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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 1389 of 3531

510(k) clearances, page 1389 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K040333	Valumax Surgical Masks (Blue, Pink, Green, Yellow, White and Peach) with or without Visors, Ties and Earloops	Valumax Intl., Inc.	FXX	Class II	2004-06-07
K040048	Fujinon Double Balloon Enteroscopy System	FUJIFILM Healthcare Americas Corporation	FDA	Class II	2004-06-07
K033276	Vpap III St-a	ResMed Corp	MNS	Class II	2004-06-07
K041401	Modification to M2376a Devicelink System	Philips North America LLC	MWI	Class II	2004-06-04
K041347	Modification to En-Bloc Biopsy System	Neothermia Corp.	GEI	Class II	2004-06-04
K041235	Philips Mp20, Mp30, Mp40, Mp50. Mp60, Mp70 and Mp90 Intellivue Patient Monitors	Philips Medizin Systeme Boeblingen GmbH	MHX	Class II	2004-06-04
K041179	Modification to the Nac Plus Needleless Access Connector	Medegen Medical Manufacturing Services	FPA	Class II	2004-06-04
K041048	Polydioxanone Synthetic Absorbable Surgical Suture	Internacional Farmaceutica, S.A. de C.V.	NEW	Class II	2004-06-04
K040868	Sepramesh Ip Bioresorbable Barrier - Permanent Mesh	Genzyme Corporation	FTM	Class II	2004-06-04
K040789	Durabraid Suture	Smith & Nephew, Inc.	GAT	Class II	2004-06-04
K040699	Laparoscopic Electrode, Reusable Indicator Shaft (Leris)	Megadyne Medical Products, Inc	GEI	Class II	2004-06-04
K040683	Bioderm Sciences Wound Dressing	Bioderm Sciences, Inc.	FRO	Unclassified	2004-06-04
K040654	Sensilase Pad 3000	Optical Sensors, Inc.	DPW	Class II	2004-06-04
K040613	Exactech Acumatch a-Series and Mcs Acetabular Shells and Liners	Exactech, Inc.	MEH	Class II	2004-06-04
K040611	Modular Radial Head Replacement Device	Zimmer GmbH	KWI	Class II	2004-06-04
K040610	Versa-Dial Humeral Head	Biomet Manufacturing Corp	KWS	Class II	2004-06-04
K040604	Innervue Diagnostic Scope System	Arthrotek, Inc.	GCJ	Class II	2004-06-04
K040559	Modification to Unity Network Id	GE Medical Systems Information Technologies, Inc.	MWI	Class II	2004-06-04
K033985	Peripatch Sleeve, Models G35, E35, G45, E45, G60, E60, 5C6, 5C8, 5C10	Pm Devices, Inc.	FTM	Class II	2004-06-04
K033819	Invacare 3G Tarsys	Invacare GmbH	ITI	Class II	2004-06-04
K041341	Golden Spyder, Model Gs-300	Golden Technologies, Inc	ITI	Class II	2004-06-03
K041201	Ultraclip II Mr	Inrad	GDW	Class II	2004-06-03
K040994	Cosmedent Core Paste	Cosmedent, Inc.	EBF	Class II	2004-06-03
K040944	Rescontrol II	ResMed Corp	BZD	Class II	2004-06-03
K040834	Navigus Passive Probe (Bl), Model Np-2000	Image-Guided Neurologics, Inc.	HAW	Class II	2004-06-03
K040791	Polymer Coat, Powder Free Nitrile Examination Glove (Blue)	Pt. Smartglove Indonesia	LZA	Class I	2004-06-03
K040790	Modification to Ltv 1000 Ventilator/breathing Circuits	Pulmonetic Systems, Inc.	CBK	Class II	2004-06-03
K040726	Ventlab Nasal CPAP Cannula	Salter Labs	BZD	Class II	2004-06-03
K040720	Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30 Mm, 55 Mm, 75 Mm	Power Medical Interventions, Inc.	GDW	Class II	2004-06-03
K040712	Air Safety Hepa, Model 3500	Air Safety, Ltd.	MOD	Class II	2004-06-03
K040681	Synthetic (White) Vinyl Patient Examination Gloves-Powder Free	Grand Work Plastic Products Co., Ltd.	LYZ	Class I	2004-06-03
K040650	Bonamates Series	Biotech One, Inc.	JEY	Class II	2004-06-03
K040589	Modification to Avant 9600 Pulse Oximeter	Nonin Medical, Inc	DQA	Class II	2004-06-03
K040458	Modification to Dash 3000/4000 Patient Monitor	GE Medical Systems Information Technologies, Inc.	MHX	Class II	2004-06-03
K040407	Quickelisa Anthrax-Pa Kit	Immunetics, Inc.	NRL	Class II	2004-06-03
K040149	Psi-Tec Peristaltic Infiltration Pump	Byron Medical	FRN	Class II	2004-06-03
K040071	Ennoble Disposable Powder Free Vinyl Synthetic Exam Gloves with Vitamin Complex, Nopal and Lanolin	Elite International, Inc.	LYZ	Class I	2004-06-03
K033790	Thermofocus 0800, 0900, 01500 and 0700 Series	Tecnimed S.r.l.	FLL	Class II	2004-06-03
K033743	Cozart Eia Amphetamines Oral Fluid Microplate Kit	Cozart Bioscience, Ltd.	DKZ	Class II	2004-06-03
K033711	Fukuda Denshi Dynascope Model Ds-5000 Central Telemetry System	Fukuda Denshi USA, Inc.	MHX	Class II	2004-06-03
K033512	Procyon Spinal System	Nas Medical Technologies, Inc.	MNH	Class II	2004-06-03
K032767	Lily Volume Meteric Administration Set, Models Ib-2111 and Cib-120Es	Lily Medical Supplies Co., Ltd.	FPA	Class II	2004-06-03
K041240	Semen Analysis Quality Control, Assayed and Unassayed	Fertility Solutions, Inc.	NRF	Class II	2004-06-02
K041203	Summit Oct Spinal System	DePuy Spine, Inc.	MNI	Class II	2004-06-02
K041134	Combomap Pressure and Flow System	Volcano Therapeutics, Inc.	OBJ	Class II	2004-06-02
K040966	Modification to Carematix Wellness System	Carematix Inc.	DRG	Class II	2004-06-02
K040748	Ana-Bel, Model 087D and Ana-Bel Cm, Model 187-Cm	Takara Belmont USA, Inc.	EHD	Class II	2004-06-02
K040729	Solaris D890 Therapy Probe	Dynatronics Corp.	ILY	Class II	2004-06-02
K040655	Swift Anterior Cervical Plate System	DePuy Spine, Inc.	KWQ	Class II	2004-06-02
K040642	Lpo Option for Drager Intensive Care Ventilator Savina	Draeget Medical AG & Co. KGaA	CBK	Class II	2004-06-02