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 2026-11-02, 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 2397 of 3531

510(k) clearances, page 2397 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K915758	Strep a Oia	Biosearch Medical Products, Inc.	GTZ	Class I	1992-01-30
K915710	Amylase (Colorimetric) Reagent Set	Tech Intl. Co.	JFJ	Class II	1992-01-30
K915681	Choledochoscope	Applied Laparoscopy	FBN	Class II	1992-01-30
K915564	Spiros	Life Support Products, Inc.	BTL	Class II	1992-01-30
K915503	Fibrinogen Fdp Control	Cala Diagnostics	DAP	Class II	1992-01-30
K915458	Ureteroscope	Psi Medical Products, Inc.	FGB	Class II	1992-01-30
K915093	Prospect(tm) Giardia Rapid Assay	Alexon, Inc.	MHI	Class II	1992-01-30
K914885	Beckman Synchron(tm) (Micro) Total Protein Test	Beckman Instruments, Inc.	CEK	Class II	1992-01-30
K914571	Neurotrac II	Moberg Medical, Inc.	GWQ	Class II	1992-01-30
K914495	E.r.c.p. Catheter	Surgitek Medical Engineering Corp.	FGE	Class II	1992-01-30
K914160	Cholesterol Regeant Set	Tech Intl. Co.	CHH	Class I	1992-01-30
K913957	Dantec Counterpoint Mk2(tm)	Dantec Medical, Inc.	GWJ	Class II	1992-01-30
K913859	Bivona Fome-Cuf(r) & Air Cuf(r), Modification	Bivona Medical Technologies	JOH	Class II	1992-01-30
K913423	Lifecare Remote Alarm II	Lifecare Services, Inc.	CBK	Class II	1992-01-30
K913422	Oxygen Tubing, 81503	Specialty Packaging Producs, Inc.	BYX	Class I	1992-01-30
K913348	The Stern Era System	Sterngold/Implamed	DZE	Class II	1992-01-30
K913261	Dwyer Eye Systems Aspiration Unit	Spectracare, Inc.	HQE	Class II	1992-01-30
K913031	K-Stim	Katecho LLC	GXY	Class II	1992-01-30
K912943	Threshold 2X Inspiratory Muscle Trainer	Health Products, Inc.	BWF	Class II	1992-01-30
K912851	Naude Urethral Stent	Cook Incorporated	KOD	Class II	1992-01-30
K912381	Low Back Strip (or) K-Back	Katecho LLC	GZJ	Class II	1992-01-30
K912027	Calcium (Arsenazo III) Reagent, Universal	Enzyme Technology, Inc.	CIC	Class II	1992-01-30
K910850	Psf-50Et	Toshiba America Medical Systems, In.C	ITX	Class II	1992-01-29
K920092	Audiotone Model A97	Miracle-Ear, Inc.	LYY	Class I	1992-01-28
K920046	Modified Ferritin Enzyme Imunoassay Test Kit	Medix Biotech, Inc.	DBF	Class II	1992-01-28
K915516	Abuscreen Online Cannabinoids Positive Control	Roche Diagnostic Systems, Inc.	LAS	Class I	1992-01-28
K915235	Clinical Assays Gamma Coat Free T4 Radioimm. Kit	Incstar Corp.	CDX	Class II	1992-01-28
K915106	Dimension Ar Clinical Chemistry System	Dupont Medical Products	JJE	Class I	1992-01-28
K915084	Beckman Sychron(tm) Triglycerides Reagent	Beckman Instruments, Inc.	CDT	Class I	1992-01-28
K914381	Horizon 9000/His Option Amplifier	Mennen Medical, Inc.	DRR	Class II	1992-01-28
K914166	Abl505 Blood Gas & Electrolyte System	Radiometer America, Inc	CHL	Class II	1992-01-28
K913986	Cholangiography/cholangioscopy/lihopaxy System	Medical Dynamics, Inc.	FGE	Class II	1992-01-28
K913576	Datascope Model Visa Central Monitor	Accucore, Inc.	DSI	Class II	1992-01-28
K902386	Model Tm101 Temperature Monitor	Fisher & Paykel Electronics, Ltd.	FLL	Class II	1992-01-28
K901507	Mcaffee Universal Spinal System (Muss)	Kirschner Medical Corp.	KWQ	Class II	1992-01-28
K915879	Hl-300 Receiver Module	Fukuda Denshi USA, Inc.	DPS	Class II	1992-01-27
K915728	Emit D.a.u. Phencyclidine Assay	Syva Co.	LCM	Unclassified	1992-01-27
K915709	Creatine Kinase-Mb (Ck-Mb) Reagent Set	Tech Intl. Co.	CGS	Class II	1992-01-27
K915701	Kodak Surecell(tm) Hcg Urine Test Kit/modification	Eastman Kodak Company	JHI	Class II	1992-01-27
K915570	Gamma Coat Assay Testosterone Radioimmunoassay Kit	Incstar Corp.	CDZ	Class I	1992-01-27
K915555	Synermed Ast/got Reagent Kit	Synermed, Inc.	CIT	Class II	1992-01-27
K915478	Sensicare Synthetic Medical Gloves	BD Becton Dickinson Vacutainer Systems Preanalytic	LYZ	Class I	1992-01-27
K915465	Digitoxin Fpia Reagent Set	Sigma Diagnostics, Inc.	LFM	Class II	1992-01-27
K915360	Laparoscopic Snare Pouch	United States Endoscopy Group, Inc.	GCJ	Class II	1992-01-27
K915178	Nova 11 Na/k/li Analyzer	Nova Biomedical Corporation	CEM	Class II	1992-01-27
K915177	Nova 5 Na/k/c1 Alalyzer	Nova Biomedical Corporation	CEM	Class II	1992-01-27
K915167	Gesco per-Q-Cath Catheter Introducer	Gesco Intl., Inc.	DYB	Class II	1992-01-27
K915136	Atraumatic Tip Angiographic Catheter	Exonix Research Corp.	DQO	Class II	1992-01-27
K915008	Permanent Pacing Pad, Modification	Oscor Medical Corp.	DTB	Class III	1992-01-27
K915007	Permanent Pacing Leads, Modification	Oscor Medical Corp.	DTB	Class III	1992-01-27