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 1921 of 3531

510(k) clearances, page 1921 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K964943	Sunglasses (Non-Prescription)	Micron Eyewear Manufactory Co., Ltd.	HQY	Class I	1997-02-25
K964935	Suture Lock	Smith & Nephew Endoscopy, Inc.	KGS	Class I	1997-02-25
K964850	Solution Administration Set with 0.22 Micron High Pressure Extended Life Filter	Baxter Healthcare Corporation	FPA	Class II	1997-02-25
K964782	Medrad Contrast Holder	Medrad, Inc.	FOX	Class I	1997-02-25
K964768	Threadloc Dental Implant Systems	Sulzer Calcitek, Inc.	DZE	Class II	1997-02-25
K964692	Perfectim	J. Morita USA, Inc.	ELW	Class II	1997-02-25
K964364	Disposable Apron	Instrument Makar, Inc.	LYU	Class I	1997-02-25
K964142	Medline Disposable Surgical Drapes and Gowns	MEDLINE INDUSTRIES, LP - Northfield	KKX	Class II	1997-02-25
K963970	Endocare Cryocare Cryosurgical System Urethral Warming System	Varian Medical Systems, Inc.	GEH	Class II	1997-02-25
K963917	Holden-Walker Humidifier-Nebulizer Kit	Holden Walker Corp.	CAF	Class II	1997-02-25
K963841	Eztest	Sgm Biotech, Inc.	FRC	Class II	1997-02-25
K963568	Mask Surgical	The Innovative Approach, Corp.	FXX	Class II	1997-02-25
K963425	Genzyme Diagnostics Contrast Mono	Sekisui Diagnostics, LLC	KTN	Class II	1997-02-25
K962981	Capiox Sp Pump Head	Terumo Medical Corp.	KFM	Class II	1997-02-25
K962874	Respiflo/s	Curtin & Associates International, Inc.	CAF	Class II	1997-02-25
K962872	Respiflo	Tyco Healthcare Deutschaland GmbH	CAF	Class II	1997-02-25
K965005	Iamin Impregnated Gauze Dressing	Procyte Corp.	MGQ	Unclassified	1997-02-24
K964975	Cohort Discectomy Systems (Cds)	Cohort Medical Products Group, Inc.	HRX	Class II	1997-02-24
K964957	Intermittent Compressor System	Eischoco, Inc.	IRP	Class II	1997-02-24
K964951	Kinemax Plus Tibial Spacers	Howmedica Corp.	JWH	Class II	1997-02-24
K964945	Innovasive Devices Rotator Cuff Fastner	Innovasive Devices, Inc.	MBI	Class II	1997-02-24
K964778	Hi-Star MRI Imaging System	Health Images, Inc.	LNH	Class II	1997-02-24
K964752	Kinematic Positioning Devices; C-Spine, Knee,shoulder	Philips North America LLC	LNH	Class II	1997-02-24
K964013	Mitek Absorbable Toggle Anchor	Mitek Products	MAI	Class II	1997-02-24
K963678	Caretone II	American Telecare, Inc.	DQD	Class II	1997-02-24
K962827	Alarm Display Unit/pager-Lan System (Adu)	Marquette Electronics, Inc.	DSI	Class II	1997-02-24
K962558	Chlamydia Igg Elisa Test System	Armkel, LLC	LJC	Class I	1997-02-24
K965249	Spyglass Angiographic Catheter	Daig Corp.	DQO	Class II	1997-02-21
K964994	Cpi Model 6240 50 Psi Nebulizer Compressor	Contemporary Products, Inc.	CAF	Class II	1997-02-21
K964773	Dentemp One Step	Majestic Drug Co., Inc.	EMA	Class II	1997-02-21
K964770	Corometrics 120 Series Maternal/fetal Monitor	GE Medical Systems Information Technologies, Inc.	HGM	Class II	1997-02-21
K964751	Ceralas Diode Laser System (Ceralas D2)	Ceram Optec, Inc.	HQF	Class II	1997-02-21
K964750	Eagle 4000 Patient Monitor	Marquette Electronics, Inc.	LOS		1997-02-21
K964719	Hudson Rci Lifesaver Single Patient Use Manual Resuscitator	Hudson Respiratory Care, Inc.	BTM	Class II	1997-02-21
K964712	Prism Xpvt System (210823)	Philips North America LLC	KPS	Class II	1997-02-21
K964699	Rheo Dopplex II (Rd 2)	Huntleigh Technology, Inc.	IYN	Class II	1997-02-21
K964055	Flexi-Site (E203-01)/ Flexi-Fit (E300)	Epic Medical Equipment Services, Inc.	DQA	Class II	1997-02-21
K963081	Indigo Medical Model Idl 830 & Model Idl 830E Laser Systems for General Gynecological Applications	Indigo Medical, Inc.	GEX	Class II	1997-02-21
K963053	9000 Series Filter & Filter/hme	Enternet Medical, Inc.	CAH	Class II	1997-02-21
K962850	Tum-E-Vac	Ethox Corp.	KDH	Class II	1997-02-21
K962765	Cordis Marker Wire Steerable Guidewire (Stabilizer with Radiopaque Markers) and (Wizdom with Radiopaque Markers)	Cordis US Corp.	DQX	Class II	1997-02-21
K962703	Thee Thermastim	Ehti Medical Corp.	IMJ	Class II	1997-02-21
K962243	Vasotherm	Ehti Medical Corp.	IMJ	Class II	1997-02-21
K961982	Tri-Flow Three Way Stopcock	North, Inc.	FMG	Class II	1997-02-21
K960097	Chartr Ep	Ics Medical Corp.	GWJ	Class II	1997-02-21
K970396	Human Chorionic Gonadotropin Calibrator	Dade Chemistry Systems, Inc.	JIW	Class II	1997-02-20
K970198	Ifa Hep2 Kit for the Detection of Antinuclear Antibodies	Scimedx Corp.	DHN	Class II	1997-02-20
K970188	Sealite Sciences, Inc. Aqualite Prolactin	Sealite Sciences, Inc.	CFT	Class I	1997-02-20
K965116	Abbott Testpack Plus Hcg Combo with Obc	Abbott Medical	JHI	Class II	1997-02-20
K965114	Tumor Marker Control	Siemens Healthcare Diagnostics Inc.	JJY	Class I	1997-02-20