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 1235 of 3531

510(k) clearances, page 1235 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K062887	Modification to G2 Filter System-Femoral Delivery Kit, Model RF-310F	Bard Peripheral Vascular Inc	DTK	Class II	2006-10-26
K062783	Sensititre Haemophilus/streptococcus Pneumoniae (Hp) Mic Plate	Trek Diagnostic Systems, Ltd.	JWY	Class II	2006-10-26
K062700	Infusomat Space Volumetric Infusion Pump System	B.Braun Medical, Inc.	FRN	Class II	2006-10-26
K062699	Perfusor Space Infusion Syringe Pump System	B.Braun Medical, Inc.	FRN	Class II	2006-10-26
K062471	Ultrasonic Surgical Aspirator System, Model Fs 1000 RF	Misonix, LLC	LFL	Unclassified	2006-10-26
K062375	Microscan Microstrep Plus Panel Erythromycin (0.015 to 2 Mcg/ml)	Siemens Healthcare Diagnostics Inc.	LRG	Class II	2006-10-26
K062260	Osteoboost-Bma	Orthos Limited	FMF	Class II	2006-10-26
K061899	Evotech Integrated Endoscope Disinfection System	Advanced Sterilization Products	FEB	Class II	2006-10-26
K061725	Stryker Aria Pneumatic System	Stryker Corp.	HBB	Class II	2006-10-26
K061700	Neotract Anchor	Neotract Inc	GAW	Class II	2006-10-26
K052055	Smisson-Cartledge Thermal Infusion System, Model Tis-1200	Smisson-Cartledge Biomedical, LLC	LGZ	Class II	2006-10-26
K062732	Tomas Pin 6 Mm	Dentaurum Inc.	OAT	Class II	2006-10-25
K062498	Profyle System	Howmedica Osteonics Corp	HRS	Class II	2006-10-25
K062461	C. Albicans Pna Fish	Advandx, Inc.	JXB	Class I	2006-10-25
K062338	Televisit	PHD Medical	DQA	Class II	2006-10-25
K062292	Unicem	3M ESPE Dental Products	EMA	Class II	2006-10-25
K062103	Darco Force Titanium Compression Screw	Darco International Corporation	HWC	Class II	2006-10-25
K061416	Selectsite C304 Deflectable Catheter System, Models C304-S59, C304-L69, C304-Xs59 & C304-Xl74	Medtronic, Inc.	DQY	Class II	2006-10-25
K061342	Malibu Spinal System	Seaspine, Inc.	NKB	Class II	2006-10-25
K060615	Cd Horizon Spinal System	Medtronic Sofamor Danek	NKB	Class II	2006-10-25
K060265	Remcore Remote Controlled Oxygen Regulator	Remcore, Inc.	CAN	Class I	2006-10-25
K053550	Ambu Blue Sensor Neo and Neo X	Ambu A/S	DRX	Class II	2006-10-25
K052944	Ambu White Sensor Cfm, Cfl	Ambu A/S	DRX	Class II	2006-10-25
K063078	Microendoscope	Acclarent Inc	EOB	Class II	2006-10-24
K062888	Middle Wheel Drive Power Chair, Cwd01	EMG Technology Co., Ltd.	ITI	Class II	2006-10-24
K062853	Modification to Stryker Spine Oasys System	Howmedica Osteonics Corp	MNI	Class II	2006-10-24
K062687	Bd Phoenix Automated Microbiology Systen - Ticarcillin-Clavulanate (Gn) 1/2 - 128/2Ug/ml	Becton Dickinson & Co	LON	Class II	2006-10-24
K062672	Grace Medical Pc Coated Tympanostomy Tubes	Grace Medical, Inc.	ETD	Class II	2006-10-24
K062665	Inovel Health Care N95 Particulate Respirators and Surgical Masks	Moldex/Metric, Inc.	MSH	Class II	2006-10-24
K062660	Catalysy	Ki Mobility	IOR	Class I	2006-10-24
K062148	Depuy Pinnacle Altrx Acetabular Cup Liner	Depuy Orthopaedics Inc.	LPH	Class II	2006-10-24
K062143	Kozy Comfort Infant Positioner	Alfred E Mann Inst. for Biomedical Engineering	FRP	Class I	2006-10-24
K061878	Electrode Coated Ball, Model Ab302c; Needle, Model An301c; Blade, Model Ae301hc	E Surgical, LLC	GEI	Class II	2006-10-24
K060971	Omi Retractable Saftey Syringe, Various	Omi Manufacturing Pty., Ltd.	MEG	Class II	2006-10-24
K060653	Thermaclear	Dermacare	GEX	Class II	2006-10-24
K062916	Cliniqa Liquid Qc Cardiac Marker Control Sp, Levels 1,2, &3	Cliniqa Corporation	JJY	Class I	2006-10-23
K062850	Autosuture Circular Eea Surgical Staplers	United States Surgical, A Division of Tyco Healthc	GDW	Class II	2006-10-23
K062446	Modification to Pinnacle Roii Hiflow Introducer Sheath	Terumo Medical Corp.	DYB	Class II	2006-10-23
K062361	Innovacon Hcg Uktra Test Device	Innovacon, Inc.	JHI	Class II	2006-10-23
K061754	Bard Composite L/p Mesh	Davol Inc., Sub. C.R. Bard, Inc.	FTL	Class II	2006-10-23
K061188	Silverhawk Peripheral Plaque Excision System	Foxhollow Technologies, Inc.	MCW	Class II	2006-10-23
K060414	Kolster Methods, Inc., Featherlift Silhouette Suture	Kmi Kolster Methods, Inc.	GAW	Class II	2006-10-23
K062903	Sbi Carpal Fusion Plate	Small Bone Innovations, Inc.	HRS	Class II	2006-10-20
K062882	Powdered Vinyl Patient Examination Gloves, Clear(non-Colored)	Suqian Green Glove Co., Ltd.	LYZ	Class I	2006-10-20
K062870	Triactiv Fx Embolic Protection System, Model Pn 60040-02; -03	DSM Biomedical, Inc.	NFA	Class II	2006-10-20
K062858	Modification to Glidesheath	Terumo Medical Corp.	DYB	Class II	2006-10-20
K062832	Vacora 14G Biopsy Probes, Models Vb14116, Vb14138	C.R. Bard Inc	KNW	Class II	2006-10-20
K062830	Biolucent Applicator Kit	Biolucent, Inc.	JAQ	Class II	2006-10-20
K062722	Sensititre Haemophilus/streptococcus Pneumoniae (Hp) Mic Plate	Trek Diagnostic Systems, Ltd.	JWY	Class II	2006-10-20
K062705	Synergies Plus Gram-Positive Mic/combo Panels with Linezolid	Siemens Healthcare Diagnostics Inc.	LON	Class II	2006-10-20