-12-27
K792425	Decarboxylase Moeller Base with or with-	Isle Media and Sterile Products, Inc.	JSE	Class I	1979-12-27
K792424	Chocolate Tellurite Agar	Isle Media and Sterile Products, Inc.	JSI	Class I	1979-12-27
K792361	System 103 Chemistry Analyzer	Gilford Instrument Laboratories, Inc.	JJE	Class I	1979-12-27
K792353	Intra-Articulated Edger-Planer System	Richard Wolf Medical Instruments Corp.	HWE	Class I	1979-12-27
K792342	Pentax Brochofiberscope Model Fb-17D,	Pentax Precision Instrument Corp.	EOQ	Class II	1979-12-27