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 1394 of 3531

510(k) clearances, page 1394 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K041087	Infinity Gamma	Draeger Medical Systems, Inc.	MHX	Class II	2004-05-12
K041072	Kuschall Champion, Kuschall Compact, Kuschall Ultra-Light	Invacare GmbH	IOR	Class I	2004-05-12
K041056	10-Second Digital Thermometer, Models St87, St89, St80, St88	Mesure Technology Co., Ltd.	FLL	Class II	2004-05-12
K040955	M3290a Intellivue Information Center Software Release E.01 and Intellivue Clinical Network on Vlan	Philips North America LLC	MHX	Class II	2004-05-12
K040945	Modification to Infinity Explorer	Draeger Medical Systems, Inc.	MSX	Class II	2004-05-12
K040939	Sky Bone Expander System (Sky System)	Disc-O-Tech Medical Technologies, Ltd.	HRX	Class II	2004-05-12
K040463	Aeskulisa Cardiolipin Agm	Aesku, Inc.	MID	Class II	2004-05-12
K040383	Triflange II Acetabular Cup System	Depuy Orthopaedics Inc.	LPH	Class II	2004-05-12
K040381	Hatric, 6&7Mm, 9&10Mm, 11&12Mm, 14&15Mm, Models Ar-13000B-07, -10, -12, -15	Arthrex GmbH	MQV	Class II	2004-05-12
K040350	Randox Amphetamine Class Assay	Randox Laboratories, Limited	DKZ	Class II	2004-05-12
K040344	Impax Ot3000 Orthopedic Workstation	Agfa Corp.	LLZ	Class II	2004-05-12
K040165	Reflexion Cannulator Steerable Electrophysiology Catheter with Lumen, Model 402805	Abbott Medical	DRA	Class II	2004-05-12
K033990	Alveolus Inc. Tb-Sts Tracheobronchial Stent System	Alveolus, Inc.	JCT	Class II	2004-05-12
K031327	Vericor	Cvp Diagnostics, Inc.	DXN	Class II	2004-05-12
K040954	Fox Plus Pta Catheter	Abbott Medical	LIT	Class II	2004-05-11
K040688	Standard Imaging E.imrt Calculator	Standard Imaging Inc.	MUJ	Class II	2004-05-11
K040585	Exactrac 4.0 and Exactrac X-Ray 6D	Brainlab, Inc.	IYE	Class II	2004-05-11
K040452	Varelisa B2 Glycoprotein I Antibodies Screen, Models 19048 and 19096	Pharmacia Deutschland GmbH	MSV	Class II	2004-05-11
K040451	Varelisa B2 Glycoprotein I Igm Antibodies, Models 18848 and 18896	Pharmacia Deutschland GmbH	MSV	Class II	2004-05-11
K040450	Varelisa B2 Glycoprotein I Iga Antibodies, Models 18948 and 18996	Pharmacia Deutschland GmbH	MSV	Class II	2004-05-11
K040449	Varelisa B2 Glycoprotein I Igg Antibodies, Models 18748 and 18796	Pharmacia Deutschland GmbH	MSV	Class II	2004-05-11
K040424	Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous Discectomy Kit, Model 1120	Clarus Medical, LLC	GEX	Class II	2004-05-11
K040208	Neptune Pad, Neptune Disc, Neptune Comfort-Band, Comfort-Band	TZ Medical Inc.	QSY	Unclassified	2004-05-11
K033912	Cradle Pacs	Cradle Technology Corp.	LLZ	Class II	2004-05-11
K033364	Chad Therapeutics Sage	Chad Therapeutics, Inc.	NFB	Class II	2004-05-11
K032747	Biotop Djt-a Safety Syringe	Biotop Technology Co., Ltd.	MEG	Class II	2004-05-11
K032016	Dermagrip-X Powder Free Latex Examination Gloves Coated with Alpha Lipoic Acid and Vitamin E, and with Protein Content	Wrp Specialty Products Sdn. Bhd.	LYY	Class I	2004-05-11
K030413	Y2k2 Enternal Feeding Manager	Moss Medical Products	KNT	Class II	2004-05-11
K041135	Vapr 3 Electrosurgical System and Vapr Ld and Lp Suction Electrodes	DePuy Mitek, Inc.	HRX	Class II	2004-05-10
K041032	Modification to Lifestent Sds and Xl Sds Biliary Endoprosthesis	Orbusneich Medical, Inc.	FGE	Class II	2004-05-10
K040920	Amylase Liquid Reagent, Model A532-200	Teco Diagnostics	JFJ	Class II	2004-05-10
K040879	Quantex Ferritin	Instrumentation Laboratory Co.	DBF	Class II	2004-05-10
K040857	Modification to Adper Prompt	3M Espe AG Dental Products	KLE	Class II	2004-05-10
K040740	Endotine Transbleph Device	Coapt Systems, Inc.	HWC	Class II	2004-05-10
K040602	Sureline Laparoscopic Clip Applier with Implantable Titanium Clips	Design Standards Corp.	FZP	Class II	2004-05-10
K040570	Randox Methadone Assay	Randox Laboratories, Limited	DJR	Class II	2004-05-10
K040403	Collagen Wound Dressing - Oral	Collagen Matrix, Inc	KGN	Unclassified	2004-05-10
K033596	Cemex Genta Bone Cement; Cemex Genta System Bone Cement	Exactech, Inc.	LOD	Class II	2004-05-10
K033324	Compression Anastomosis Clip (Cac)	Niti Medical Technologies, Ltd.	FZP	Class II	2004-05-10
K024245	Envoy Patient Monitor	Mennen Medical, Inc.	OMC	Class II	2004-05-10
K041065	Panalok Rc Loop Anchor	DePuy Mitek, Inc.	JDR	Class II	2004-05-07
K041060	E-Z Lubricating Jelly	Chester Labs, Inc.	KMJ	Class I	2004-05-07
K041016	Nova Glucose Low/high Level Control Solutions	Nova Biomedical Corporation	JJX	Class I	2004-05-07
K040981	Usw Needleknife Papillotome	Wilson-Cook Medical Inc.	KNS	Class II	2004-05-07
K040949	Viaduct Miniscope and Accessories	Acueity, Inc.	GCT	Class II	2004-05-07
K040838	Medline Strider Mini 4	MEDLINE INDUSTRIES, LP - Northfield	INI	Class II	2004-05-07
K040818	Medline Strider Mini 3	MEDLINE INDUSTRIES, LP - Northfield	INI	Class II	2004-05-07
K040679	Rich-Mar Autoprism Infrared Lamp	Rich-Mar Corp.	ILY	Class II	2004-05-07
K040600	Genex Bone Graft Substitute	Biocomposites, Ltd.	MQV	Class II	2004-05-07
K040588	Synthes (USA) 2.4 Mm Lcp Wrist Plate	Synthes (USA) Products LLC	HRS	Class II	2004-05-07