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 2026-10-21, 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 3019 of 3529

510(k) clearances, page 3019 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K850088	Arterial Extension Set	Medical Matrix, Inc.	FPA	Class II	1985-02-02
K850253	Econo Mate -Oxygen Concentrator	Mountain Medical Equipment, Inc.	CAW	Class II	1985-02-01
K850136	Cardio Data Mk4 Holter Analysis System	Cardio Data	DSI	Class II	1985-02-01
K850128	Syste Mate Tibc Hem No. 67225	Em Diagnostic Systems, Inc.	JMO	Class I	1985-02-01
K850032	A Family of Tracheobronchial Suction Catheter Prod	Paco Research Corp.	BSY	Class I	1985-02-01
K850008	Sopheia/mp Cortisol Eia Kit	Siemens Healthcare Diagnostics Inc.	CGR	Class II	1985-02-01
K845026	Amerlex-M Progesterone Radioimmunoassay Kit Code	Amersham Corp.	JLS	Class I	1985-02-01
K844888	Spacelabs Series 600 Patient Monitors	Spacelabs, Inc.	DRT	Class II	1985-02-01
K844784	Dps-33000 Nuclear Medicine Imaging Computer	Philips North America LLC	LLZ	Class II	1985-02-01
K844783	Dps-3300 Micro Nuclear Medicine Imaging Computer	Philips North America LLC	LLZ	Class II	1985-02-01
K844781	Membrane Kits-Kc1, CO2 & 02 for Instrument-Lab	Shaban Mfg. Co.	CHL	Class II	1985-02-01
K844767	Radioimmunoassay of Human Serum Plasma or Urine to	Biotecx Laboratories, Inc.	CGI	Class I	1985-02-01
K844687	Medtronic Model 6912	Medtronic, Inc.	DTD	Class II	1985-02-01
K844598	Lariat Catheter	Mallinckrodt Critical Care	DQO	Class II	1985-02-01
K844442	Rapid Diagnostic Kit	Portable Medical Laboratories, Inc.	LIB	Class I	1985-02-01
K844180	The Mcp-70-Se System	Ellis Pharmaceutical Consulting, Inc.	KQA	Class II	1985-02-01
K844023	Aquaform Electrodes with Aquapore	Biostim, Inc.	GXY	Class II	1985-02-01
K843977	Pulse-Aid Device	James J. Lally	LIX	Class II	1985-02-01
K843828	Cobas Reagents for Tobramycin & Calibra	Roche Diagnostic Systems, Inc.	LFW	Class II	1985-02-01
K843827	Cobas Reagents for Gentamicin & Calibrat	Roche Diagnostic Systems, Inc.	LCQ	Class II	1985-02-01
K843826	Cobas Immunoassay for Theophylline & Cal	Roche Diagnostic Systems, Inc.	LGS	Class II	1985-02-01
K843825	Cobas Reagents Phenobarbital & Phenobar	Roche Diagnostic Systems, Inc.	LGQ	Class II	1985-02-01
K843824	Cobas Fp Reagents for Phenytoin & Calibr	Roche Diagnostic Systems, Inc.	LGR	Class II	1985-02-01
K843807	Seamed Model 6000	Seamed Corp.	DTE	Class II	1985-02-01
K843777	Seamed 4000	Seamed Corp.	DTE	Class II	1985-02-01
K843555	Cardiac Computer Sp1445	Gould, Inc.	DXG	Class II	1985-02-01
K842908	Variable Prime Cobe Membrane Lung	Cobe Laboratories, Inc.	DTZ	Class II	1985-02-01
K841084	Arrhythmia System Ac-11	Fukuda Denshi USA, Inc.	DSI	Class II	1985-02-01
K840037	Modified Smec Percutaneous Intra-Aortic	Smec, Inc.	DSP	Class II	1985-02-01
K844558	Umi Amniocentesis Kit W/spinal Needle	Universal Medical Instrument Corp.	HIO	Class I	1985-01-31
K843643	Color Doppler 880	Irex Corp.	DXK	Class II	1985-01-31
K844640	Polystat, Biological Stain	Surgipath Medical Industries, Inc.	IAB	Class I	1985-01-30
K844634	Pdc 104 & Pdc 304 Style Culture Collection & Trans	Precision Dynamics Corporation	JSM	Class I	1985-01-30
K844571	Campypak Plus W/palladium Catalyst Dispos. Hydroge	BD Becton Dickinson Vacutainer Systems Preanalytic	KZJ	Class I	1985-01-30
K844568	Titertek Duluter/dispenser 78-640-00	Flow Laboratories, Inc.	JTC	Class I	1985-01-30
K844552	Bio-Stat III Plate Washer	Whittaker Bioproducts, Inc.	JTC	Class I	1985-01-30
K844499	Medsentry Softouch System	Medsentry Corp.	FNM	Class II	1985-01-30
K842518	Uniloc-Cementless & Self Tap Acetabular	American Ortomed Corp.	KWA	Class III	1985-01-30
K842466	Titanium Mittelmeier Type Acetabular	American Ortomed Corp.	KWA	Class III	1985-01-30
K850110	Vision -Formerly Pda- Alkaline Phosphatase	Abbott Medical	CJE	Class II	1985-01-29
K844832	Wets & Dries	Abco Dealers, Inc.			1985-01-29
K844610	Perry Suturing Set W/anesthetic	Perry, Div.			1985-01-29
K844093	Jcm Labs Custom Prescription & Accent in-the-Ear	Jcm Labs, Inc.	ESD	Class I	1985-01-29
K843138	Cmv Test	Microbiological Research Corp.	LIN	Class II	1985-01-29
K842216	Cultureset Hsv Isolation & Id Sys	Ortho Diagnostic Systems, Inc.	GQL	Class II	1985-01-29
K842039	Argon Dual Lumen Hemodialysis, Catheter	Argon Medical Corp.	KNZ	Class II	1985-01-29
K845023	Storz Plastic Surgery & Examination Lounge 7000	Storz Instrument Co.	LGX	Class I	1985-01-28
K845020	Syste Mate Iron, Hem No. 67224	Em Diagnostic Systems, Inc.	JIY	Class I	1985-01-28
K844820	Flow Med Sk 140 Buret	D.R.O. Medical, Inc.	FPA	Class II	1985-01-28
K844730	Bard Harvard Mini-Infuser 400 Multi Dose Syringe	C.R. Bard Inc	FRN	Class II	1985-01-28