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 2026-10-21, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 542 of 3529

510(k) clearances, page 542 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K173963	DRI Benzodiazepine Assay	Microgenics Corporation	JXM	Class II	2018-02-21
K173629	CELERITY 20 Steam Process Challenge Device for Gravity Cycles	STERIS Corporation	FRC	Class II	2018-02-21
K173626	Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles	STERIS Corporation	FRC	Class II	2018-02-21
K172950	TSN Transseptal Needle	Pressure Products Medical Device Manufacturing LLC	DRC	Class II	2018-02-21
K172647	Reprocessed ArthroCare ENT Coblator	ReNovo, Inc.	NUJ	Class II	2018-02-21
K172338	Catasyn Advanced Technology Wound Hydrogel	Synedgen, Inc.	FRO	Unclassified	2018-02-21
K171620	PiCCO Catheter	Pulsion Medical Systems SE	KRB	Class II	2018-02-21
K170866	Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579	HONSUN (NANTONG) Co., Ltd.	DXN	Class II	2018-02-21
K163377	Captura Disposable Bronchoscope Biopsy Forceps	Wilson-Cook Medical Inc.	EOQ	Class II	2018-02-21
K180176	SeaSpine NewPort Spinal System	SeaSpine Orthopedics Corporation	NKB	Class II	2018-02-20
K173513	WS80A Diagnostic Ultrasound System	Samsung Medison Co., Ltd.	IYN	Class II	2018-02-20
K173270	Tri-Staple 2.0 Reinforced Reload	Medtronic, Inc.	GDW	Class II	2018-02-20
K173228	U-MED Powder Free Polyethylene Examination Gloves,Blue Color	Jiangsu U-Med Rubber & Plastic Products Co., Ltd.	LZA	Class I	2018-02-20
K172885	HydroPICC	Access Vascular, Inc	LJS	Class II	2018-02-20
K172423	PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)	Edwards Lifescience, LLC	DQE	Class II	2018-02-20
K171605	Elecsys CA 15-3 II	Roche Diagnostics GmbH	MOI	Class II	2018-02-20
K170683	Aesculap Video Assisted Thoracic Surgery (VATS) INstruments	Aesculap Inc	GCJ	Class II	2018-02-20
K172390	Optima Coil System	Blockade Medical, LLC (D.B.A. Balt USA)	HCG	Class II	2018-02-18
K180141	SPIWay Endonasal Access Guide	SPIWay, LLC	LYA	Class I	2018-02-16
K180128	Warrior 14 guidewire	Vascular Solutions LLC	DQX	Class II	2018-02-16
K180123	Breast BI 7 MR Coil 1.5T Mammavention	NORAS MRI products GmbH	MOS	Class II	2018-02-16
K173587	Magseed Magnetic Marker Systtem	Endomagnetics Ltd	NEU	Class II	2018-02-16
K173460	NeuroEEG	Memory MD, Inc.	GWQ	Class II	2018-02-16
K173409	Wireless Audio System	NeoCoil, LLC	LNH	Class II	2018-02-16
K172934	Needle Free Transseptal Cannula	Pressure Products Medical Device Manufacturing LLC	DRC	Class II	2018-02-16
K172361	EEA Circular Stapler with Tri-Staple Technology	Medtronic, Inc.	GDW	Class II	2018-02-16
K172348	AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10	Aesku.Diagnostics GmbH & Co. KG	LSW	Class II	2018-02-16
K172208	NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet	Nevap, Inc.	BTR	Class II	2018-02-16
K171646	ACISTCVi® Contrast Delivery System	Acist Medical Systems, Inc.	DXT	Class II	2018-02-16
K171600	Renal Access Cobra Catheter, Kumpe Access Catheter	Cook Incorporated	KOD	Class II	2018-02-16
K171521	DUS R-50S (Urine Chemistry system)	DFI Co., Ltd.	JIL	Class II	2018-02-16
K180138	AtriCure cryoICE cryo-ablation probe (CRYO2)	AtriCure, Inc.	GXH	Class II	2018-02-15
K180137	AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF)	AtriCure, Inc.	GEH	Class II	2018-02-15
K173877	BOWA Neutral Electrodes	Bowa-Electronics GmbH & Co. KG	GEI	Class II	2018-02-15
K173750	Prelude IDeal Hydrophilic Sheath Introducer	Merit Medical Systems, Inc.	DYB	Class II	2018-02-15
K173644	Gazelle Polypropylene Suture and Delivery Device	Dura Tap, LLC	GAW	Class II	2018-02-15
K173636	Velocity	Varian Medical Systems, Inc.	LLZ	Class II	2018-02-15
K173580	Vinyl Patient Examination Glove (Yellow)	Nature Medical Products Co., Ltd.	LYZ	Class I	2018-02-15
K173352	Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever)	Concentric Medical, Inc.	POL	Class II	2018-02-15
K173288	CorPath GRX System	Corindus, Inc.	DXX	Class II	2018-02-15
K173212	Instant-view-PLUS immunochemical Fecal Occult Blood Test	Alfa Scientific Designs, Inc.	KHE	Class II	2018-02-15
K172613	Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit	The Binding Site Group Ltd.	PCN	Class II	2018-02-15
K171604	Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set, and Fallopian Tube Catheterization Wire Guide with Platinum Tip	Cook Incorporated	LKF	Class II	2018-02-15
K171535	Surgical Isolation Gown	Jingzhou Haixin Green Cross Medical Products Co.,Ltd	FYC	Class II	2018-02-15
K180158	Surgical Laser fibers	Quanta System Inc.	GEX	Class II	2018-02-14
K173651	Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set	Fresenius Medical Care Renal Therapies Group, LLC	KDJ	Class II	2018-02-14
K173567	Sera	Interacoustics a/S	EWO	Class II	2018-02-14
K173565	Sunrise 6200, Sunrise 7200	Jk-Holding GmbH	LEJ	Class II	2018-02-14
K173545	TEMED Gas Diffuser	Temed	HIF	Class II	2018-02-14
K173185	SEURAT™ Universal Pedicle Screw System	CTL Medical Corporation	NKB	Class II	2018-02-14