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 2026-10-29, 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 2634 of 3530

510(k) clearances, page 2634 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K892213	Acs Colloid Osmotic Pressure Calibrator	Analytical Control Systems	JIW	Class II	1989-06-21
K890930	Patient Examination Gloves	Thaima Products Co., Ltd.	LYY	Class I	1989-06-21
K890864	Handtymp Screener Model 2000 + 2002 Remote Trans.	Rastronics USA, Inc.	ETY	Class II	1989-06-21
K890125	Sanitary Napkin Pads	Landen Corp.	HHD	Class I	1989-06-21
K884978	Pharma-Plast Insulin Infusion Set	Pharma-Plast USA, Inc.	LZG	Class II	1989-06-21
K882596	Mp Test	Diatech Diagnostica, Ltd.	LJZ	Class I	1989-06-21
K893633	Model 5330 External a-V Sequential Demand Pulse	Medtronic, Inc.	DTE	Class II	1989-06-20
K893605	Sri Luteinizing Hormone Immunoenzymetric Assay	Serono-Baker Diagnostics, Inc.	CEP	Class I	1989-06-20
K893567	Argenco 52 Type IV Dental Gold Alloy	Argen Precious Metals, Inc.	EJT	Class II	1989-06-20
K893564	Argenco 30 Type IV Dental Gold Alloy	Argen Precious Metals, Inc.	EJT	Class II	1989-06-20
K893563	Argenco 42 Type IV Dental Gold Alloy	Argen Precious Metals, Inc.	EJT	Class II	1989-06-20
K893554	Argenco 60 Type IV Dental Gold Alloy	Argen Precious Metals, Inc.	EJT	Class II	1989-06-20
K893423	Qbc III Centrifugal Hematology System	BD Becton Dickinson Vacutainer Systems Preanalytic	GKZ	Class II	1989-06-20
K893392	Cpm-1 System Oximeter/cardiac Output Computer	Baxter Healthcare Corporation	DXG	Class II	1989-06-20
K893245	L30-Lb- Infant Limb Band	Contour Electrodes, Inc.	DRX	Class II	1989-06-20
K893243	Intra Aortic Balloon	Datascope Corp.	DSP	Class II	1989-06-20
K893224	Rep Glyco-8 Kit, #3208/Rep Glyco-16 Kit, #3207	Helena Laboratories, Corp.	LCP	Class II	1989-06-20
K892844	Ast Reagent (Procedure Number 158)	Sigma Chemical Co.	CIT	Class II	1989-06-20
K892818	Rep(tm) Ld-2 Stat Kit, Cat. No. 3078	Helena Laboratories, Corp.	CFE	Class II	1989-06-20
K892331	Enzymatic Urea Nitrogen Reagent Set	American Monitor Corp.	CDQ	Class II	1989-06-20
K892227	Edentec Model 2001 Modular Memory Unit (Mmu)	Edentec Corp.	DSH	Class II	1989-06-20
K892005	Shock Advisory Adapter for Use W/lifepak 9	Physio Control, Inc.	MKJ	Class III	1989-06-20
K891923	Amresco Product Number 7426	American Research Products Co.	CFR	Class II	1989-06-20
K891782	Hsv-2 Elisa Test System	Zeus Scientific LLC	GQL	Class II	1989-06-20
K891542	Ebna-Check(tm) Test Kit	Diagnostic Technology, Inc.	LLM	Class I	1989-06-20
K891457	Dr. Volkner's Lamellar Turning Bed(tm)	James Consolidated, Inc.	FNM	Class II	1989-06-20
K891162	Hsv-1 Elisa Test System	Zeus Scientific LLC	GQL	Class II	1989-06-20
K890926	Surecut Bmb Bone Marrow Biopsy/aspiration Needle	Meadox Surgimed, Inc.	FMI	Class II	1989-06-20
K890828	Periflux Pf3	Perimed AB	DPW	Class II	1989-06-20
K890827	Il1400, Bgelectrolyte Analyzer	Instrumentation Laboratory Co.	CHL	Class II	1989-06-20
K890819	Hsv-Check(tm) Test Kit	Diagnostic Technology, Inc.	HIS	Class II	1989-06-20
K890807	Guide Wire Introducer	Datascope Corp.	DQX	Class II	1989-06-20
K890794	Daig Pacel(tm) Flow Directed Pacing Catheter	Daig Corp.	LDF	Class II	1989-06-20
K890639	Resubmitted Ebv/igm-Check Test Kit	Diagnostic Technology, Inc.	LJN	Class I	1989-06-20
K890505	Usci Grey/black Guide Wire	C.R. Bard Inc	DQX	Class II	1989-06-20
K890047	Vascucare Percutaneous Angioscopy Delivery System	Vascucare, Inc.	LYK	Class II	1989-06-20
K890018	Pacemaker Lead Adapter	Ela Medical, Inc.	DTB	Class III	1989-06-20
K893479	Cholesterol Reagent Set	American Monitor Corp.	CHH	Class I	1989-06-19
K893268	Latex Examination Gloves	Regulus Intl. Corp.	LYY	Class I	1989-06-19
K893211	Rep Spe-8 Kit, Cat.# 3172/Rep Spe-16 Kit Cat.#3171	Helena Laboratories, Corp.	CEF	Class I	1989-06-19
K893179	Warden Latex Examination Gloves	Kuo Jun Ent. Co., Ltd.	LYY	Class I	1989-06-19
K893107	Champ-Paq Latex Patient Examination Gloves	Winmed Instruments Mfg. Corp.	LYY	Class I	1989-06-19
K893015	Latex Examination Gloves	Universal Gloves Private, Ltd.	LYY	Class I	1989-06-19
K892975	Low Powder Single Use Latex Exam Gloves	Phoenix Medical Technology, Inc.	LYY	Class I	1989-06-19
K892905	Direct Bilirubin for Manual or Automated Appli.	Catachem, Inc.	CIG	Class II	1989-06-19
K892654	Biostix (Tm)hcg--Simple Pregnancy Test	Princeton Biomedix	DHA	Class II	1989-06-19
K892471	Patient Examination Gloves (Latex)	Tabri Gloves Sdn. Bhd.	LYY	Class I	1989-06-19
K892414	Qualitex Latex Examination Gloves	Agri-Bag Corp.	LYY	Class I	1989-06-19
K892247	Patient Examiaination Gloves (Latex)	Jiann FA Rubber Factory Co., Ltd.	LYY	Class I	1989-06-19
K891958	The Royal Gloves (Patient Exam Gloves)	Taizhu Latex Glove Factory, Ltd.	LYY	Class I	1989-06-19