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 1438 of 3531

510(k) clearances, page 1438 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K032030	Blink Cl Lubricant Eye Drops	Advanced Medical Optics, Inc.	LPN	Class II	2003-09-25
K032025	Sentinol Nitinol Billary Stent System	Boston Scientific Corporation	FGE	Class II	2003-09-25
K031485	Rinspiration System	Kerberos Proximal Solutions, Inc.	DQO	Class II	2003-09-25
K030393	Optical Low Coherence Reflectometry (Olcr) Pachymeter	Haag-Streit Holding AG	MXK	Class II	2003-09-25
K032780	Inviro Snap Safety Syringe, 1Cc, 3Cc, 5Cc, and 10Cc	Inviro Medical	MEG	Class II	2003-09-24
K032681	Konica Laser Imager, Model Drypro Model 771	Konica Medical and Graphic Corporation	LMC	Class II	2003-09-24
K032678	Modification to: Aurora	Aurora Imaging Technology, Inc.	LNH	Class II	2003-09-24
K032635	Drystar 5300 Medical Image Printer, Model 5300	Agfa Corp.	LMC	Class II	2003-09-24
K032505	Air Press Massager	Telebrands Corp.	IRP	Class II	2003-09-24
K032489	Wu's 4-Wheeled Neo Scooter, Wt-M4jr	Wu's Tech Co., Ltd.	INI	Class II	2003-09-24
K032402	Rodeo Model, Rd12, Rd14, Rd16, Radio Transit Model, Rd12t, Rd14t, Rd16t,	Convaid Products LLC	IOR	Class I	2003-09-24
K032277	Justwin Scooter, Model Js-401	Joy Ride Tech Co., Ltd.	INI	Class II	2003-09-24
K032157	Telemis-Medical Solution	Telemis S.A.	LLZ	Class II	2003-09-24
K031971	Global Cap Resurfacing Replacement Shoulder	Depuy Orthopaedics Inc.	HSD	Class II	2003-09-24
K031898	Ekf Diagnostic Hemo Control Hemoglobin Measurement System	Ekf Diagnostic GmbH	GKR	Class II	2003-09-24
K031360	Gi Supply Biliary Stent	Gi Supply	FGE	Class II	2003-09-24
K031356	Hemaprompt Gastric	Aerscher Diagnostics	KHE	Class II	2003-09-24
K030187	Reprocessed Electrophysiology Catheter	Alliance Medical Corp.	NLH	Class II	2003-09-24
K032833	Myosystem with Customizing	Otto Bock Healthcare LP	GXY	Class II	2003-09-23
K032773	Diamond D High Impact Denture Acrylic	Mycone Dental Supply Co., Inc.	EBI	Class II	2003-09-23
K032771	Medrad Continuum Mr Infusion System	Medrad, Inc.	FRN	Class II	2003-09-23
K032769	Eyesopen Tonometer	Eye-Deas, LLC	HKY	Class II	2003-09-23
K032709	Modular Plus Hip Stem	Plus Orthopedics	LWJ	Class II	2003-09-23
K032707	Contour Se Microspheres (Syringe)	Boston Scientific Corporation	HCG	Class II	2003-09-23
K032642	Beeline System	Mckinley, Inc.	FRN	Class II	2003-09-23
K032606	Optetrak Total Knee System Asymmetric Femoral Components Size 6 Psoterior-Stabilizing, Cemented Femoral Components	Exactech, Inc.	JWH	Class II	2003-09-23
K032553	Trufill Dcs Orbit Detachable Coil and Trufill Dcs Syringe, Also Known as Trufill Dcs Orbit Detachable Coil System	Cordis Neurovascular, Inc.	HCG	Class II	2003-09-23
K032468	Suturtek Fastclose Sternum Closure Device	Suturtek Incorporated	GAQ	Class II	2003-09-23
K032440	F-11 Folding Power Chair	Wheelchair & Scooter Express	ITI	Class II	2003-09-23
K032364	Microlife Digital Underarm Electronic Thermometer, Model Mt 18E1 (V932)	Microlife Intellectual Property GmbH	FLL	Class II	2003-09-23
K032242	Personna Plus Safety Scalpel System	Omi Manufacturing Pty., Ltd.	GES	Class I	2003-09-23
K031944	Vinyl Examination Gloves, Powder Free and Pink Color	Arista Latindo Industrial, Ltd. P.T.	LZA	Class I	2003-09-23
K031897	Pf-2 Battery Operated Electric Four Wheel Power Scooter	Imc-Heart Way LLC	INI	Class II	2003-09-23
K031895	Ksea Opserver Lap	Karl Storz Endoscopy-America, Inc.	FET	Class II	2003-09-23
K031670	Sterile Powder Free Latex Surgical Glove with Polymer Coating	P.T. Saptindo Surgica	KGO	Class I	2003-09-23
K031669	Sterile Powder Free Synthetic Surgical Glove with Polymer Coating	P.T. Saptindo Surgica	KGO	Class I	2003-09-23
K031531	S&t Microsurgical Suture	S & T AG	GAR	Class II	2003-09-23
K031449	Modification to the Trabecular Metal Glenoid - Bigliani/flatow the Complete Shoulder Solution	Implex Corp.	KWS	Class II	2003-09-23
K031305	Olympus Ultrasonic Surgical System	Olympus Optical Co., Ltd.	LFL	Unclassified	2003-09-23
K031214	Cyclone Anterior Cervical Plate System	Encore Medical, LP	KWQ	Class II	2003-09-23
K030966	Contour Emboli Pva and Fastracker-325 Infusion Catheter	Boston Scientific Corporation	NAJ	Class II	2003-09-23
K030904	Palamed	Heraeus Medical GmbH Technology	LOD	Class II	2003-09-23
K030903	Osteopal	Heraeus Kulzer GmbH & Co. KG	LOD	Class II	2003-09-23
K030902	Palacos R	Heraeus Kulzer GmbH & Co. KG	LOD	Class II	2003-09-23
K023429	Rowenta Inc. Bodypartner Vision, Model Bm 210 (2079565620)	Rowenta, Inc.	MNW	Class II	2003-09-23
K032778	Large Volume Fluid Reservoir	Belmont Medical Technologies	LGZ	Class II	2003-09-22
K032510	Acon Quik-Check II Midstream Home Pregnancy Test	Acon Laboratories, Inc.	LCX	Class II	2003-09-22
K032380	Wagner Cone Prosthesis	Centerpulse Orthopedics, Inc.	LZO	Class II	2003-09-22
K032299	Bd Phoenix Automated Microbiology System,-Ampicillin 0.5.-32 Ug/ml	Becton Dickinson & Co	LON	Class II	2003-09-22
K032187	Anthrex Titanium Opening Wedge Osteotomy System	Arthrex GmbH	HRS	Class II	2003-09-22