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 1828 of 3531

510(k) clearances, page 1828 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K980020	Activelock Modular Femoral Hip System	Metagen, LLC	LPH	Class II	1998-04-03
K974380	Rejuveness	Rejuveness Pharamceuticals, Inc.	MDA	Class I	1998-04-03
K973704	Profusion Bone Void Filler	Biogeneration	MQV	Class II	1998-04-03
K973334	Oz Power Syringe	Cardiovascular Innovations	DXT	Class II	1998-04-03
K972824	The Breather Inspiratory/expiratory Muscle Trainer	PN Medical	BWF	Class II	1998-04-03
K980896	Quickcard Pro Hcg Test, Model 9008	Phamatech Inc.	JHI	Class II	1998-04-02
K980860	Hdi 1000 Diagnostic Ultrasound System	Atlantis Diagnostics Intl., Inc.	IYO	Class II	1998-04-02
K980807	Nitrile Examnation Gloves- Powderfree (Small, Medium and Large)	Pt. Eka Wira Asia	LZA	Class I	1998-04-02
K980796	Terumo Allergy Syringe	Terumo Corp.	FMF	Class II	1998-04-02
K980755	B-D E Ml Pen	BD Becton Dickinson Vacutainer Systems Preanalytic	FMF	Class II	1998-04-02
K980729	Nitrile Examination Gloves- Pre-Powdered (Small, Medium & Large)	Pt. Eka Wira Asia	LZA	Class I	1998-04-02
K980611	Powdered Latex Examination Gloves	Servicom Services Sdn Bhd	LYY	Class I	1998-04-02
K980521	Digoxin Assay for the Technicon Ra / Opera Systems	Bayer Corp.	KXT	Class II	1998-04-02
K980499	Il Test Antithrombin	Instrumentation Laboratory Co.	JBQ	Class II	1998-04-02
K980312	Nova Lite Endomysial	Inova Diagnostics, Inc.	DBL	Class II	1998-04-02
K980306	Gyrex 2T Prestige, Gyrex Prima Itg, Gyrex Privilege, Gyrex V-Ep	Elscint, Inc.	LNH	Class II	1998-04-02
K980224	Alexander Manufacturing Co. Rechargeable Battery Part Number Ms822	Alexander Mfg. Co.	MOQ	Class I	1998-04-02
K980221	Silimed Nasal Retainer	Silimed, LLC	LYA	Class I	1998-04-02
K980181	Terumo Disposable Hypodermc Syringe	Terumo Medical Corp.	FMF	Class II	1998-04-02
K980168	Computed Radiography Quality Assurance Software	Analogic Corp.	LLZ	Class II	1998-04-02
K980077	Para-Pak Spincon	Meridian Diagnostics, Inc.	LKS	Class I	1998-04-02
K974662	Powder-Free Latex Examination Glove	Ideal Quality Sdn Bhd	LYY	Class I	1998-04-02
K974660	Latex Examination Glove	Ideal Quality Sdn Bhd	LYY	Class I	1998-04-02
K980865	Quickscreen Pro Multi Drug Screening Test , Model 9140-9147, 9061,9066, 9071, 9076, 9081 and 9131	Phamatech Inc.	DKZ	Class II	1998-04-01
K980804	Sabre Bt Blunt0tip Surgical Trocar	Endoscopic Concepts, Inc.	FBQ	Class II	1998-04-01
K980367	Aeroset System	Abbott Medical	CGZ	Class II	1998-04-01
K980166	Lightsource or Illuminator	Cuda Products Co.	HET	Class II	1998-04-01
K980155	Endobutton Continuous Loop	Smith & Nephew, Inc.	GAT	Class II	1998-04-01
K980019	Htl Male Condom	Reddy Medtech Health Products, Ltd.	HIS	Class II	1998-04-01
K974351	Biolog 3000 Electrocardiograph	Micromedical, Inc.	DPS	Class II	1998-04-01
K974002	Ethanol-Sl Assay, Catalogue Number 240-12	Sekisui Diagnostics P.E.I. Inc.	DIC	Class II	1998-04-01
K973563	Bipore Balloon Dilatation Catheter	Bipore, Inc.	LIT	Class II	1998-04-01
K973441	Leksell Gammaplan	Patterson Consulting Group, Inc.	IWB	Class II	1998-04-01
K971749	Easygo Aspirator	Precision Medical, Inc.	BTA	Class II	1998-04-01
K980919	All Silicone 2-Way & 3-Way Foly Balloon Catheter and Nelaton Catheter	Fortune Medical Instrument Corp.	EZL	Class II	1998-03-31
K980027	Peregrine Shielded Diffusion Probe	Peregrine Surgical, LLC.	MPA	Class II	1998-03-31
K980025	Peregrine Tapered Diffusion Probe	Peregrine Surgical, LLC.	MPA	Class II	1998-03-31
K974897	Cobe Brat 2 System with Modified Standard Volume Processing Set	LivaNova USA, Inc.	CAC	Class II	1998-03-31
K974600	Uromed Patch	Uromed Corp.	MNG	Class I	1998-03-31
K974493	Fiegert Endotech Flexible Fiberoptic Endoscopes, Fiegert Endotech Flexible Video-Endoscopes	Fiegert-Endotech Medizintechnik GmbH	FDS	Class II	1998-03-31
K973698	Scion Balloon Elevator	Scion International, Inc.	GCJ	Class II	1998-03-31
K973684	Leksell Viewscope, Leksell Surgiscope, Leksell Freehand	Elekta Instrument AB	HAW	Class II	1998-03-31
K973527	Cardio-Pager System	Data Critical Corp.	MSX	Class II	1998-03-31
K972993	Chase Femoral Access Cannulation Set	Chase Medical, Inc.	DWF	Class II	1998-03-31
K980818	Polyvue, Silver Chord and Unisoft (Methafilcon a) Spherical, Aspherical, Toric and Multifocal Hydrophilic Contact Lense)	Stephen A. Dunn, Inc.	LPL	Class II	1998-03-30
K980114	Magnetic Resonance Diagnostic System	GE Healthcare	LNH	Class II	1998-03-30
K980043	Careside Creatinine	Exigent Diagnostics, Inc.	JFY	Class II	1998-03-30
K974902	Jms Apheresis Needle	JMS Co., Ltd.	FIE	Class II	1998-03-30
K974636	Flosi Rigid Gas Permeable Contact Lens	Futuristic Design Assoc.	HQD	Class II	1998-03-30
K974210	Shielded Cabinet X-Ray Radiation Source Device Model Rs 3000	Rad-Source, Inc.	MOT	Unclassified	1998-03-30