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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 2303 of 3531

510(k) clearances, page 2303 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K924455	Synthes (USA) Titanium Locked Spiked Washer	Synthes (USA) Products LLC	HTN	Class II	1993-05-12
K924280	3M Tegasorb Thin Hydrocolloid Dressing	3M Company	KMF	Class I	1993-05-12
K924155	Sura Snap	Metalor Dental USA Corp.	DZE	Class II	1993-05-12
K923965	Nk Grasp Sensor, Model Ga002	Nk Biotechnical Engineering Co.	LBB	Class II	1993-05-12
K923964	Nk Grasp Sensor, Model Ga001	Nk Biotechnical Engineering Co.	LBB	Class II	1993-05-12
K923869	Codman Sof'wire Titanium Cable System	Cerenovus, Inc.	JDQ	Class II	1993-05-12
K923458	Contact Lens Case	Nomax, Inc.	LRX	Class II	1993-05-12
K923235	Bioclusive Mvp Transparent Dressing	Johnson & Johnson MEDICAL GmbH	KGX	Class I	1993-05-12
K922861	Biometric Screw Fixation Cup	Osteo Technology, Inc.	JDL	Class III	1993-05-12
K920188	Threaded Pins	Kirschner Medical Corp.	MBJ	Class III	1993-05-12
K931536	Emit(r) D.a.u. Benzodiazepine Assay	Syva Co.	JXM	Class II	1993-05-11
K931530	Bile Spot Reagent	Hardy Diagnostics	JTN	Class II	1993-05-11
K931467	Chek-Stix Control Strips for Urinalysis	Kulzer GmbH	JJW	Class I	1993-05-11
K931413	Ferric Chlorid Reagent, 10%	Hardy Diagnostics	JTO	Class I	1993-05-11
K931409	Immulite Cortisol	Siemens Healthcare Diagnostics Inc.	CGR	Class II	1993-05-11
K931367	Vacutainer Brand Luer Adapter	BD Becton Dickinson Vacutainer Systems Preanalytic	JKA	Class II	1993-05-11
K931361	Il Test Phosphorus	Instrumentation Laboratory Co.	CEO	Class I	1993-05-11
K931234	Hemocard Control Hb-Aa, Ae, Faa, Fae	Isolab, Inc.	JCM	Class II	1993-05-11
K930932	Synermed Creatine Kinase Reagent Kit	Synermed, Inc.	CGS	Class II	1993-05-11
K930878	Bactidrop(tm) Mucap	Remel Inc	JTO	Class I	1993-05-11
K930684	Bard William Harvey Two Stage Cannula	C.R. Bard Inc	DWF	Class II	1993-05-11
K930484	Delfia(r) Hgh Kit	Wallac Oy	CFL	Class I	1993-05-11
K930212	Thromboplatin-M with Calcium	Sigma Diagnostics, Inc.	GJS	Class II	1993-05-11
K930148	Technicon H* 3 Rtx System (in-Vitro Diag. System)	Kulzer GmbH	GKZ	Class II	1993-05-11
K930143	Aynelisa M2-Antibodies	Elias U.S.A., Inc.	DBM	Class II	1993-05-11
K930142	Synelisa U1-Snrnp (68Kda)-Antibodies	Elias U.S.A., Inc.	LKO	Class II	1993-05-11
K930141	Synelisa Sm Abs/rnp-Sm ABS	Elias U.S.A., Inc.	LKP	Class II	1993-05-11
K930074	In-Vitro Diagnostic Reagent Set	Horizon Diagnostics, Inc.	JGJ	Class I	1993-05-11
K925715	Rs Optiguard Gown & Drape Material	Baxter Healthcare Corporation	FYA	Class II	1993-05-11
K925648	Smart-Screener (Auditory)	Intelligent Hearing Systems Corp.	GWJ	Class II	1993-05-11
K925388	Life Shield Healthcare Products Breathing Filter	Life Shield Healthcare Products, Inc.	CAH	Class II	1993-05-11
K924673	Clearview Hcg	Unipath, Ltd.	JHI	Class II	1993-05-11
K924285	Model 3500 Mr-Compatible Pulse Oximeter	Magnetic Resonance Equipment Corp.	DQA	Class II	1993-05-11
K923272	Cobe Cms-HF Hollow Fiber Membrane Oxygenator	Cobe Laboratories, Inc.	DTZ	Class II	1993-05-11
K922737	Vidas Toxo Ig6 Assay (Tx6)	Biomerieux Vitek, Inc.	LGD	Class II	1993-05-11
K922551	Solace Powder Free Latex Examination Gloves	Wembley Rubber Products (M) Sdn Bhd	LYY	Class I	1993-05-11
K920902	Modification of Sarns Two Stage Venous Cannula	3M Health Care, Sarns	DWF	Class II	1993-05-11
K930620	Bard(r) William Harvey(r) Arterial Straigh Cannula	C.R. Bard Inc	DWF	Class II	1993-05-07
K925821	Comfortron	M. D. Supply, Inc.	GZJ	Class II	1993-05-07
K925717	Calf Garment Dvt10(s) Compressible Limb Sleeve	Huntleigh Healthcare Ltd.	JOW	Class II	1993-05-07
K925621	Irrigation/aspiration Tubing Set	Kirwan Surgical Products, LLC	GAA	Class I	1993-05-07
K924457	Micromanipulator	Laser Engineering, Inc.	GEX	Class II	1993-05-07
K924282	Model 320 Mr-Compatible Pulse Oximeter	Magnetic Resonance Equipment Corp.	DQA	Class II	1993-05-07
K924206	Medtronic Bio-Medicus Bio-Console Model 540E	Medtronic Bio-Medicus, Inc.	DWA	Class II	1993-05-07
K924167	Crit-Line	Noninvasive Medical Technology Corp.	JPI	Class II	1993-05-07
K923692	Stoma Measuring Device	Applied Medical Technologies	KNT	Class II	1993-05-07
K923229	Medarmor Finger Tip, Puncture Resistant Underglove	Medical Armor Corp.	LYU	Class I	1993-05-07
K922894	Lazer-Trach Tracheal Tube	Sheridan Catheter Corp.	BTR	Class II	1993-05-07
K921930	Siemens Sirecust 700 Bedsides/accessories, Modifi	Siemens Medical Electronics	DPS	Class II	1993-05-07
K921669	Marquette Sl Series Transport Remote Acquisition	Marquette Electronics, Inc.	LOS		1993-05-07