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 2165 of 3531

510(k) clearances, page 2165 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K943039	Spectacle Frames	Rodenstock USA Inc.	HQY	Class I	1994-09-06
K942760	Pneumatic Wire Tensioner	Smith & Nephew Richards, Inc.	HSZ	Class I	1994-09-06
K942722	Module Program	Electone, Inc.	LRB	Class I	1994-09-06
K942424	Dma Microprotein Procedure	Data Medical Associates, Inc.	CEK	Class II	1994-09-06
K942322	Sunglasses	Suntory Industrial Co.	HQY	Class I	1994-09-06
K942259	Technicuff	Technicuff Corp.	DXQ	Class II	1994-09-06
K941763	Electronic-Amplified Stethoscope	Hsues' Brothers Medical, Inc.	DQD	Class II	1994-09-06
K941744	Pbi Plus Hdl Precipitating Reagent	Merchant House Scientific	LBR	Class I	1994-09-06
K941691	Revo Rotator Cuff Repair System	Linvatec Corporation	HRX	Class II	1994-09-06
K941589	Syringe Filter Devices	Gelman Sciences, Inc.	FMF	Class II	1994-09-06
K940760	Fluids Pack for Coring 238	Alko Diagnostic Corp.	JIX	Class II	1994-09-06
K940723	Body Boot	Mark-Clark	LYU	Class I	1994-09-06
K940449	Delfia Shbg Kit	Wallac Oy	CDZ	Class I	1994-09-06
K940306	Octostop Compensating Filters	Octostop, Inc.	KPR	Class II	1994-09-06
K940107	Virectomy Lens	Visionary Technologies of Miami, Inc.	HJK	Class II	1994-09-06
K936060	Atomspec Gf Blood Lead Workstation	Thermo Jarrell Ash Corp.Div.Thermo Inst.	DOF	Class II	1994-09-06
K935281	Arbo H87p, H85p, H27p Disposable Monitoring Electrodes	Arbo Medical, Inc.	DRX	Class II	1994-09-06
K934704	Auto Suture Disposable Endoscope Sheath	United States Surgical, A Division of Tyco Healthc	GCJ	Class II	1994-09-06
K934520	Vital-Port Vascular Access System	Med Institute, Inc.	LJT	Class II	1994-09-06
K920596	Full Spectrum Ule Fiber, Model Ff101	Gerald J. Shirk, M.D.	GEX	Class II	1994-09-06
K943849	Gromment Style Venturi Tube	Micromed Development Corp.	ETD	Class II	1994-09-02
K943847	Bobbin Style Venturi Vent Tube	Micromed Development Corp.	ETD	Class II	1994-09-02
K943838	Argesol #760	Argen Precious Metals, Inc.	EJT	Class II	1994-09-02
K943753	Frame Spectacle	Optic Tech Corp.	HQZ	Class I	1994-09-02
K943275	Medpor Surgical Implant Material	Porex Surgical, Inc.	HPZ	Class II	1994-09-02
K943125	Quadraspheric Fundus Lens	Volk Optical Inc	HJK	Class II	1994-09-02
K942752	Marquette Ear Probe Sensor	Marquette Electronics, Inc.	DPZ	Class II	1994-09-02
K942745	Exmoor Single Use Myringotomes	Exmoor Plastics Limited	LRC	Class I	1994-09-02
K942716	Audio Expert Audiometer	Beltone Electronics Corp.	EWO	Class II	1994-09-02
K942655	4 Channel Dispenser	Tecan U.S.	JQW	Class I	1994-09-02
K942634	Pembush	Crossroads Trading Co.	JEQ	Class I	1994-09-02
K942609	Mrt-150A Shoulder Coil	Toshiba America Mri, Inc.	LNH	Class II	1994-09-02
K942242	Auto Ref-Keratometer, Rk-3	Cannon U.S.A., Inc.	HKO	Class I	1994-09-02
K942114	Roche Tdm Calibration Verification Test Set	Roche Diagnostic Systems, Inc.	DIF	Class I	1994-09-02
K942083	Advanced Therapy Dosimeter	Keithley Instruments, Inc.	IYE	Class II	1994-09-02
K941820	Duotip-Test	Lincoln Diagnostics, Inc.	SCL	Class II	1994-09-02
K941726	Sunglasses	Yowmost Enterprise Co., Ltd.	HQY	Class I	1994-09-02
K941476	Model 2600 Procart	Compressor Technologies, Ltd.	EIA	Class I	1994-09-02
K940894	Magna Sl	Magna-Lab, Inc.	LNH	Class II	1994-09-02
K940632	I-125 Rapid Strand	Medi-Physics Inc. dba Nycomed Amersham Imaging	IWI	Class II	1994-09-02
K940406	Disposable, Ambulatory, Infusion Pumps	VLV Associates, Inc.	MEB	Class II	1994-09-02
K940393	Peregrine Wide Angle Light Pipe	Peregrine Surgical, LLC.	HJM	Class II	1994-09-02
K935906	Ranir Plax Rx	Ranir/Dcp Corp.	EAX	Class I	1994-09-02
K935444	Octostop(r) Chair (New Model	Octostop, Inc.	IXR	Class II	1994-09-02
K922270	Physiotech 4000 or Norodyn 8000	Myo-Tronics, Inc.	HCC	Class II	1994-09-02
K943991	O-R-Ez Tip Cleaner	O-R-Ez, Inc.	GEI	Class II	1994-09-01
K943542	Aspen Surgical Systems Accessory Electrode	Conmedcorp	GEI	Class II	1994-09-01
K942866	Clinical Blood Gas Mixture	Nordan Smith Welding Supplies	BXK	Class I	1994-09-01
K942542	Slase 210 Plus Holmium Laser System	Sunrise Technologies, Inc.	GEX	Class II	1994-09-01
K941710	Scimed Transend Steerable Guide Wire and Accessories	Scimed Peripheral Interventions	DQX	Class II	1994-09-01