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 842 of 3530

510(k) clearances, page 842 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K122304	Human C1 Inactivator Kit for Use on Spaplus	The Binding Site Group Ltd.	DBA	Class II	2013-04-15
K122076	Personal Health Center (Phc)	Adflow Health Networks, Inc.	DXN	Class II	2013-04-15
K130929	Zmed Vp4000	Zmed, Inc.	LLZ	Class II	2013-04-12
K130884	Xeleris 3.1 Processing and Review Workstation	GE Medical Systems F.I. Haifa	LLZ	Class II	2013-04-12
K130803	Ugeo H70c Diagnostic Ultrasound System	Samsung Medison Co., Ltd.	IYN	Class II	2013-04-12
K130761	Liquichek Immunology Control, Level 1,2,3, Trilevel Minipak	Bio-Rad Laboratories Inc.	JJY	Class I	2013-04-12
K130678	Biomarc Gold Fiducial Marker	Carbon Medical Technologies, Inc.	IYE	Class II	2013-04-12
K130677	Aptus Heli-Fx Aortic Securement System	Aptus Endosystems, Inc.	OTD	Class II	2013-04-12
K130119	Portable Digital Color Doppler Ultrasound System	Sonoscape Company Limited	IYN	Class II	2013-04-12
K123935	Ihealth Bg5/bg5l Wireless Smart Glucose Monitoring System	Andon Medical co., Ltd	NBW	Class II	2013-04-12
K123430	Microslider Tearaway Introducer Set	Galt Medical Corp	DYB	Class II	2013-04-12
K123387	Quikclot Hemostatic Dressing	Z-Medica, LLC	QSY	Unclassified	2013-04-12
K122994	Intramedullary Nail System	Weigao Orthopaedic Device Co., Ltd.	MNH	Class II	2013-04-12
K122537	Prousound Alpha 7 Ver. 6.0 Diagnostic Ultrasound System Model: Prosound Alpha 7 Ver. 6.0	Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical	IYN	Class II	2013-04-12
K122464	Midas Touch, Nitrile Examination Gloves, Powder-Free, Orange	Industrial Clothings, Ltd.	LZA	Class I	2013-04-12
K122418	Iolmaster 500	Carl Zeiss Meditec Inc	HJO	Class II	2013-04-12
K122223	New: Intellivue Cl Respiration Pod New: Specialized Assessory: Mobile Cl Resp Attachment Modified: Intellivue Patient Mo	Philips Medizin Systeme Boeblingen GmbH	BZQ	Class II	2013-04-12
K113439	Euroimmun Euroline Profile Autoimmune Liver Disease 8Ag (Igg)	Euroimmun US Inc.	NIY	Class II	2013-04-12
K130813	Mentor Cpx 4 Breast Tissue Expanders and Mentor Cpx 4 with Suture Tabs Breast Tissue Expanders	Mentor	LCJ	Unclassified	2013-04-11
K130711	Infinity Centralstation with Infinity M300	Draeger Medical Systems, Inc.	MHX	Class II	2013-04-11
K130465	Epic 10S	Biolase MG LLC	GEX	Class II	2013-04-11
K130306	Incite Anchored Cervical Interbody Device	Incite Innovation, LLC	OVE	Class II	2013-04-11
K130291	S4 Spinal System	Aesculap Implant System, Inc.	NKB	Class II	2013-04-11
K130121	Short Port Blunt Tip Trocar	Boston Scientific Corporation	GCJ	Class II	2013-04-11
K130120	Extremity Medical Ip Fusion System	Extremity Medical, LLC	HWC	Class II	2013-04-11
K130056	Patient Monitor	LD Technology LLC	MWI	Class II	2013-04-11
K123777	Multilaser System	Ultralight Laser Technologies, LLC	GEX	Class II	2013-04-11
K123700	Fore-Sight Elite Absolute Tissue Oximeter	Cas Medical Systems, Inc.	MUD	Class II	2013-04-11
K123461	Staxx(r) Ib System	Spine Wave Inc	MAX	Class II	2013-04-11
K123393	Healicoil Suture Anchor with Regenesorb	Smith & Nephew, Inc.	MAI	Class II	2013-04-11
K123339	Tk1 Total Knee System	Novosource, LLC	JWH	Class II	2013-04-11
K123293	Pastelle Q-Switched Nd: Yag Laser	Won Technology Co., Ltd.	GEX	Class II	2013-04-11
K122812	Jiajian Electro-Acupuncture Stimulators	Wuxi Jiajian Medical Instrument Co., Ltd	BWK	Unclassified	2013-04-11
K122505	Single Use Preloaded Sphincterotome V	Olympus Medical Systems Corp.	KNS	Class II	2013-04-11
K122455	Synthes Small External Fixation System, Synthes Large External Fixation System	Synthes GmbH	KTT	Class II	2013-04-11
K122239	Foundation Knee System with Tinbn Coating Foundation Ps Knee System with Tinbn Coating 3Dknee System with Tinbn Coating	Encore Medical, LP	JWH	Class II	2013-04-11
K122069	Storm Mini Screw	Lancer Orthodontics, Inc.	OAT	Class II	2013-04-11
K130646	Cd Horizon Spinal System	Medtronic Sofamor Danek USA Inc	NKB	Class II	2013-04-10
K130637	Jetstream Xc 2.4/3.4 System; Jetstream Xc 2.1/3.0 System; Jetstream Sc 1.85 System; Jetstream Sc 1.6 System	Medrad, Inc.	MCW	Class II	2013-04-10
K123784	Straumann Dental Implant System	Straumann USA, LLC	DZE	Class II	2013-04-10
K123708	Spine Coil	USA Paramed Medical Systems, Inc.	MOS	Class II	2013-04-10
K123703	Healgen Hcg One Step Pregnancy Test (Strip), Healgen Hcg One Step Pregnancy Test (Cassette)	Healgen Scientific LLC	LCX	Class II	2013-04-10
K122996	Assurance Alar Sensor Model 10078; Ab-N Adapter Cable Model 10085	Xhale	DQA	Class II	2013-04-10
K122470	Pentax Epk-I5010 Video Processor	PENTAX of America, Inc.	PEA	Class II	2013-04-10
K130665	Wondofo Multi-Drug Urine Test Cup / Panel	Guangzhou Wondfo Biotech Co., Ltd.	DJG	Class II	2013-04-09
K130571	Devon Cirona 6100 Dvt	Devon Medical, Inc.	JOW	Class II	2013-04-09
K130383	Synapse 3D Cardiac Tools	FUJIFILM Healthcare Americas Corporation	LLZ	Class II	2013-04-09
K130371	Clearfil Majesty Es Flow	Kuraray Noritake Dental, Inc.	EBF	Class II	2013-04-09
K130321	Liaison Aldosterone, Liaison Aldosterone Control Set, Liaison Aldosterone Calibration Verifiers	Diasorin Inc.	CJM	Class II	2013-04-09
K130215	Gore Acuseal Vascular Graft	W. L. Gore & Associates, Inc.	DSY	Class II	2013-04-09