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 2850 of 3529

510(k) clearances, page 2850 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K864211	Il Test 97575-15, Heparin Assay	Instrumentation Laboratory Co.	KFF	Class II	1987-01-05
K863470	Daltex IV Infusion Pump	Daltex Medical Sciences, Inc.	FRN	Class II	1987-01-05
K862867	Eub-310 Ultrasonic Scanner	Hitachi Medical Corp. of America	IYO	Class II	1987-01-05
K861205	1990A Bio-Resistance Body Composition Analyzer	Valhalla Scientific, Inc.	DSB	Class II	1987-01-05
K853952	Metriflow Afm-100 Peripheral Vascular Blood Flowme	Metriflow, Inc.	DPW	Class II	1987-01-05
K864262	Arterial 20/40 Micron Filters W/wo Heparin Coating	Johnson & Johnson Professionals, Inc.	DTM	Class II	1987-01-02
K864235	Bard(r) Wm Harvey(r) Blood Oxygenator/model H-1600	C.R. Bard Inc	DTZ	Class II	1987-01-02
K864007	Embolectomy/thrombectomy Balloon Catheter	Uresil, LLC	DXE	Class II	1987-01-02
K863308	2200I Physiological Monitor	Datascope Corp.	DXG	Class II	1987-01-02
K862724	Vein Valve Cutter	American Edwards Laboratories	DQY	Class II	1987-01-02
K862459	Modified Circuit Burn-in Process Implantable Pulse	Medtronic, Inc.	DXY	Class III	1987-01-02
K862211	Ultrasound Transducer Assembly	Johnson & Johnson Professionals, Inc.	ITX	Class II	1987-01-02
K864939	Beckman Dri-Stat Triglycerides-Gpo Reagent Kit	Beckman Instruments, Inc.	CDT	Class I	1986-12-31
K864906	Alanine Amino Transferase Alt/sgpt	Tech-Co, Inc.	CKA	Class I	1986-12-31
K864776	A549 (Human Lung Carcinoma) Culture Cells	Bartels Immunodiagnostic Supplies, Inc.	KIR	Class I	1986-12-31
K864715	Easy-Test Albumin (Alb), Item No. 67529/93	Em Diagnostic Systems, Inc.	CIX	Class II	1986-12-31
K864713	Chloride Reagent	Sigma Diagnostics, Inc.	CHJ	Class II	1986-12-31
K864634	Ap1 Colorimeter	Awareness Technology, Inc.	JJQ	Class I	1986-12-31
K864303	Qko (Tm) Amylase B-Ha	FUJIFILM Healthcare Americas Corporation	JFJ	Class II	1986-12-31
K864236	Synchron Cx3	Beckman Instruments, Inc.	JJF	Class I	1986-12-31
K863580	Dermatec Transparent Film Dressing	Dermatec, Inc.	NAD	Class I	1986-12-31
K863069	Magnesiometer	J. D. Assoc.	JGJ	Class I	1986-12-31
K864892	Ellison Arthroscopy Cheater	Buckman Co., Inc.	HRX	Class II	1986-12-30
K864570	Pamitex,long Love,desire,skin Less,ginza,love Time	Dongkuk Techco Rubber Industries	HIS	Class II	1986-12-30
K864495	Medsurg Vascular Access Port Infusion Tray	Medsurg Industries, Inc.			1986-12-30
K864881	Arthroscopic Ankle Holder	Mizuho Orthopedic Systems Inc	FWZ	Class I	1986-12-29
K864880	Collins Positioning Device	Mizuho Orthopedic Systems Inc	FWZ	Class I	1986-12-29
K864788	Exactech Total Hip Instruments	Exactech, Inc.			1986-12-29
K864781	Maclee/boin Medica Sterile Needle/syringe 20Ml/cc	Mac Lee Medical Products	FMF	Class II	1986-12-29
K864779	Maclee/boin Medica Sterile Needle/syringe 50Ml/cc	Mac Lee Medical Products	FMF	Class II	1986-12-29
K864778	Maclee/boin Medica Sterile Needle/syringe 30Ml/cc	Mac Lee Medical Products	FMF	Class II	1986-12-29
K864777	Maclee/boin Medica Sterile Needle & Syringe 3Ml/cc	Mac Lee Medical Products	FMF	Class II	1986-12-29
K864764	Culturia Macconkey-Mug/cled Systems	Clinical Convenience Products, Inc.	JSI	Class I	1986-12-29
K864747	Various Syringes W/needles, W/out Needles, Needles	JMS Co., Ltd.	FMF	Class II	1986-12-29
K864676	Heyer-Schulte Hermetic External Csf Drain. System	American V. Mueller	JXG	Class II	1986-12-29
K864653	Model 2060 W/6 Cm(2) & Model 2100 W/10 Cm(2) Trans	Rich-Mar Corp.	IMJ	Class II	1986-12-29
K864639	Reusable Surgical Keratoscope	JEDMED Instrument Company	HLR	Class I	1986-12-29
K864630	Kc/emg Diagnostic Electromyograph	Chattanooga Group, Inc.	IKN	Class II	1986-12-29
K864625	Myopac (Tm), Model 9600	Medical Devices Inc.	IPF	Class II	1986-12-29
K864584	Fluorovision Contrast Enhancer	Digivision, Inc.	JAA	Class II	1986-12-29
K864558	U66 Ems	Suntec Health & Fitness Group, Inc.	IPF	Class II	1986-12-29
K864292	Disposal Surgical Instruments for Ophthalmology	Eye-Ko, Inc.	HNQ	Class I	1986-12-29
K864284	Muscle Master (Medium Voltage Stimulator)	Modern Systems Technology, Inc.	IPF	Class II	1986-12-29
K864264	Tricotex Wound Contact Layer Dressing	Smith & Nephew, Inc.	NAB	Class I	1986-12-29
K864263	Neoprobe Portable Radioisotope Detector	Neoprobe Corp.	IZD	Class I	1986-12-29
K864138	Minimed Model 404-S External Infusion Pump	Medtronic, Inc.	FRN	Class II	1986-12-29
K864076	Hercon Antiseptic Transparent Dressing	Hercon Laboratories Corp.	KGX	Class I	1986-12-29
K863970	Mlc Endothelial Cell Counter	Mlc Technologies	HJO	Class II	1986-12-29
K863780	Ada-1000 (Advanced Digital Array)	Diasonics, Inc.	IYO	Class II	1986-12-29
K863736	Fms Model 110	Flir Medical Systems	IYM	Class III	1986-12-29