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 2332 of 3531

510(k) clearances, page 2332 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K924235	Amo Elite	Advanced Medical Optics, Inc.	HQC	Class II	1992-12-23
K924186	Lpia-Ferritin Assay	Seradyn, Inc.	DEF	Class I	1992-12-23
K924052	Infinity Micro Irrigator	Infinity Surgical Technology, Inc.	KYG	Class I	1992-12-23
K923895	Quikseal	Mirage Dental Systems	EBC	Class II	1992-12-23
K923836	.016' X .016 Nickel Titanium Uprighting Spring	Ultimate Wireforms, Inc.	DZC	Class I	1992-12-23
K923731	Staclot La Test Kit	American Bioproducts Co.	GFO	Class II	1992-12-23
K923601	Pancretec Provider Infusion Pump -- Modificaiton	Abbott Medical	FRN	Class II	1992-12-23
K923537	Encore Ds-DNA	Trinity Biotech USA	LRM	Class II	1992-12-23
K922955	Zenon Plus	Jeneric/Pentron, Inc.	EJS	Class II	1992-12-23
K922899	Model 4280 Surgical Extension Cable	Pace Medical	DSA	Class II	1992-12-23
K922741	Lorenz 1.0 Mm System	Biomet Microfixation	JEY	Class II	1992-12-23
K922238	Leaplaza Frame	Spintech, Inc.	KWP	Class II	1992-12-23
K921632	Insert, Optical, Chemical Biological Mask	Lawrence Technologies, Inc.	HQZ	Class I	1992-12-23
K921283	Adhesive, Bracket and Tooth Conditioner Resin	Jeneric/Pentron, Inc.	DYH	Class II	1992-12-23
K920877	The Keystone System	S & M Instrument Co.	BZG	Class II	1992-12-23
K920684	New Tooth Material	Dentsply Intl.	ELM	Class II	1992-12-23
K915573	Venous Reservoir W/cardiotomy Filter	Baxter Healthcare Corporation	DTN	Class II	1992-12-23
K914823	Omron Oscillometric Digit Blood Pres Monit-Hem-706	Omron Healthcare Co., Ltd.	DXN	Class II	1992-12-23
K910811	Sensor Shield	Medical Taping Systems, Inc.	DQA	Class II	1992-12-23
K925931	Rt2 Rigidity and Tumescence Test	Compass Medical Technologies, Inc.	LIL	Unclassified	1992-12-21
K925273	Gdc 3445	Deringer-Ney, Inc.	EJS	Class II	1992-12-21
K924509	Calcium Chloride/diethylbarb Acetate Buff Solution	Behring Diagnostics, Inc.	JPA	Class II	1992-12-21
K923699	Diagnostic Intravascular Catheter	Applied Vascular	DQO	Class II	1992-12-21
K923657	Supple Peri-Guard	Bio-Vascular, Inc.	FTM	Class II	1992-12-21
K923646	Codman Endoflex Grasping and Biopsy Forceps	Cerenovus, Inc.	GWG	Class II	1992-12-21
K923462	Delight	Planmeca U.S.A. Inc	EAZ	Class I	1992-12-21
K923461	Pm2002 Proline, Pm2002 Proline Ec	Planmeca U.S.A. Inc	KLC	Class I	1992-12-21
K922674	Naviguide Hydrophilic Coated Guidewire	Meadox Medicals, Div. Boston Scientific Corp.	DQX	Class II	1992-12-21
K922437	Handpiece Models Ms-350, Rs-350; Air Motor N-270	Dabi-Atlante America Corp.	EFB	Class I	1992-12-21
K920891	Roadrunner(tm) Wire Guide, Modification	Cook Inc.	DQX	Class II	1992-12-21
K924915	Scale Set Solutions/405nm Cat#1480-650Nm Cat#1479	Helena Laboratories, Corp.	JJY	Class I	1992-12-18
K924691	Olympus Iron Reagent	Olympus Corp.	JIY	Class I	1992-12-18
K924453	Multi-Channel Discrete Analyzer (Mda-180)	bioMerieux, Inc.	JPA	Class II	1992-12-18
K924426	Magnetic Resonance Diag Device Access Applic Pkg	Siemens Medical Solutions USA, Inc.	LNH	Class II	1992-12-18
K922842	Stylet and Tracheal Lightwand (Stl)	Laerdal California, Inc.	BSR	Class I	1992-12-18
K920936	Rmi External Coronary Artery Occluder	Research Medical, Inc.	DXC	Class II	1992-12-18
K920154	Bsm-8800A Bedside Monitor	Nihon Kohden America Inc	DSI	Class II	1992-12-18
K926035	Bard Leg Bag Holder	C.R. Bard Inc	FAQ	Class I	1992-12-17
K925997	Kodak Ektascan Sp Cassette	Eastman Kodak Company	IXJ	Class I	1992-12-17
K925716	Bennett Overhead Tube Crane Model No. B-OTC	Bennett X-Ray Corp.	IYB	Class I	1992-12-17
K925559	Biliary Stone Dislodger	Annex Medical, Inc.	LQR	Class II	1992-12-17
K925302	Philips Integris H/hm System	Philips North America LLC	IZF	Class II	1992-12-17
K925151	Liquichek Ck-Mb Control Levels 1,2, And3	Bio-Rad	JJT	Class I	1992-12-17
K924828	Bi-N	Xre Corp.	IZI	Class II	1992-12-17
K924796	Lung Diffusion Gas Mixture	Gulf States Airgas	BXK	Class I	1992-12-17
K924795	Blood Gas Mixture	Gulf States Airgas	BXK	Class I	1992-12-17
K924594	Delfia Digoxin Kit	Wallac Oy	KXT	Class II	1992-12-17
K924592	Davol Knot Pusher	Davol, Inc.	GCJ	Class II	1992-12-17
K924499	Elite Test Strips Glucometer	Kulzer GmbH	CGA	Class II	1992-12-17
K924459	Digiscan 2	Siemens Medical Solutions USA, Inc.	IXK	Class II	1992-12-17