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 1380 of 3531

510(k) clearances, page 1380 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K041159	Jms Absorbable Anchor and Applicator	Jms, Inc.	GDW	Class II	2004-07-27
K041103	Acnelift	Inner Act, LLC	GEX	Class II	2004-07-27
K041000	Durepair Dura Regeneration Matrix	Medtronic Neurosurgery	GXQ	Class II	2004-07-27
K040560	Etest for Antifungal Suscepttibility Testing	Ab Biodisk	NGZ	Class II	2004-07-27
K040107	Cyto-Chex Bct	Streck Laboratories, Inc.	JKA	Class II	2004-07-27
K033592	Reprocessed Surgical Scissors and Graspers	Clearmedical, Inc.	GEI	Class II	2004-07-27
K041921	Ge Signa Profile 6 Inch Gp Coil	GE Healthcare	MOS	Class II	2004-07-26
K041602	Panorama 1.0T	Philips North America LLC	LNH	Class II	2004-07-26
K041420	Angiodynamics, Inc. Morpheus Picc and Procedure Kit	Boston Scientific Corporation	LJS	Class II	2004-07-26
K041403	Eclipse with Aaa	Varian Medical Systems, Inc.	MUJ	Class II	2004-07-26
K030290	Periolase Nd:yag Dental Laser System	Millennium Dental Technologies, Inc.	GEX	Class II	2004-07-26
K041942	M2376a Devicelink System	Phillips Medical Systems	MWI	Class II	2004-07-23
K041907	Trio Monitor	Datascope Corp.	MWI	Class II	2004-07-23
K041842	Norian Srs Fast Set Putty	Synthes (USA) Products LLC	MQV	Class II	2004-07-23
K041813	Ge Logiq 7 Ultrasound Bt04	GE Medical Systems Ultrasound and Primary Care Dia	IYN	Class II	2004-07-23
K041790	Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-Cane03 and Lcane03a Software	GE Healthcare	MHX	Class II	2004-07-23
K041750	Pts Panels Chol+glu Test Panel	Polymer Technology Systems	NBW	Class II	2004-07-23
K041727	Modification to Atlantis Pv Imaging Catheter, Model 36456	Boston Scientific Corporation	OBJ	Class II	2004-07-23
K041726	High Flux Hemodialysis Membrane Dialyzer or High Flux Hollow Fiber Dialyzer, Models Aps-R, -M, -S, -E, and -Ex	Asahi Kasei Medical MT Corp. Oita Works	KDI	Class II	2004-07-23
K041695	Liberty 9000 8-Ch Breast Coil with Disposable Biopsy Plate	GE Healthcare Coils	LNH	Class II	2004-07-23
K041678	Karma Power Wheelchair, Model Kp-25	Karma Medical Products Ltd.	ITI	Class II	2004-07-23
K041675	Picus, Parus, Falco and Aquila Ultrasound Systems	Pie Medical	IYN	Class II	2004-07-23
K041665	L1-Pro System	Pelikan Technologies, Inc.	FMK	Class II	2004-07-23
K041523	Xps 3000 System	Medtronic Xomed, Inc.	ERL	Class II	2004-07-23
K041465	Sinon Sn-L402 Lightweight Wheelchair	Sinon Corporation	IOR	Class I	2004-07-23
K041312	Nobelrondo Dental Ceramic-Alumina	Nobel Biocare Uas, Inc.	EIH	Class II	2004-07-23
K041167	Pioneer Surgical Technology Quantum Spinal System	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	NKB	Class II	2004-07-23
K041138	Leo Colors, Leo Aspheric Colors, Leo Toric Colors	CooperVision, Inc.	LPL	Class II	2004-07-23
K041070	Straumann Temporary Coping	Straumann USA, LLC	NHA	Class II	2004-07-23
K040979	Elekta Microdrive, Model 916716	Elekta Instrument AB	HAW	Class II	2004-07-23
K040913	Ngdi (Next Generation Diagnostic Instrument)	Bausch & Lomb Incorporated	MXK	Class II	2004-07-23
K040844	Life Spine Neo Anterior Cervical Plate System	Life Spine	KWQ	Class II	2004-07-23
K040754	American Bantex Ms 4 Mini Scooter	American Bantex Corp.	INI	Class II	2004-07-23
K040483	Equestra Fluid Delivery System	Medtronic Sofamor Danek	HRX	Class II	2004-07-23
K040019	Silverseal	Noble Fiber Technologies, Inc.	MGQ	Unclassified	2004-07-23
K031996	Extentrac Elite	Advanced Back Technologies	ITH	Class II	2004-07-23
K031088	Trimed Plan, Version 2.2	Trimed Systems, Inc.	MUJ	Class II	2004-07-23
K041938	Maximus Os (Overdenture System)	BioHorizons Implant Systems Inc	DZE	Class II	2004-07-22
K041819	Goodknight 425, Modelm-114500-00	Mallinckrodt Developpement France	BZD	Class II	2004-07-22
K041807	Lung Car 1.1	Medicsight	OEB	Class II	2004-07-22
K041759	Ace Connect Internal Connection	Ace Surgical Supply Co., Inc.	DZE	Class II	2004-07-22
K041719	Oncentra-Visir	Nucletron BV	MUJ	Class II	2004-07-22
K041716	PTFE Felts and Pledgets	Boston Scientific Corporation	DXZ	Class II	2004-07-22
K041713	Super Revo Herculine Suture Anchor	Linvatec Corporation	MBI	Class II	2004-07-22
K041701	Afga Cr25.0 Computed Radiography System	Agfa Corp.	MQB	Class II	2004-07-22
K041671	Imagenmd	Cardiovascular Imaging Technologies, LLC	KPS	Class II	2004-07-22
K041646	Thermotek Q5	Saat, Ltd.	FLL	Class II	2004-07-22
K041583	Peek Cement Restrictor X-Box	Innovasis, Inc	JDK	Class II	2004-07-22
K041544	Cook Sidearm Core Tissue Biopsy Device	Urological, Inc.	KNW	Class II	2004-07-22
K041453	Smith & Nephew Tumescent Catheter Inversion System, Model 7210023	Smith & Nephew, Inc.	DWQ	Class II	2004-07-22