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 817 of 3530

510(k) clearances, page 817 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K121817	Vcare a	Ivt Medical Ltd.	OMP	Class II	2013-09-17
K113738	Creodent Solidex Custom Abutment	Creodent Prosthetics Ltd	NHA	Class II	2013-09-17
K132053	Rampart-O, Rampart-T	Spineology, Inc.	MAX	Class II	2013-09-16
K131494	Heart Sync	Graphic Controls Acquisition Corp.dba Nissha Medical Technologies	MKJ	Class III	2013-09-16
K131398	Novoknee Total Knee System	Novosource, LLC	JWH	Class II	2013-09-16
K130996	Erchonia Emerge	Erchonia Medical, Inc.	NHN	Class II	2013-09-16
K130802	OTC Electrical Stimulator (Mt9001), OTC TENS Device (Lt3060)	Shenzhen Dongdixin Technology Co., Ltd.	NUH	Class II	2013-09-16
K130760	Electrosurgical Generator	Beijing Jinhengwei Technology Development Co., Ltd.	GEI	Class II	2013-09-16
K123991	Depuy Corail Amt Hip Prosthesis	Depuy France S.A.S.	KWY	Class II	2013-09-16
K123957	Pneupac Parapac Plus	Abbott Medical	BTL	Class II	2013-09-16
K132578	Interlock - 18 Fibered Idc Occlusion System	Boston Scientific Corporation	KRD	Class II	2013-09-13
K132573	Vitek 2 Ast St Moxifloxacin, Vitek 2 Ast Streptococcus Moxifloxacin	bioMerieux, Inc.	LON	Class II	2013-09-13
K132249	Advia Centaur Ft4, Advia Centaur T4	Siemens Healthcare Diagnostics Inc.	CEC	Class II	2013-09-13
K132175	Edwards Lifesciences Intraclude Intra-Aortic Catheter	Edwards Lifesciences LLC	DXC	Class II	2013-09-13
K131854	Cerox	Or-Nim Medical, Ltd.	DPW	Class II	2013-09-13
K131508	Vysis D7s486/cep 7 Fish Probe Kit	Abbott Molecular, Inc.	PFG	Class II	2013-09-13
K131409	Cas Psi Knee System	Orthosoft, Inc.	JWH	Class II	2013-09-13
K131084	Sasmar Original, Sasmar Classic	Sasmar, Inc.	NUC	Class II	2013-09-13
K131059	Pioneer Elite Diode Laser	Cao Group, Inc.	GEX	Class II	2013-09-13
K130873	Vwing Vascular Needle Guide, 4Mm X 07Mm; Vwing Vascular Needle Guide, 6Mm X 07Mm; Vwing Vascular Needle Guide, 8Mm X 07M	Vital Access	PFH	Class II	2013-09-13
K130641	Logic Stand-Alone Intervertebral Body Fusion Device	Binder Biomedical, Inc.	OVD	Class II	2013-09-13
K124031	Da Vinci Fluorescence Imaging Vision System	Intuitive Surgical, Inc.	OWN	Class II	2013-09-13
K124026	Lobster Auto-Injector	Scandinavian Health Ltd.	KZH	Class II	2013-09-13
K123902	Physical Monitoring Registration Unit-S (Pmru-S)	Oktx, LLC	IKN	Class II	2013-09-13
K123866	Tanyx	Medecell Us, Inc.	NUH	Class II	2013-09-13
DEN130023	Urolift System	Neotract Inc	PEW	Class II	2013-09-13
K132505	Acculif Tl and Pl Cage	Coalign Innovations, Inc.	MAX	Class II	2013-09-12
K132302	Qxlink	Vieworks Co., Ltd.	LLZ	Class II	2013-09-12
K132198	Adaptain, Adaptain Fastwrap, Envelock, Biowai	Ceremed, Inc.	KHJ	Class II	2013-09-12
K132137	Multistim	Metron Medical Australia, Pty, Ltd.	IPF	Class II	2013-09-12
K131802	Expedium, Viper. Viper 2 Spine System	Depuy Spine, A Johnson & Johnson Company	OSH	Class II	2013-09-12
K131578	Iprophy Mobile	Nakanishi Inc.	EKX	Class I	2013-09-12
K130925	Automatic Blood Pressure Monitor	HONSUN (NANTONG) Co., Ltd.	DXN	Class II	2013-09-12
K130703	Vivorte Bvf	Vivorte, Inc.	MBP	Class II	2013-09-12
K130604	Universal Paste Stains and Glaze	Prismatik Dentalcraft, Inc.	EIH	Class II	2013-09-12
K130417	Audifon Sueno Cic, Audifon Sueno S, Audifon Sueno T Cic, Audifon Sueno T S	Audifon-USA, Inc.	KLW	Class II	2013-09-12
K124037	Jung Rim Single Use Hypodermic Syringe with Needle	Jung Rim Medical Industrial Co., Ltd.	FMF	Class II	2013-09-12
K112796	Surgical Gown (Eo Sterilized)	Cobes Industries Co., Ltd.	FYA	Class II	2013-09-12
K131565	Xtag Cyp2c19 Kit V3	Luminex Molecular Diagnostics Inc	NTI	Class II	2013-09-11
K131491	Kitazato Iui Catheter	Kitazato Medical Co., Ltd.	MQF	Class II	2013-09-11
K131208	Bausch + Lomb Procomfort (Samfilcon a) Contact Lens, Bausch + Lomb Procomfort (Samfilcon a) Contact Lens for Presbyopia,	Bausch & Lomb Incorporated	LPL	Class II	2013-09-11
K131111	Ihealth Fingertip Pulse Oximeter	Andon Health Co., Ltd	DQA	Class II	2013-09-11
K131021	Pulse Oximeter	Nonin Medical, Inc	DQA	Class II	2013-09-11
K130841	Shofu Block Hc	Shofu Dental Corp.	EBF	Class II	2013-09-11
K132005	Retrograde Femoral Nail	Advanced Orthopaedic Solutions, Inc.	HSB	Class II	2013-09-10
K131250	Tiger Spine System	Corelink, LLC	NKB	Class II	2013-09-10
K131043	Apex Universal Adhesive	Apex Dental Materials, Inc.	KLE	Class II	2013-09-10
K123896	Ccs-200 Spirometer	Benson Medical Instruments Co.	BZG	Class II	2013-09-10
K123567	First Response Gold Digital Pregnancy Test	Church & Dwight Co., Inc.	LCX	Class II	2013-09-10
K132465	Biosign Flu a + B, Status Flu a & B	Princeton BioMeditech Corp.	PSZ	Class II	2013-09-09