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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 1779 of 3531

510(k) clearances, page 1779 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K981912	Human Iga Subclass Bnii Combi Kit	The Binding Site	CFN	Class II	1998-12-04
K981816	Cue Ambulatory Volumetric Infusion Pump	Becton Dickinson Curlin, LLC	FRN	Class II	1998-12-04
K981781	Electrosurgical Unit	Hill-Med, Inc.	GEI	Class II	1998-12-04
K984071	Liquichek Homocysteine Control, Cat #644	Bio-Rad	JJX	Class I	1998-12-03
K983583	Depuy Acromed Moss and Moss Miami Spinal Systems	Depuy, Inc.	KWP	Class II	1998-12-03
K983452	Nelson Resurfacing Head	Zimmer GmbH	KXA	Class II	1998-12-03
K983165	Osteo 4.0Mm Cannulated Screw System	Osteonics Corp.	HWC	Class II	1998-12-03
K983128	Implex Hedrocel Replacement Cup Insert Model Numbers 02-246-Xxyyy, 02-247-Xxyyy, 02-248-Xxyyy	Implex Corp.	JDI	Class II	1998-12-03
K983116	Electrosurgical Inflatable Basket Electrodes	Conway Stuart Medical, Inc.	GEI	Class II	1998-12-03
K982764	Premier Cryptosporidium	Meridian Diagnostics, Inc.	MHJ	Class II	1998-12-03
K972991	Monitor One Ndx	Qmed, Inc.	DPS	Class II	1998-12-03
K983870	Osteonics Restoration Ha Hip Stems	Osteonics Corp.	MEH	Class II	1998-12-02
K983710	150Mm Cocr Bimetric Head/neck Replacement Hip Stem- Color Buff Finish	Zimmer GmbH	JDI	Class II	1998-12-02
K983491	Depuy Duraloc Acetabular Cup System-Enduron Liner	Depuy Orthopaedics Inc.	LPH	Class II	1998-12-02
K983317	Barron Microkeratome System, Model B2000	Barron Precision Instruments, L.L.C.	HNO	Class I	1998-12-02
K983279	Endocam Camera Systems 5502 with Electronic Ccd Endoscope	Richard Wolf Medical Instruments Corp.	GCJ	Class II	1998-12-02
K983026	Pacemaker Data Pmd Transmitter, Model Cg-4000	Card Guard Scientific Survival, Ltd.	DXH	Class II	1998-12-02
K982212	Veritas Bipolar, Insulated, 0.5Mm Tip, Model N301-005 Veritas Bipolar, Insulated 1.0Mm Tip Model N301-010	Synergetics Inc	GEI	Class II	1998-12-02
K981881	Drg Sherlock Mf Bone Screw, Cocrmo Self-Tapping, Ti Alloy Self-Tapping/self Drilling, Cocrmo Self-Tapping/ Self Drilling	Doctor'S Research Group, Inc.	DZL	Class II	1998-12-02
K981171	Eradic-All	Theratechnologies Inc.	EIA	Class I	1998-12-02
K984131	Coagulation Control Level 3 (Abnormal)	Pacific Hemostasis	GGC	Class II	1998-12-01
K984130	Coagulation Control Level 2 (Abnormal)	Pacific Hemostasis	GGC	Class II	1998-12-01
K984129	Coagulation Control Level 1 (Normal)	Pacific Hemostasis	GIZ	Class II	1998-12-01
K983871	Rita Model 70 Electrosurgical Probe	Boston Scientific Corporation	GEI	Class II	1998-12-01
K983847	Modification of: Odyssey I Dental Water Unit	Germiphene Corp.	EIA	Class I	1998-12-01
K983503	Roche Diagnostics, Boehringer Mannheim Corporation Inorganic Phosphorus Reagent Catalog Number 1730347	Boehringer Mannheim Corp.	CEO	Class I	1998-12-01
K983424	Abbott Archeitect Total B-Hcg	Abbott Medical	DHA	Class II	1998-12-01
K983415	Delivery Sheath	Conway Stuart Medical, Inc.	FED	Class II	1998-12-01
K983072	Ambulatory Eeg/sleep Recorder and Accessories, Model # Ssr3201	Nihon Kohden America Inc	OLV	Class II	1998-12-01
K983065	Mentor Ultrasound-Assisted Tissue Removal System	Mentor	LFL	Unclassified	1998-12-01
K974617	Peripheral Vascular Dilator	Endovascular Instruments, Inc.	DRE	Class II	1998-12-01
K974259	Venous Flex II Peripheral and Intra-Operative Access Venous Return Cannulae	Edwards Lifesciences LLC	DWF	Class II	1998-12-01
K971336	Caird Technology Spirometer	Caird Technology	BZG	Class II	1998-12-01
K984034	The Aptus (Automated) Application of the Anca Screen Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for	Zeus Scientific LLC	MOB	Class II	1998-11-30
K983975	Belmont Fluid Management System (Fms2000)	Belmont Medical Technologies	FRN	Class II	1998-11-30
K983869	Dispatch Hospital Cleaner Disinfectant Towels with Bleach	Caltech Industries, Inc.	LRJ	Class I	1998-11-30
K983751	Quadrant Unichem	Cavex Holland B.V.	EBF	Class II	1998-11-30
K983750	Deroyal Industries, Inc Tracecart Sharps Collection Container	DeRoyal Industries, Inc.	FMI	Class II	1998-11-30
K983668	Modification of Pq1	Ultradent Products Inc.	KLE	Class II	1998-11-30
K983532	Powder Free Copolymer Nitrile Medical Examination Glove, Colored	Shanghai Antares Industries, Inc.	LYZ	Class I	1998-11-30
K983531	Powdered Nitrile Medical Examination Glove, Colored	Shanghai Antares Industries, Inc.	LYZ	Class I	1998-11-30
K983515	Kls Intraoral Vertical Distractor	KLS-Martin L.P.	MQN	Class II	1998-11-30
K983490	Terumo Venoject,luer Adapter	Terumo Corp.	JKA	Class II	1998-11-30
K983244	Sensititre 18-24 Hr Susceptibility Plates(addition of Meropenem)	Trek Diagnostic Systems, Ltd.	JTW	Class I	1998-11-30
K983240	Neutralon Pf Powder Free Brown Latex Surgical Gloves	Johnson & Johnson Medical, Div. of Ethicon, Inc.	KGO	Class I	1998-11-30
K983172	Accu-Base Hemoglobin A1c Sample Collection Kit	Diabetes Technologies, Inc. (Dti)	LCP	Class II	1998-11-30
K982898	Immuglo Anti-Neutrophil Cytoplasmic Antibody (Anca) Test Sytem	Immco Diagnostics, Inc.	MOB	Class II	1998-11-30
K982877	Matang Powder-Free Low Protein Latex Patient Examination Glove	Matang Mfg. Sdn. Bhd.	LYY	Class I	1998-11-30
K982797	Blunt T-Peel Introducer Model Number Pe-16Picb, Pe-18Picb, Pe-20Picb, Pe-24Picb	Luther Medical Products, Inc.	DYB	Class II	1998-11-30
K982716	Omnigrace Latex Examination Glove, Powder-Free, with Protein Claim	Omnigrace (Thailand), Ltd.	LYY	Class I	1998-11-30