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 2218 of 3531

510(k) clearances, page 2218 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K936122	Rionet Hearing Aid Hb-53Ci	Authorized Hearing Systems, Inc.	ESD	Class I	1994-03-21
K936106	Air Conduction Hearing Aid: Ikon Pp	Unitron Industries, Inc.	ESD	Class I	1994-03-21
K935758	Hygoflex Saliva-Ejector	J.h.orsing AB	DYN	Class I	1994-03-21
K935616	Saliva Ejector Disposable	ASA Instruments S.r.l.	DYN	Class I	1994-03-21
K935369	Fast Spin Echo (Fse)	Resonex, Inc.	LNH	Class II	1994-03-21
K935237	Stryker Endoscopic Instruments and Accessories	Stryker Corp.	GEI	Class II	1994-03-21
K935109	Sdr (Soft Dissector Rake)	Phx Technologies Corp.	GCJ	Class II	1994-03-21
K934358	Kodak Ektachem Dt Slides (Fe)	Eastman Kodak Company	JQE	Class I	1994-03-21
K934350	Kodak X-Omat M43a, M43, & Clinic 1 Processors	Eastman Kodak Company	IXW	Class II	1994-03-21
K934273	Kodak Ektachem Clinical Chemistry Slide Alcohol (Alc)	Eastman Kodak Company	DMT	Class II	1994-03-21
K934071	Kodak Ektachem Dt Slides (Urcr)	Eastman Kodak Company	CGX	Class II	1994-03-21
K933930	Puritan-Bennett Companion 550 Liquid Oxygen Portable Unit	Medtronic, Inc.	BYJ	Class II	1994-03-21
K933759	Rubbercare Lopro Patient Examination Gloves, Powdered	Perusahaan Pelindung Getah (M) Sdn Bhd	LYY	Class I	1994-03-21
K933731	Medtronic Model 5028 Target Tip, Bipolar, Implantable, Tined, Ventricular, Transvenous Lead	Medtronic, Inc.	DTB	Class III	1994-03-21
K932718	Acufex Metal Acl Cannula	Acufex Microsurgical, Inc.	HRX	Class II	1994-03-21
K931641	Porocoat Porous Coating	Depuy, Inc.	LPH	Class II	1994-03-21
K931300	Flash Dent	Chicago X-Ray Systems, Inc.	EHD	Class II	1994-03-21
K926544	Pharmacia Deltec Peripherally Inserted Venous Cath	Pharmacia Deltec, Inc.	FOZ	Class II	1994-03-21
K923497	Flushing Irrigation Set	Orion Life Systems, Inc.	KDH	Class II	1994-03-21
K940688	Trocar Tube	Phx Technologies Corp.	GCJ	Class II	1994-03-18
K940672	Cleo Tl80w Professional Cleo Tl80w Professional R, Cleo Tl100 W Professional	Philips Lighting Co.	LEJ	Class II	1994-03-18
K940069	Dressing Change Kit	Mason-Keller Corp.	FYA	Class II	1994-03-18
K936303	Treatment Table Modification	Tri W-G, Inc.	INQ	Class I	1994-03-18
K935808	Revolution Lower Limb Cpm Unit	Toronto Medical Corp.	BXB	Class I	1994-03-18
K935305	Cynosure Phototome Surgical Diode Laser	Cynosure, LLC	GEX	Class II	1994-03-18
K935234	Stryker Endoscopic Video Accessories	Stryker Corp.	GCJ	Class II	1994-03-18
K934195	Vita Celay Blanks and Vita Celay Optimizer	Vident	EIH	Class II	1994-03-18
K934155	Watts Rake with Leur Port & Aqua-Probe Tip	Phx Technologies Corp.	GCJ	Class II	1994-03-18
K934153	Watts Rake with Leur Lock Port	Phx Technologies Corp.	GCJ	Class II	1994-03-18
K933949	Disposable Arthroscopic Accessory	United States Surgical, A Division of Tyco Healthc	HRX	Class II	1994-03-18
K932592	Brace Neutralizer	Smith and Nephew Donjoy, Inc.	GZJ	Class II	1994-03-18
K932062	Ophthalas 532 Solid State Photocoagulator	Alcon Laboratories	GEX	Class II	1994-03-18
K930314	Heartline Transtelephonic ECG Receiving Console	Aerotel Ltd.	DXH	Class II	1994-03-18
K926314	Hydra Fitness Model 311 Total Power	Henley Intl.	ISD	Class II	1994-03-18
K940610	Aurolite 9	Argen Precious Metals, Inc.	EJT	Class II	1994-03-17
K940580	Aurolite 6	Argen Precious Metals, Inc.	EJT	Class II	1994-03-17
K940579	Aurium 239	Argen Precious Metals, Inc.	EJT	Class II	1994-03-17
K940485	Aurolite 2A	Argen Precious Metals, Inc.	EJT	Class II	1994-03-17
K936086	Sterile Video Camera Cover and Drape	Micromedical Devices, Inc.	KXK	Class II	1994-03-17
K935639	Insufflation Tubing Sterile and Non-Sterile	Charles Polo & Co., Inc.	HIF	Class II	1994-03-17
K935424	Widex R.c. 2 (Remote Control)	Widex Hearing Aid Co., Inc.	ESD	Class I	1994-03-17
K934551	Verifuse Ambulatory Pump	Block Medical, Inc.	MEA	Class II	1994-03-17
K934451	Hasson 360 Series Endoscopic Grasping Forceps	Cook Incorporated	HET	Class II	1994-03-17
K934236	Legend (Manual Wheelchair)	Fortress Lite-Style Wheelchairs, Inc.	IOR	Class I	1994-03-17
K934234	Vision (Manual Wheelchair)	Fortress Lite-Style Wheelchairs, Inc.	IOR	Class I	1994-03-17
K933965	Apex Medical Air Pumps	Apex Medical, Inc.	FNM	Class II	1994-03-17
K933698	100 Series Endoscopic Grasping Forceps	Cook Incorporated	HET	Class II	1994-03-17
K933296	Model #310Ge1500 Wrist Coil	Medic, Inc.	LNH	Class II	1994-03-17
K933295	Model 700Ge1500 Cardiac Vascular Coil for G.e. 1.5T Signa	Medic, Inc.	LNH	Class II	1994-03-17
K933130	Trogard Trocar Sleeve Retaining Thread	Conmedcorp	HET	Class II	1994-03-17