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 2026-11-09, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,227 of the 176,624 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	2,827

176,624 records, page 1724 of 3533

510(k) clearances, page 1724 of 3533
K number	Device	Applicant	Product code	Class	Decision date
K992106	Modus System Self-Drilling Screws	Medartis AG	HWC	Class II	1999-09-17
K992094	Giltech Plus Hydrogel Skin Dressing	Giltech Plus, Inc.	NAE	Class I	1999-09-17
K991998	Gamma-B 25-Hydroxy Vitamin D Ria	Immunodiagnostic Systems Ltd.	MRG	Class II	1999-09-17
K991974	Futura Glass Ionomer Silver Reinforced	Ab Ardent	EMA	Class II	1999-09-17
K991927	Medi-Test Combi 11	Macherey-Nagel-Duren	JIL	Class II	1999-09-17
K991532	Drx Qt. Hcg	Metrika, Inc.	DHA	Class II	1999-09-17
K991480	Excel Ge Blood Glucose Test Strips & Code Strip	Selfcare, Inc.	CGA	Class II	1999-09-17
K990810	Arglaes-Ab Antimicrobial Barrier Film Dressing & Island Dressing	Maersk Medical A/S	FRO	Unclassified	1999-09-17
K990641	Caltag Fetal Hemoglobin Test	Caltag Laboratories, Inc.	GHQ	Class II	1999-09-17
K990362	Instrument, Ultrasonic, Scalpel	Ethicon Endo-Surgery Inc	GEI	Class II	1999-09-17
K990194	Biobutton	Linvatec Corporation	HWC	Class II	1999-09-17
K984358	Olympus Distal Attachment, Models Mh-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597	OLYMPUS Corporation of the Americas	FDS	Class II	1999-09-17
K983410	@ Target	Brainlab, Inc.	HAW	Class II	1999-09-17
K983097	Tens/fes/nmes Electrodes	Uni-Patch, Inc.	GXY	Class II	1999-09-17
K992892	Stepping Kinematic Imaging Platform (Skip)	Magnetic Moments, LLC	LNH	Class II	1999-09-16
K992839	Socket Stapes Piston W/o Loop, Schobel, Schobel-Causse	Heinz Kurz GmbH Medizintechnik	ETB	Class II	1999-09-16
K992788	Bear Cub 750 Psv	Bear Medical Systems, Inc.	CBK	Class II	1999-09-16
K992143	Modification to Pasco Mic and Mic/id Panels (Clindamycin)	Pasco Laboratories, Inc.	JWY	Class II	1999-09-16
K990642	Echoflow Doppler Blood Velocity Meter	Echocath, Inc.	JOP	Class II	1999-09-16
K984573	Opti-Free Express Multi-Action Cleaning and Rewetting Drop	Alcon Laboratories	LPN	Class II	1999-09-16
K983717	Bp-Tel Trans-Telephonic Blood Pressure Measurement System	Aerotel Medical Systems (1998), Ltd.	DXN	Class II	1999-09-16
K981047	Fresh Air	Colorado Medtech, Inc.	CAW	Class II	1999-09-16
K992910	Affinity Nt Hollow Fiber Oxygenator with Plasma Resistant Fiber with Balance Biocompatible Surface (Model 511B)	Medtronic, Inc.	DTZ	Class II	1999-09-15
K992825	Cordis Extreme Pta Balloon Catheter	Cordis US Corp.	LIT	Class II	1999-09-15
K992814	Cynosure Accolade Laser	Cynosure, LLC	GEX	Class II	1999-09-15
K992755	Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Cordis Crimping Tools, Cordis Introducer Tube	Cordis, A Johnson & Johnson Co.	FGE	Class II	1999-09-15
K992475	Careside CO2, Total	Careside, Inc.	KHS	Class II	1999-09-15
K992399	Additional Ims Assays for the Bayer Advia Ims System	Bayer Corp.	CIX	Class II	1999-09-15
K992268	Nac Prn Needleless Access Connector	The Kipp Group	FPA	Class II	1999-09-15
K992072	Bolus Accessory Set	Halyard Health	FPA	Class II	1999-09-15
K991883	Redi-Test Opiates	Advantage Diagnostics Corp.	DJG	Class II	1999-09-15
K983762	Nuclisens Cmv Pp67	bioMerieux, Inc.	LIN	Class II	1999-09-15
K983232	Padtak Pediatric Defib/cardiovert/pace/monitor-Radiotransparent (2X2.25),model 2602, Padtak Pediatric Defib/cardiovert	TZ Medical Inc.	DRO	Class II	1999-09-15
K983196	Padtak Pace/defib/cardiovert Monitoring Electrode(s)	TZ Medical Inc.	DRO	Class II	1999-09-15
K992917	Aerochamber Plus Valved Holding Chamber	Trudell Medical Intl.	CAF	Class II	1999-09-14
K992807	Bio-Logic Evoked Potential for Abaer I	Bio-Logic Systems Corp.	GWJ	Class II	1999-09-14
K992730	Hwa (and) Silktex Pre-Powdered Latex Examination Glove	Hwa Teh Industrial Sdn. Bhd.	LYY	Class I	1999-09-14
K992661	Control III Elite	Maril Products, Inc.	LRJ	Class I	1999-09-14
K992557	Qualatex Powdered Latex Examination Gloves	Tan Sin Lian Industries Sdn. Bhd.	LYY	Class I	1999-09-14
K992540	Xenon Light Source Pes 1	Laser-Optik-Systeme GmbH & Co. KG	GCT	Class II	1999-09-14
K992464	Synthetic Powdered Vinyl Patient Examination Gloves	Shijiazhuang Dilly Plastics Products Co., Ltd.	LYZ	Class I	1999-09-14
K992437	Schoelly Rigid Endoscopes	Fiber Imaging Technologies, Inc.	GCJ	Class II	1999-09-14
K992302	Dermaphylyx Skin Protectors, Protect It Skin Protectors	Dermaphylyx, Inc.	MGP	Unclassified	1999-09-14
K992171	Coated Sterile Latex Powder-Free Surgical Gloves with Protein Content Labeling Claim (50 Micrograms or Less)	Medtronic, Inc.	KGO	Class I	1999-09-14
K992128	Dash Siliconized Polymer Coated Powder Free Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms	Dash Medical Gloves Sdn Bhd	LYY	Class I	1999-09-14
K992110	Premier Anterior Cervical Plate System	Sofamor Danek USA,Inc.	KWQ	Class II	1999-09-14
K992050	Lumenon Xenon Light Source	Biomet Microfixation	GCT	Class II	1999-09-14
K991529	Csm Stretta Control Module Electrosurgical Generator, Model S400	Conway Stuart Medical, Inc.	GEI	Class II	1999-09-14
K991419	Modified Ham's F-10 Basal Medium, Modified Hams's F-10 Basal Medium Hepes, Modified Ham's F-10 Supplement (50X) Iyophili	FUJIFILM Biosciences Inc.	MQL	Class II	1999-09-14
K991125	Sauflon Aerotab Disinfecting System for the Disinfection of Soft (Hydrophilic) Contact Lenses	Sauflon Pharmaceuticals, Ltd.	LPN	Class II	1999-09-14