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 2784 of 3530

510(k) clearances, page 2784 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K873250	Isomune-Amylase and Isomune-Amylase Control	Roche Diagnostic Systems, Inc.	CIJ	Class II	1987-10-20
K873112	Phadebas Rast/phadezym Rast Allergen Disc	Pharmacia, Inc.	DHB	Class II	1987-10-20
K873077	Pharmacia Ige Eia	Pharmacia, Inc.	JHR	Class II	1987-10-20
K873074	Sodium and Potassium by Ion Selective	American Monitor Corp.	JGS	Class II	1987-10-20
K873068	Oxygen Analyzer Model 800 Series	Salter Instrumentation, Inc.	CCL	Class II	1987-10-20
K873051	Stratus(r) Hfsh Fluorometric Enzyme Immunoassay	American Dade	CGJ	Class I	1987-10-20
K873050	Vascular Access Catheter W/antimicrobial Cuff	C.R. Bard Inc	FOZ	Class II	1987-10-20
K872981	Acs Indeflator Plus (Modification #2)	Advanced Cardiovascular Systems, Inc.	DXT	Class II	1987-10-20
K872962	Breast-Scan(tm)	Thermascan, Inc.	LHM	Class I	1987-10-20
K872952	Ultrasonic Air-in-Line Detector (Aild)	Imed Corp.	FRN	Class II	1987-10-20
K872946	Phadebas Rast/phadezym Rast Allergen Disc	Pharmacia, Inc.	DHB	Class II	1987-10-20
K872908	Endometrial Sampler	Zinnanti Surgical Instruments, Inc.	HHK	Class II	1987-10-20
K872839	Antinuclear Antibody Test	Cappel Diagnostics, Inc.	LJM	Class II	1987-10-20
K872791	Porex Nerve Locator	Porex Medical	ETN	Class II	1987-10-20
K872742	Warm Weigh Models I-20/W-30 Infant Scale	Air-Shields, Inc.	FMT	Class II	1987-10-20
K872741	Nutripump	I M, Inc.	FRN	Class II	1987-10-20
K872736	Prophylactic (Condom)	Circle Rubber Corp.	HIS	Class II	1987-10-20
K872730	Result Plus/hcg Pregnancy Test	Ortho Diagnostic Systems, Inc.	JHI	Class II	1987-10-20
K872539	Eurogenetics Crp Elisa	Eurogenetics	DCN	Class II	1987-10-20
K872505	Diascan* Blood Glucose Self-Monitoring Test Strips	Home Diagnostics, Inc.	CGA	Class II	1987-10-20
K872070	Chromotitre E.i.a. Toxoplasma Igm	Ismunit Istituto Immunologico Intaliano	LGD	Class II	1987-10-20
K871948	Angel Latex Prophylactics (Condoms)	Angel Intl. Trading Co., Inc.	HIS	Class II	1987-10-20
K871922	Portable Ph, Mv, Temp Meter W/auto. Temp Compensa.	Chemfet Corp.	FFT	Class I	1987-10-20
K871921	General Purpose Combination Ph Electrode	Chemfet Corp.	FFT	Class I	1987-10-20
K871446	Hologic Models Blk-1, Dpa/qdr-1 & Qct-1	Hologic, Inc.	KGI	Class II	1987-10-20
K871344	Pathfinder 3, Auto Surveyor and Surveyor	Reynolds Medical, Ltd.	DSI	Class II	1987-10-20
K871036	Condom Takaso Rubber Products Sdn/bdh	Takaso Rubber C/O Interstate Supplier, Inc.	HIS	Class II	1987-10-20
K870726	Rt5000 Echocardiography #H4100c/ce	General Electric Co.	JOP	Class II	1987-10-20
K870656	Imed(r) 980C Volumetric Infusion Pump	Imed Corp.	FRN	Class II	1987-10-20
K870516	Albumin Screen Test	Sclavo, Inc.	JIQ	Class I	1987-10-20
K865107	Aero-Vent Aerosol Unit	Medi Nuclear Corp., Inc.	IYT	Class II	1987-10-20
K873963	Coherent Xa-30 CO2 Surgical Laser	Coherent Medical Group	GEX	Class II	1987-10-19
K873749	Ciba Corning/shimadzu Model 570 Chem. Analyzer	Ciba Corning Diagnostics Corp.	JJE	Class I	1987-10-19
K873617	Gemstar II System	Electro-Nucleonics Laboratories, Inc.	JJE	Class I	1987-10-19
K873609	Vehicle, Motorized (3-Wheeled Electric Cart)	American Dynatec Corp.	INI	Class II	1987-10-19
K873363	Uric Acid Pap	Boehringer Mannheim Corp.	KNK	Class I	1987-10-19
K873836	Mammographic Kvp Meter Model 232	Radiation Measurements, Inc.	IZH	Class II	1987-10-16
K873599	Edi 320	Cybex	KQX	Class I	1987-10-16
K872871	Neonatal Spunlace Breathable Poly. Fabric Ecg(rcr)	Labeltape Meditect, Inc.	DRX	Class II	1987-10-16
K874044	Intra-Articular Arthroscopic Shaver	MEDLINE INDUSTRIES, LP - Northfield	HWE	Class I	1987-10-15
K873780	Modification Rubella Igm Eia Test Kit	Labsystems, Inc.	LFX	Class II	1987-10-15
K873759	Labeling Change Coat-a-Count Methaqualone	Siemens Healthcare Diagnostics Inc.	KXS	Class II	1987-10-15
K873758	Labeling Change Coat-a-Count Serum Morphine	Siemens Healthcare Diagnostics Inc.	DJG	Class II	1987-10-15
K873757	Labeling Change Coat-a-Count Morphine in Urine	Siemens Healthcare Diagnostics Inc.	DJG	Class II	1987-10-15
K873756	Labeling Change Pcp (Phencyclidine) in Urine	Siemens Healthcare Diagnostics Inc.	LCM	Unclassified	1987-10-15
K873755	Labeling Change Amphetamine Double Antibody	Siemens Healthcare Diagnostics Inc.	DKZ	Class II	1987-10-15
K873754	Labeling Change Barbiturates in Urine	Siemens Healthcare Diagnostics Inc.	DIS	Class II	1987-10-15
K873753	Labeling Change Cannabinoids Double Anti. in Urine	Siemens Healthcare Diagnostics Inc.	LDJ	Class II	1987-10-15
K873752	Labeling Change Cocaine Metabolite Double Antibody	Siemens Healthcare Diagnostics Inc.	DIO	Class II	1987-10-15
K873751	Labeling Change Coat-a-Count Cocaine Metabolite	Siemens Healthcare Diagnostics Inc.	DIO	Class II	1987-10-15