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 1775 of 3531

510(k) clearances, page 1775 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K984268	Variant II Hemoglobin A1c Program	Bio-Rad	LCP	Class II	1998-12-17
K984218	Oasis	Glimex Corp.	HIS	Class II	1998-12-17
K984175	The Aptus (Automated) Application of the Anti-Cardiolipin Igm Elisa Test System	Zeus Scientific LLC	MID	Class II	1998-12-17
K983954	Alastat Microplate Mixed Allergen Panels	Siemens Healthcare Diagnostics Inc.	DHB	Class II	1998-12-17
K983789	Careside Calcium, Original	Careside, Inc.	CJY	Class II	1998-12-17
K983473	Fertilmarq Test Kit	Embryotech Laboratories, Inc.	POV	Class II	1998-12-17
K983468	Fasttake Adapter, Model # P/n 020-072-01	Selfcare, Inc.	JQP	Class I	1998-12-17
K983432	Supreme II Control Solutions	Chronimed, Inc.	JJX	Class I	1998-12-17
K983403	Salter Labs Nebulizer Exhalation Aerosol Filter	Salter Labs	CAF	Class II	1998-12-17
K983310	Sensititre 18-24 Hour Susceptibility Plates with Sparfloxacin	Accumed Intl., Inc.	JTT	Class II	1998-12-17
K983305	Sci-Pharm Desensitizing Varnish	Scientific Pharmaceuticals, Inc.	LBH	Class II	1998-12-17
K983255	Modification to: Premier Platinum Hpsa	Meridian Diagnostics, Inc.	LYR	Class I	1998-12-17
K982981	New Zimmer Shoulder System	Zimmer GmbH	KWT	Class II	1998-12-17
K982426	Spife Alkaline Hemoglobin	Helena Laboratories, Corp.	JBD	Class II	1998-12-17
K984353	Osteo 9Mm Ic Tibial Nail	Osteonics Corp.	HSB	Class II	1998-12-16
K984185	Modification to Tac-S Monopolar Cautery Probe Family	Oratec Interventions, Inc.	GEI	Class II	1998-12-16
K984044	Quadrant Posterior Dense	Cavex Holland B.V.	EBF	Class II	1998-12-16
K983967	Pediatric Cannulated Osteotomy Plates	Zimmer GmbH	HRS	Class II	1998-12-16
K983876	Millenium Sledgehammer, Formula 99 and Naturalyke H.c., High Impact Denture Acrylic	Mycone Dental Supply Co., Inc. (A/K/A Keystone Ind	EBI	Class II	1998-12-16
K983807	Lyphochek Tumor Marker Control, Model #580	Bio-Rad	JJY	Class I	1998-12-16
K983672	Dyna-Lok Spinal System	Sofamor Danek USA,Inc.	MNI	Class II	1998-12-16
K983609	Cook Test Tube Heater	Cook Ob/Gyn	MQG	Class II	1998-12-16
K983606	Is Borrelia Burgdorferi Igm Test System	Columbia Bioscience, Inc.	LSR	Class II	1998-12-16
K983605	Is Borrelia Burgdorferi Igg/igm Elisa Test System	Columbia Bioscience, Inc.	LSR	Class II	1998-12-16
K983587	Hysteroscopic Gift Catheter Sets	Cook Ob/Gyn	MQF	Class II	1998-12-16
K983561	Fujinon Evl-F Video Laproscope	FUJIFILM Healthcare Americas Corporation	GCJ	Class II	1998-12-16
K983543	Accu-Pulse 1000 CO2 Surgical Laser System	Argus Photonics Group	GEX	Class II	1998-12-16
K983530	Synthes Posterior Universal Spinal System	Synthes (USA) Products LLC	KWP	Class II	1998-12-16
K983502	Osteonics Secur-Fit Ad Generation II Acetabular Component System	Osteonics Corp.	LPH	Class II	1998-12-16
K983495	Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, Model#'s 222020-248120, 240050-240980, 241130-246620, 4240420	Syntec Scientific Corp.	HWC	Class II	1998-12-16
K983454	Pain Care 2000	Breg, Inc.	MEB	Class II	1998-12-16
K983414	Everbond	Espe Dental AG	KLE	Class II	1998-12-16
K983362	Nu-Gel * Wound Dressing	Johnson & Johnson MEDICAL GmbH	MGQ	Unclassified	1998-12-16
K983331	Medtronic Ps Medical Innervision Ventricular Catheter, 15Cm Model 99102	Medtronic PS Medical	HCA	Class II	1998-12-16
K983293	Auto Suture Laparoscopes Device	United States Surgical, A Division of Tyco Healthc	GCJ	Class II	1998-12-16
K983277	Lightsource or Illuminator Model I-100	Cuda Products Co.	HBI	Class II	1998-12-16
K983173	Biatain Foam Adhesive Dressing	MEDLINE INDUSTRIES, LP - Northfield	FRO	Unclassified	1998-12-16
K983169	Polymer Threaded Anchor	Orthopaedic Biosystems, Ltd.	MBI	Class II	1998-12-16
K983163	Biatain Foam Dressing	MEDLINE INDUSTRIES, LP - Northfield	FRO	Unclassified	1998-12-16
K983073	i.v. Extension Set or i.v. Administration Set	Amphenol Critical Medical Technologies, LLC	FPA	Class II	1998-12-16
K982804	Spyrogel Hydrogel Wound and Burn Dressing	Innovative Technologies (Us), Inc.	MGQ	Unclassified	1998-12-16
K982650	Autologous Blood Management System (Abms)	Dideco S.p.A.	CAC	Class II	1998-12-16
K982316	Laseaway Alexandrite Laser System	Silver Creek, Inc.	GEX	Class II	1998-12-16
K980926	Duration II Acetabular Components-Ethylene Oxide Sterilization	Howmedica Corp.	JDI	Class II	1998-12-16
K980925	Duration II Tibial Inserts-Ethylene Oxide Sterilization	Howmedica Corp.	JWH	Class II	1998-12-16
K980637	Implex Continuum Knee Unity Tibial Component	Implex Corp.	JWH	Class II	1998-12-16
K980475	Unipulse CO2 Surgical Laser System	Nidek, Inc.	GEX	Class II	1998-12-16
K970736	Braun Prefilled Syringe	B.Braun Medical, Inc.	FOZ	Class II	1998-12-16
K984324	Architect Prolactin Mastercheck, Model Number 6C27-05	Bio-Rad	JJX	Class I	1998-12-15
K984323	Architect Lh Mastercheck, Model Number 6C25-05	Bio-Rad	JJX	Class I	1998-12-15