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 1039 of 3531

510(k) clearances, page 1039 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K091428	Easyone Pro Respiratory Analysis System	Ndd Medizitechnik AG	BTY	Class II	2010-01-27
K100076	Atrium C-Qur Ovt Mesh	Atrium Medical Corporation	FTL	Class II	2010-01-26
K093681	Meridian Guidewire	Medtronic, Inc.	DQX	Class II	2010-01-26
K093363	Cocr and Oxinium Femoral Heads and R3 Xlpe Liners	Smith & Nephew, Inc.	MBL	Class II	2010-01-26
K093070	Devilbiss Intellipap/ Sleepcube Bilevel St, Dv56 St Series	Sunrise Medical, Inc.	MNS	Class II	2010-01-26
K092845	Respisens	Nomics	IYE	Class II	2010-01-26
K092257	Jaloskin	Fidia Advanced Biopolymers SRL	FRO	Unclassified	2010-01-26
K091949	Microscan Microstrep Plus, Model B1027-201	Siemens Healthcare Diagnostics Inc.	LTT	Class II	2010-01-26
K094036	Turbo-Tandem System Model 472-110	Spectranetics Corp.	MCW	Class II	2010-01-25
K094020	Grind No More Generation II	Ranir, LLC	OBR	Unclassified	2010-01-25
K093464	Rapidsorb Plus Screw System	Synthes (USA) Products LLC	DZL	Class II	2010-01-25
K093364	Solo Micropump Insulin Delivery System	Medingo, Ltd.	LZG	Class II	2010-01-25
K092224	Tigr Surgical Mesh , Model Wk-6	Novus Scientific AB	FTL	Class II	2010-01-25
K092106	U-Right Td-3132 Blood Pressure Monitor, Fora P 20 Blood Pressure Monitor, Model Td-3132, Td-3132	Taidoc Technology Corporation	DXN	Class II	2010-01-25
K091717	Any Plus Spinal Fixation System	GS Medical Co., Ltd.	NKB	Class II	2010-01-25
K093986	Af 620 Ph.i.s.i.o., Af 640 Ph.i.s.i.o. Arterial Filters	Corcym Inc.	DTM	Class II	2010-01-22
K093985	Nipro Safetouch Locktail Safety Fistula Needle	Nipro Medical Corporation	FIE	Class II	2010-01-22
K093968	Osv II Low Flow Low Pro Valve	Integra LifeSciences Corporation	JXG	Class II	2010-01-22
K093950	Biofoam Bone Wedge Model Assorted	Wrightmedicaltechnologyinc	HRS	Class II	2010-01-22
K093823	Full Automatic (Nibp) Blood Pressure Monitor, Model Hl888v, Full Automatic (Nibp) Blood Pressure Monitor, Model Hl868jm	Health & Life Corporation	DXN	Class II	2010-01-22
K093781	Modified: Newdeal Hallu Plates	Newdeal SAS	HRS	Class II	2010-01-22
K093185	Owl Universal RF System Urf-3Ap (Ml)	Diros Technology, Inc.	GXD	Class II	2010-01-22
K093162	Fidelis Plus III D, at Fidelis D, Powerlase at D / Fidelis Plus III, at Fidelis, Powerlase at / Fidelis Er III D, Ht Fid	Fotona D.D.	GEX	Class II	2010-01-22
K093080	Metaphor Metabolic Monitor	TreyMed, Inc.	BZL	Class II	2010-01-22
K092818	BIPAP Avaps Ventilatory Support System	Respironics, Inc.	MNS	Class II	2010-01-22
K092684	Laparoscopic Retractors	Medtronic, Inc.	GCJ	Class II	2010-01-22
K092360	Acp4 Spinal Implant System	Xtant Medical Holdings, Inc.	KWQ	Class II	2010-01-22
K092098	Patient Specific Acetabular Reconstruction Prosthesis	Smith & Nephew, Inc.	LPH	Class II	2010-01-22
K091387	Bti Dental Implant 5.5-6.5	B.T.I. Biotechnology Institute, S.L.	DZE	Class II	2010-01-22
K091328	Siphonx Gravitational Antisiphon Device	Sophysa	JXG	Class II	2010-01-22
K093972	Bd Microtainer Map Microtube for Automated Process, Model 363706	Becton Dickinson & Co	JKA	Class II	2010-01-21
K093947	Alimaxx-B Uncovered Biliary Stent System Endoscopic	Merit Medical Systems, Inc.	FGE	Class II	2010-01-21
K093944	Medacta Total Hip Prothesis System-Amisten H , Quadra H, Quadra S	Medacta International SA	LZO	Class II	2010-01-21
K093919	Microplex Coil System-Cosmos Model 100933Cssr-V, 101036Cssr-V, 101141Cssr-V, 101245Cssr-V	Terumo Cardiovascular Systems Corporation	HCG	Class II	2010-01-21
K093918	Jetstream G3 L System Model Pv31400 (Jetstream G3 L Catheter with Control Pod); Pvcn100 (Pv Console)	Pathway Medical Technologies, Inc.	MCW	Class II	2010-01-21
K093911	Fogarty Occlusion Catheter	Edwards Lifesciences LLC	MJN	Class II	2010-01-21
K093587	Dental Mercury	Dmg USA, Inc.	ELY	Class II	2010-01-21
K093427	Fdr Acselerate System, Dr-Id 200 Flat Panel Detector	FUJIFILM Healthcare Americas Corporation	MQB	Class II	2010-01-21
K093370	Fu Hong Industries Limited Soother Teether	Fu Hong Industries, Ltd.	KKO	Class II	2010-01-21
K093217	5 Mm Harmonic Ace Instrument (Used with Da Vinci Is1200 & Is2000/is3000 System)	Intuitive Surgical, Inc.	NAY	Class II	2010-01-21
K093195	Echotip Ultra Endobronchial High Definition Ultasound Needle, Model: Echo-Hd-22-Ebus-O	Cook Ireland Ltd.	FCG	Class II	2010-01-21
K093092	Odyssey Workstation	Stereotaxis Inc	DQK	Class II	2010-01-21
K093075	Aragon Surgical RF System Teleo Instrument	Aragon Surgical, Inc.	GEI	Class II	2010-01-21
K092388	Duragen Plus Dural Regeneration Matrix- Spinal Matrix, Model Dp2013sm, Integra Spinal Mend Dural Regeneration Matrix, Mo	Integra LifeSciences Corporation	GXQ	Class II	2010-01-21
K092263	Enduravent-5 Ventilator	Providence Global Medical, Inc.	CBK	Class II	2010-01-21
K092250	Medline Red Rubber Urethral Catheter	MEDLINE INDUSTRIES, LP - Northfield	EYB	Class II	2010-01-21
K092124	Axialif 2L, Axialif 2-Level System, Axialif Apollo, Axialif II	Trans1 Incorporated	KWQ	Class II	2010-01-21
K092096	Endoform Dermal Template	Mesynthes, Ltd.	KGN	Unclassified	2010-01-21
K091863	Awbat-S Plus, Awbat-D Plus, Awbat-M Plus	Aubrey, Inc.	FRO	Unclassified	2010-01-21
K091425	Quantum M Composite Nailing System	N.M.B. Medical Applications, Ltd.	HSB	Class II	2010-01-21