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 1763 of 3531

510(k) clearances, page 1763 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K990160	Microtac-Bone Anchor System	Influence, Inc.	MBI	Class II	1999-02-16
K984523	Igel 56 UV (Hefilcon C) Soft (Hydrophilic) Contact Lens	Igel Vision Care Pte, Ltd.	LPL	Class II	1999-02-16
K984489	Sensititre 18-24 Hour Susceptibility Plates	Accumed Intl., Inc.	JWY	Class II	1999-02-16
K984463	Quantase Phe/gal Screening Assay	Quantase, Ltd.	JNB	Class II	1999-02-16
K984143	Fibra-Sonics Phaco III or Iiip Fragmentation System	Fibra Sonics, Inc.	HQC	Class II	1999-02-16
K984136	Bardex Lubri-Sil I.c. Foley Catheter	Bard Medical Div.	MJC	Class II	1999-02-16
K984089	Zymed Telemetry System, Model Easi View	Zymed Medical Instrumentation	DSI	Class II	1999-02-16
K984080	Instant-View Pregnancy Combo Dip-Strip Test	Alfa Scientific Designs, Inc.	JHI	Class II	1999-02-16
K984079	Instant-View Pregnancy Urine Dip-Strip Test	Alfa Scientific Designs, Inc.	JHI	Class II	1999-02-16
K984077	Instant-View Pregnancy Combo Test	Alfa Scientific Designs, Inc.	JHI	Class II	1999-02-16
K984076	Instant-View Pregnancy Urine Test	Alfa Scientific Designs, Inc.	JHI	Class II	1999-02-16
K984075	Instant-View Pregnancy Urine Mid-Stream Test	Alfa Scientific Designs, Inc.	LCX	Class II	1999-02-16
K983070	Ck	Abbott Medical	CGS	Class II	1999-02-16
K982599	The Fremstad Ring	Ophthalmic Solutions, LLC	HOZ	Class II	1999-02-16
K981831	Is Ebv-Ea-D Igg Elisa Test System	Diamedix Corp.	GNP	Class I	1999-02-16
K981829	Is Ebv-Ebna-1 Igg Elisa Test System	Diamedix Corp.	GNP	Class I	1999-02-16
K990259	Disetronic Multifuse Infusion Pump System	Disetronic Medical Systems	FRN	Class II	1999-02-12
K990130	Wilson-Cook Pancreatic Wedge Stent	Wilson-Cook Medical Inc.	FGE	Class II	1999-02-12
K990083	Cadd Administration Set, Cadd 250Ml Flexible Medication Reservoir, Modified Securit Shell, Security Shell Adapter	Sims Deltec, Inc.	FPA	Class II	1999-02-12
K990078	D-Sign IV (R&d Project Dw265#37)	Ivoclar North America, Inc.	EJS	Class II	1999-02-12
K990077	D-Sign III (R&d Project Dw264#7)	Ivoclar North America, Inc.	EJS	Class II	1999-02-12
K990005	Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System	Spinal Concepts, Inc.	KWQ	Class II	1999-02-12
K984442	Agee-Wristjack Fracture Reaction System (Sterile Version), Model Cfd-147	Hand Biomechanics Lab Inc	JEC	Class II	1999-02-12
K984409	Elk Laser Film Digitizer	Nishimoto Sangyo Co., Ltd.	LMA	Class II	1999-02-12
K984408	130 Modified Integral Femoral Component	Zimmer GmbH	LPH	Class II	1999-02-12
K984309	Nbr 4 Mils, Nitrile Examination Glove Non-Sterile Powdered	Sumirubber Industries (Kedah) Sdn. Bhd.	LZA	Class I	1999-02-12
K984221	Functional MRI Package for Magetetom Vision Mr	Siemens Corp.	LNH	Class II	1999-02-12
K984134	Natura Denture Teeth	Davis Schottlander & Davis, Ltd.	ELM	Class II	1999-02-12
K984115	Scarease & Scarease Adhesive Gel	Scarease, Inc.	MDA	Class I	1999-02-12
K984109	Aesculap Axial Clip Applier	Aesculap Inc	HCI	Class II	1999-02-12
K984106	Mammary Sizer, Mammary Prothesis Sizer	Specialty Surgical Products, Inc.	MRD	Unclassified	1999-02-12
K983887	Up-Grade and Up-Grade Pro	Medisim Ltd.	FLL	Class II	1999-02-12
K983539	Trajectory Guide, Model # Tgx-Xxx	Image-Guided Neurologics, Inc.	HAW	Class II	1999-02-12
K983104	Norian Periodontal/dental Cement (Pdc)	Norian Corp.	LYC	Class II	1999-02-12
K983016	Gauze, Sponges, Cat # 11-003	Vitalcare Group, Inc.	EFQ	Unclassified	1999-02-12
K983010	Self Cath Set/safety Cath	Rusch Intl.	FCM	Class II	1999-02-12
K982915	Sci-Pharm Dfv Varnish	Scientific Pharmaceuticals, Inc.	LBH	Class II	1999-02-12
K982371	Medco Aspirator IV	Medco Mfg.	BTA	Class II	1999-02-12
K982333	Modification to Uldall Double Lumen Hemodialysis Catheter Set and Tray	Cook Inc.	MSD	Class II	1999-02-12
K981913	Prevue(tm) Borrelia Burgdorferi Antibody Detection Assay	Chembio Diagnostic Systems, Inc.	LSR	Class II	1999-02-12
K980723	2.0Mm Expandable Lemaitre Valvulotome (Elv 2.0- Gnt)	Vascutech, Inc.	MGZ	Class II	1999-02-12
K990098	Ventlab Verify II	Salter Labs	BTR	Class II	1999-02-11
K990044	Lobob Universal Contact Lens Cleaner	Lobob Laboratories, Inc.	LPN	Class II	1999-02-11
K990043	Smoothlase Alexandrite Laser System	Leisegang Medical, Inc.	GEX	Class II	1999-02-11
K984574	Infinity Glucose Reagent	Sigma Diagnostics, Inc.	CFR	Class II	1999-02-11
K984258	Neurovasx Sub-Microinfusion Catheter	Neuro Vasx, Inc.	DQO	Class II	1999-02-11
K984215	Welch Allyn Front-Line Doc	Welch Allyn Inc	LLZ	Class II	1999-02-11
K984154	Apf Porous Coated Line Extension	Zimmer GmbH	JDI	Class II	1999-02-11
K984058	Acist Injector System, Model Cl100 H	Acist Medical Systems, Inc.	IZQ	Class II	1999-02-11
K983836	Rigid Gas Permeable Contact Lens Solution	Polymer Technology Div. Wilmington Partners, L.P.	MRC	Class II	1999-02-11