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 2665 of 3530

510(k) clearances, page 2665 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K885216	Attachable Lanz (Tentative)	Mallinckroot, Inc.	BSK	Class II	1989-03-14
K885207	Kodak Multiloader 700	Eastman Kodak Company	IXW	Class II	1989-03-14
K885155	Mentor Mds	Imex	IYN	Class II	1989-03-14
K885145	Medsurg Greene Needle	Medsurg Industries, Inc.	DWO	Class I	1989-03-14
K885122	Needle Stick	Poncy, Inc.	FMI	Class II	1989-03-14
K885047	Vista Mr 2055 Hp System	Philips North America LLC	LNH	Class II	1989-03-14
K884622	Surgical Gloves	Globe Ent., Inc.	KGO	Class I	1989-03-14
K884552	Continuous Epidural Anesthesia Kit W/poly Catheter	Arrow Intl., Inc.	CAZ	Class II	1989-03-14
K884047	Fluoroslide Pneumocystis Carinii (Ifa) Assay	Disease Detection International, Inc.	LYF	Class II	1989-03-14
K881865	Norland Model Xr-26 X-Ray Bone Densitometer	Norland Corp.	KGI	Class II	1989-03-14
K881336	Brymascan-a	Brymill Corporation	IYO	Class II	1989-03-14
K891016	Sharplan Model 2106	Sharplan Lasers, Inc.	GEX	Class II	1989-03-13
K890885	Abuscreen Fp for Cocaine Metabolite	Roche Diagnostic Systems, Inc.	DIO	Class II	1989-03-13
K890649	Omnifit Uhmwpe Acetabular Shell Cement Space Syst.	Osteonics Corp.	JDI	Class II	1989-03-13
K890583	Hi Chem Calibration Standards Levels 1 and 2	Hichem Diagnostics	JIX	Class II	1989-03-13
K890543	Impres-Mb Reagent a and Reagent B	Intl. Immunoassay Laboratories, Inc.	JHX	Class II	1989-03-13
K890493	Florida Probe Periodontal Probe	Florida Probe Corp.	EIL	Class I	1989-03-13
K890145	20/20 Orthodontic Ceramic Bracket	American Orthodontics	EJF	Class I	1989-03-13
K890089	Rapid Diag. System for Mycobacterium Gordonae	Hologic, Inc.	LQF	Class I	1989-03-13
K885078	Lipase Sr Liquid Stable Reagent Set	Medical Analysis Systems, Inc.	CET	Class I	1989-03-13
K884941	Acticlot C Kit	American Diagnostic Corp.	GGP	Class II	1989-03-13
K884940	Rellplate C Kit, Rellplate C Bulk Plates	American Diagnostic Corp.	GGP	Class II	1989-03-13
K884314	Leonard Medical 1.7Mm Arthroscope	Leonard Medical, Inc.	HRX	Class II	1989-03-13
K884301	Edwards Disposable Arthroscopy Cannula	Baxter Healthcare Corporation	HRX	Class II	1989-03-13
K884140	Ros-Tr System	Ross Systems C/O Arent,Fox,Kintner,Plotkin,Kahn	DZE	Class II	1989-03-13
K883409	Aegis(tm) Condoms	Green Cross Medical Supplies Corp.	HIS	Class II	1989-03-13
K882538	Progene Microalbuminuria Screen	Progene Corp.	JIR	Class I	1989-03-13
K890886	Abuscreen Fp for Amphetamine	Roche Diagnostic Systems, Inc.	DKZ	Class II	1989-03-10
K890785	Astra T2, T3, T4, T6 Pulse Generators New Package	Cardiac Pacemakers, Inc.	DXY	Class III	1989-03-10
K890734	Dry Tips	Microcopy, Div. Neo-Flo, Inc.	KHR	Class I	1989-03-10
K890727	Non-Sterile, Bulk Gauze Sponges	Cypress Medical Products LLC	EFQ	Unclassified	1989-03-10
K890726	Tracheostomy Care and Cleaning Kits	Cypress Medical Products LLC	LRO	Class II	1989-03-10
K890578	Hi Chem Wash Concentrate Reagent #88805	Hichem Diagnostics	JQW	Class I	1989-03-10
K890538	Guards Latex & Safe-Contact Examination Gloves	Boston Medical Corp.	LYY	Class I	1989-03-10
K890504	Cardiotomy/autotransfusion/pleural Drainage Venous	Gish Biomedical, Inc.	JOD	Class II	1989-03-10
K890277	Hemostasis Valve, with or without Side Port	Oscor Medical Corp.	DYB	Class II	1989-03-10
K885247	Standard, Tuohy Borst & Dual Valve Y-Connector	Baxter Healthcare Corporation	LIT	Class II	1989-03-10
K885092	Barium Enema Tubes: No. 3001000, 3001001, 3001002	Medical Imaging Systems, Inc.	KPL	Class II	1989-03-10
K884982	M68 K Karaya Gum Disp. Microtape ECG Electrode,68	S & W Medico Teknik	DRX	Class II	1989-03-10
K884981	F40 K Karaya Gum Disp. Pe-Foam ECG Electrode, 40Mm	S & W Medico Teknik	DRX	Class II	1989-03-10
K884757	Clinistat Cholesterol Reagent Test	Kulzer GmbH	CHH	Class I	1989-03-10
K884402	Extra Strength Skin Less Skin Condom	Okamoto U.S.A., Inc.	HIS	Class II	1989-03-10
K884218	Audioscope 3 Model 23300 Accessories	Welch Allyn Inc	EWO	Class II	1989-03-10
K883427	Virgo(r) Vzv-Igg Elisa	Electro-Nucleonics, Inc.	GQX	Class II	1989-03-10
K883282	Virgo Hsv-1 Igg Elisa	Electro-Nucleonics, Inc.	GQO	Class II	1989-03-10
K883281	Virgo Hsv-2 Igg Elisa	Electro-Nucleonics, Inc.	GQO	Class II	1989-03-10
K881604	Vena Cava Filter	Vena-Tech, Inc.	DTK	Class II	1989-03-10
K881470	Soken Plus(tm) Electronic Muscle Stimulator	Rehab Medical Specialties, Inc.	IPF	Class II	1989-03-10
K874232	Muscle Stim. Devices, Bm 2000,4000,6000,8000	Health Systems Intl., Inc.	IPF	Class II	1989-03-10
K890957	Hycor Sentry Drugs of Abuse Urine Control:	Hycor Biomedical	DIF	Class I	1989-03-09