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 1746 of 3531

510(k) clearances, page 1746 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K990593	Pelvx Incontinence Dish, Model 301-306	Deschutes Medical Products, Inc.	HHW	Class II	1999-05-24
K990574	Stick-on Disposable Nasal Mask, Model 312174, 1001964	Respironics, Inc.	MNT	Class II	1999-05-24
K990045	Beraclamp, Model Bc-1	Poamax LLC	KNA	Class II	1999-05-24
K983862	Cloud 1 Humidification System	Respiratory Support Products, Inc.	BTT	Class II	1999-05-24
K981549	Lactation Techniques Model B	Lactation Techniques, Inc.	HGX	Class II	1999-05-24
K991732	Centrafix External Fixator	Owandar Medical, Ltd.	JEC	Class II	1999-05-21
K991644	Microgas 7650 Transcutaneous Monitor	Linde Medical Sensors AG	KLK	Class II	1999-05-21
K991428	Ascent Knee System	Zimmer GmbH	JWH	Class II	1999-05-21
K991317	Powder-Free Latex Surgeon's Glove Safeskin Pfs Plus Contains 50Mlgm or Less of Total Water Extractable Protein per Gram	Safeskin Corp.	KGO	Class I	1999-05-21
K991270	Smartemp	Parkell, Inc.	EBG	Class II	1999-05-21
K991039	Easysafe Retracting Needle Syringe	Saf-T-Med, Inc.	FMF	Class II	1999-05-21
K990882	Laglove Brand Colored Nitrile Examination Gloves (Powder Free)	La Glove (M) Sdn. Bhd.	LZA	Class I	1999-05-21
K990878	Brightway Brand Blue Nitrile Examination Gloves (Powder Free)	Brightway Holdings Sdn. Bhd.	LZA	Class I	1999-05-21
K990572	Sonotome	Sonokinetics, Inc.	LFL	Unclassified	1999-05-21
K990346	Bayer Advia 1650 Chemistry System	Bayer Corp.	JGS	Class II	1999-05-21
K984395	Surgeon's Gloves	Sri Anusham Rubber Industries Pvt., Ltd.	KGO	Class I	1999-05-21
K984328	Leksell Gamma Knife Target System, Model 24001	Elekta Instrument AB	IWB	Class II	1999-05-21
K984261	Surestep Blood Glucose Monitoring System	Lifescan, Inc.	CGA	Class II	1999-05-21
K991435	Aii-Pro 100 Plus and All-Pro 200	All-Pro Imaging Corp.	IXW	Class II	1999-05-20
K991221	Vestogum	Espe Dental AG	ELW	Class II	1999-05-20
K991220	Vitron H	Espe Dental AG	EBI	Class II	1999-05-20
K991057	Extra Large Body Coil for Opart (Mrt-600)	Toshiba America Mri, Inc.	MOS	Class II	1999-05-20
K990839	Tru-Core I Reusable Biopsy Instrument	Medical Device Technologies, Inc.	KNW	Class II	1999-05-20
K990710	Barrierplus Synthetic Powder-Free Surgical Gloves	Barriermed Glove Co.	KGO	Class I	1999-05-20
K990690	Polymer Coated Powderfree Latex Examintation Gloves	Top Glove Sdn. Bhd.	LYY	Class I	1999-05-20
K990560	Life Imaging Systems, Model L3di	Life Imaging Systems, Inc.	IYO	Class II	1999-05-20
K990193	Iodine Brachytherapy Seeds, Model 3000	Implant Sciences Corp.	KXK	Class II	1999-05-20
K984270	Vapo-Solution for Use in Mdt Harvey Chemiclave Sterilizers, Models 5000, 5500, and 6000	Roger L. Goodman, D.D.S., P.C.	MED	Class II	1999-05-20
K983840	Wallach Quantum 500 Electrosurgical Generator (Proposed)	CooperSurgical, Inc.	HGI	Class II	1999-05-20
K973592	Walkcare P200 System	A.Stein - Regulatory Affairs Consulting	JOW	Class II	1999-05-20
K973078	Wrist Blood Pressure Meter Model Se-330	Sein Electronics Co., Ltd.	DPW	Class II	1999-05-20
K991583	Neurosign 400, 4 Channel Motor Nerve Monitor	Magstim Inc.	ETN	Class II	1999-05-19
K991460	Modification to Zplate-Atl Anterior Fixation System	Sofamor Danek	MNH	Class II	1999-05-19
K991429	Diamond II Valve	Phoenix Biomedical Corp.	JXG	Class II	1999-05-19
K991387	Elan Alkaline Phosphate Reagent Kit	Elan Holdings, Inc.	CJE	Class II	1999-05-19
K991364	Modification to Tenor Spinal System-Plates	Sofamor Danek USA,Inc.	MNH	Class II	1999-05-19
K991182	Modification of N/t Protein Control Sl	Siemens Healthcare Diagnostics Inc.	JJY	Class I	1999-05-19
K991120	Vacutainer Brand Ctad Tube (Multiple)	Becton Dickinson Vacutainer Systems	JKA	Class II	1999-05-19
K991010	Acp	Abbott Diagnostics Mfg., Inc.	CKB	Class II	1999-05-19
K990894	Etb Trocar System	The Altomec Corp.	GCJ	Class II	1999-05-19
K990731	Eastgate Personal Monitor	Eastgate Trading Corp.	GCJ	Class II	1999-05-19
K990645	Gallini Atra-Cut Needle	Gallini U.S., LLC	KNW	Class II	1999-05-19
K990635	Vista Stereoscope System	Vista Medical Technologies, Inc.	GCJ	Class II	1999-05-19
K990538	Brainmaster 2E Module and Software Biofeedback Device	Brainmaster	HCC	Class II	1999-05-19
K990522	Waratah Digital EEG and Sleep Acquisition Devices with, or without, Pulse Oximetry,cardinal Digital EEG and Sleep Acquis	Lamont Medical, Inc.	OLV	Class II	1999-05-19
K990016	Vitros Immunodiagnostic Products Anemia Controls	Ortho-Clinical Diagnostics, Inc.	JJY	Class I	1999-05-19
K984407	BIPAP Harmony S/t, Model 1001445	Respironics, Inc.	MNS	Class II	1999-05-19
K984285	Osteogram Bone Densitometer	Compumed, Inc.	KGI	Class II	1999-05-19
K983831	Vectorvision2	Brainlab, Inc.	HAW	Class II	1999-05-19
K991589	Flexible Vascular Clamp, Version 2	Medtronic, Inc.	DXC	Class II	1999-05-18