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 2232 of 3531

510(k) clearances, page 2232 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K935603	Extracorporeal Temperature Sensor	Smiths Industries Medical Systems, Inc.	FLL	Class II	1994-02-15
K935382	Graspers	Mectra Labs, Inc.	GCJ	Class II	1994-02-15
K935293	Fluid Aspiration Needle	Surgin Surgical Instrumentation, Inc.	GCJ	Class II	1994-02-15
K935098	Baby Board	Sentry Medical Products, Inc.	BTX	Class I	1994-02-15
K934682	Surgical Video Camera and Accessories	Medical Dynamics, Inc.	FWF	Class I	1994-02-15
K934601	Ndm Hydrogauze Wound Dressing	Ndm Acquisition Corp.	NAE	Class I	1994-02-15
K933364	Promed Biopsy Needle	VLV Associates, Inc.	DWO	Class I	1994-02-15
K933131	Bistat 70/70-I Electrosurgical Unit	Medical and Scientific Enterprises, Inc.	GEI	Class II	1994-02-15
K931779	Ehl Pulse Generator	Psi Medical Products, Inc.	FFK	Class II	1994-02-15
K931321	Csd 200/300/400/500 Dynamometer	John Chatillon & Sons, Inc.	LBB	Class II	1994-02-15
K931244	Bone Plate	Acu Med, Inc.	HRS	Class II	1994-02-15
K931214	P.c.a. Modular Knee System	Howmedica Corp.	HSX	Class II	1994-02-15
K930747	Bird 8400Ti Adult Volume Ventilator	Bird Products Corp.	CBK	Class II	1994-02-15
K930607	Gripper	Surgical Instrument, Inc.	GCJ	Class II	1994-02-15
K925890	Mirror, Mouth	Protector, Inc.	EKJ	Class I	1994-02-15
K925889	Forceps, Dressing, Dental	Protector, Inc.	EKJ	Class I	1994-02-15
K925888	Explorer, Operative	Protector, Inc.	EKJ	Class I	1994-02-15
K922989	Wiltek Irrigaiton/aspiration Tube Set	Wiltek Medical, Inc.	BYY	Class II	1994-02-15
K921274	Metallic Toatal Hip System	Zimmer GmbH	LPH	Class II	1994-02-15
K920978	Ula (Poliglecaprone 251) Synthetic Absor Sut, Dyed	Ethicon, Inc	GAN	Class II	1994-02-15
K915459	Flowmate Hand Pump	Psi Medical Products, Inc.	KOD	Class II	1994-02-15
K936286	Atr-2900Df (with Depth Filter)/cap-35Df (with Depth Filter)	Gish Biomedical, Inc.	DTN	Class II	1994-02-14
K935577	Scimed Entre II Ptca Guide Wire	Scimed Life Systems, Inc.	DQX	Class II	1994-02-14
K935379	Urological Balloon Dilatation Catheter	Boston Scientific Corporation	EZN	Class II	1994-02-14
K934714	Endodontic Pulp Canal Spreader	Excellence in Endodontics, Inc.	ELC	Class II	1994-02-14
K934525	Auto Suture Disposable Umbilical Clip Applier	United States Surgical, A Division of Tyco Healthc	HFW	Class II	1994-02-14
K934398	Accu-Beam Tissue Drill & Aspiration/injection Needle	Transamerican Technologies Intl.	GCJ	Class II	1994-02-14
K934299	Dyonics Disposable Arthroscopic Surgery Blades Modification	Smith & Nephew Dyonics, Inc.	HRX	Class II	1994-02-14
K934270	Acufex Arthroscope	Acufex Microsurgical, Inc.	HRX	Class II	1994-02-14
K933751	Lifeshield Blood Collection Device	Sherwood Medical Co.	FMI	Class II	1994-02-14
K932843	Flexible Video Sigmoidoscope System W/disp. Sheath	Cogentix Medical, Inc.	FAM	Class II	1994-02-14
K932298	Pro's Neo-Lastics	Professional Positioners, Inc.	ECI	Class I	1994-02-14
K931511	Geritrex Sterile Water for Irrigation	Geritrex Corp.	JOL	Class II	1994-02-14
K931094	Procel(tm) Dermaliner Glove	W. L. Gore & Associates, Inc.	LYU	Class I	1994-02-14
K931048	4-Sure Nelaton Catheter	Boston Pacific Medical, Inc.	EZD	Class II	1994-02-14
K931047	4-Sure Female Catheter	Boston Pacific Medical, Inc.	EZD	Class II	1994-02-14
K930155	Miniball Abutment	Steri-Oss, Inc.	DZE	Class II	1994-02-14
K926071	Onco-Vial Adapter	David Bull Laboratories, USA, Inc.	LHI	Class II	1994-02-14
K924219	Endosseous Implants	The Stern Metals Co., Inc.	DZE	Class II	1994-02-14
K920410	Emilith Electromechanicalimpactor Lithotripsy Prob	Psi Medical Products, Inc.	FFK	Class II	1994-02-14
K915655	Stability Femoral Prosthesis W/hap	Depuy, Inc.	MEH	Class II	1994-02-14
K926481	Valleylab Model E252oh, Force Gsu(tm) Handset	Medtronic, Inc.	GEI	Class II	1994-02-12
K936113	Indiperse	Indisperse Distributing, Inc.	EJJ	Class II	1994-02-10
K935742	Skin Scrub Tray	Cush Medical Products	FRG	Class II	1994-02-10
K935685	Tracheostomy Care Tray	Cush Medical Products	FRG	Class II	1994-02-10
K935683	Suture Removal Tray	Cush Medical Products	FRG	Class II	1994-02-10
K935682	Laceration Tray	Cush Medical Products	FRG	Class II	1994-02-10
K935681	Incision/drainage Tray	Cush Medical Products	FRG	Class II	1994-02-10
K935514	Vacuum Tube Holder Culture Medium Vial Holder	Kawasumi Laboratories Co., Ltd.	FMI	Class II	1994-02-10
K935499	Pmt Silicone Sheeting	PMT Corp.	MDA	Class I	1994-02-10