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 2321 of 3531

510(k) clearances, page 2321 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K923500	Beausoleil Frame	Oliver Peoples, Inc.	HQZ	Class I	1993-02-16
K923435	Corneal Topography System	Par Microsystems Corp.	HLQ	Class I	1993-02-16
K922949	Surgical Gown	Robert J. Sislian, Inc.	FYA	Class II	1993-02-16
K922939	Bard Monopty Disposable Core Biopsy Isnt. W/ Cent.	C.R. Bard Inc	KNW	Class II	1993-02-16
K914618	Sunglasses	La Salle Imports, Inc.	HQY	Class I	1993-02-16
K930150	Safe-T-Tube Radiopaque	Boston Medical Products, Inc.	BTR	Class II	1993-02-12
K926222	Owren's Veronal Buffer #5375 & Fibronogen Kit#5376	Helena Laboratories, Corp.	JPA	Class II	1993-02-12
K926122	Fluorex	Toshiba America Medical Systems, In.C	JAA	Class II	1993-02-12
K926092	Miracle-Ear Model Hl	Miracle-Ear, Inc.	ESD	Class I	1993-02-12
K926091	Audiotone Model a-98	Miracle-Ear, Inc.	ESD	Class I	1993-02-12
K926083	Nuclear Patient Sanning Tables, Various Types	Biodan Medical Systems, Ltd.	IYX	Class I	1993-02-12
K926060	Synchron Cx5ce Clinical Analyzer	Beckman Instruments, Inc.	JJE	Class I	1993-02-12
K926013	Sporicidin Brand Disinfect Towel, Spray/solut Modi	Sporicidin Intl.	LRJ	Class I	1993-02-12
K925969	Adams Scientific Sensitivity Discs	Adams Scientific, Inc.	JTN	Class II	1993-02-12
K925918	Pressure Turing and Accessories	Applied Medical Resources Corp	GCM	Class II	1993-02-12
K925833	Cordis Steerable Guidewire	Cordis US Corp.	DQX	Class II	1993-02-12
K925829	Waggoner Dental Manufacturing Steriwater System	Waggoner Dental Mfg.	EIA	Class I	1993-02-12
K925804	Schneider Hydro-Sil Guidewire	Schneider Intl., Ltd.	DQX	Class II	1993-02-12
K925646	Ssd-2000 Diag. Ultrasound Sys.&ust-979-3.5 Trans.	Aloka Co., Ltd.	IYO	Class II	1993-02-12
K925594	Mdl 29001 Medi Elec-Mech Tilt Exam/treatment Table	Tri W-G, Inc.	INQ	Class I	1993-02-12
K925553	Hi Chem CO2 Alkaline Buffer Reagent Kit,prod#88813	Hichem Diagnostics	JFL	Class II	1993-02-12
K925552	Hi Chem CO2 Acid Reagent Kit,product Number 88812	Hichem Diagnostics	JFL	Class II	1993-02-12
K925512	Ceramic Femoral Head-28Mm Long, Modification	Dow Corning Wright	LZO	Class II	1993-02-12
K925498	Vidas Estradiol (E2) Assay	Biomerieux Vitek, Inc.	CHP	Class I	1993-02-12
K925486	Ust-5522-7.5 & Ust-5522L-7.5 Intraoperative Trans.	Aloka Co., Ltd.	ITX	Class II	1993-02-12
K925381	Acs Hi-Torque Balance(tm) Guide Wire	Advanced Cardiovascular Systems, Inc.	DQX	Class II	1993-02-12
K925372	Osteonics(r) 700 Series Total Knee Mod Femor Comp	Osteonics Corp.	JWH	Class II	1993-02-12
K925336	Valu-Plus Pad	Valmed SRL	KNN	Class I	1993-02-12
K925272	Pediatric Tilt Chair	Labac Systems, Inc.	IOR	Class I	1993-02-12
K925247	Stoneheart Roller Aid	Stoneheart, Inc.	INM	Class I	1993-02-12
K925198	Kaiser No Cannula Thoracoscopy/laparoscopy Instr	Pilling Co.	GCJ	Class II	1993-02-12
K925148	Auto Suture Surgical Mesh Deployer	United States Surgical, A Division of Tyco Healthc	FTL	Class II	1993-02-12
K925146	Folding, Wheelchair	Brownstone Trading Co.	IOR	Class I	1993-02-12
K925043	Elbow Cpm Orthosis	Electrobionics Corp.	BXB	Class I	1993-02-12
K925009	2D Tof Angiograhy Measuring Function	FUJIFILM Healthcare Americas Corporation	LNH	Class II	1993-02-12
K924848	Kaye Scoot-About, Model Sb1	Kaye Products, Inc.	INM	Class I	1993-02-12
K924686	Rem-Air	Mellenair Ent., Inc.	INX	Class II	1993-02-12
K924542	Nasal-Sinus Packing	Ultracell Medical Technologies, Inc.	EMX	Class I	1993-02-12
K924521	Disposable Concentric Needle Electrode	Chalgren Enterprises, Inc.	IKT	Class II	1993-02-12
K924441	u.s. Medical Ps-6000 Wheelchair Scale	U.S. Medical Corp.	INF	Class I	1993-02-12
K924439	Becton Dickinson Interlink Vial Access Cannula	BD Becton Dickinson Vacutainer Systems Preanalytic	FMI	Class II	1993-02-12
K924414	The Bte Dynamic Lift	Baltimore Therapeutic Equipment Co.	IKK	Class II	1993-02-12
K924379	Ultima(tm) Total Hip System Cemented Femoral Stem	Johnson & Johnson Orthopaedics, Inc.	KWL	Class II	1993-02-12
K924323	The Universal Bone Cement Resistor	Biodynamic Technologies, Inc.	JDI	Class II	1993-02-12
K924314	Mobile Standing Frame	Metatech Corp.	IPL	Class II	1993-02-12
K924289	Kallestad Rsv Microplate Eia	Bio-Rad Laboratories Inc.	MCE	Class I	1993-02-12
K924093	Electric Hi Lo Tilt Table	Midland Mfg. Co.	INQ	Class I	1993-02-12
K923977	Akrotech 4000	Lumex, Inc.	IOQ	Class II	1993-02-12
K923912	Moore Manufacture Model-Mhbtl	Moore Mfg., Inc.	ILK	Class II	1993-02-12
K923857	Artromot Sb Elbow Attachment	Buckman Co., Inc.	BXB	Class I	1993-02-12