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 893 of 3530

510(k) clearances, page 893 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K112817	Microeeg System	BSG Corp	GWQ	Class II	2012-06-19
K112508	I-Root 100	S-Denti Co., Ltd.	LQY	Unclassified	2012-06-19
K112030	Synthes Radial Head Prosthesis System	Synthes (USA) Products LLC	KWI	Class II	2012-06-19
K120910	Cardiq Xpress 2.0 with Snapshot Freeze Option Cardiq Xpress 2.0 Reveal	GE Medical Systems SCS	JAK	Class II	2012-06-18
K120854	Synthes Va Lcp Ankle Trauma System	Synthes (USA) Products LLC	HRS	Class II	2012-06-18
K120527	Alpha Orthopaedics At2 System	Alpha Orthopaedics	GEI	Class II	2012-06-18
K120503	Cmi Implant Is II Active	Neobiotech Co., Ltd.	DZE	Class II	2012-06-18
K120159	Beauticem Sa	Shofu Dental Corp.	EMA	Class II	2012-06-18
K112763	Matrixbrush Endometrial Sampler	Post Oak Innovations, Inc.	HFE	Class II	2012-06-18
K112184	Cirrus Photo	Carl Zeiss Meditec Inc	OBO	Class II	2012-06-18
K121533	St Aia-Pack Homocysteine; St Aia-Pack Homocysteine Calibrator Set; Aia-Pack Homocysteine Control Set	Tosoh Bioscience Inc	LPS	Class II	2012-06-15
K121362	1.5T 16Ch Flex Speeder Large	NeoCoil, LLC	MOS	Class II	2012-06-15
K121246	Medyssy Lt Cage System	Medyssey Co., Ltd.	MAX	Class II	2012-06-15
K121130	Polaris Spinal System-Ballista Spinal Rods	Highridge Medical, LLC	NKB	Class II	2012-06-15
K121118	Fora Comfortscan Ear Thermometer	Foracare, Inc.	FLL	Class II	2012-06-15
K120912	Infiniti(r) Vision System	Alcon Manufacturing, Ltd.	HQC	Class II	2012-06-15
K120870	Greenlight Moxy Fiber Optic	American Medical Systems, Inc.	GEX	Class II	2012-06-15
K120823	Bvm Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors	Fresenius Medical Care North America, Design Cente	FJK	Class II	2012-06-15
K120600	Duragen Secure Dural Regneration Matrix	Integra Pain Management	GXQ	Class II	2012-06-15
K120203	Tm-400 Device	Zimmer Trabecular Metal Technology, Inc.	MAX	Class II	2012-06-15
K113613	Digital Color Doppler Ultrasound Imaging System	Shantou Institute of Ultrasonic Instuments	IYN	Class II	2012-06-15
K113456	Ready View	GE Healthcare (GE Medical Systems Scs)	LLZ	Class II	2012-06-15
K112754	Ivent101	Versamed Medical Systems, Inc.	CBK	Class II	2012-06-15
K112742	Audit Microlq Spinal Fluid Control	Aalto Scientific Ltd.	JJY	Class I	2012-06-15
K111863	Signature Planner,signature Guides	Materialise N.V.	JDI	Class II	2012-06-15
K121677	Surefire Hi-Flow Microcatheter	Surefire Medical, Inc.	DQO	Class II	2012-06-14
K121470	Fully Automatic Wireless Blood Pressure Wrist Monitor	Andon Health Co., Ltd	DXN	Class II	2012-06-14
K121451	Cardioblate Maps Surgical Mapping, Ablation, Pacing , and Sensing Device	Medtronic, Inc.	OCL	Class II	2012-06-14
K121442	Powerflex Pro Percutaneous Transluminal Angioplasty Catheter	Cordis US Corp.	LIT	Class II	2012-06-14
K121385	Vector	R4 Vascular, Inc.	LIT	Class II	2012-06-14
K121208	Obix Perinatal Data System 7.0	Clinical Computer Systems, Inc.	HGM	Class II	2012-06-14
K120801	Chison Diagnostic Ultrasound System	Chison Medical Imaging Co., Ltd.	IYN	Class II	2012-06-14
K120648	Synapse 3D Lung and Abdomen Analysis	FUJIFILM Healthcare Americas Corporation	LLZ	Class II	2012-06-14
K113449	Fusion Flat Panel	Icrco, Inc.	MQB	Class II	2012-06-14
K113395	Revere 4.5 Stabilization System	Globus Medical, Inc.	NKB	Class II	2012-06-14
K113152	Ultrasonic Surgery Machine	Dmetec.Co., Ltd.	DZI	Class II	2012-06-14
K113008	Kodama Intravascular Ulrasound Catheter	Silicon Vally Medical Instruments, Inc.	OBJ	Class II	2012-06-14
K111136	Expedium Spine System, Viper System, Viper 2 System	DePuy Spine, Inc.	NKB	Class II	2012-06-14
K111048	Synthes Scout Tack Fixation	Synthes GmbH	OMR	Class II	2012-06-14
K121571	Tubeclear	Actuated Medical, Inc.	KNT	Class II	2012-06-13
K121437	Mini Maxlock Extreme Plating System	TORNIER Inc.	HRS	Class II	2012-06-13
K121424	Expression Information Portal	Invivo Corporation	MWI	Class II	2012-06-13
K121129	Spineology Peek Lumbar Interbody Fusion Device	Spineology, Inc.	MAX	Class II	2012-06-13
K121051	Concierge Guiding Catheter	Merit Medical Systems, Inc.	DQY	Class II	2012-06-13
K120658	Durablue Sterilization Wrap	Cardinal Health200, LLC	FRG	Class II	2012-06-13
K120573	Medart 620	MEDART ApS	GEX	Class II	2012-06-13
K120546	Aquilion Premium	Toshiba Medical Systems Corporation, Japan	JAK	Class II	2012-06-13
K120506	Parietex Composite Ventral Patch	Sofradim Production	FTL	Class II	2012-06-13
K120345	Honour Spacer System	Nexxt Spine LLC	ODP	Class II	2012-06-13
K112897	Renovis Surgical Hip Joint Replacement Prosthesis	Renovis Surgical Technologies, LLC	OQG	Class II	2012-06-13