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 2026-10-26, 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 772 of 3530

510(k) clearances, page 772 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K131183	Med-Rx Oral/enteral Syringe	Canadian Hospital Specialties Ltd.	KNT	Class II	2014-06-03
K123795	Axon-Bus Prosthetic System	Otto Bock Austria	GXY	Class II	2014-06-03
K140774	Terumo Capiox Fx15 and Fx25 Hollow Fiber Oxygenator/reservoir	Terumo Cardiovascular Systems Corporation	DTZ	Class II	2014-06-02
K140468	Bd Phoenix Automated Microbiology System - Ceftaroline (0.625-4 Ug/ml)	Becton Dickinson & Co	LON	Class II	2014-06-02
K140364	Chison Diagnostic Ultrasound System, Convex Probe, Linear Probe, Phased and Convex Probe, Pencil and Convex Probe	Chison Medical Imaging Co., Ltd.	IYN	Class II	2014-06-02
K140358	Compressyn Staple	Dallen Medical, Inc.	JDR	Class II	2014-06-02
K140337	Brightmatter Planning Software	Synaptive Medical Inc	LLZ	Class II	2014-06-02
K140234	Aspiron Acp System	CG MedTech Co., Ltd.	KWQ	Class II	2014-06-02
K133872	Aria Wifi Smart Scale	Fitbit LLC	MNW	Class II	2014-06-02
K133682	Schoelly Arthroscope	Schoelly Fiberoptic, GmbH	HRX	Class II	2014-06-02
K133633	Chocolate Ptca Bolloon Catheter	Trireme Medical, Inc.	LOX	Class II	2014-06-02
K133556	Virage Oct Spinal Fixation System	Zimmer Spine, Inc.	KWP	Class II	2014-06-02
K133478	Powder Free Polyethylene Examination Gloves	Shijiazhuang Hongzan Plastic Technology Co.,Ltd	LZA	Class I	2014-06-02
K132016	Lumix 3 Plus and Lumix 3 Ultra System	Texas Applied Biomedical Services	ILY	Class II	2014-06-02
K141138	Surflash Safety i.v. Catheter	Kofu Factory of Terumo Corp.	FOZ	Class II	2014-05-30
K141124	Spiral Flow Vascular Arteriovenous Graft	Vascular Flow Technologies Ltd	DSY	Class II	2014-05-30
K140875	Optossol Compression Device System	Genossis, LLC	JDW	Class II	2014-05-30
K140787	Pls (Posterior Lumbar System)	Sintea Plustek, LLC	MNH	Class II	2014-05-30
K140773	Terason Usmart3300 Ultrasound System	Teratech Corp.	IYN	Class II	2014-05-30
K140676	Profemur Tl Classic Long Neck Hip Stems	Microport Orthopedics Inc.	LZO	Class II	2014-05-30
K140594	Body Fat Analyzer and Scale	Conmo Electronic Company Limited	MNW	Class II	2014-05-30
K140559	Sechrist Monoplace Hyperbaric Oxygen Chamber	Sechrist Industries Inc	CBF	Class II	2014-05-30
K140428	Ultrasound Scanner System Bk2300	BK Medical ApS	IYO	Class II	2014-05-30
K140211	Ultrasonic Mesh Nebulizer	Foshan Gaunying Electronics Co., Ltd	CAF	Class II	2014-05-30
K133859	Watch-Pat200u (Wp200u)	Itamar Medical	MNR	Class II	2014-05-30
K133779	Cp Relief Wand	Mid-America Medical Innovations, LLC	GZJ	Class II	2014-05-30
K133328	Aero-Al Lumbar Cage System	Stryker Corp.	OVD	Class II	2014-05-30
K133198	Ultrapro Comfort Plug	Ethicon, Inc	FTL	Class II	2014-05-30
K133123	Non Sterile, Poweder Free Blue Nitrile Examination Gloves - 8623F	Yty Industry (Manjung) Sdn. Bhd.	LZA	Class I	2014-05-30
K132730	Bio-Probe Disposable Insert with; Balance Biosurface, Carmeda Bioactive Surface, Trillium Biosurface	Medtronic, Inc.	DPT	Class II	2014-05-30
K132378	X-Mind Unity	De Gotzen S.r.l.	EHD	Class II	2014-05-30
K132173	Family Healthware	Sanitas, Inc.	DRG	Class II	2014-05-30
K131712	A-Tone Ipl System	Ybk Investment, Inc.	ONF	Class II	2014-05-30
K131319	T1/t2/t3 Turbine Family	Sirona Dental Systems GmbH	EFB	Class I	2014-05-30
K130304	Lma Family of Airways	The Laryngeal Mask Co., Ltd.	CAE	Class I	2014-05-30
K123940	Demequicktm (Rapid Absorbable) Synthetic Surgical Suture	Demetech Corp.	GAM	Class II	2014-05-30
K140822	Drive Rail System	Devise Ortho, Inc.	KTT	Class II	2014-05-29
K140565	Variax 2 Compression Plating System	Stryker Trauma GmbH	HRS	Class II	2014-05-29
K140555	Journey II Bcs Constrained Inserts	Smith & Nephew, Inc.	JWH	Class II	2014-05-29
K140326	Xgeo Gf50	Samsung Electronics Co., Ltd.	KPR	Class II	2014-05-29
K140190	Night Shift	Advanced Brain Monitoring, Inc.	MYB	Class II	2014-05-29
K140163	Koala Toco	Clinical Innovations, LLC	HFM	Class II	2014-05-29
K140158	S.e.a.l. Fracture Fusion Tube	Dne, LLC	KTT	Class II	2014-05-29
K140049	Moves Slc	Thornhill Research Inc	BTL	Class II	2014-05-29
K132852	Peek Cage for the Vertebral Spine	Neoortho Produtos Ortopedicos S/a	MAX	Class II	2014-05-29
K132506	Sleeptight Mouthpiece, Sleeppro, Quietnite, Altitude Mouthpiece, Sleep Easy	Michael D Williams Dds PA	LRK	Class II	2014-05-29
K131954	Medi Pen Needle	Shanghai Carelife International Trading Co. Ltd	FMI	Class II	2014-05-29
K131600	Urs-2Gp (Glucose Protein) Urine Strips	Teco Diagnostics	JIL	Class II	2014-05-29
K131304	Sentio Mmg	Innovative Surgical Solutions, LLC ("Iss")	PDQ	Class II	2014-05-29
DEN140002	Euroimmun Anti-Pla2r Ifa	Euroimmun US Inc.	PGV	Class II	2014-05-29