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 1882 of 3531

510(k) clearances, page 1882 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K972167	Plasma Catecholamine Kit	Bioanalytical Systems, Inc.	CHQ	Class I	1997-08-04
K970508	Echo View/shimasonic Diagnostic Ultrasound System	Shimadzu Medical Systems	IYO	Class II	1997-08-04
K972756	Modification of Est Culture System II - Myco	Accumed Intl., Inc.	MDB	Class I	1997-08-01
K972682	Quickstick One Step Hcg Pregnancy Test	Phamatech Inc.	LCX	Class II	1997-08-01
K972331	Innofluor Gentamicin Assay System	Oxis Intl., Inc.	LGQ	Class II	1997-08-01
K972239	Elite H-D Vinyl Polysiloxane Impression Materials .Putty Soft/normal Setting /Putty Soft/fast Setting	Zhermack S.p.A.	ELW	Class II	1997-08-01
K972180	Dried Gram-Negative Mic/combo Panels	Dade Microscan, Inc.	JWY	Class II	1997-08-01
K972160	Crp-Lex System: C-Reactive Protein Antigen Detection in Serum: Slide Agglutnation Latex Test	Trinity Laboratories, Inc.	DCK	Class II	1997-08-01
K972105	Phonak Epica	Phonak, Inc.	ESD	Class I	1997-08-01
K971992	Uromed Alternative Bladder Control Continence Device(abcpn-0026)	Uromed Corp.	FHA	Class I	1997-08-01
K971950	Infinitech Multi-Spot Slit Lamp Laser Adapter	Infinitech, Inc.	HQF	Class II	1997-08-01
K971933	Port-Neb	Medic-Aid, Ltd.	CAF	Class II	1997-08-01
K971814	Improvements to the Mehl Ruby Laser	Mehl/Biophile Intl., Inc.	GEX	Class II	1997-08-01
K971645	Reganes Spinal Needle (Various)	Avid N.I.T., Inc.	MIA	Class II	1997-08-01
K971309	Urea	Derma Media Lab., Inc.	CDQ	Class II	1997-08-01
K971050	Golden Hawk	Golden Technologies, Inc	INI	Class II	1997-08-01
K971043	Golden Eagle	Golden Technologies, Inc	INI	Class II	1997-08-01
K970926	Double Lumen Picc	B.Braun Medical, Inc.	LJS	Class II	1997-08-01
K970669	Aeroquip Safestart IV Catheter	Aeroquip Medical Products	FOZ	Class II	1997-08-01
K970664	Glucose Reagent	Derma Media Lab., Inc.	CFR	Class II	1997-08-01
K970561	Graft Patch	Organogenesis, Inc.	FTL	Class II	1997-08-01
K970401	Medi-Dyne Guiding Catheter	Medi-Dyne, Inc.	DQY	Class II	1997-08-01
K970048	Synthes(usa)titanium Locking Plate System(tilps)	Synthes (USA) Products LLC	KWQ	Class II	1997-08-01
K965187	Spectrum II, Spectrum Plus, and Spectrum Max-Sd	Sparta Surgical Corp.	GZJ	Class II	1997-08-01
K964296	N-Assay Tia Apo B Test Kit	Crestat Diagnostics, Inc.	DER	Class II	1997-08-01
K964294	N-Assay Tia Apo A1/b Multi Calibrator	Crestat Diagnostics, Inc.	DER	Class II	1997-08-01
K964292	N-Assay Tia Apo A1 Test Kit	Crestat Diagnostics, Inc.	DER	Class II	1997-08-01
K961050	Reliefband TENS Unit (Modification)	Maven Labs, Inc.	GZJ	Class II	1997-08-01
K972794	Digoxin Dg-II Fpia Reagent Set	Sigma Diagnostics, Inc.	KXT	Class II	1997-07-31
K972590	Nevada Eyeworks, Luigi Lanatta Sunglasses	Lbi U.S.A.	HQY	Class I	1997-07-31
K972550	Audifon H24 Agc/audifon H25 Agc/audifon H30 Agc	Trutone	ESD	Class I	1997-07-31
K972237	Hand Held Medispacer	Thayer Medical Corportation	CAF	Class II	1997-07-31
K972153	Alternating Pressure Air Flotation Mattress	Decubiti Concepts, Inc.	FNM	Class II	1997-07-31
K972100	Vented External Male Urinary Catheter(vented Cath 5000)	Advanced Care Medical Products	EXJ	Class I	1997-07-31
K971996	Medivision Arthroscop	Medivision Scope Service Center, Inc.	HRX	Class II	1997-07-31
K971832	Ivalon Pva Surgical Spear, Ivalon Eye Drain, 80Cc, Ivalon Eye Drain, 400Cc, Ivalon Eye Wick	M-Pact Worldwide Management Corp.	HOZ	Class II	1997-07-31
K971770	Apollo Knee Femoral Spacers	Sulzer Orthopedics, Inc.	JWH	Class II	1997-07-31
K971617	Endoscopic Ventricular Catheter	Integra Neurocare, LLC	JXG	Class II	1997-07-31
K970644	Aeroquip Safestart (Tm) IV Cath (Tm) System	Aeroquip Medical Products	FOZ	Class II	1997-07-31
K970470	Evt Expandable Sheath	Guidant Cardiac and Vascular Surgery	DRE	Class II	1997-07-31
K970207	Medi-Tech 5 French Nighthawk Selective Angiographic Catheters	Boston Scientific Corporation	DQO	Class II	1997-07-31
K965001	Intuitive Surgical Monarch Laparoscopic Manipulator	Intuitive Surgical, Inc.	GCJ	Class II	1997-07-31
K964092	Tms Comfort Series Nasal CPAP Mask	Tiara Medical Systems, Inc.	BZD	Class II	1997-07-31
K963744	Benz B36 (Kolfocon B) Rigid Gas Permeable (Hydrophobic) Daily Wear Contact Lens (Tinted, Lathe-Cut from Lens Blank)	Benz Research and Development LLC	HQD	Class II	1997-07-31
K963512	Benz B17 (Kolfocon a) Rigid Gas Permeable (Hydrophobic Daily Wear Contact Lens (Clear and Tinted, Lathe-Cut from Lens Bl	Benz Research and Development LLC	HQD	Class II	1997-07-31
K972552	Audifon H20 Pc/audifon H32 Pp	Trutone	ESD	Class I	1997-07-30
K972132	Sigma Diagnostics Valproic Acid Fpia Reagent Set, Sigma Diagnostics Valproic Acid Fpia Calibrators	Sigma Diagnostics, Inc.	LEG	Class II	1997-07-30
K972097	Phonak Microzoom P 2	Phonak, Inc.	ESD	Class I	1997-07-30
K972056	Standard Endoscope	Laser-Optik-Systeme GmbH & Co. KG	GCJ	Class II	1997-07-30
K972024	Coda Automated Eia Analyzer	Bio-Rad	JJI	Class I	1997-07-30