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 2026-10-26, 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 2781 of 3530

510(k) clearances, page 2781 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K873194	Spectramed Respiratory Gas Analyzer	Draeger, Inc.	CBS	Class II	1987-10-30
K873075	Adac Model Arc-5000, Gamma Camera	Philips North America LLC	JWM	Class II	1987-10-30
K873048	Kodak Sv6500 Printer/ Sv65 Finisher/ Sv100 Set	Eastman Kodak Company	LMB	Class I	1987-10-30
K872182	Polystan Wire Reinforced Catheters and Cannulae	Polystan C/O Vitalcor, Inc.	DQY	Class II	1987-10-30
K872163	Impra Dual Lumen Subclavian Catheter	Impra, Inc.	DQY	Class II	1987-10-30
K872090	The Robicsek - Pruitt Aortic Balloon Occlusion Kit	Ideas for Medicine, Inc.	DQT	Class II	1987-10-30
K871810	Plan-32 Software	Oncology Systems, Inc.	JAD	Class II	1987-10-30
K864981	Toxoplasma Gondii	Virion (U.S.), Inc.	GMN	Class II	1987-10-30
K874279	Ahh Natural Breast Form	Pacific Prosthetics, Inc.	GBI	Class I	1987-10-29
K874080	Revised Labeling for Syva Amphetamine Assay	Syva Co.	DKZ	Class II	1987-10-29
K874049	Multichem Albumin Reagent S0902	Simmler Inc	CIX	Class II	1987-10-29
K873994	Easy-Test Albumin (Alb), Item No. 19039	Em Diagnostic Systems, Inc.	CIX	Class II	1987-10-29
K873898	Revised Labeling for Syva Opiate Assays	Syva Co.	DJG	Class II	1987-10-29
K873855	Emit Qst Gentamicin Assay	Syva Co.	LCD	Class II	1987-10-29
K873635	Easy-Test Alkaline Phosphatase (Alp) #19021	Em Diagnostic Systems, Inc.	CJE	Class II	1987-10-29
K873589	Perfect Suntanning Bed	Wolff System Technology Corp.	LEJ	Class II	1987-10-29
K873518	Affinity Total Thyroxine Immunit	BD Becton Dickinson Vacutainer Systems Preanalytic	KLI	Class II	1987-10-29
K873469	Todd Medical/skilled Care Products	Todd Medical, Inc.	LRP	Class I	1987-10-29
K873460	Ophthalas Dye Ophthalmic Laser	Biophysic Medical, Inc.	HQF	Class II	1987-10-29
K873436	Emds Amikacin Calibrator Item No. 67633/95	Em Diagnostic Systems, Inc.	DLJ	Class II	1987-10-29
K873426	Easy-Test Emit(r) Amikacin (Amik) No. 16645	Em Diagnostic Systems, Inc.	KLP	Class II	1987-10-29
K873425	Easy-Test Salicylate (Sal) #16691	Em Diagnostic Systems, Inc.	DKJ	Class II	1987-10-29
K873011	Quantimetrix Serum Alcohol Control Level 1 and 2	Quantimetrix Medical Industries	LAS	Class I	1987-10-29
K872643	Cox Rapid Heat Transfer Sterilizer	Cox Sterile Products, Inc.	KMH	Class II	1987-10-29
K874201	Revised Labeling for Syva Cocaine Metabolite Assay	Syva Co.	DIO	Class II	1987-10-28
K874200	Revised Labeling for Syva Propoxyphene Assays	Syva Co.	JXN	Class II	1987-10-28
K874199	Revised Labeling for Syva Methaqualone Assays	Syva Co.	KXS	Class II	1987-10-28
K874173	Biotis (Tm) Bhi with Hrbc, Chlora/gentam/cyclohexi	Otisville Biopharm, Inc.	JSJ	Class I	1987-10-28
K874172	Biotis (Tm) Inhibitory Mold Agar (Double Pour)	Otisville Biopharm, Inc.	JSJ	Class I	1987-10-28
K874156	Sticker Label for Drugs of Abuse Assays	Syva Co.	LDJ	Class II	1987-10-28
K874079	Revised Labeling for Syva Cannabinoid Assays	Syva Co.	LDJ	Class II	1987-10-28
K874055	Iron Reagent	Trace Scientific, Ltd.	JMO	Class I	1987-10-28
K874038	Multichem Inorganic Phosphorous S0923	Simmler Inc	CEO	Class I	1987-10-28
K874019	Staphslide	Ncs Diagnostics, Inc.	JWX	Class I	1987-10-28
K873999	Premier-Total (Tm) Hip	Intermedics Orthopedics	JDI	Class II	1987-10-28
K873919	Tangent Screen	Richmond Products, Inc.	HOJ	Class I	1987-10-28
K873918	Head & Chin Rests	Richmond Products, Inc.	HRH	Class I	1987-10-28
K873915	Jackson Cross Cylinder Test	Richmond Products, Inc.	HOR	Class I	1987-10-28
K873909	Reading Charts-Cards (Distance and Nearpoint)	Richmond Products, Inc.	HOX	Class I	1987-10-28
K873899	Revised Labeling for Syva Methadone Assays	Syva Co.	DJR	Class II	1987-10-28
K873872	Hcg Enzyme Immunoassay Test Kit Catalog #Mb-1013	Medix Biotech, Inc.	DHA	Class II	1987-10-28
K873854	Emit Gentamicin Assay	Syva Co.	LCD	Class II	1987-10-28
K873849	Altairex Bucky/cassette Tray Combination	Altairex Manufacturing, Inc.	IXQ	Class II	1987-10-28
K873815	Ioi Bipolar Prosthesis	Intermedics Orthopedics	KWY	Class II	1987-10-28
K873715	Bone Pin Cutter 18	Military Engineering, Inc.	HXZ	Class I	1987-10-28
K873585	Porous Coated Acetabular Cup	Johnson & Johnson Professionals, Inc.	JDI	Class II	1987-10-28
K873459	Alta Systems Tibial/upper Extremity Diaphyseal Plt	Howmedica Corp.	KTT	Class II	1987-10-28
K873429	Freeman-Samuelson Mark II Press-Fit Total Knee	Protek, Inc.	MBV	Class II	1987-10-28
K873377	Closed Chest Drainage Set W/sutures	Gish Biomedical, Inc.	GBS	Class I	1987-10-28
K873281	Carbamazepine (Fpia) Calibrator Kit	Windsor Laboratories, Inc.	DLJ	Class II	1987-10-28