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 821 of 3530

510(k) clearances, page 821 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K132099	Arthrocare Coblator Iq Dlr Spinewand, Arthrocare Coblator Iq Dlg Spinewand	ArthroCare Corporation	GEI	Class II	2013-08-22
K131969	Symbotex(tm) Composite Mesh	Sofradim Production	FTL	Class II	2013-08-22
K131884	Avenir Cemented Hip Stem	Zimmer GmbH	LZO	Class II	2013-08-22
K131736	Myosure Tissue Removal Device (1 Pack), Myosure Tissue Removal Device (3 Pack)	Hologic, Inc.	HIH	Class II	2013-08-22
K131707	3B Resmart CPAP and Auto CPAP Systems, Bmc Resmart CPAP and Auto CPAP Systems	3B Medical Inc	BZD	Class II	2013-08-22
K131657	Flower Small and Medium Implant Set	FLOWER ORTHOPEDICS Corporation dba Conventus Flower	HRS	Class II	2013-08-22
K131581	Myosure Tissue Removal Device (1 Pack and 3 Pack)	Hologic, Inc.	HIH	Class II	2013-08-22
K131523	Cryoballoon Focal Ablation System	PENTAX of America, Inc.	GEH	Class II	2013-08-22
K131451	Paltop Dental Implant - Sterile Accessories	Paltop Advanced Dental Solutions Ltd	DZE	Class II	2013-08-22
K131432	Clearfil Se Bond 2 Kit; Clearfil Se Bond 2 Value Pack; Clearfil Se Bond 2 Trial Pack; Clearfil Se Bond 2 Bond; Clearfil	Kuraray Noritake Dental, Inc.	KLE	Class II	2013-08-22
K131310	Gmk Full Pe Tibial Components	Medacta International SA	JWH	Class II	2013-08-22
K131126	Opti Cca-Ts2	Opti Medical Systems Inc	CHL	Class II	2013-08-22
K131097	Legacy3 6Mm Length Implants	Implant Direct Sybron Manufacturing LLC	DZE	Class II	2013-08-22
K131085	Central Venous Pressure System - Mespere Venus 1000	Mespere Lifesciences Inc.	PFA	Class II	2013-08-22
K130951	Sim	Simavita Pty Limited	KPN	Class II	2013-08-22
K130936	Aerodr System with P-31	Konica Minolta Medical & Graphic, Inc.	MQB	Class II	2013-08-22
K130714	Progigy Support Catheter	Radius Medical, LLC	DQY	Class II	2013-08-22
K130301	Latex Surgeon's Gloves (Powdered and Powder Free)	Elimedical Devices (Fujian), Inc.	KGO	Class I	2013-08-22
K130076	Promolux, Promolux Hi, Weropress, Premeco Pcs	Merz Dental GmbH	EBI	Class II	2013-08-22
K130027	Disposable Neutral Electrode Gp202	Cathay Manufacturing Corp.	GEI	Class II	2013-08-22
K130012	Wet Platinum Personal Lubricant	Trigg Laboratories, Inc.	NUC	Class II	2013-08-22
K122627	Gio Digital Pressure Guages	Galemed Corp.	CAP	Class II	2013-08-22
K122100	Powdered Vinyl Examination Gloves	Wang Tong Xinghua Co., Ltd.	LYZ	Class I	2013-08-22
K132304	Epiq Diagnostic Ultrasound System	Philips North America LLC	IYN	Class II	2013-08-21
K131862	3Dvh	Sun Nuclear Corporation	IYE	Class II	2013-08-21
K131584	Imdx Flu A/b and Rsv for Abbott M2000	Intelligent Medical Devices, Inc.	OCC	Class II	2013-08-21
K131391	Jusha-M32 Medical Display	Nanjing Jusha Display Technology Co., Ltd	LLZ	Class II	2013-08-21
K131158	Corview	Marrek, Inc.	LLZ	Class II	2013-08-21
K130696	Caresens N Link Blood Glucose Monitoring System; Caresens N Link Multi Blood Blucose Monitoring System	I-SENS, Inc.	NBW	Class II	2013-08-21
K130627	Swing-Off Screw	Advanced Interventional Technology, LLC	HWC	Class II	2013-08-21
K130454	Lifepak 20 Defibrillator/monitor, Lifepak 20E Defibrillator/monitor	Physio Control, Inc.	MKJ	Class III	2013-08-21
DEN130013	Vitek Ms	bioMerieux, Inc.	PEX	Class II	2013-08-21
K132365	Spondylolisthesis Spinal Fixation, Spinal Pedicle Fixation	Accel Spine	MNI	Class II	2013-08-20
K132228	Ugeo Pt60a Diagnostic Ultrasound System	Samsung Medison Co., Ltd.	IYO	Class II	2013-08-20
K131842	Sterican Cannula	B.Braun Medical, Inc.	FMI	Class II	2013-08-20
K131803	Guardian Urethral Sheath	Solace Therapeutics	KNY	Class II	2013-08-20
K131785	Pagoda Pedicle Screw System	Ortho Development Corp.	NKB	Class II	2013-08-20
K131466	Mapcheck2, Arccheck	Sun Nuclear Corporation	IYE	Class II	2013-08-20
K131254	Kimvent Microcuff Subglottic Suctioning Endotracheal Tube	Kimberly-Clark Corporation	BTR	Class II	2013-08-20
K131129	Cas Psi Shoulder	Zimmer CAS	KWS	Class II	2013-08-20
K131071	Staxx Ibl System	Spine Wave Inc	MAX	Class II	2013-08-20
K130960	Suresubtraction Ortho	Toshibamedical Systems Corporation	JAK	Class II	2013-08-20
K130749	Syngo.mr General; Syngo.mr Cardiology; Syngo.mr Vascular	Siemens Medical Solutions USA, Inc.	LLZ	Class II	2013-08-20
K130436	Multilink Hybrid Abutment Cement	Ivoclar Vivadent, Inc.	EMA	Class II	2013-08-20
K123563	Leadcare (R) Ultra (Tm) Blood Lead Testing System	Magellan Diagnostics, Inc.	DOF	Class II	2013-08-20
K122766	Thermo Scientific Qms Everolimus Assay	Microgenics Corporation	OUF	Class II	2013-08-20
K113806	Kimguard One Step Sterilization Wrap	Kimberly-Clark Health Care	FRG	Class II	2013-08-20
K132263	Axera 2 Access System	Arstasis, Inc.	DYB	Class II	2013-08-19
K131488	Ace Albumin Reagent, Ace Total Protein Reagent, Ace Calcium-Arsenazo Reagent and Ace Phosphorus Reagent	Alfa Wassermann Diagnostics Technologies, LLC	CIX	Class II	2013-08-19
K132334	Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc) Set	Cook Inc.	LJS	Class II	2013-08-16