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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2862 of 3529

510(k) clearances, page 2862 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K863725	Cataract Diamond Knife	Medical Technology Development Corp.	HNN	Class I	1986-10-31
K863581	Modified Model 5320 T.e.d. Compression Limb	The Kendal Co.	JOW	Class II	1986-10-31
K863547	Medtronic Model 5455 Disposable Surgical Cable	Medtronic, Inc.	DRO	Class II	1986-10-31
K863537	Cordis Reusable Inflation Device for Angioplasty	Cordis US Corp.	DXT	Class II	1986-10-31
K863517	Foley Catheters	Instrumentation Industries, Incorporated	KOD	Class II	1986-10-31
K863444	Grieshaber Global Control Tubing Set	Grieshaber & Co.	HQC	Class II	1986-10-31
K863405	Cardiolife Tec 7200	Nihon Kohden America Inc	LDD	Class II	1986-10-31
K863404	Cardiolife Tec 7100	Nihon Kohden America Inc	LDD	Class II	1986-10-31
K863282	Care + Plus Catheter Care Tray	Welmed Systems, Inc.	KOD	Class II	1986-10-31
K863281	Care + Plus Irregation Tray	Welmed Systems, Inc.	KOD	Class II	1986-10-31
K863246	Miralite	Mira, Inc.	HQF	Class II	1986-10-31
K863040	Disposable Intravenous Hyperalimentation Bags	Cher Mel Corp.	KPE	Class II	1986-10-31
K862966	3.2Mm Unipolar & Bipolar Lead Connectors (Vs-1)	Oscor Medical Corp.	DTB	Class III	1986-10-31
K862949	Hatcher Stone Extractor - Disposable Catheter	Oscor Medical Corp.	LQR	Class II	1986-10-31
K862911	Bi-Plane Transrectal Probe Number H4221t	General Electric Co.	ITX	Class II	1986-10-31
K862742	Nephrostomy Set	Meadox Surgimed, Inc.	LJE	Unclassified	1986-10-31
K862740	Quinton Q.cath	Quinton, Inc.	DQK	Class II	1986-10-31
K862634	Tdmac-Heparin Coated Rmi Carotid by-Pass Shunt	Research Medical, Inc.	DWF	Class II	1986-10-31
K862451	Luer Lock Skirt	Hewlett-Packard Co.	DTL	Class II	1986-10-31
K864111	Sterile Field #605 Fenestrated Sterile Field #606	Graham Medical Products	KKX	Class II	1986-10-30
K864101	Cook (R) Vein Graft Ring Markers	Cook Inc.	KPK	Class II	1986-10-30
K864064	Latex Surgical Gloves	Futuremed Div. of Future Impex Corp.	KGO	Class I	1986-10-30
K864026	Nonconductive Shoe Cover	Kimberly-Clark Corporation	FXP	Class I	1986-10-30
K864020	Ice Pick	Med-Tool, Inc.			1986-10-30
K864019	Needle Nose Pliers	Med-Tool, Inc.	HTC	Class I	1986-10-30
K864018	Hacksaw	Med-Tool, Inc.			1986-10-30
K864017	Slotted Punch	Med-Tool, Inc.			1986-10-30
K863998	Coltene Jet-Mixer	Coltene, Inc.	EID	Class I	1986-10-30
K863769	Evacuator Tips	Medical Group	EHZ	Class I	1986-10-30
K863767	Glass Mouth Mirrors, Reusable	Medical Group	EAX	Class I	1986-10-30
K863766	Disposable Mouth Mirrors, Single Use Only	Medical Group	EAX	Class I	1986-10-30
K863753	Foundations Plus Double Band Ear Support 3000	Foundations Plus, Inc.	KGX	Class I	1986-10-30
K863638	Gutta Percha Points	Endodent, Inc.	EKM	Class I	1986-10-30
K863411	Gutta Percha	Endodent, Inc.	EKM	Class I	1986-10-30
K863243	Shiner Stress Directing Attachment	Js & R - R & D Co.	EGG	Class I	1986-10-30
K863207	Ohmeda 'B' Series Gas Delivery System	GE Healthcare	BSZ	Class II	1986-10-30
K862950	White-Siposs Tube, Cat No Ws-1	American Omni Medical, Inc.	BTR	Class II	1986-10-30
K862385	Schein Bleaching Unit	Henry Schein, Inc.	EEG	Class I	1986-10-30
K864119	Uric Acid Test	U. S. Diagnostics, Inc.	KNK	Class I	1986-10-29
K864074	Elastic Stain	Sigma Diagnostics, Inc.	IAC	Class I	1986-10-29
K864049	Mcarthur Microscope, Standard Metal Version	Portable Medical Laboratories, Inc.	IBJ	Class I	1986-10-29
K864039	Microhematocrit Centrifuge	Plaza Medical, Inc.	GKF	Class II	1986-10-29
K864021	Tissue Culture Flask	Fenwal Laboratories	KJA	Class I	1986-10-29
K864014	Lombard Dowell Agar Base	Gibco Laboratories Life Technologies, Inc.	KZI	Class I	1986-10-29
K863844	Immuno Biotech's Lamb's Quarters Allergen Disc	Immuno Nuclear Corp.	DHB	Class II	1986-10-29
K863822	Enzymun-Test(r) Ige	Boehringer Mannheim Corp.	DGC	Class II	1986-10-29
K863723	Norfolk Norport/subcutan. Implanted Drug Depot	Norfolk Medical Products, Inc.	LJT	Class II	1986-10-29
K863720	Hd-100 Hemodialysis Systems and Accessories	Water Pure, Inc.	FIP	Class II	1986-10-29
K863718	Emds(tm) Phosphorus (Phos) Testpacks, #67678/95	Em Diagnostic Systems, Inc.	CEO	Class I	1986-10-29
K863660	Emds Uric Acid (Urc a) Testpack, Item #67664/95	Em Diagnostic Systems, Inc.	CDO	Class I	1986-10-29