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 726 of 3530

510(k) clearances, page 726 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K143395	Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit	Otodynamics, Ltd.	EWO	Class II	2015-02-23
K143382	DentiAnn Smart Sil	Seilglobal Co., Ltd	ELW	Class II	2015-02-23
K143260	Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/Divider	Sterilmed Inc	NUJ	Class II	2015-02-23
K143214	SCARLET® AC-T Secured Anterior Cervical Cage	Spineart SA	OVE	Class II	2015-02-23
K143105	Picosure Workstation	Cynosure, LLC	GEX	Class II	2015-02-23
K142128	Kangaroo Enteral Feeding Syringes with Enfit Connector	Medtronic, Inc.	PNR	Class II	2015-02-23
K141429	Sorrento Bone Graft Substitute	Haider Biologics, LLC	MQV	Class II	2015-02-23
K142345	Talos-C(HA) Cervical Intervertebral Body Fusion Devices	Meditech Spine, LLC	ODP	Class II	2015-02-22
K141246	Life Spine Sacroiliac Joint Fixation System	Life Spine	OUR	Class II	2015-02-22
K150148	Terason uSmart3300 Ultrasound System	Teratech Corp.	IYN	Class II	2015-02-20
K150024	Bissinger Monopolar Cables	Guenter Bissinger Medizintechnik GmbH	GEI	Class II	2015-02-20
K143705	NeedleCam HD Visualization System	Biovision Technologies, LLC	HRX	Class II	2015-02-20
K143635	KINETIS Total Knee System	Mako Surgical Corp.	JWH	Class II	2015-02-20
K143431	Giselle (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted)	I-Codi Co., Ltd.	LPL	Class II	2015-02-20
K143191	IntelliSense Drill	Mcginley Innovations	HWE	Class I	2015-02-20
K143135	Spring Coil Guidewire	Neometrics, Inc.	DQX	Class II	2015-02-20
K143122	Volcano iFR Harvest Software (Offline)	Volcano Corporation	IYO	Class II	2015-02-20
K142888	Fingertip Pulse Oximeter	Beijing Choice Electronic Technololgy Co., Ltd.	DQA	Class II	2015-02-20
K142693	ZywieAI Software Library	Zywie, Inc.	DPS	Class II	2015-02-20
K142511	U50 Diagnostic Ultrasound System	Edan Instruments, Inc.	IYN	Class II	2015-02-20
K142435	3S Safety Syringe with/without Needle	Sincere Medical Device Co., Ltd.	MEG	Class II	2015-02-20
K142432	StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit	Bioness, Inc.	GZF	Class II	2015-02-20
K142248	Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF Therapy Return Electrode, Prostiva RF Therapy Tubing System, Prostiva RF Therapy Telescope	Urologix, LLC	GEI	Class II	2015-02-20
K142205	NuVasive X-CORE(R) Expandable VBR System	NuVasive Inc	MQP	Class II	2015-02-20
K142167	Medentika Abutment System	Medentika GmbH	NHA	Class II	2015-02-20
K141401	Easy Out	Feet for Life Podiatry Center	HWC	Class II	2015-02-20
K133019	Fiberion Ophthalmic Endolaser Probe	Emtron Elektronik ve Mekanik Sanayi ve Ticaret Lim	HQF	Class II	2015-02-20
K132868	Carricell	Etex Corp.	MQV	Class II	2015-02-20
K132220	Pj's Serenity	Limerick, Inc.	HGX	Class II	2015-02-20
K150147	Lubrigyn cream	Uniderm Farmaceutici SRL	NUC	Class II	2015-02-19
K150097	Gm60a-32S & Gm60a-40S	Samsung Electronics Co., Ltd.	IZL	Class II	2015-02-19
K150005	Checkpoint, Checkpoint Head & Neck	Ndi Medical, LLC	ETN	Class II	2015-02-19
K143457	NeuroBlate System	Monteris Medical Corp	GEX	Class II	2015-02-19
K143381	Sensititre Susceptibility Plates	Thermo Fisher Scientific Oy	JWY	Class II	2015-02-19
K143111	Codman Certas Plus Programmable Valve; Codman Certas Toll Kit	Medos International SARL	JXG	Class II	2015-02-19
K143049	LYNC intramedullary implant	Novastep	HTY	Class II	2015-02-19
K143005	FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0	BioFire Diagnostics, LLC	PCH	Class II	2015-02-19
K142996	StaXx(R) XD System	Spine Wave Inc	MQP	Class II	2015-02-19
K142597	Vienna System	Mick Radio-Nuclear Instruments, Inc.	JAQ	Class II	2015-02-19
K142436	3S Safety Insulin Syringe	Sincere Medical Device Co., Ltd.	MEG	Class II	2015-02-19
K142358	Osstell IDx	Osstell AB	EKX	Class I	2015-02-19
K141798	Sypher Spacer System	Biogennix, LLC	OVD	Class II	2015-02-19
K141410	Oragene Dx Ogd-500.001	DNA Genotek Inc.	OYJ	Class II	2015-02-19
K141285	Busse Extension Set	Busse Hospital Disposables	FPA	Class II	2015-02-19
DEN140044	23Andme Personal Genome Service (Hereinafter Known as Pgs)	23AndMe, Inc.	PKB	Class II	2015-02-19
K150246	Medtronic Model 5392 External Pulse Generator (EPG)	Medtronic, Inc.	DTE	Class II	2015-02-18
K143270	Optima XR646	GE Hualun Medical Systems Co., Ltd.	KPR	Class II	2015-02-18
K142774	Polysmith Sleep System	Neurotronics, LLC	OLV	Class II	2015-02-18
K141587	E-Z Clear Smoke Evacuation Electrosurgical Pencil;clear Nozzle Extention, Ulpa Filter, Charcoal Filter, Adapter	Megadyne Medical Products, Inc	GEI	Class II	2015-02-18
K141434	Saturn 5 Laser	Research Instruments Ltd	MRX	Class II	2015-02-18