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 2195 of 3531

510(k) clearances, page 2195 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K940602	Extra Large Quad Flex Spine Coil	FUJIFILM Healthcare Americas Corporation	LNH	Class II	1994-05-23
K940133	The Expandacell Ear Pack	Denver Splint Co.	LRD	Class I	1994-05-23
K936153	3M 1156 Multi-Input System	3M Information,Imaging and Electronic Sector	LMD	Class I	1994-05-23
K935047	Auto Delfia	Wallac Oy	KHO	Class I	1994-05-23
K934179	Disposable Bag Decanter	Byron Medical	KPE	Class II	1994-05-23
K931664	Sharps Disposable Containers	Bemis Mfg. Co.	MMK	Class II	1994-05-23
K926100	Spiral Lock Dental Implant System	Robert A James	DZE	Class II	1994-05-23
K925796	Spiral Lock Dental Implant System	Robert A James	DZE	Class II	1994-05-23
K925312	Hand Instrument Calculus Removal	Implant Support Systems, Inc.	DZE	Class II	1994-05-23
K942000	Burn Dressing Tray	Medcare Custom Packaging, Inc.	FRG	Class II	1994-05-20
K941946	Lca Angiographic Imaging System	GE Healthcare	IZI	Class II	1994-05-20
K941676	Sterivent and Sterivent S	Mallinckrodt Medical	CAH	Class II	1994-05-20
K941455	Sterile Gauze Product Line	Cush Medical Products	EFQ	Unclassified	1994-05-20
K941286	Suture Manipulator	Richard Wolf Medical Instruments Corp.	GCJ	Class II	1994-05-20
K941216	Hydroderm Extra Thin Intelligent Hydrocollioid Dressing	Wilshire Medical Products	KMF	Class I	1994-05-20
K941149	Dermaassist Hydrocolloid Dressing	Wilshire Medical Products	FRO	Unclassified	1994-05-20
K940965	Eliminator Balloon Dilator	C.R. Bard Inc	FGE	Class II	1994-05-20
K936021	Bacticard Strep	Remel Inc	JTO	Class I	1994-05-20
K933902	Moblvac III	Aeros Instruments, Inc.	BTA	Class II	1994-05-20
K926136	Watsystem	Watsystem Div. of Itc	BXB	Class I	1994-05-20
K942106	Super/fluff Sponges	Lorrex Health Products	EFQ	Unclassified	1994-05-19
K942071	Lorrex Non-Woven Sponges Non-Sterile	Lorrex Health Products	EFQ	Unclassified	1994-05-19
K942070	Lorrex Cover Sponges Sterile2's and Non-Sterile	Lorrex Health Products	EFQ	Unclassified	1994-05-19
K941956	Lorrex Gauze Pads	Lorons International Corp.	EFQ	Unclassified	1994-05-19
K941356	Microflow Irrigation System	JEDMED Instrument Company	GBQ	Class I	1994-05-19
K941269	Gore Smoother II and Gore Bptb	W. L. Gore & Associates, Inc.	HRX	Class II	1994-05-19
K941159	Directdraw Superserum-G Directdraw Superserum-Mini-G	Accriva Diagnostics, Inc.	JKA	Class II	1994-05-19
K941049	Musclemax Electrical Muscle Stimulator	Smith & Nephew, Inc.	IPF	Class II	1994-05-19
K940709	Scissors, Grasping Forceps, Needle Holders, Dissectors	Baxter Healthcare Corporation	HET	Class II	1994-05-19
K940141	Laparaoscopes Electronic with Sterile Sheath	Micro Medical Devices, Inc.	GCJ	Class II	1994-05-19
K936247	Medicon Instruments Trocars, Trocar Sleeves and Reduction Sleeves	Medicon Instruments, Inc.	DRC	Class II	1994-05-19
K935786	Corson and Nezhat Suction/irrigation Probes	Cabot Medical Corp.	GCJ	Class II	1994-05-19
K933794	Ani Biocard(tm) Hcg Test	Canadian Bioclinical, Ltd.	LCX	Class II	1994-05-19
K930745	Burron Expediter Braided Balloon Pta Catheter	B.Braun Medical, Inc.	LIT	Class II	1994-05-19
K930666	Reusable Laparoscopic Instruments W/ Electrocautery	Snowden-Pencer	GEI	Class II	1994-05-19
K941846	Bone Marrow Biopsy Tray	Kormed, Inc.	LRO	Class II	1994-05-18
K941578	Statvac Portable Suction Unit	Laerdal California, Inc.	BTA	Class II	1994-05-18
K941574	Retro Mirror	Union Broach, Div. Moyco Industries, Inc.	EAX	Class I	1994-05-18
K941527	Model 2300 General Purpose Suction Pump	Product & Educational Services	JCX	Class II	1994-05-18
K941526	Model 2000 Mild Intermittent Suction Pump	Product & Educational Services	JCX	Class II	1994-05-18
K941525	Model 2200 Thoracic Suction Pump	Product & Educational Services	JCX	Class II	1994-05-18
K941164	Tap Express Ejector	Tap Express, Inc.	EHZ	Class I	1994-05-18
K941163	Mon-Klenz	Calgon Vestal Div.	FLG	Class I	1994-05-18
K940958	Non-Prescription Sunglasses	Great Future Works, Ltd.	HQY	Class I	1994-05-18
K940906	Gore-Tex Cardiovascular Patch	W. L. Gore & Associates, Inc.	DXZ	Class II	1994-05-18
K940432	Microcoagulation Prothrombin Time Test	Accriva Diagnostics, Inc.	GJS	Class II	1994-05-18
K940334	Amigo J-9	Amigo Mobility Intl., Inc.	INI	Class II	1994-05-18
K940263	Nph-Klenz	Calgon Corp.	FLG	Class I	1994-05-18
K940011	Malleable Blunt Dissector Instrument, 5 Mm	Phx Technologies Corp.	GCJ	Class II	1994-05-18
K936213	Arthroscopes and Accessories	Micro Medical Devices, Inc.	HRX	Class II	1994-05-18