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 2026-11-09, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,227 of the 176,624 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	2,827

176,624 records, page 1722 of 3533

510(k) clearances, page 1722 of 3533
K number	Device	Applicant	Product code	Class	Decision date
K992558	Nitrile Patient Examination Gloves, Powdered, Non-Sterile	Riverstone Resources Sdn Bhd	LZA	Class I	1999-09-27
K992420	Modification of Pasco Mic and Mic/id Panels	Pasco Laboratories, Inc.	JTN	Class II	1999-09-27
K992117	Pre-Powdered Latex Examination Glove with Oat-Starch Powder	Pamitex Industries Sdn Bhd	LYY	Class I	1999-09-27
K991667	Broadline or Towels	Broadline Medical Industries	KKX	Class II	1999-09-27
K992988	Prestige Lx Blood Glucose Test System	Home Diagnostics, Inc.	CGA	Class II	1999-09-24
K992986	Salter Labs Single Patient Use Exhalation Aerosol Filter	Salter Labs	CAF	Class II	1999-09-24
K992981	Elecsys Estradiol Calset II	Roche Diagnostics GmbH	JIT	Class II	1999-09-24
K992972	Arthrocare System 2000 Controller, Arthrocare Cable, Footswitch, Powercord, Arthrocare Electrosurgery Wand, Models H2000	ArthroCare Corporation	GEI	Class II	1999-09-24
K992946	Renew Receiver	Abbott Medical	GZB	Class II	1999-09-24
K992882	Leksell Image Guidance Surgical System, View Scope, Surgiscope,elekta Insight	Elekta Instrument AB	HAW	Class II	1999-09-24
K992876	Vapr 2.3 Mm Side Effect Electrode for Use with Vapr System	Mitek Products	HRX	Class II	1999-09-24
K992860	Disposable Powder Free Vinyl Synthetic Examination Gloves, White Color	Shijiazhuang Hongray Plastic Products Co., Ltd.	LYZ	Class I	1999-09-24
K992687	Millenium Microkeratome, Model Imd-001	Industrial & Medical Design, Inc.	HMY	Class I	1999-09-24
K992686	Disposable Powder Free Nitrile Exam Glove, Blue Color	Sheen More Ent. Co., Ltd.	LZA	Class I	1999-09-24
K992671	Qtexx Pre-Powdered Nitrile Examination Gloves	Latexx Partners Bhd.	LZA	Class I	1999-09-24
K992594	A-15 Hemodialyzer	Althin Medical AB	FJI	Class II	1999-09-24
K992572	Ntero RF Sleeve	Ntero Surgical, Inc.	GEI	Class II	1999-09-24
K992526	Flexible Nasopharyngo-Laryngoscopes, Flexible Bronchoscope	Richard Wolf Medical Instruments Corp.	EOB	Class II	1999-09-24
K992517	Biocheck Ferritin Elisa Model Bc-1025	BioCheck Inc	DBF	Class II	1999-09-24
K992444	Modification of: Cell-Dyn 1200 System	Abbott Medical	GKZ	Class II	1999-09-24
K992432	Bact/alert Fn	bioMerieux, Inc.	MDB	Class I	1999-09-24
K992250	Core Audible Trocar II	Core Dynamics, Inc.	GCJ	Class II	1999-09-24
K992175	Extra-Care Latex Patient Examination Glove, Powder-Free, Polymer Coated	Ultrawin Sdn Bhd	LYY	Class I	1999-09-24
K991800	Hemochek Urine Collection Kit	Osborn Group, Inc.	JIQ	Class I	1999-09-24
K991633	Quickvue Influenza A/b Test	Ortho-Clinical Diagnostics, Inc.	PSZ	Class II	1999-09-24
K991620	Visine for Contacts	Pfizer Inc	LPN	Class II	1999-09-24
K991381	Pureception Lower Phase, Pureception Upper Phase, Pureception with Hepes-Buffered Ham's F-10 and Hsa	Pacific Andrology, Inc.	MQL	Class II	1999-09-24
K991378	Phosphate Buffered Saline (Pbs), Phosphate Buffered Saline with Calcium, Magnesium, Glucose, Pyruvate and Phenol Red	Sage Biopharma	MQL	Class II	1999-09-24
K991090	Peachtree Proportional Head Control Unit (Phc-3)	Dynamic Systems, Inc.	ITI	Class II	1999-09-24
K990931	Ez-Hbt Helicobacter Blood Test	Metabolic Solutions, Inc.	MSQ	Class I	1999-09-24
K990900	Microkeratome, Model Mk-2000	Nidek, Inc.	HNO	Class I	1999-09-24
K990816	Avcore System	Modular Cutting Systems, Inc.	HWE	Class I	1999-09-24
K990662	Disposable Heating Tubing Set #7642Hses	Wisap Gesellschaft Fur Wissenschaftl. App. Bau mbH	HIF	Class II	1999-09-24
K990253	Securline Operating Room Camera Drape, Model 3600	Amba Medical, Ltd.	KKX	Class II	1999-09-24
K984210	Silverlon Wound Packing Strips	Argentum International, LLC	FRO	Unclassified	1999-09-24
K992938	Rotorblade Suture Anchor	Li Medical Technologies, Inc.	MAI	Class II	1999-09-23
K992849	Qbc Star Centrifugal Hematology System	BD Becton Dickinson Vacutainer Systems Preanalytic	GKZ	Class II	1999-09-23
K992577	Photon Radiosurgery System (Prs)	Photoelectron Corporation	JAD	Class II	1999-09-23
K992565	A-18 Hemodialyzer	Althin Medical AB	FJI	Class II	1999-09-23
K992480	Medifix Single and Double Puncture Laparoscopes	Medifix, Inc.	HET	Class II	1999-09-23
K992474	Arthroscope / Medifix Inc.	Medifix, Inc.	HRX	Class II	1999-09-23
K992367	Ebi Xfix Dynafix System Ha Coated Screws	Electro-Biology, Inc.	HWC	Class II	1999-09-23
K992348	Synthes Spiral Blade for Humeral Nail (Sbhn)	Synthes (USA) Products LLC	JDS	Class II	1999-09-23
K992282	Micro-France Liposuction Cannulas	Xomed, Inc.	QPB	Class II	1999-09-23
K992270	Miraclebreath Tongue Cleaner	Stellar Labs, Inc.	LCN	Class I	1999-09-23
K992168	Moss Miami 6.35Mm Polyaxial Screw	Depuyacromed	KWQ	Class II	1999-09-23
K992159	Surgisis Sling	Cook Biotech, Inc.	PAG	Class II	1999-09-23
K992153	Pe-Plus Acetabular Cup	Plus Orthopedics	JDI	Class II	1999-09-23
K992026	Soring Gmbh, Sonoca 300	Soring GmbH Medizintechnik	BTA	Class II	1999-09-23
K991646	Agility Steerable Guidewire	Cordis Neurovascular, Inc.	DQX	Class II	1999-09-23