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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2545 of 3530

510(k) clearances, page 2545 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K896040	King of Hearts Cdm	Instromedix, Inc.	DXH	Class II	1990-05-15
K901639	Model 4050-64; 5.25 & 4065-64; 6.50 Loop Coil	Medical Advances, Inc.	LNH	Class II	1990-05-14
K901544	Wako(tm) Autokit Uric Acid	FUJIFILM Healthcare Americas Corporation	KNK	Class I	1990-05-14
K901455	The Kirschner Universal Power Tool System	Kirschner Medical Corp.	HSZ	Class I	1990-05-14
K901334	Hycor Accupinch Thc Test	Hycor Biomedical	LDJ	Class II	1990-05-14
K901124	Chem I Clinical Analyzer Urine Magnesium	Technicon Instruments Corp.	JGJ	Class I	1990-05-14
K900919	Modified Hitachi Mrp-20 Magnetic Resonance Diagnos	Summit World Trade Corp.	LNH	Class II	1990-05-14
K900665	Dressing Change Kit	Healthdyne Cardiovascular, Inc.	FXX	Class II	1990-05-14
K900156	Ap201 Dental X-Ray Film Processor	Allied Photo Products Co., Inc.	EGY	Class II	1990-05-14
K894911	Sensory Needle Electrode Dne 111-115,116-117,118	Dantec Electronics, Inc.	GXZ	Class II	1990-05-14
K901716	Klein Connector(tm)	Jeff Klein Surgical, Inc.	GCE	Class I	1990-05-11
K901715	Klein Cork(tm)	Jeff Klein Surgical, Inc.	GCE	Class I	1990-05-11
K901321	Sharp-Safe, Biodegradeable,disp., Needle Disp. Box	Sharp Safe, Inc.	LDQ		1990-05-11
K901280	Disposible EEG Needle Electrodes	Medicotest, Inc.	GXZ	Class II	1990-05-11
K901274	Testpack Plus Strep a	Abbott Medical	GTZ	Class I	1990-05-11
K900996	Vitek Anaerobe Identification Card	Vitek Systems, Inc.	JSP	Class I	1990-05-11
K900904	Candela Directable Biliary Catheter System	Candela Corporation	FGE	Class II	1990-05-11
K900851	Digital Image Enhancement System	Atomic Products Corp.	LLZ	Class II	1990-05-11
K900740	Specimex Dc	Soredex Medical Systems	GXZ	Class II	1990-05-11
K900713	Herptran Concentrate	E.I. Dupont de Nemours & Co., Inc.	LGC	Class II	1990-05-11
K900697	Cedars-Sinai Quantitative Thallium-201 Analysis	Nuccardiac Software, Inc.	LLZ	Class II	1990-05-11
K901965	Mpr-4A - Micro-Plate Reader	Tosoh Corp.	JJQ	Class I	1990-05-10
K901345	Modified Fsh Enzyme Immunoassay Test Kit No.mb1050	Medix Biotech, Inc.	CGJ	Class I	1990-05-10
K901123	Chem 1 Clinical Analyzer Urine Urea Nitrogen	Technicon Instruments Corp.	CDQ	Class II	1990-05-10
K900879	Soft-Wedge(tm) Syringe	Baxter Healthcare Corporation	DYG	Class II	1990-05-10
K900797	Stockert Shiley Dual Pressure Control Module Xr	Shiley, Inc.	DXS	Class II	1990-05-10
K897174	Olympus(tm) Total Bilirubin	Em Diagnostic Systems, Inc.	CIG	Class II	1990-05-10
K897118	Satellite a Blood Acetaminophen Monitoring System	Medisense, Inc.	LDP	Class II	1990-05-10
K896444	Iontophoresis Device - Electrode Rh 800	Iomed, Inc.	EGJ	Class II	1990-05-10
K896314	Endoscopic Uses of the Argon Laser in General Surg	Hgm Medical Laser Systems, Inc.	GEX	Class II	1990-05-10
K902001	Surgical Retention Bar	Acufex Microsurgical, Inc.	KGS	Class I	1990-05-09
K901924	Reads(r) Anti-Ena (Sm/rnp) Test Kit	Biosearch Medical Products, Inc.	LLL	Class II	1990-05-09
K901506	Aneroid Sphygmomanometer, Doctor Type	Yamasu Co., Ltd.	DXQ	Class II	1990-05-09
K901385	Gabriel Medical Cls Thermal Recorder	Gabriel Medical, Inc.	DSF	Class I	1990-05-09
K901358	Bard Biopotential Amplifier II	C.R. Bard Inc	DRQ	Class II	1990-05-09
K901332	Pk-55 Andover Medical Part #5455 Label Change	BIOTRONIK AG	DTC	Class II	1990-05-09
K901145	Ndm Switchpen Holster	Ndm Corp.	GEI	Class II	1990-05-09
K900967	Modified Alpha Mc-9R C-Arm	Instrumentarium Imaging, Inc.	OXO	Class II	1990-05-09
K900945	Lamin-Add Adhesive Surgical Drape & Cath. Dressing	Palex Medical, Inc.	KKX	Class II	1990-05-09
K900835	Modified Perm-Cath	Quinton, Inc.	LFJ	Class II	1990-05-09
K900815	Sarns 9000 Perfusion System W/alert Only Level	3M Company	DTW	Class II	1990-05-09
K900657	Universal Delivery System Catheter	Microvena Corp.	DQY	Class II	1990-05-09
K900628	Modular Hip System	Richards Medical Co., Inc.	LZO	Class II	1990-05-09
K900551	Matrx Disposable Non-Invasive Gelled Pacing Elec.	Matrix Medica, Inc.	DRS	Class II	1990-05-09
K900193	Mthf-9R Mobil C-Arm Image Intensifier Unit	Imt America, Inc.	OXO	Class II	1990-05-09
K896568	Dualyse-Cath - Codes #1132.212, 1132.112	Vygon Corp.	LFJ	Class II	1990-05-09
K896422	Burron Ambulatory Drug Delivery System	Burron Medical, Inc.	FRN	Class II	1990-05-09
K895117	Hto Compressing Staple	Howmedica Corp.	JDR	Class II	1990-05-09
K894100	Oxytrak(tm) Pulse Oximeter	Critikon Company, LLC	DQA	Class II	1990-05-09
K901890	Mark IV Floatation Therapy Bed	Hydrothermic Floatation Systems, Inc.	IOQ	Class II	1990-05-07