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 889 of 3530

510(k) clearances, page 889 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K121856	Ultraverse 014 and 018 Pta Balloon Dilatation Catheters Line Extension	C.R. Bard Inc	LIT	Class II	2012-07-11
K121838	Liebel-Flarsheim Direct Digital Imaging System	Mallinckrodt, Inc.	MQB	Class II	2012-07-11
K121794	Liquichek Urine Chemistry Control	Bio-Rad, Diagnostics Grp.	JJY	Class I	2012-07-11
K121746	Randox Microalbumin Control Level 1 and Control Level 2 (Liquid)	Randox Laboratories, Limited	JJX	Class I	2012-07-11
K120969	Ac Lens Branded Contact Lens Case	Arlington Contact Lens Services,Inc.	LRX	Class II	2012-07-11
K120650	Poise Personal Lubricant	Kimberly-Clark Corporation	NUC	Class II	2012-07-11
K120424	Medsource IV Adminstration Set	Medsource International, LLC	LHI	Class II	2012-07-11
K113819	Mongoose Angiographic Catheter	Pediacath, Inc.	DQO	Class II	2012-07-11
K113421	Minicat	Xoran Technologies, LLC	JAK	Class II	2012-07-11
K113349	Human Ch50 Reagent Pack for Use on the Spaplus, Human Ch50 Calibrator Set for Use on the Spaplus, Human Ch50 Controls Fo	The Binding Site Group Ltd.	DAE	Class II	2012-07-11
K112748	Slimplicity Solo Anterior Cervical Plate System	Spinal USA	KWQ	Class II	2012-07-11
K112010	Aerochamber Plus Flow-Vu Anti-Static Valved Holding Chamber (Vhc)	Trudell Medical Intl.	NVP	Class II	2012-07-11
K111939	M/29tm - Pressure Injectable	Flexicath, Ltd.	FOZ	Class II	2012-07-11
K111781	Gymform Dual Flex Belt Model Wb-162	Well Brain International, Ltd.	NGX	Class II	2012-07-11
K121807	V5ms Transducer	Siemens Medical Solutions USA, Inc.	ITX	Class II	2012-07-10
K121471	Lightscalpel Family of Handpiece Tips for CO2 Surgical Lasers	Lightscalpel Inc	GEX	Class II	2012-07-10
K121449	Directpath	Cybernet Systems Co., Ltd.	LLZ	Class II	2012-07-10
K121426	Aynergetics Disposable Spetzler-Malis Standard Bipolar Forceps	Synergetics Inc	GEI	Class II	2012-07-10
K121133	Caresens N Voice Blood Glucose Monitoring System	I-SENS, Inc.	NBW	Class II	2012-07-10
K120773	Nellcor Bedside Spo2 Patient Monitoring System	Medtronic, Inc.	DQA	Class II	2012-07-10
K120639	Performax Pediatric Se Total Face Mask	Respironics, Inc.	CBK	Class II	2012-07-10
K120584	Power Free Stretch Vinyl Patient Examination Gloves	Wealth on (Jiangsu) Co., Ltd.	LYZ	Class I	2012-07-10
K120474	Gyrus Acmi Telescope Storage-Sterilization Tray	Gyrus ACMI, Inc.	KCT	Class II	2012-07-10
K120263	Volux 21C, Digital Extraoral Source X-Ray System	Genoray Co., Ltd.	MUH	Class II	2012-07-10
K112872	Statim 2000 G4 Cassette	Scican Ltd.	FLE	Class II	2012-07-10
DEN120011	Proteus Ingestion Confinmation Systems	Proteus Biomedical, Inc.	OZW	Class II	2012-07-10
K121650	S-Scan	Esaote S.p.A.	LNH	Class II	2012-07-09
K121407	Oxyband Wound Dressing	O2s, LLC	FRO	Unclassified	2012-07-09
K120374	Seviin Reverse Shoulder	Ingen Orthopedics, LLC	PHX	Class II	2012-07-09
K120305	Thinkingnet, Thinkingpacs/ris - Proprietary Name Fro Thinkingnet, Thinkingarchive (or Nupax) - the Management and Archiv	Thinking Systems Corp.	LLZ	Class II	2012-07-09
K113610	Ana-Screen with Mdss	Bio-Rad Laboratories Inc.	LKJ	Class II	2012-07-09
K121601	Synthes 2.7/3.5Mm Variable Angle Lcp Ankle Trauma System-Anterolateral Distal Tibia Plate	Synthes (USA) Products LLC	HRS	Class II	2012-07-06
K121125	Flexstent Biliary Self-Expanding Stent System	Flexible Stenting Solutions, Inc.	FGE	Class II	2012-07-06
K121096	Venus Lumbar Intervertebral Body Fusion Cage System	L&K Biomed Co.,Ltd.	MAX	Class II	2012-07-06
K121030	Sacks Holdings Inc.'s Contact Lens Storage Case	Sacks Holdings, Inc.	LRX	Class II	2012-07-06
K120937	Sunflower Warner	Atom Medical Corporation	FMT	Class II	2012-07-06
K120807	Synthes Multiloc Humeral Nailing System	Synthes (USA) Products LLC	HSB	Class II	2012-07-06
K120726	Flight 60 Ventilator	Flight Medical Innovations Ltd.	CBK	Class II	2012-07-06
K120649	Autosure Voice 3 Plus Blood Glucose Monitoring System	Apex Biotechnology Corp.	NBW	Class II	2012-07-06
K120582	Heatlux	Home Skinovations, Ltd.	ILY	Class II	2012-07-06
K120468	Ncircle(r) Nitinol Tipless Stone Extractor Ngage(r) Nitinol Stone Extractor	Cook Incorporated	GCJ	Class II	2012-07-06
K120302	Mechanical Wheelchair	Novaf Andalucia 2007, S.L.	IQC	Class II	2012-07-06
K120195	Safety Subcutaneous Tissue Infusion Set	Multi-Med, Inc.	FPA	Class II	2012-07-06
K113621	Smartdrive Wheelchair Power-Assist	Permobil, AB	ITI	Class II	2012-07-06
K112674	Navis Torquer	Navis Medical,Inc	DQX	Class II	2012-07-06
K121683	Acculif Tl Cage	Coalign Innovations, Inc.	MAX	Class II	2012-07-05
K121680	Cd Horizon Spinal System	Medtronic Sofamor Danek USA Inc	NKB	Class II	2012-07-05
K121464	Blue Power Free Nitrile Examination Glove	Northstar Healthcare Holdings	LZA	Class I	2012-07-05
K120739	Aequalis Adjustable Modular Reverse Shoulder System	TORNIER Inc.	PHX	Class II	2012-07-05
K120733	Simplant Go	Materialise Dental NV	LLZ	Class II	2012-07-05