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 1416 of 3531

510(k) clearances, page 1416 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K032124	Durex Play Lubricant	Ssl Americas, Inc.	HIS	Class II	2004-01-16
K031617	Mediplus Single Use Lower Gi Manometry Catheter	Mediplus Ltd.	KLA	Class II	2004-01-16
K030341	Modification to Inspiration Ventilator System	Event Medical Ltd	CBK	Class II	2004-01-16
K034065	Modification to X-Port Duo Port	C.R. Bard Inc	LJT	Class II	2004-01-15
K034023	Microlife Digital Infrared Ear Thermometer, Model Ir1de1-1	Microlife Intellectual Property GmbH	FLL	Class II	2004-01-15
K034002	Gamma3 Nail System	Howmedica Osteonics Corp	HSB	Class II	2004-01-15
K033964	Solar 9500 Information Monitor	GE Medical Systems Information Technologies, Inc.	MHX	Class II	2004-01-15
K033927	Arthoscopy Pump A115	Novanta Medical GmbH	HRX	Class II	2004-01-15
K033890	Advance Double High Insert	Wrightmedicaltechnologyinc	JWH	Class II	2004-01-15
K033815	Bio-Oss, Bio-Oss Blocks and Bio-Oss Collagen	Geistlich Pharma AG	NPM	Class II	2004-01-15
K033780	Modification to Seraquest Vca Igm	Quest Intl., Inc.	LJN	Class I	2004-01-15
K033773	Concept Hp Add-on; Concept Hp Enamel	Ivoclar Vivadent, Inc.	EBF	Class II	2004-01-15
K033675	Prosmile Air Polisher and Prophylaxis Powder	Sirona Dental Systems GmbH	KOJ	Class II	2004-01-15
K033654	Force Fiber	Teleflex Medical	GAT	Class II	2004-01-15
K033639	Acumed Lower Extremity Congruent Plate System	Acumed LLC	HWC	Class II	2004-01-15
K033513	Easi ECG Algorithm	Philips North America LLC	DRW	Class II	2004-01-15
K033483	Kls-Martin Ortho Anchorage System	KLS-Martin L.P.	DZE	Class II	2004-01-15
K033472	Tescera U-Bar and Barrels	Bisco Inc	EBI	Class II	2004-01-15
K033462	Early Cleavage Medium (Ecm)	FUJIFILM Biosciences Inc.	MQL	Class II	2004-01-15
K033455	Electro-Nerve Stimulator TENS, Model Bmls03-5	BioMedical Life Systems Inc.	GZJ	Class II	2004-01-15
K033432	Lexatite Quick Acrylic	Imtec Corp.	EBG	Class II	2004-01-15
K033423	Revolix Laser Systems	Allmed Systems, Inc.	GEX	Class II	2004-01-15
K033406	Small Bone Fixation System	Hand Innovations, Inc.	HTY	Class II	2004-01-15
K033376	Ugytex Mesh	Sofradim Production	FTL	Class II	2004-01-15
K033342	Scorpio Knee System - Tibial Inserts	Howmedica Osteonics Corp	JWH	Class II	2004-01-15
K033310	Remeex System for Urinary Incontinence	Specialities Remeex International, S.L.	OTN	Class II	2004-01-15
K033279	Gold Dental Casting Alloys	Bego U.S.A.	EJT	Class II	2004-01-15
K032891	Trans1 Trans-Sacral Spinal Access and Preparation Kit	TranS1	HRX	Class II	2004-01-15
K032108	Search Evolution (Lc) Total Knee System (Porous Coated)	Aesculap Inc	MBH	Class II	2004-01-15
K031128	B-Smart, Model B-01	Macosta Medical USA, LLC	CAZ	Class II	2004-01-15
K030267	EEG Monitor with Bis, Model a-2000	Aspect Medical Systems, Inc.	OLW	Class II	2004-01-15
K024185	Biodhoc	Future Medical Systems, Inc.	HTY	Class II	2004-01-15
K033936	Bard Eliminator Pet Balloon Dilators	C.R. Bard Inc	KNQ	Class II	2004-01-14
K033853	Modification to V-Cath Poly Picc	Hdc Corp.	FOZ	Class II	2004-01-14
K033560	Bd Phoenix Automated Microbiology System - Ceftazidime 0.5-64 Ug/ml-Gram-Negative Id/ast or Ast Only Phoenix Panels	Becton Dickinson & Co	LON	Class II	2004-01-14
K033557	Bd Phoenix Automated Microbiology System - Ticarcillin/clavulanate-Gram Negative	Becton Dickinson & Co	LON	Class II	2004-01-14
K033087	Oracle Oral Mask, Model Hc451a	Fisher & Paykel Healthcare, Inc.	BZD	Class II	2004-01-14
K032972	Aerochamber Max Valved Holding Chamber	Trudell Medical Intl.	CAF	Class II	2004-01-14
K032245	Arthrex Fibertape (Tm), 2Mm, Arthrex Fibertape (Tm), 3Mm, Arthrex Fibertape (Tm), 4Mm, Models Ar-7237, Ar-7238, Ar-7239	Arthrex GmbH	GAT	Class II	2004-01-14
K031908	Med2000 Spa Nebulizer Compressors, Models P1 and P2, with Nebulizer, and Med2000 Spa Nebulizer, Model A1/c (Andyflow)	Med2000 S.r.l.	CAF	Class II	2004-01-14
K031896	Nasal-Air Critical Care	Innomed Technologies	MNS	Class II	2004-01-14
K030739	Infusion Dynamics (Id) Power Infuser, Model M100b-3A with Blood Cartridge	Infusion Dynamics, Inc.	FRN	Class II	2004-01-14
K033850	Medtronic Ps Medical Strata Nsc Valve and Shunt Assemblies with and without Bioglide	Medtronic Neurosurgery	JXG	Class II	2004-01-13
K033569	Flowmedica Bifurcated Infusion System, Infusion Catheter and Introducer Sheath	Flowmedica, Inc.	KRA	Class II	2004-01-13
K033556	Synthes (USA) Lcp Dynamic Helical Hip System	Synthes (USA) Products LLC	KTT	Class II	2004-01-13
K033323	D 903 Avant Adult Hollow Fiber Oxygenator and D 903 Avant 2 Ph.i.s.i.o. Adult Hollow Fiber Oxygenator with Coating	Dideco S.p.A.	DTZ	Class II	2004-01-13
K033312	Ebi Top Loading Mas Spinal Fixation System	Ebi, LLC	NKB	Class II	2004-01-13
K033293	Med-Logics, Model Ml7090	Med-logics Inc	HNO	Class I	2004-01-13
K033289	Modification to Jet-X Ha Coated Half Pins	Smith & Nephew, Inc.	JDW	Class II	2004-01-13
K032966	The Answer Screw Supplementation System	Simplicity Orthopedic Solutions, LLC	HWC	Class II	2004-01-13