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 1377 of 3531

510(k) clearances, page 1377 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K041297	Polymedco Oc Light Fobt Test	Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, LLC	KHE	Class II	2004-08-12
K041244	Polygram Net Biofeedback Application	Medtronic, Inc.	HCC	Class II	2004-08-12
K041202	Hemosure One-Step Fecal Occult Blood Test	W.H.P.M., Inc.	KHE	Class II	2004-08-12
K041192	Architect Stat Troponin-I Immunoassay	Fisher Diagnostics	MMI	Class II	2004-08-12
K041057	Flo-Rite	Ameriflo Corp.	NFB	Class II	2004-08-12
K040792	Polymer Coated, Powder Free Latex Examination Glove (White)	Pt. Smartglove Indonesia	LYY	Class I	2004-08-12
K040717	Nunc Ivf Multidish 4 Wells Nunclon	Nunc A/S	MQK	Class II	2004-08-12
K040314	Healicoll	Encoll Corp.	KGN	Unclassified	2004-08-12
K040307	Hanson Scar Ade	Hanson Medical, Inc.	MDA	Class I	2004-08-12
K033843	Spectrum Central Venous Catheter with or without Hydrophilic Coating	Cook Inc.	FOZ	Class II	2004-08-12
K033027	Shinmed Various Models of Electro-Surgical Pencils, Sw12200, Sw12202, Sw12300	Shining World Health Care Co., Ltd.	GEI	Class II	2004-08-12
K032192	Pre-Vacuum Autoclave with Steam Generator and Vertical Sliding Door, Models 4472 Ep-1V and 5596 Ep-1V	Tuttnauer USA Co. Ltd.	FLE	Class II	2004-08-12
K042009	Mark III Phased Array Shoulder Coil	GE Healthcare Coils	MOS	Class II	2004-08-11
K041948	Sparc, Monarc, Bioarc Sp and Bioarc to Sling Systems	American Medical Systems, Inc.	OTN	Class II	2004-08-11
K041780	New Brid	Medical Imaging Solutions, Inc.	OWB	Class II	2004-08-11
K041728	Hcg Detector Combi, Hcg Detector Stix, Hcg Detector Cassette	Immunostics, Inc.	JHI	Class II	2004-08-11
K041697	Terumo Circuit Connectors	Terumo Cardiovascular Systems Corporation	DTL	Class II	2004-08-11
K041438	Advanced D-Dimer Assay	Siemens Healthcare Diagnostics Inc.	DAP	Class II	2004-08-11
K041334	Alcomate, Model Ca2000	KHN Solutions LLC	DJZ	Class I	2004-08-11
K041266	Pediatric Reference Database	Hologic, Inc.	KGI	Class II	2004-08-11
K040848	Ez Smart	Vip International Wholesalers, Corp.	NBW	Class II	2004-08-11
K040745	Modified Concentric Retriever, Model 90038	Concentric Medical, Inc.	DQY	Class II	2004-08-11
K040710	Tego Needle Free Access Access Device	Abbott Medical	FPA	Class II	2004-08-11
K033736	Merci Retriever, Models 90065, 90066	Concentric Medical, Inc.	NRY	Class II	2004-08-11
K041888	Curved Peek Tetris Spinal Implant	Signus Medizintechnik GmbH	MQP	Class II	2004-08-10
K041264	Elekta Oy	Elekta Neuromag Oy	OLX	Class II	2004-08-10
K041231	West Nile Virus Igm Capture Elisa, Model E-Wnv02m	Panbio Limited	NOP	Class II	2004-08-10
K041049	Binaxnow Influenza a & B Test	Binax, Inc.	PSZ	Class II	2004-08-10
K040651	Hommed Sentry Iiib-F Patient Monitor System	Hommed, LLC	DXN	Class II	2004-08-10
K042028	Vinyl Examination Glove, Powder-Free, Non-Sterile	Zibo Borui Plastic & Rubber Products Co., Ltd.	LYZ	Class I	2004-08-09
K041956	EMG - Essential Gas Module, Model M1013a	Draeget Medical AG & Co. KGaA	CCK	Class II	2004-08-09
K041953	Versastim, Perfoamax, Surgi-Stim, Faststart	Conmedcorp	GXY	Class II	2004-08-09
K041831	Progeny Mpse Intraoral Dental X-Ray Sensor	Progeny, Inc.	MUH	Class II	2004-08-09
K041748	Azog, Inc. Hcg One-Step Urine Home Pregnancy Test (Dip Stick, Cassette and Midstream)	Azog, Inc.	LCX	Class II	2004-08-09
K041562	Cryotip	FUJIFILM Biosciences Inc.	MQH	Class II	2004-08-09
K041555	Securview Dx Softcopy Workstation	Hologic, Inc.	LLZ	Class II	2004-08-09
K041548	Sentec Digital Monitor Model #Sdm	Sentec AG	LKD	Class II	2004-08-09
K041492	Astra Tech Implants - Dental System	Astra Tech, Inc.	DZE	Class II	2004-08-09
K041386	Raven Protest - Steam	Raven Biological Laboratories, Inc.	FRC	Class II	2004-08-09
K041197	Modification to Verte-Stack Spinal System	Medtronic Sofamor Danek	MQP	Class II	2004-08-09
K041076	Delta T	Penlon, Ltd.	CAD	Class II	2004-08-09
K033648	Performance Water Treatment System	Performance Water Systems, LLC	FIP	Class II	2004-08-09
K033135	Stryker Wireless Universal Footswitch System	Stryker Corp.	KNS	Class II	2004-08-09
K032954	Elpha, Models II 500, II 1000, II 2000, II 3000 and E80	Danmeter A/S	IPF	Class II	2004-08-09
K030774	Stimulen Collagen	Southwest Technologies Inc	KGN	Unclassified	2004-08-09
K042014	Digital Blood Pressure Monitor, Models Se-9000, Se-9200 and Se-9400	Sein Electronics Co., Ltd.	DXN	Class II	2004-08-06
K041990	Fuji Medical Cr Console, Model Flash Iip	FUJIFILM Healthcare Americas Corporation	LLZ	Class II	2004-08-06
K041980	Msi S-500L RF Generator	Medsphere International, Inc.	GEI	Class II	2004-08-06
K041827	Dualflex Rx Ercp Cannula, Models 4681, 4682	Boston Scientific Corporation	GCJ	Class II	2004-08-06
K041809	Permanent Pacing Lead, Model Py2	Oscor Inc.	DTB	Class III	2004-08-06