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 2909 of 3529

510(k) clearances, page 2909 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K860543	Blood Urea Nitrogen (Bun) Testcard	Ilex Corp.	CDS	Class II	1986-04-21
K860451	Murex (Tm), Suds (Tm), Hcg Assay	Murex Corp.	LCX	Class II	1986-04-21
K860334	Visi-Check Hlh Test Monoclonal	Bioclinical Systems, Inc.	CEP	Class I	1986-04-21
K860333	Micro-Elisa Hlh Test Kit Monoclonal	Bioclinical Systems, Inc.	CEP	Class I	1986-04-21
K853889	Cordia Cmv-M	Cordis US Corp.	LKQ	Class II	1986-04-21
K853089	Super Algin, Alginamine, Empress Dustfree	PSP Dental Co., Ltd.	ELW	Class II	1986-04-21
K861383	Solex Therapeutic Pad	Intl. Diathermics Research, Inc.	IRT	Class II	1986-04-18
K861373	Human Lung Carcinoma Cells (A549)	Viromed Laboratories, Inc.	KIR	Class I	1986-04-18
K861312	Lyfo-Kwik (Tm) Coagulase Plasma	Micro-Bio-Logics	JTL	Class I	1986-04-18
K861289	Basic Light	Burton Medical Products Corp.	KZF	Class I	1986-04-18
K861218	Aqua Ark, Immersion Hydrobath	Aqua Ark, Inc.	ILJ	Class II	1986-04-18
K861206	Nautilus Leg Extension Testing & Rehabilitation	Nautilus Sports/Medical Industries, Inc.	IKK	Class II	1986-04-18
K861016	Gamma Slide Test for Infectious Mononucleosis	Gamma Biologicals, Inc.	KTN	Class II	1986-04-18
K860821	Biodex System	Biodex Corp.	IKK	Class II	1986-04-18
K860632	Ebi Hand Massaging Pump (Hmp)	Electro-Biology, Inc.	IRP	Class II	1986-04-18
K860354	Sepracell Lymphocyte Separation Medium	Sepratech Corporation C/O Keller and Heckman	JCF	Class I	1986-04-18
K860162	Flo-Gard 6200 Volumetric Infusion Pump	Travenol Laboratories, S.A.	FRN	Class II	1986-04-18
K854991	Reumagen Asl	Biokit USA, Inc.	GTQ	Class I	1986-04-18
K854355	Greenleaf Smart Polygraph Program	Greenleaf Science Corp.	BZQ	Class II	1986-04-18
K852436	Ambulase	Xanar, Inc.	GEX	Class II	1986-04-18
K861285	Skin Mesh Device	Precision Modified Devices	GFD	Class I	1986-04-17
K861258	Permaband (Orthodontic Adhesive)	Ortho Source	DYH	Class II	1986-04-17
K861251	Amp Closed Urinary Drainage Bag, 1011 & 1011N	American Medical Products LLC	KNX	Class II	1986-04-17
K861239	Acrylic Solder	Parker Laboratories, Inc.	EBI	Class II	1986-04-17
K861215	Gauze Sponges Usp Type VII	Selomas, Inc.	EFQ	Unclassified	1986-04-17
K861137	Orthomed Orthopaedic Fixation Staples	Biomedical Exports, Inc.	JDR	Class II	1986-04-17
K861114	Mallory/head - Pf Acetabular Component	Zimmer GmbH	JDI	Class II	1986-04-17
K860833	Epidural Anesthesia Tray	Travenol Laboratories, S.A.	CAZ	Class II	1986-04-17
K860822	Lasersonics Laser Cystoscope Model Fcy-6-35	Cooper Lasersonics, Inc.	FAJ	Class II	1986-04-17
K860748	Hitachi 736	Boehringer Mannheim Corp.	JJE	Class I	1986-04-17
K860736	Fischer Imaging Fx325r X-Ray Generator	Fischer Imaging Corp.	IZO	Class I	1986-04-17
K860708	Photo Clearfil Opaquer	Kuraray Co.	EBF	Class II	1986-04-17
K860659	End Tidal CO2 Sampling Circuit	Life Design Systems, Inc.	BZO	Class I	1986-04-17
K860653	Pure Titanium Screw-Type for Dental Implant	Otc/America	DZE	Class II	1986-04-17
K860647	Es600 Immunoassay System	Boehringer Mannheim Corp.	JJE	Class I	1986-04-17
K860552	Peritone Disposal Sheath - Rubber and Vinyl	Laurie Ann Kaiser, Ph.D.	HIR	Class II	1986-04-17
K860545	Vaporizer Spacer	Southmedic Inc.	CAD	Class II	1986-04-17
K860537	The Cell Care System	The Clell Corp.	KMI	Class I	1986-04-17
K860240	Cns-Ep System and Ep 1.0 Software	Cns, Inc.	GWF	Class II	1986-04-17
K860219	Sasssy Semi Automatic Sleep Scoring System	Grass-Telefactor Product Group	OLV	Class II	1986-04-17
K860212	Cardiofax ECG-6353	Nihon Kohden America Inc	DPS	Class II	1986-04-17
K860170	Voroba Technologies, Assoc. Quantum Hearing Aid	Voroba Technologies Assoc.	ESD	Class I	1986-04-17
K860118	Sunbeam Ultrasonic Denture Cleaner Model 4220	Northern Electric Co. Div. of Sunbeam Corp.	EFT	Class I	1986-04-17
K854639	Biomecca Central Cs1	Biomecca Australia, Ltd.	DRT	Class II	1986-04-17
K854478	Rei-90/90 Radiographic Table	Radiological Engineering, Inc.	IXR	Class II	1986-04-17
K854201	Omron Digital Bp Monitor Hem-700Cp	Omron Tateisi Electronics Co.	DXN	Class II	1986-04-17
K853774	Em Electrode	Electromed Intl., Ltd.	DRX	Class II	1986-04-17
K844772	6.0 Mhz La6060 Transducer & 4.0 Mhz La4011 Transdu	Philips North America LLC	ITX	Class II	1986-04-17
K861252	Non-Circular Orbiting Option	Siemens Gammasonics, Inc.	KPS	Class II	1986-04-16
K860732	Enzymatic Uric Acid Reagent	Trace Scientific, Ltd.	KNK	Class I	1986-04-16