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 2026-11-02, 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 968 of 3531

510(k) clearances, page 968 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K101468	3M Basic Disposable Surgical Gown, 3M Hp Disposable Surgical Gown, 3M Reinforced Disposable Surgical Gown, 3M Disposable	3M Company	FYA	Class II	2011-04-14
K093914	Newdeal Compression Plates	Newdeal SAS	HRS	Class II	2011-04-14
K110742	Onestep Adult Multi-Function Electrode	ZOLL Medical Corporation	MKJ	Class III	2011-04-13
K110259	Architex Space Maintenance System	Medtronic Sofamor Danek USA Inc	JEY	Class II	2011-04-13
K103795	Dbx Demineralized Bone Matrix Putty	Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics	MQV	Class II	2011-04-13
K103784	Dbx Demineralized Bone Matrix Putty	Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics	MQV	Class II	2011-04-13
K103556	Ips E.max Cad Crystall / Connect and Ips E.max Cad Crystal / Add-on Connect (for Cad-on Technique)	Ivoclar Vivadent, Inc.	EIH	Class II	2011-04-13
K103336	Mps450 Multiparameter Simulator	Fluke Biomedical	DRT	Class II	2011-04-13
K103015	Odrc-Dynamic Hip Screw System	Orthopaedic Device Research Center	KTT	Class II	2011-04-13
K101412	Eva Tpn Bag	Valmed SRL	KPE	Class II	2011-04-13
K101201	Straight Abutment, 4.2, 4.6, 5.0, 6.4, Implant 6.0, Implant 7.0, Implant 8.0 Model: 002061, 002062, 002063, 002064,	Kat Implants, LLC	DZE	Class II	2011-04-13
K110366	Syngo.ct Cardiac Function	Siemens Corp.	JAK	Class II	2011-04-12
K110334	Waldo Patient Monitor	Waldo Health	DRG	Class II	2011-04-12
K110023	Infusion Adapter C100	Carmel Pharma AB.	LHI	Class II	2011-04-12
K103565	Medvoxel Heartpro Software Application	Medvoxel Systems, Inc.	LLZ	Class II	2011-04-12
K103200	Propep Delivery Device	Rhythmlink International, LLC	FMF	Class II	2011-04-12
K102943	Coreleader Algi-Fiber Wound Dressing Model Adw 05050	Coreleader Biotech Co., Ltd	FRO	Unclassified	2011-04-12
K100321	Dimension Vista Loci Ca 125 Flex Reagent Cartridge,and Dimensions Vista Loci 6 Cal, Model#'s K6455, and Kc604	Siemens Healthcare Diagnostics Inc.	LTK	Class II	2011-04-12
K110763	Latarjet Cortical Screw Set	T.A.G. Medical Products Corporation Ltd	HWC	Class II	2011-04-11
K110101	Taper Oxinium Femoral Head	Smith & Nephew, Inc.	LZO	Class II	2011-04-11
K101332	Amc-20 Portable Dental Cart Model Amc-20	Aseptico, Inc.	EIA	Class I	2011-04-11
K101072	Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-Apatite	Howmedica Osteonics Corp	LPH	Class II	2011-04-11
K110920	Uf-760Ag	Fukuda Denshi Co., Ltd.	ITX	Class II	2011-04-08
K110814	Ambit Tunneler	Summit Medical Products, Inc.	BSO	Class II	2011-04-08
K110802	A-Channels Lumbat Spine Coils 17; 4-Channels Lumbar Spine Coils 18	Esaote S.p.A.	LNH	Class II	2011-04-08
K110667	Image-Arena and Image-Arena Applications	TOMTEC Imaging Systems GmbH	LLZ	Class II	2011-04-08
K110563	Pressure Right, Single-Use, Disposable, Pressure-Sensitive Emetic-Management Wrist Strip	Therapeutics 101, Inc (dba Pressure Point, Inc.)	MVV	Unclassified	2011-04-08
K110479	Acuity Whisper View Guide Wires	Boston Scientific Corporation	DQX	Class II	2011-04-08
K110411	Atama System	Monteris Medical Corp	MOS	Class II	2011-04-08
K110304	Apex Er. Yag / Ipl System	Sandstone Medical Technologies, LLC	GEX	Class II	2011-04-08
K110147	Ultrasighthd C31 with Imagesense and Remote Viewer Telemedicine	Sti Medical Systems	HEX	Class II	2011-04-08
K110138	Paired Hydrogel Electrode	Neurovision Medical Products Inc	ETN	Class II	2011-04-08
K110127	Prelude III Tongue Suspension System	Siesta Medical, Inc.	ORY	Class II	2011-04-08
K110117	Atricure Bipolar System	AtriCure, Inc.	OCL	Class II	2011-04-08
K110116	Xeros Dry Mouth Pump	Lorin Technologies Corporation	LFD	Unclassified	2011-04-08
K110092	Take 1 Advanced Rigid Tray	Sybron Dental Specialties, Inc.	ELW	Class II	2011-04-08
K110067	Lp Cage	Medyssey Co., Ltd.	MAX	Class II	2011-04-08
K103759	Atlantis Abutment in Zirconia for Osseospeed Tx Profile Implant	Astra Tech, Inc.	NHA	Class II	2011-04-08
K103672	Reusable Pph Circular Stapler Handle, Pph Circular Stapler Reload & Accessory Set	Ethicon Endo-Surgery Inc	GDW	Class II	2011-04-08
K103600	Portable X-Ray System	Digimed Co., Ltd	EHD	Class II	2011-04-08
K103549	Denovo Teddy Gel Infant Heel Warmer	Denovo Products, LLC	MPO	Class I	2011-04-08
K103298	Acam 5 Audiometer System	Acousticon GmbH	EWO	Class II	2011-04-08
K103140	Nicolet Wireless EEG	Medtronic, Inc.	GWL	Class II	2011-04-08
K103083	Agilis Es Steerable Introducer	Abbott Medical	DYB	Class II	2011-04-08
K102222	Ultimate Vit Enhamcer (Uve)	Medical Instrument Development Laboratories, Inc.	HQE	Class II	2011-04-08
K102212	D-Stat Dry Silver; D-Stat Dry Clear Silver; D-Stat Dry Wrap Silver; Thrombix Silver	Vascular Solutions LLC	QSX	Unclassified	2011-04-08
K101888	Scenaria Whole-Body X-Ray CT System	FUJIFILM Healthcare Americas Corporation	JAK	Class II	2011-04-08
K101805	Hydrofix Vaso Shield	Mimedx Group, Inc.	OMR	Class II	2011-04-08
K101754	Thermo Scientific Cedia Opiate Oft Assay	Microgenics Corporation	DJG	Class II	2011-04-08
K101753	Thermo Scientific Cedia Methamphetamine Oft Assay	Microgenics Corporation	LAF	Class II	2011-04-08