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 1391 of 3531

510(k) clearances, page 1391 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K032897	C. Difficile Toxin a + B Fecal Antigen Detection Microwell Elisa Kit Model; Cdiff-96	IVD Research, LLC.	LLH	Class I	2004-05-27
K032397	Dual Yellow Laser, Model Dual Yellow D10b	Norseld Pty. Ltd.	GEX	Class II	2004-05-27
K031738	Smiths Medical Insulin Infusion Pump with Cozmonitor Glucose Meter	Abbott Medical	LZG	Class II	2004-05-27
K041236	Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052	Nobel Biocare AB	NHA	Class II	2004-05-26
K041095	Photosilk Pulsed Light System	Cynosure, LLC	GEX	Class II	2004-05-26
K040696	Modification to Nxstage System One	NxStage Medical Inc	KDI	Class II	2004-05-26
K040555	Impax Client Embrace	Agfa Corp.	LLZ	Class II	2004-05-26
K040246	Fukuda Denshi Dynascope Model Ds-7141 Portable Patient Monitor	Fukuda Denshi USA, Inc.	MHX	Class II	2004-05-26
K031517	Zargis Acoustic Cardioscan	Zargis Medical Corp.	DQD	Class II	2004-05-26
K041193	A&i Scooter, Sc-402	Well Success Biotech, Inc.	INI	Class II	2004-05-25
K041190	A&i Power Wheelchair, Pc-401	Well Success Biotech, Inc.	ITI	Class II	2004-05-25
K041187	A&i Scooter, Sc-301	Well Success Biotech, Inc.	INI	Class II	2004-05-25
K041067	Heartsine Samaritan Pad	HeartSine Technologies Ltd	MKJ	Class III	2004-05-25
K041055	Medline Strider Maxi 4	MEDLINE INDUSTRIES, LP - Northfield	INI	Class II	2004-05-25
K041054	Medline Strider Maxi 3	MEDLINE INDUSTRIES, LP - Northfield	INI	Class II	2004-05-25
K041053	Medline Strider Micro 3	MEDLINE INDUSTRIES, LP - Northfield	INI	Class II	2004-05-25
K040995	Synerad Multi Digital X-Ray System, Model An6150	Analogic Corp.	KPR	Class II	2004-05-25
K040929	Trigen Adolescent Tan	Smith & Nephew, Inc.	HSB	Class II	2004-05-25
K040881	Metacryl	Great Lakes Orthodontics, Ltd.	EBI	Class II	2004-05-25
K040656	Modification to Smith & Nephew Intramedullary Hip Screw	Smith & Nephew, Inc.	HWC	Class II	2004-05-25
K040500	Arthrotek Lactonail	Arthrotek, Inc.	HTY	Class II	2004-05-25
K040480	Sonotrax Ultrasonic Pocket Doppler	Edan Instruments, Inc.	KNG	Class II	2004-05-25
K040461	Econolith E3000, Model 3000 (Sw-6)	Medispec, Ltd.	LNS	Class II	2004-05-25
K040412	Trident T Acetabular Shells	Stryker Orthopaedics	LPH	Class II	2004-05-25
K033849	Simplant System	Materialise N.V.	LLZ	Class II	2004-05-25
K033642	Smartlank Wireless, Model 001970	Mrl, A Welch Allyn Company	MKJ	Class III	2004-05-25
K033540	Transxchange Support Catheter	Medtronic, Inc.	DQY	Class II	2004-05-25
K033457	M2 Compatible Microkeratome Blade	Micro Specialties, Inc.	HNO	Class I	2004-05-25
K032977	Jms Bypass Tube	JMS North America Corp.	DWF	Class II	2004-05-25
K032945	Simplex X	Stryker Corp.	LOD	Class II	2004-05-25
K032914	Modification To:raven Bacterial Spore Strips	Raven Biological Laboratories, Inc.	FRC	Class II	2004-05-25
K031673	Refobacin -Palacos G	Heraeus Kulzer GmbH & Co. KG	LOD	Class II	2004-05-25
K041295	Rn Synocta Ucla Gold Abutment for the Straumann Dental Implant	Straumann USA, LLC	NHA	Class II	2004-05-24
K041290	Rta Model D Retinal Thickness Analyzer	Talia Technology, Ltd.	HLI	Class II	2004-05-24
K041218	Griffin Spect/ct Imaging System	Philips North America LLC	KPS	Class II	2004-05-24
K041152	Thinset 1.8 Ml Reservoir, Model 326A; Thinset 3.0 Ml Reservoir, Model 332A	Applied Diabetes Research, Inc.	FRN	Class II	2004-05-24
K040378	Kodak Directview Cr Cassette/gp/15 X 30 Cm, Catalog# 8418253	Eastman Kodak Company	IXA	Class II	2004-05-24
K040337	I-Flow Elastomeric Pump (on-Q, Painbuster, C-Bloc, Homepump)	Halyard Health	MEB	Class II	2004-05-24
K040296	Phosphoplastin Rl	R2 Diagnostics, Inc.	GJS	Class II	2004-05-24
K040255	Polyflux 14L, 17L, 21L Hemodialyzer/filter Labeled for Single Use	Gambro Renal Products	KDI	Class II	2004-05-24
K041291	Rinspiration System	Kerberos Proximal Solutions, Inc.	DQO	Class II	2004-05-21
K041182	Syntegra	Philips North America LLC	KPS	Class II	2004-05-21
K041073	Document Salicylate Cal Ver	Microgenics Corporation	JJY	Class I	2004-05-21
K041046	Maxim Accel (Vanguard) Ps+ Bearings	Zimmer GmbH	JWH	Class II	2004-05-21
K040957	Noa III Enteral Nutrition Pump	Caesarea Medical Electronics, Ltd.	LZH	Class II	2004-05-21
K040895	Integrity Temporary Cement	Dentsply Intl.	EMA	Class II	2004-05-21
K040809	Crymed Cryo-Ablator	Crymed Technologies, Inc.	GEH	Class II	2004-05-21
K040735	Alm X'ten (X10) Surgical Light System	Alm S.A.	FSY	Class II	2004-05-21
K040676	Medtronic Minimed Paradigm Insulin Pump, Models Mmt-515 and Mmt-715	Medtronic, Inc.	LZG	Class II	2004-05-21
K040639	Isurg Disposable Subdermal Needle Electrode	Isurgical	GXZ	Class II	2004-05-21