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 2026-10-19, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 3047 of 3529

510(k) clearances, page 3047 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K842364	Handheld Pacemaker Programmer & Softwar	Cardiac Pacemakers, Inc.	KRG	Class III	1984-09-24
K840668	Electrode Pacemaker, Perm & Temp	Vitatron Medical BV	DTB	Class III	1984-09-24
K843607	Labopettor	Medical Technomics, Ltd.	JQW	Class I	1984-09-21
K843606	Precision Dispenser	Medical Technomics, Ltd.	JQW	Class I	1984-09-21
K843483	Pharma-Plast Petri Dish	Zimmar Consulting, Ltd.	LIB	Class I	1984-09-21
K843362	Ringcaps	Medical Technomics, Ltd.	GIO	Class I	1984-09-21
K843361	Minicaps	Medical Technomics, Ltd.	GIO	Class I	1984-09-21
K843260	Angiosys Femoral Angiography Drape	Angiosystems, Inc.	KKX	Class II	1984-09-21
K843259	Angio Sys Fluoroscope Drape	Angiosystems, Inc.			1984-09-21
K843258	Angio Sys Brachial Angio Drape	Angiosystems, Inc.			1984-09-21
K843257	Angio Sys Sterile Field Cover	Angiosystems, Inc.			1984-09-21
K842943	Axcan Uterine Succion Injector	Axcan Scientific Corp.	HIG	Class II	1984-09-21
K842931	Drabkin Reagent	E K Ind., Inc.	KAG	Class I	1984-09-21
K842768	Ace/fisher External Fixator	Buckman Co., Inc.	KTT	Class II	1984-09-21
K842544	Stanbio Quick-Tell Monoclonal Indirect	Stanbio Laboratory	JHJ	Class II	1984-09-21
K842502	Wrinkle Chapeau Blacky	Circle Rubber Corp.	HIS	Class II	1984-09-21
K842308	12Ssl-Sc	Marquette Electronics, Inc.	LOS		1984-09-21
K843458	Emit 700 Amphetamine Assay New Product	Syva Co.	DKZ	Class II	1984-09-20
K843380	Acid Phosphatase Assay Kit	Diagnostic Chemicals, Ltd. (USA)	CKE	Class II	1984-09-20
K843353	Raichem Calcium Reagent	Reagents Applications, Inc.	CIC	Class II	1984-09-20
K843334	Systemate Gpt 67209	Em Diagnostic Systems, Inc.	CKA	Class I	1984-09-20
K843333	Systemate Got 67208	Em Diagnostic Systems, Inc.	CIT	Class II	1984-09-20
K843329	Systemate D-Bili 67213	Em Diagnostic Systems, Inc.	CIG	Class II	1984-09-20
K843328	Systemate T-Bili 67212	Em Diagnostic Systems, Inc.	CIG	Class II	1984-09-20
K843263	Arrow-Johans ECG Adaptor	Arrow Intl., Inc.	DQY	Class II	1984-09-20
K843216	Eclipse Heart Support for Coronary Arter	Biotrac Laboratories	GAD	Class I	1984-09-20
K843188	Wells Johnson Co. Chaj-Chir-Suction Tip	Wells Johnson Co.	JOL	Class II	1984-09-20
K843185	Ivac C80014 Y Solution Admin. Set	Y	FPA	Class II	1984-09-20
K843060	Sentra	Cardiac Pacemakers, Inc.	DTD	Class II	1984-09-20
K843035	Sang-a Petrolatum Gauze Usp Sterile	Tech-Cons Ltd., Intl.	FRO	Unclassified	1984-09-20
K842666	Nu-Thor Thoracostomy Kit	Intl. Medical Devices, Ltd.	KGZ	Class I	1984-09-20
K842648	General Surgery Tray	DeRoyal Industries, Inc.	LRO	Class II	1984-09-20
K842625	Custom Neuro Tray	DeRoyal Industries, Inc.			1984-09-20
K842533	Amizyme-Andna Test Kit	Amico Lab, Inc.	LJM	Class II	1984-09-20
K842532	Amizyme-Ana Test Kit	Amico Lab, Inc.	LJM	Class II	1984-09-20
K842517	Unilet Lancet	Ulster Scientific, Inc.	FML	Class I	1984-09-20
K841621	Back Radius Cutter	Plastafil, Inc.	HTX	Class I	1984-09-20
K841620	Front Radius Cutter	Plastafil, Inc.	HTX	Class I	1984-09-20
K840832	Servomed Oxcardiore Spirograph 324/111	Litton Medical Electronics	DRT	Class II	1984-09-20
K840739	Medilaser-S Mel-444-S	Mochida Pharmaceutical Co., Ltd	GEX	Class II	1984-09-20
K840209	Servomed Medivision Scope Smv-235	Litton Medical Electronics	DXJ	Class II	1984-09-20
K834094	Austin Endolymph Dispersment Shunt	Treace Medical, Inc.	ESZ	Class II	1984-09-20
K831792	Self-Aligning Acetabular Component	Endomedics, Inc.	JDL	Class III	1984-09-20
K843488	Electrostim 380	Micron Instruments, Inc.	IPF	Class II	1984-09-19
K843313	Top Disposable Spinal Needle	Top Surgical Manufacturers Co.	BSP	Class II	1984-09-19
K843212	Low Pressure Alarm for Oxygen Cylinder	Hospitak, Inc.	BXH	Class I	1984-09-19
K843167	Sonic Aid Green Ultrasound Gel	Wpc Brands, Inc.	IYO	Class II	1984-09-19
K843157	Disposable Tissue Effect Biosensor-T	Pan Dynamics Medical Corp.	FLL	Class II	1984-09-19
K842712	Medcolator Model Gx	Medco Products, Co., Inc.	IPF	Class II	1984-09-19
K842359	Automatic Patient Chair Pm2000 & a	Planmeca U.S.A. Inc			1984-09-19