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 1787 of 3531

510(k) clearances, page 1787 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K973985	As/3 Anaesthesia Delivery Unit (As/3 Adu)	Datex-Engstrom, Inc.	BSZ	Class II	1998-10-30
K983785	Autovent 1000	O-Two Systems Intl., Inc.	BTL	Class II	1998-10-29
K983705	Emt Resuscitator	O-Two Systems Intl., Inc.	BTL	Class II	1998-10-29
K983643	Genesis Bls	O-Two Systems Intl., Inc.	BTL	Class II	1998-10-29
K983447	Wise (II) Image Management System	Sectra-Imtec AB	LMB	Class I	1998-10-29
K983436	Gammamed Plus High Dose Rate Remote Afterloading System	Gammamed USA	JAQ	Class II	1998-10-29
K983273	Xct 2000 L Pqct Bone Densitometer	Medical Systems Corp.	KGI	Class II	1998-10-29
K982916	Medrad 1.5T, 1.0T & 0.5T Shoulder Coil, Models M64shc, M42shc, M21shc	Medrad, Inc.	MOS	Class II	1998-10-29
K982835	Electrode Switchbox, Model 11-081002	Cardima, Inc.	DRF	Class II	1998-10-29
K982834	Restgrid Package/gyroscan Nt	Philips North America LLC	LNH	Class II	1998-10-29
K982824	X-Ray Timer Model I.e.d. 7888 I.d. 7881 and B764id	I.E.D., Inc.	KPR	Class II	1998-10-29
K982789	Medical Air Compressor, Model # 8413419	Drager, Inc.	BTI	Class II	1998-10-29
K982676	Airwatch II Zone	Enact Health Management Systems	BZH	Class II	1998-10-29
K982675	Airwatch II Zoneless	Enact Health Management Systems	BZH	Class II	1998-10-29
K982673	Just Between US, Personal Lubricant & Condom	Key West Fragrance & Cosmetic	HIS	Class II	1998-10-29
K982131	Nitra-Touch Powder-Free Nitrile Medical Examination Glove	Ansell Edmont Industrial, Inc.	LZA	Class I	1998-10-29
K981508	Vectorvision Spine Module	Brainlab, Inc.	HAW	Class II	1998-10-29
K981497	Steritec Disposable Biological Test Pack-Eo Gas	Steritec Products Mfg. Co., Inc.	FRC	Class II	1998-10-29
K981096	Sempermed Surgeons' Gloves - Supreme	Semperit Technische Produkte Gesellshaft	KGO	Class I	1998-10-29
K983709	Synchron Systems Dat Low and High Urine Controls 1	Siemens Healthcare Diagnostics Inc.	DIF	Class I	1998-10-28
K983184	Mepilex	Molnlycke Health Care	MGP	Unclassified	1998-10-28
K983091	Elan-2	Kerr Dental Materials Center	EBF	Class II	1998-10-28
K983082	Begocer G	Bego U.S.A.	EJT	Class II	1998-10-28
K983081	Begopal 300	Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & Co	EJS	Class II	1998-10-28
K983080	Aurolloyd Kf	Bego U.S.A.	EJT	Class II	1998-10-28
K982970	Mri's All Silicone Irrigation 3-Way Foley Catheter	Mri Manufacturing and Research, Inc.	EZL	Class II	1998-10-28
K982810	Shelhigh No-React Vascupatch	Shelhigh, Inc.	DXZ	Class II	1998-10-28
K982793	Piezo Tronic	Advanced Medical Devices, Inc.	ELC	Class II	1998-10-28
K982733	Olympus Mh-246R Balloon Sheath, for Bronchial Use	Olympus Optical Co., Ltd.	ITX	Class II	1998-10-28
K982723	Maico Ma42	Bernafon-Maico, Inc.	EWO	Class II	1998-10-28
K982693	Medine Disposable Sterile Zoned Impervious Surgical Gowns	MEDLINE INDUSTRIES, LP - Northfield	FYA	Class II	1998-10-28
K982662	Depuy Profile Round Head Interference Screw, Depuy Phantom Resorbable Interference Screw	Depuy Orthopaedics Inc.	HWC	Class II	1998-10-28
K982541	Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 & 368608	Becton Dickinson Vacutainer Systems	FMI	Class II	1998-10-28
K982225	Spiracle Technology-Bi-Flow Demand/resuscitator Valve, Model 504	Spiracle Technology	BTL	Class II	1998-10-28
K982082	Handisol Wound Healing	National Biological Corp.	FTC	Class II	1998-10-28
K981528	Sonoline Elegra Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	IYO	Class II	1998-10-28
K981207	Clearplan Easy Fertility Monitor	Unipath, Ltd.	NGE	Class I	1998-10-28
K980799	High Viscosity Composite Temporary (Provisional) Material	Cosmedent, Inc.	EBG	Class II	1998-10-28
K974581	Millennia 3500 Series Monitor with Anthesthetic Agent	Invivo Research, Inc.	DRT	Class II	1998-10-28
K973138	Spirocard	VectraCor, Inc.	BZG	Class II	1998-10-28
K983548	Ferritin Calibrator	Siemens Healthcare Diagnostics Inc.	JIT	Class II	1998-10-27
K983510	Chemstrip 101 Urine Analyzer	Boehringer Mannheim Corp.	KQO	Class I	1998-10-27
K983339	Osteo Dynatroc Proximal Femoral Nail	Osteonics Corp.	HSB	Class II	1998-10-27
K983014	Summit Acetabular System	Johnson & Johnson Professionals, Inc.	LPH	Class II	1998-10-27
K982949	Elecsys Psa, Model 2010	Boehringer Mannheim Corp.	LTJ	Class II	1998-10-27
K982948	Elecsys Psa, Model # Elecsys 1010	Boehringer Mannheim Corp.	LTJ	Class II	1998-10-27
K980977	Piolax Hydrophilic Guidewire	Piolax Medical Devices, Inc.	DQX	Class II	1998-10-27
K983265	Depuy Ace Composite Locking Nut	Depuy Ace Medical Co.	HTN	Class II	1998-10-26
K983197	Surgical Dynamics Rodding System (Previously Known as the Aurora Titanium Spinal Rod System)	United States Surgical, A Division of Tyco Healthc	KWP	Class II	1998-10-26
K982893	3M Tegasorb Hydrocolloid Dressing	3M Company	KMF	Class I	1998-10-26