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 2596 of 3530

510(k) clearances, page 2596 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K895152	Binder Submalar Facial Implant II	Implantech Associates Inc	LZK	Class II	1989-10-27
K895131	Model 2031 Tmj Surface Coil	Medical Advances, Inc.	LNH	Class II	1989-10-27
K895084	Aperture	Custom Medical Products, Ltd.	IZS	Class II	1989-10-27
K894931	Sophycamera Dsx Rectangular	Sopha Medical Systems, Inc.	IYX	Class I	1989-10-27
K894908	Latex Patient Examination Gloves	Shanghai Shen Hua Rubber and Plastics Co., Ltd.	LYY	Class I	1989-10-27
K894892	Hd-2200 Pneumo-Dop Vascular Testing System	Koven and Assoc., Inc.	DSB	Class II	1989-10-27
K894890	Crystalline C2 and Crystalline L3	Confi-Dental Products Co.	EBF	Class II	1989-10-27
K894742	Reloading of X-Ray Tube Housing Assem., Various	Inmark Corp.	ITY	Class I	1989-10-27
K894493	Binder Submalar Facial Implant	Implantech Associates Inc	LZK	Class II	1989-10-27
K894384	K.e.e. Oxygen Concentrator	Kee Medical Services, Inc.	CAW	Class II	1989-10-27
K894206	Intopo	Acacia, Inc.	FMF	Class II	1989-10-27
K894010	Surgical Gloves	Green Cross Medical Supplies Corp.	KGO	Class I	1989-10-27
K893845	Peds Water Filled Catheter/transducer System	Medical Associated Services, Inc.	BZC	Class II	1989-10-27
K893693	H.u. i.v. Drop Counter	Li-Lien Corp.	FLN	Class II	1989-10-27
K893518	Mt/s Software Release 5.0.	Diasonics, Inc.	LNH	Class II	1989-10-27
K892886	Percussionaire Oscillatron-1 Medical Respirator	Percussionaire Corp.	CBK	Class II	1989-10-27
K892839	Palgarapid	Espe GmbH (US)	ELW	Class II	1989-10-27
K892705	Ebs2605 Infant Hugger	Equilibrated Bio Systems, Inc.	BTY	Class II	1989-10-27
K892397	Modified Cedars-Sinai Quanti Thallium-201 Analysis	Nuccardiac Software, Inc.	LLZ	Class II	1989-10-27
K891695	View 1000	Virtual Imaging, Inc.	LLZ	Class II	1989-10-27
K891692	Mip Mr	Kontron Electronics	LLZ	Class II	1989-10-27
K891689	Mipron/umipron	Kontron Electronics	LLZ	Class II	1989-10-27
K891671	Hedy Patient Examination Gloves (Latex)	Hedd Industry Corp.	LYY	Class I	1989-10-27
K891070	Phenylalanine (Ninhydrin Reaction)	Alpkem Corp.	JNB	Class II	1989-10-27
K890799	Curietron 192 High Dose Rate	Cis-Us, Inc.	JAQ	Class II	1989-10-27
K890205	Automix Compounder Y - Adaptor Set	Stedim, Inc.	LHI	Class II	1989-10-27
K890204	Automix Compounder Vented Spike Adaptor	Stedim, Inc.	LHI	Class II	1989-10-27
K895113	Coordinator	Cardiotronics, Inc.	LDD	Class II	1989-10-26
K894991	Electro Blue ECG Elect. Foam, Silver/silver Chlo.	Labeltape Meditect, Inc.	DRX	Class II	1989-10-26
K894945	Non-Invasive Blood Pressure Module	Marquette Electronics, Inc.	DXN	Class II	1989-10-26
K894607	Paq10 Paper Chart Recorder	Protocol Systems, Inc.	DSF	Class I	1989-10-26
K894588	Defib/pacing Pads	Conmedcorp	DRO	Class II	1989-10-26
K894240	Neos 02	Biotronik Cardiac Pacemakers	DXY	Class III	1989-10-26
K893643	Novametrix Mdls 500A, 505A, 515A, & 7000A Oximeter	Novametrix Medical Systems, Inc.	DQA	Class II	1989-10-26
K895672	Technicon Dax System - Sodium (Ise) Method	Technicon Instruments Corp.	JGS	Class II	1989-10-25
K895571	N-Acetylprocainamide (Napa) (Fpia) Kit	Tudor Laboratories, Inc.	LAN	Class II	1989-10-25
K895528	Gel Alkaline Phosphatase Isoenzyme Control No.5104	Helena Laboratories, Corp.	JJX	Class I	1989-10-25
K895046	Remote Reservoir Adapter Cassette W/bag Spike	Pharmacia Deltec, Inc.	FPA	Class II	1989-10-25
K894966	Plasma Catecholamines by Hplc	Bio-Rad	CHQ	Class I	1989-10-25
K894941	Coat-a-Count (Tm) Hcg Irma	Siemens Healthcare Diagnostics Inc.	JHI	Class II	1989-10-25
K894790	Quidel Hcg Test	Ortho-Clinical Diagnostics, Inc.	JHI	Class II	1989-10-25
K894415	Dymax Endovaginal Biopsy Guide	Dymax Corp	HGL	Class II	1989-10-25
K894371	Nipro Safelet Cath	Pharma-Plast USA, Inc.	FOZ	Class II	1989-10-25
K895994	Rheumelisa Assay for Ss-A/ro Autoantibodies	Lipogen, Inc.	LJM	Class II	1989-10-24
K895957	L.t.c. 1000 Urinary Drainage Bag	Intl. Medical Marketing, Inc.	KNX	Class II	1989-10-24
K895844	Thrombelastograph(r)	Haemoscope Corp.	GKP	Class II	1989-10-24
K895727	Background Suction Matt	Applied Medical Technologies	NAB	Class I	1989-10-24
K895726	Vessel Occluder	Applied Medical Technologies	GDJ	Class I	1989-10-24
K895683	Bernard Vessel Approximator	Applied Medical Technologies	HRQ	Class I	1989-10-24
K895682	Vessel Loops	Applied Medical Technologies	GDX	Class I	1989-10-24