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 2026-10-22, 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 2874 of 3529

510(k) clearances, page 2874 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K862471	Wearable Twenty-Four Channel Vibrotactile Vocoder	Institute of Logopedics	LRA	Unclassified	1986-09-12
K862441	Ez Load Model 30, All Level Cot	Ferno-Washington Inc	FPO	Class II	1986-09-12
K862221	E-Z Clean	American Medical Products LLC	GEI	Class II	1986-09-12
K861621	Cardian II Cr45a	Cardiac Recorders, Ltd.	DRT	Class II	1986-09-12
K863374	Code-a-Well Series 1-600, 1-625	Plastic Injectors, Inc.	JTC	Class I	1986-09-11
K863318	Aerosol-T	Southmedic Inc.	BZA	Class I	1986-09-11
K863296	Infuse-a-Port Explant Kit	Intermedics/Infusaid, Inc.	LJT	Class II	1986-09-11
K863267	Magnesium Procedure	Data Medical Associates, Inc.	CFA	Class I	1986-09-11
K863266	Iron Procedure	Data Medical Associates, Inc.	JIY	Class I	1986-09-11
K863264	Inorganic Phosphorus Procedure	Data Medical Associates, Inc.	CEO	Class I	1986-09-11
K863181	Healthcheck Therm-Strip	Healthcheck Corp.	FQZ	Class I	1986-09-11
K863111	Cholinesterase	J. D. Assoc.	DIH	Class I	1986-09-11
K863070	Fast Mucoproteins	J. D. Assoc.	JQN	Class I	1986-09-11
K863064	Cholesterol-E (Free)	J. D. Assoc.	CHH	Class I	1986-09-11
K863050	Albumeter	J. D. Assoc.	CIX	Class II	1986-09-11
K862673	Model 6615 Floscan Doppler Diagnostic Catheter	Medtronic, Inc.	DQO	Class II	1986-09-11
K862642	Gram Negative Fluorescent Identification Panel	American Micro Scan	LQM	Class I	1986-09-11
K862426	Pulse Oximeter	Draeger, Inc.	DPZ	Class II	1986-09-11
K862360	Acs Hi-Torque Flex-T Guide Wire	Advanced Cardiovascular Systems, Inc.	DQX	Class II	1986-09-11
K862196	Toxonostika Igm Microelisa System	bioMerieux, Inc.	LGD	Class II	1986-09-11
K862107	Penn & Olympus Ureteroscopy Guide Sheath & Dilator	Penn Medical Devices, Inc.	ODC	Class II	1986-09-11
K863313	Grip Strength Device (Gsd)	Devcom, Inc.	IKK	Class II	1986-09-09
K863299	Modified Q50 Medical Treadmill	Quinton, Inc.	IOL	Class I	1986-09-09
K863293	Disposable Suction Cannula No. 902008-000	Lifestream Int'L, Inc.	GEA	Class I	1986-09-09
K863280	Dermamarker	Dermacare Products, Inc.	FZZ	Class I	1986-09-09
K863279	Surgi-Tek Tube Positioner	Dermacare Products, Inc.			1986-09-09
K863260	Blood Urea Nitrogen(bun) Procedure	Data Medical Associates, Inc.	CDQ	Class II	1986-09-09
K863169	Model as-72 Administration Set	Life-Tech Intl., Inc.	FAP	Class II	1986-09-09
K863128	Peritoneal Dialysis Catheters	Thermedics, Inc.	FJS	Class II	1986-09-09
K863113	Uricmeter	J. D. Assoc.	KNK	Class I	1986-09-09
K863078	Creatinine-E	J. D. Assoc.	JFY	Class II	1986-09-09
K863076	Ureafast	J. D. Assoc.	CDL	Class II	1986-09-09
K863074	Total Proteins	J. D. Assoc.	CEK	Class II	1986-09-09
K863073	Total Lipids	J. D. Assoc.	CFD	Class I	1986-09-09
K863072	Fosforometer	J. D. Assoc.	CEO	Class I	1986-09-09
K863071	Phospholipids-E	J. D. Assoc.	CEQ	Class I	1986-09-09
K863063	Cholesterol-E Fast (Total)	J. D. Assoc.	CHH	Class I	1986-09-09
K863061	Clorofast	J. D. Assoc.	CHJ	Class II	1986-09-09
K863055	Bilifast	J. D. Assoc.	CIG	Class II	1986-09-09
K863052	Alpha Amylase	J. D. Assoc.	CJA	Class II	1986-09-09
K863051	Alp S.c.e.	J. D. Assoc.	CJE	Class II	1986-09-09
K862909	Re-Trake Weiss Emergency Airway & Thoracic System	Intl. Medical Devices, Ltd.	BTO	Class II	1986-09-09
K862718	Versa Stim	Conmedcorp	GXY	Class II	1986-09-09
K862716	Hemofiltration System 10	Gambro, Inc.	FII	Class II	1986-09-09
K862640	Amylase Lts	Electro-Nucleonics Laboratories, Inc.	CJA	Class II	1986-09-09
K862539	Silicone Double Coil Ureteral Stent with Suture	Mentor	FAD	Class II	1986-09-09
K862484	Hci Y-Connector	Hospital Concepts, Inc.	KOD	Class II	1986-09-09
K862304	Drake Willock Central Dialysate Delivery System	Cd Medical, Inc.	FKQ	Class II	1986-09-09
K861896	Uni-TENS Xl TENS	Solcoor, Inc.	GZJ	Class II	1986-09-09
K861895	Uni-TENS	Solcoor, Inc.	GZJ	Class II	1986-09-09