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 2000 of 3531

510(k) clearances, page 2000 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K960251	Comsat Adult,pediatric,infant,neonatal Disposable Sensor and Comsat Reusable Finger Sensor	Aristo Medical Products, Inc.	DQA	Class II	1996-03-26
K960098	Rmi Internal Mammary Artery Cannula	Research Medical, Inc.	DQR	Class II	1996-03-26
K960007	Storz Mvs 1011A Disposable Fiberoptic Endoilluminator	Storz	MPA	Class II	1996-03-26
K955818	Foamseal Retrograde Cardioplegia Catheter	Quest Medical, Inc	DWF	Class II	1996-03-26
K954147	Manan Malecot Basket Drainage Catheter	Argon Medical Devices, Inc	FEW	Class II	1996-03-26
K954132	Manan Manta Catheter Fixation Disk	Argon Medical Devices, Inc	KNY	Class II	1996-03-26
K954043	Manan Biliary Drainage Catheter	Argon Medical Devices, Inc	FGE	Class II	1996-03-26
K953945	Retrograde Coronary Sinus Perfusion Cannula with Elongated & Treaded Cuff & Introducer Stylet	Dlp, Inc.	DWF	Class II	1996-03-26
K953713	Manan General Utility Drainage Catheter	Argon Medical Devices, Inc	LJE	Unclassified	1996-03-26
K953601	Manan Universal Sump Drainage Catheter	Argon Medical Devices, Inc	LJE	Unclassified	1996-03-26
K960537	K2 Bone Screw System	Kinetikos Medical, Inc.	HWC	Class II	1996-03-25
K960533	K3 Bone Screw System	Kinetikos Medical, Inc.	HWC	Class II	1996-03-25
K960506	A-Dec Performer Control Unit	A-dec, Inc.	EIA	Class I	1996-03-25
K960313	Mueller Hinton Agar with 2% Naci	Remel Inc	JTZ	Class II	1996-03-25
K960291	Tinted Ocu-Flex 53 (Occufilcon B) Soft Hydrophilic Contact Lens	Ocu-Ease Optical Products, Inc.	LPL	Class II	1996-03-25
K960224	Geratherm Mercuiry Free Clinical Thermometer	Rg Ent., Inc.	FLK	Class II	1996-03-25
K960148	Circon-Surgitek Classic Double Pigtail Ureteral Stent	Cabot Medical Corp.	FAD	Class II	1996-03-25
K960093	Protec Roll Gauze	Derivadas Degasa S.A. de C.V.	EFQ	Unclassified	1996-03-25
K960012	Stryker Adel Bassinet	Stryker Corp.	FMS	Class II	1996-03-25
K955900	Novalens/novawet Sphjerical & Perception & Vanguard Multifocal &/or Bifocal (Rosifocon a) Rigid Gas Permeable Contact Lr	Novavision, Inc.	HQD	Class II	1996-03-25
K955839	Multi-Med Multi-Lumen Central Venous Catheter	Baxter Edwards	FOZ	Class II	1996-03-25
K955832	Cordis Ventricular Antechamber (Va)	Cordis US Corp.	JXG	Class II	1996-03-25
K955820	Braun Hemostasis Introducers	B.Braun Medical, Inc.	DYB	Class II	1996-03-25
K955817	Coridis Webster Deflectable Braided-Tip Electrode Catheter	Cordis Webster, Inc.	DRF	Class II	1996-03-25
K951935	Prodigy Superpulse Nd:yag Surgical Laser Systems & Accessories	Xintec Corporation	GEX	Class II	1996-03-25
K951876	Protege Er:yag Surgical Laser System and Accessories	Xintec Corporation	GEX	Class II	1996-03-25
K951722	Perceptor Compensator Morse Manifold	Namic	DRS	Class II	1996-03-25
K950314	Dantec Monopolar Lumen Electrode (13R18 and 13R19)	Dantec Medical, Inc.	GXZ	Class II	1996-03-25
K960879	Amalgamibond Plus	Parkell, Inc.	KLE	Class II	1996-03-22
K960712	Binax Strep a Test	Binax, Inc.	GTZ	Class I	1996-03-22
K960565	Acorn Anterior/posterior Composite Restorative	Dent Zar, Inc.	EBF	Class II	1996-03-22
K960524	Alta Cfx Im Rod System	Howmedica Corp.	HSB	Class II	1996-03-22
K960295	Long Life Rx-12	Rexton, Inc.	ESD	Class I	1996-03-22
K960244	Document Tdm Ultra Assayed Control	Casco Standards	DIF	Class I	1996-03-22
K960241	CPR General Surgery Tray	Custom Pack Reliability	LWI	Class II	1996-03-22
K960054	900Udx Urine Pathology System	Intl. Remote Imaging Systems	KQO	Class I	1996-03-22
K955881	Retinol Binding Rid Kit	The Binding Site	CZS	Class I	1996-03-22
K955874	Altacare	Asf Industries, Inc.	FNM	Class II	1996-03-22
K955871	Howmedica Asymmetric Stem Femoral Component	Howmedica Corp.	LPH	Class II	1996-03-22
K955869	Scimed Encore 26 Inflation Device/encore 30 Inflation Device	Scimed Life Systems, Inc.	MAV	Class II	1996-03-22
K955860	Multi III, IV	Excel Tech., Ltd.	LIH	Class II	1996-03-22
K955387	Isotron III, Isotron IV	Excel Tech., Ltd.	LIH	Class II	1996-03-22
K954963	Schuhli Implant System	Synthes (USA) Products LLC	HRS	Class II	1996-03-22
K954897	Hytec Autoimmune Kits (Rnp)	Hycor Biomedical	LKO	Class II	1996-03-22
K954896	Hytec Autoimmune Kits (Sm)	Hycor Biomedical	LKP	Class II	1996-03-22
K953643	Hematil 18 (H-18)	Texas Intl. Laboratories, Inc.	GKZ	Class II	1996-03-22
K953606	Best Pregnancy Test	Ameritek, Inc.	LCX	Class II	1996-03-22
K941823	Leksell Neuro Generator and Accessories	Elekta Instruments, Inc.	GXD	Class II	1996-03-22
K941173	Anti-Keratin-Hmw Primary Anti-Body	Ventana Medical Systems Inc	DEH	Class II	1996-03-22
K935161	Keratin Primary Antibody	Ventana Medical Systems Inc	DEH	Class II	1996-03-22