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 784 of 3530

510(k) clearances, page 784 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K140637	Peregrine System Infusion Catheter	Ablative Solutions, Inc.	KRA	Class II	2014-03-26
K140415	Monotex	Riverpoint Medical, LLC	NBY	Class II	2014-03-26
K140300	Collagen Tendon Sheet-Ddi (Cts-Ddi)	Rotation Medical, Inc.	OWY	Class II	2014-03-26
K140029	Amiplivue Hsv 1&2 Assay	Ortho-Clinical Diagnostics, Inc.	OQO	Class II	2014-03-26
K133807	Mars Monitor Itc US, Mars Treatment Kit Type 1116/1 - X-Mars US, Prismaflex Control Unit	Gambro Renal Products	FLD	Class II	2014-03-26
K133775	Exsalt Sd7 Wound Dressing with Adhesive Backing	Exciton Technologies Inc.	FRO	Unclassified	2014-03-26
K133680	Encore System	Siesta Medical, Inc.	ORY	Class II	2014-03-26
K133599	Corgrip	Halyard Health	KNT	Class II	2014-03-26
K133544	Op300	Palodex Group Oy	OAS	Class II	2014-03-26
K133539	Total Across	Medtronic, Inc.	DQY	Class II	2014-03-26
K133508	Resolutionmd Mobile	Calgary Scientific, Inc.	LLZ	Class II	2014-03-26
K132759	Ventrain	Dolphys Medical B.V.	BTL	Class II	2014-03-26
K132320	Intellivue Cl Respiration Pod	Philips Medizinsysteme Boeblingen GmbH, Cardiac an	BZQ	Class II	2014-03-26
K131939	Amico Dh-W35 Ophthalmoscope Series	Amico Diagnostic Incorporated	HLI	Class II	2014-03-26
K131760	Whip Mix Preppies Plus	Whip-Mix Corp.	EJR	Class I	2014-03-26
K140457	Nautilus Spinal System	Life Spine	NKB	Class II	2014-03-25
K140452	Vega Knee System	Aesculap Inc	JWH	Class II	2014-03-25
K140449	Cd Horizon Spinal System	Medtronic Sofamor Danek	NKB	Class II	2014-03-25
K140393	Randox Ammonia Ethanol Control Levels 1, 2 and Level 3	Randox Laboratories, Limited	JJY	Class I	2014-03-25
K140137	Safety Biopsy Needle System	PFM Medical GmbH	FCG	Class II	2014-03-25
K140079	Silex Sacroiliac Joint Fusion System	Xtant Medical Holdings, Inc.	OUR	Class II	2014-03-25
K133993	Caas Workstation	PIE Medical Imaging B.V.	IZI	Class II	2014-03-25
K133972	Aspire Cristalle	FUJIFILM Healthcare Americas Corporation	MUE	Class II	2014-03-25
K133673	Illumigene Pertusis DNA Amplification Assay, Illumigene Pertussis External Control Kit, Illumipro-10 Automated Isotherma	Meridian Bioscience Inc	OZZ	Class II	2014-03-25
K133663	Nio Color 2Mp	Barco N.V.	LLZ	Class II	2014-03-25
K133640	Asir-V	GE Healthcare	JAK	Class II	2014-03-25
K132965	Solace Sound Generators	Amplisound Hearing Products & Services	KLW	Class II	2014-03-25
K132017	Hc550 Respiratory Humidifier, Adult Ventilator Circuit	Fisher & Paykel Healthcare, Inc.	BTT	Class II	2014-03-25
K131703	Nova Stat Profile Prime Ccs Analyzer System	Nova Biomedical Corporation	CHL	Class II	2014-03-25
K133974	Variax Distal Radius Plating System	Stryker Leibinger	HRS	Class II	2014-03-24
K133593	T:slim Insulin Delivery System	Tandem Diabetes Care, Inc.	LZG	Class II	2014-03-24
K133453	Iovera	Myoscience, Inc.	GXH	Class II	2014-03-24
K133382	Qb Test	Qbtech AB	LQD	Unclassified	2014-03-24
K133232	Prevena Incision Management System with Customizable Dressing, Prevena Incision Managemant System with Peel& Place Dres	Kci USA, Inc. (Kinetic Concepts, Inc.)	OMP	Class II	2014-03-24
K133125	Withings Blood Presure Monitor	Withings	DXN	Class II	2014-03-24
K132656	Prodense Bone Graft Substitute	Wrightmedicaltechnologyinc	MQV	Class II	2014-03-24
K132250	Integra Freedom Wrist Arthroplasty System	Integra LifeSciences Corporation	JWJ	Class II	2014-03-24
K130550	Rsp Modular Glenoid Baseplate, Glenoid Taper Adapter, Retaining Screw	Encore Medical, LP	PHX	Class II	2014-03-24
K140524	Terason Usmart3200 and Benq Up200ultrasound System	Teratech Corp.	IYN	Class II	2014-03-21
K133944	Range, Spinal System, Everest Spinal System	K2M, Inc	NKB	Class II	2014-03-21
K133786	Dornoch Duo Suction Cart with: Dl2800 Lid, Cl500 Lid, Dornoch Quad Suction Cart with: Dl2800 Lid, Cl500 Lid	Dornoch Medical Systems	JCX	Class II	2014-03-21
K133782	Nova Fa Dr System	Sedecal S.A.	MQB	Class II	2014-03-21
K133735	Eye Secret 55 UV Aspheric (Methafilcon a) Soft (Hydrophilic) Contact Lens	Yung Sheng Optical Co., Ltd.	LPL	Class II	2014-03-21
K133657	Discovery Pet/ct 710	GE Healthcare	KPS	Class II	2014-03-21
K132607	Ns 2500 Holmium Laser System	New Star Lasers, Inc.	GEX	Class II	2014-03-21
K132144	Kerator	LK Consulting Group USA, Inc.	DZE	Class II	2014-03-21
K132104	Elibra Soft-Tissue Force Sensor	Kamm & Associates	ONN	Class II	2014-03-21
K132031	Afinion Lipid Panel and Afinion Lipid Panel Control	Axis-Shield Poc AS	CHH	Class I	2014-03-21
K132011	Apoteca Dug Compounding Dosing Device,apoteca i.v. Transfer Set	Aea SRL	FMF	Class II	2014-03-21
K131877	Save II, Save II Basic	Automedx, Inc.	BTL	Class II	2014-03-21