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 2704 of 3530

510(k) clearances, page 2704 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K883650	Instrumentarium Ulf Mr Imaging System Version 110	Instrumentarium Corp.	LNH	Class II	1988-09-16
K883558	Vitek Gram-Negative Identification Card	Vitek Systems, Inc.	JSS	Class I	1988-09-16
K883325	Performed Crown (Stainless Steel)	Whitecap Dental Co.	ELZ	Class I	1988-09-16
K883086	Intersept*prebypass Filter	Medtronic Blood Systems, Inc.	KRJ	Class II	1988-09-16
K883016	Polysafe Implant. Pacing Leads W/tined Fixa. Tip	Cardiac Control Systems, Inc.	DTB	Class III	1988-09-16
K882803	Et Hi-Flow Soft Tip/et Hi-Flow/enhanced Torque St	Advanced Cardiovascular Systems, Inc.	DQY	Class II	1988-09-16
K882720	Scimed R30 Silicone Assist Reservoir	Scimed Life Systems, Inc.	DTN	Class II	1988-09-16
K882716	Procedure Packs Solution Administration Sets	Procedure Packs, Inc.	DQD	Class II	1988-09-16
K882664	Mrl Oximeter	Medical Research Laboratories, Inc.	DQA	Class II	1988-09-16
K882655	Procedure Packs Press. Monitor/administration Line	Procedure Packs, Inc.	DQO	Class II	1988-09-16
K881297	Baro-Graf 24	Instromedix, Inc.	DRS	Class II	1988-09-16
K883771	Sunglasses, Imported	Norcon, Inc.	HQY	Class I	1988-09-15
K883657	Skid Resistant, Long Lasting Shoe Covers	James River Corp.	FXP	Class I	1988-09-15
K883614	Cytoguard(r)	Survival Technology, Inc.	FMF	Class II	1988-09-15
K883613	Oper. Table for Percutan. Trans. Coronary Angio.	Stierlen-Maquet AG	GDC	Class I	1988-09-15
K883510	Degupal 4	Degussa Dental, Inc.	EJS	Class II	1988-09-15
K883507	Heraeus C Special	Degussa Dental, Inc.	EJS	Class II	1988-09-15
K883311	Count-a-Dose	Pavel Jordan & Associates, Inc.	FMF	Class II	1988-09-15
K883255	Komet Surgical Bur	Komet Medical, Div. of Brasseler USA I, L.P.	GFF	Class I	1988-09-15
K883213	Nidek Opeating Microscope Delivery System (Omds)	Nidek, Inc.	HQF	Class II	1988-09-15
K883199	Modification to the Site Peristaltic Module System	Chiron Vision Corp.	HQC	Class II	1988-09-15
K883099	Site Macrobore Phaco Needle	Site Microsurgical Systems, Inc.	HQC	Class II	1988-09-15
K882821	Vitrabond Light Cure Glass Ionomer Liner	3M Company	EKJ	Class I	1988-09-15
K882721	Itc-Ite Type Hear Aid/hear-O-Inc Mdl Favorite Ear	Hear-O Inc. C/O L.P. Leale & Assoc.	ESD	Class I	1988-09-15
K882605	Euro-Med Clear-Vue Disposable Vaginal Speculum	Buckman Co., Inc.	HIB	Class II	1988-09-15
K882556	Becton Dickinson Pca Infuser - Software Modifi.	BD Becton Dickinson Vacutainer Systems Preanalytic	FRN	Class II	1988-09-15
K881889	Canon IOL Estimator Ku-1	Canon Medical Components U.S.A., Inc.	IYO	Class II	1988-09-15
K881811	Cobe Centrysystem Hollow Fiber Dialyzers	Cobe Laboratories, Inc.	FJI	Class II	1988-09-15
K883622	Instrumentarium Ulf Mr Imaging System	Instrumentarium Corp.	LNH	Class II	1988-09-14
K883434	Ambu Spur (Single Patient Use Resuscitator)	Ambu, Inc.	BTM	Class II	1988-09-14
K883087	Prolog Mp 658M Pulse Generator	Pacesetter Systems	DXY	Class III	1988-09-14
K883072	Digitron 2, Digital Substraction Angio. System	Siemens Gammasonics, Inc.	IZI	Class II	1988-09-14
K882557	Coulter Clone B1 Monoclonal Antibody	Coulter Immunology	GKZ	Class II	1988-09-14
K882394	Medtronic Epidural Catheter Kit Model 8716	Medtronic, Inc.	CAZ	Class II	1988-09-14
K882311	Shimadzu Lateral C-Arm Mh-31	Shimadzu Precision Instruments, Inc.	JAA	Class II	1988-09-14
K882052	Omega Nv(tm) Balloon Dilatation Catheter	Cook Inc.	LIT	Class II	1988-09-14
K881697	Breast Lesion Localization Needle	BD Becton Dickinson Vacutainer Systems Preanalytic	IZH	Class II	1988-09-14
K881478	Modified Keymed Flexible Esophageal Dilators	KEYMED (Medical & Industrial Equipment) Ltd	KNQ	Class II	1988-09-14
K870722	Label Chg for Erika Model 9608 Arterial Blood Line	National Medical Care, Medical Products Div., Inc.	FJK	Class II	1988-09-14
K883679	Wheels-Off Quick Release Axle System	Rolcontrol Products, Co., Inc.	KNN	Class I	1988-09-13
K883678	4007 Model Recliner Controller	Rolcontrol Products, Co., Inc.	ITI	Class II	1988-09-13
K883674	Manual Swing Arm	Rolcontrol Products, Co., Inc.	ITI	Class II	1988-09-13
K883673	Power Mechanical Recliner	Rolcontrol Products, Co., Inc.	ITI	Class II	1988-09-13
K883672	Paralyzed Veterans of America Power Recliner	Rolcontrol Products, Co., Inc.	ITI	Class II	1988-09-13
K883671	805 Power Chair Conversion System	Rolcontrol Products, Co., Inc.	ITI	Class II	1988-09-13
K883581	Opmi Cs	Carl Zeiss, Inc.	EPT	Class I	1988-09-13
K883578	S 21 Instrument Stand	Carl Zeiss, Inc.	FSH	Class I	1988-09-13
K883504	Durazyme(r) Cpk	American Monitor Corp.	CGS	Class II	1988-09-13
K883485	Stryker Pressure Monitor System	Stryker Corp.	FTY	Class I	1988-09-13
K883474	Thoracic Catheters	Westmark, Sterile Packing Systems, Inc. (Sps)	GBX	Class I	1988-09-13