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 2185 of 3531

510(k) clearances, page 2185 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K941445	Extension Set with Anti-Siphon Valve	Pharmacia Deltec, Inc.	FPA	Class II	1994-06-29
K941404	Impulse 4000 Defibrillator/transcutaneous Pacer Analyzer	Hogan & Hartson	DRL	Class II	1994-06-29
K940554	Tnco, Inc. Arthroscopic Surgical Instruments	Tnco, Inc.	HRX	Class II	1994-06-29
K940222	Smith and Nephew Spine Deflecting Forceps	Smith & Nephew, Inc.	HRX	Class II	1994-06-29
K940164	Super-Sil	Finetone Hearing Instruments	ESD	Class I	1994-06-29
K930657	D-C-S System	Pina-Vertriebs	KWP	Class II	1994-06-29
K930515	Alpha Spinal System	Alphatec Spine, Inc.	KWP	Class II	1994-06-29
K942033	R&d Batteries, Part Nos. 5243, 5104, and 5481	R & D Batteries, Inc.	BTA	Class II	1994-06-28
K940501	Re-Sharpenable Saw Blades	Adven Medical	GFA	Class I	1994-06-28
K940239	Eye Tray	Cush Medical Products	LRP	Class I	1994-06-28
K940126	Avecor Pre-Bypass Filter	Avecor Cardiovascular, Inc.	KRJ	Class II	1994-06-28
K933389	Opus Cmv-G	Pb Diagnostic Systems, Inc.	LFZ	Class II	1994-06-28
K932099	Acumed Flexible Cannula	Acu Med, Inc.	HRX	Class II	1994-06-28
K932090	Acufex Disposable Meniscal Cannula	Acufex Microsurgical, Inc.	HRX	Class II	1994-06-28
K931847	Bio-Prep Cement Restrictor	Biomedical Devices, Inc.	LZN	Class II	1994-06-28
K931836	Acufex Smooth and Threaded Pins	Acufex Microsurgical, Inc.	HTY	Class II	1994-06-28
K926332	Diagnostic Ultrasound System, Type 3535, Modified	B & K Medical A/S	IYO	Class II	1994-06-28
K923002	Enteroclysis Tube	Biosearch Medical Products, Inc.	KNT	Class II	1994-06-28
K920631	Bioject Jet Injection System	Bioject, Inc.	KZE	Class II	1994-06-28
K942459	Curasalt Hypertonic Saline Dressing	Kendall Healthcare Products Co. Div.Of Tyco Health	KMF	Class I	1994-06-27
K942144	Urethra-Brush	Rovers Diagnostic Devices	FDX	Class II	1994-06-27
K942030	Biopsy Scissors	Surgical Technologies, Inc.	OCZ	Class II	1994-06-27
K941863	O.b. Tampon	Personal Products Co.	HEB	Class II	1994-06-27
K941779	Karl Storz 11274 Series Flexible Fiberscope	Karl Storz Endoscopy-America, Inc.	FAJ	Class II	1994-06-27
K941728	Monopolar Coagulating Polypectomy Snare	Endoscopic Innovations, Inc.	KNS	Class II	1994-06-27
K941693	Medicam Endocoupler and Beamsplitter	M.P. Video, Inc.	GCJ	Class II	1994-06-27
K941203	Medical Imaging Workstation II (Miw II)	Cemco, Inc.	LMD	Class I	1994-06-27
K941086	Pacspro II	Advanced Video Products, Inc.	LMD	Class I	1994-06-27
K940140	Hm-Cryo	Hill-Med, Inc.	GEH	Class II	1994-06-27
K935224	Volume Neck Coil for the Gyrex V-Dix	Elscint, Inc.	LNH	Class II	1994-06-27
K935102	Saturn Light	Burton Medical Products Corp.	FTA	Class II	1994-06-27
K933768	Coagulator, Laparoscopic, Lunipolar/accessories	Mahe-Medizintechnik	HET	Class II	1994-06-27
K933202	Venus Diagnostic Ultrasound System	GE Healthcare	IYN	Class II	1994-06-27
K925478	Electrosurgical Electrode	Megadyne Medical Products, Inc	HGI	Class II	1994-06-27
K925225	The Bte Vector; Analysis System for the Low Back	Baltimore Therapeutic Equipment Co.	KQX	Class I	1994-06-27
K925061	Heller Transilluminating Stylette	Device Resources	KNT	Class II	1994-06-27
K924437	Hemospal Kit B22 / Multiflow 60 Kit	C.G.H. Medical, Inc.	KDI	Class II	1994-06-27
K942484	Verres Needle	Linvatec Corporation	FHO	Class II	1994-06-24
K942244	Replacement Batteries/welch Allyn #72200 Power Handle	National Custom Ent., Inc.	ERA	Class I	1994-06-24
K942074	Flexfinder Guidewire	Flexmedics	KNY	Class II	1994-06-24
K942068	American Catheter Sphincterotome	Intl. Medical, Inc.	KNS	Class II	1994-06-24
K942036	Eurostar Super, Eurostar Vfc	Starkey Laboratories, Inc.	ESD	Class I	1994-06-24
K941768	Phonak Microvox Resonal Fm System	Phonak, Inc.	EPF	Class II	1994-06-24
K941587	Hearing Tech	Hearing Tech, Inc.	ESD	Class I	1994-06-24
K940464	Karl Storz Uretero-Renoscope/ureterscope	Karl Storz Endoscopy-America, Inc.	FGB	Class II	1994-06-24
K935278	Karl Storz Fixed Magnification Telescope/karl Storz Variable Magnification Telescope	Karl Storz Endoscopy-America, Inc.	FAJ	Class II	1994-06-24
K933800	Fluorofilm(r)	American Custom Medical, Inc.	EMX	Class I	1994-06-24
K933601	Fliptip Safety Needle	Syntuition, Inc.	FMI	Class II	1994-06-24
K933056	Diagnostic Ultrasound System Type 3535, Modified	B & K Medical A/S	IYO	Class II	1994-06-24
K932953	Dermal Gloves	George Glove Company, Inc.	LYU	Class I	1994-06-24