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 1315 of 3531

510(k) clearances, page 1315 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K051224	Bosworth Seal	Harry J. Bosworth Co.	EBC	Class II	2005-07-28
K050857	Bib Pta Balloon Catheter	Numed Inc	NVM	Class II	2005-07-28
K050808	Coronary Sinus Access Kit, Model Kcs8f-01	Cardio-Optics, Inc.	LYK	Class II	2005-07-28
K050687	Axiom Eps8000	Axiom Worldwide, Inc.	IPF	Class II	2005-07-28
K050635	Allfim Implant Systems	Cowellmedi Co., Ltd.	DZE	Class II	2005-07-28
K042726	Quest Diagnostics Haircheck-Dt (Pcp	Quest Diagnostics, Inc.	LCM	Unclassified	2005-07-28
K042579	Bindazyme Human Asca Igg and Iga Eia Diagnostic Test Kit	The Binding Site	NBT	Class II	2005-07-28
K042125	Aft	Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics	MQV	Class II	2005-07-28
K051942	Malibu Spinal System	Seaspine, Inc.	KWP	Class II	2005-07-27
K051921	The Edge Detector, Model 1118	Sun Nuclear Corporation	IYE	Class II	2005-07-27
K051868	Grandio Flow	Voco GmbH	EBF	Class II	2005-07-27
K051867	Grandio	Voco GmbH	EBF	Class II	2005-07-27
K051845	The Bioplate Resorbable Endobrow Fixation System	Bioplate Inc	JEY	Class II	2005-07-27
K051756	Modification To:trabecular Metal Femoral Cone Augments, Models 03-125-Zzzz	Zimmer Trabecular	JWH	Class II	2005-07-27
K051681	Dermillume Red, Model Hr1000	Care Electronics, Inc.	ILY	Class II	2005-07-27
K051631	Excalibur IV Light Therapy System, Model Sgex4-001	Stargate International, Inc.	NHN	Class II	2005-07-27
K051600	Synthes (USA) Distraction Osteogenesis System	Synthes (USA) Products LLC	KTT	Class II	2005-07-27
K051581	Sanarus Cassi II Rotational Core Biopsy System, Model Cs2000	Sanarus Medical, Inc.	KNW	Class II	2005-07-27
K051516	Trabecular Metal Revision Shell Liners	Zimmer GmbH	JDI	Class II	2005-07-27
K051509	Erbe Erbokryo Ca Cryosurgical Unit & Accessories	Erbe USA Inc	GEH	Class II	2005-07-27
K051506	Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt, Spring-Cut, Bio-Cut - Soft Tissue Biopsy	Sterylab S.r.l.	FCG	Class II	2005-07-27
K051488	Medicinelodge Zipknot	Medicinelodge, Inc.	NVH	Class II	2005-07-27
K051478	Microscan Synergies Plus Gram Positive Mic/combo Panels - Rifampin	Siemens Healthcare Diagnostics Inc.	LON	Class II	2005-07-27
K051454	Aleutian Spacer System	K2M, Inc	MQP	Class II	2005-07-27
K051393	Disposable Powder Free Vinyl Exam Glove Yellow Color	Ever Global Enterprise Corporation	LYZ	Class I	2005-07-27
K050979	S4 Spinal System	Aesculap Inc	MNI	Class II	2005-07-27
K050681	Omnitech System & Easy Lock Osteosystem with Xtremities Plates	Trimed Inc	HRS	Class II	2005-07-27
K050651	Medtronic Orthopaedic Trauma Application	Medtronic Navigation, Inc	HAW	Class II	2005-07-27
K050463	Clever Td-1107 Ear/skin/surface Ir Thermometer, Clever Td-1110 Ear/skin/surface Ir Thermometer	Taidoc Technology Corporation	FLL	Class II	2005-07-27
K050461	Xia 4.5 Spinal System	Howmedica Osteonics Corp	MNH	Class II	2005-07-27
K050436	Ms 9/5 Hematology Analyzer	Melet Schloesing Laboratories USA	GKZ	Class II	2005-07-27
K051919	Modification to: Usgi Shapelock Endoscopic Guide	Usgi Medical	FED	Class II	2005-07-26
K051778	Nitrile Powdered Examination Gloves (Blue)	Hartalega Sdn Bhd	LZA	Class I	2005-07-26
K051310	Plc Screw	Smith & Nephew, Inc.	HWC	Class II	2005-07-26
K051150	Total Intact Pth Immunochemiluminometric (Icma) Assay Kit	Scantibodies Laboratory Inc.	CEW	Class II	2005-07-26
K051141	Whole Pth (1-84) Specific Immunochemiluminometric Assay (Icma), Model 3Kg002	Scantibodies Laboratory Inc.	CEW	Class II	2005-07-26
K050823	Direct Hdl Cholesterol and Direct Hdl/ldl Calibrator	Teco Diagnostics	LBR	Class I	2005-07-26
K050542	Marian Infant Feeding Tube (Guardianpicc Percutaneous Central Venous Catheter	Marian Medical, Inc.	LJS	Class II	2005-07-26
K051790	3M Littmann Electronic Stethoscope, Model 4100	3M Company	DQD	Class II	2005-07-25
K051746	Elekta Esarte Frame System	Elekta Instrument AB	HAW	Class II	2005-07-25
K051743	R2 Breast Imaging Workstation	R2 Technology, Inc.	LLZ	Class II	2005-07-25
K051720	Synthes (USA) Bone Marrow Aspiration Syringe	Synthes (USA) Products LLC	FMF	Class II	2005-07-25
K051687	Elecsys Precicontrol Universal	Roche Diagnostics GmbH	JJY	Class I	2005-07-25
K051457	Sentinel Plasmaproteins Cal 3X	Sentinel CH SpA	JIX	Class II	2005-07-25
K051350	Synergies Plus Gram-Positive Mic/combo Panels	Siemens Healthcare Diagnostics Inc.	LON	Class II	2005-07-25
K051261	Dynatron X3 , Dynatron Xp Ir Light Pad, D405 Ir Light Probe	Dynatronics Corp.	ILY	Class II	2005-07-25
K051194	Bd Onecath Peripherally Inserted Central Catheter, Models 384647, 384667, 384687, 384648, 384668, 384688, 384649, 384669	Becton Dickinson & Co	LJS	Class II	2005-07-25
K051019	Safety Needle	Sarstedt ApS	JKA	Class II	2005-07-25
K050891	Tox A/b Quick Chek	Techlab, Inc.	LLH	Class I	2005-07-25
K050862	3Tp Workspace	3tp, LLC	LLZ	Class II	2005-07-25