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 1369 of 3531

510(k) clearances, page 1369 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K041837	Innolatex Male Latex Condoms Colored and Scented	Innolatex Sdn. Bhd	HIS	Class II	2004-09-24
K041792	Fresenius Staysafe Patient Connectors, Model 050-87211	Fresenius Medical Care Renal Therapies Group, LLC	KDJ	Class II	2004-09-24
K041349	Luminescent Immunoassay Kit for the Detection of Estradiol in Saliva and Serum	Ibl GmbH	CHP	Class I	2004-09-24
K041129	Personal Lubricating Gel	Qualis, Inc.	NUC	Class II	2004-09-24
K041002	Fidis Celiac	Biomedical Diagnostics S.A.	MST	Class II	2004-09-24
K042456	Lysus Infusion System	Ekos Corp.	QEY	Class II	2004-09-23
K042374	Stockert Scp Rhythm	Stockert Instrumente GmbH	DWA	Class II	2004-09-23
K042276	D-Vapor	Draeger, Inc.	CAD	Class II	2004-09-23
K042105	Clipper Diagnostic Electrode Catheter	Bard Electrophysiology	DRF	Class II	2004-09-23
K042016	Datascope Proguide Chronic Dialysis Catheter	Datascope Corp.	MSD	Class II	2004-09-23
K041909	Vascular Solutions Langston Dual Lumen Pigtail Catheter (Dlp)	Vascular Solutions LLC	DQO	Class II	2004-09-23
K041722	Modification to Vbr Spinal System	DePuy Spine, Inc.	MQP	Class II	2004-09-23
K041591	Scorpio-Flex Posterior Stabilized Tibial Insert Components	Howmedica Osteonics Corp	JWH	Class II	2004-09-23
K041279	Implanteo Implantology Motor	Anthogyr	EKX	Class I	2004-09-23
K041127	Modification to: Reprocessed Oximax Pulse Oximeter Sensors	Sterilmed Inc	NLF	Class II	2004-09-23
K042463	Holter Plus	Rozinn Electronics, Inc.	DQK	Class II	2004-09-22
K042426	Tmd 0.5Ml Safety Syringe (Fa18 Series 0.5Ml/fa58 Series U-100 Insulin/fa78 Series Tuberculin)	Taiject Medical Device Co., Ltd.	MEG	Class II	2004-09-22
K042122	Smartinfuser Painpump	Precise Medical Products	MEB	Class II	2004-09-22
K041902	Mantra Electrode	Mantra Intl. (Hk), Ltd.	GXY	Class II	2004-09-22
K041890	Cryocor Model 1250 (Breva) Series Surgical Probes, Model 1255-15-12	Cryocor, Inc.	OCL	Class II	2004-09-22
K041734	Ambu Disposable ECG Electrode	Ambu, Inc.	DRX	Class II	2004-09-22
K041330	Iplan! Flow	Brainlab, Inc.	HAW	Class II	2004-09-22
K040915	Magnitude 3150M MRI Patient Monitor, Model 3150M	Invivo Research, Inc.	MWI	Class II	2004-09-22
K040213	Mhlx7ec Transducer	Microhelix, Inc.	ITX	Class II	2004-09-22
K032922	Clarissa Infant Ncpap Cannula	Airways Ltd., Inc.	CBK	Class II	2004-09-22
K042462	American Dental Implant	American Dental Implant Corporation	DZE	Class II	2004-09-21
K042354	Modification to: Cresco Ti Implant Concept	Cresco TI Systems AB	DZE	Class II	2004-09-21
K042215	Radiopaque, Glass Ionomer Endodontic Cement	Premier Dental Products Co	EMA	Class II	2004-09-21
K042042	Ultrasound Capture System	Heartlab, Inc.	LLZ	Class II	2004-09-21
K041805	Microscope System	Miras Mirror Imaging Solutions, Ltd.	EIA	Class I	2004-09-21
K041779	Nipro Disposable Stopcocks, Models 3W-Rc. Ncn-3, 3W-R, 3W-L	Nipro Medical Corporation	FMG	Class II	2004-09-21
K041732	Cavermap Surgical Aid	Blue Torch Medical Technologies	FGM	Class I	2004-09-21
K040070	Artelon Spacer Cmc-1	Artimplant AB	KYI	Class II	2004-09-21
K042378	Non-Sterile Powder Free Blue Nitrile Patient Examination Glove	Shijiazhuang Tillotson Rubber Products Co., Ltd.	LZA	Class I	2004-09-20
K042346	Lncs Oximetry Sensors	Masimo Corporation	DQA	Class II	2004-09-20
K042341	Ultraclip II US	Inrad	NEU	Class II	2004-09-20
K042296	Biomarc Preloaded Tissue Marker Device	Carbon Medical Technologies, Inc.	NEU	Class II	2004-09-20
K042261	Macropore Puricel Lipoplasty System	Macropore Biosurgery, Inc.	QPB	Class II	2004-09-20
K042205	Bone Fusion Plate System	Wrightmedicaltechnologyinc	HRS	Class II	2004-09-20
K042142	Chad Therapeutics Lotus, Models Om-700 and Om-700S	Chad Therapeutics, Inc.	NFB	Class II	2004-09-20
K042100	Blackstone Ascent Poct System 5.5Mm/3.0mm Single Axial Connector	Blackstone Medical, Inc.	MNI	Class II	2004-09-20
K041863	Vitros Chemistry Products RF Reagent, Vitros Chemistry Products Calibrator Kit 16, Vitros Chemistry Products Fs	Ortho-Clinical Diagnostics, Inc.	DHR	Class II	2004-09-20
K041593	Featherlift Extended Length Aptos Thread	Surgical Specialties Corp	GAW	Class II	2004-09-20
K041524	Ge Datex-Ohmeda Heliox Delivery System	GE Healthcare	CBK	Class II	2004-09-20
K041491	Zewa Mfm-007 Blood Pressure Monitor	Zewa, Inc.	DXN	Class II	2004-09-20
K041268	Silversite or Calgitrol	Adri	MGQ	Unclassified	2004-09-20
K040209	Iris Medical Iq 810 Photocoagulator	Iridex Corporation	HQF	Class II	2004-09-20
K032878	Kung Shin, Hmef Sk203	Kung Shin Plastics Co. Ltd.	CAH	Class II	2004-09-20
K042428	Sceptrep3 Pet/ct	FUJIFILM Healthcare Americas Corporation	KPS	Class II	2004-09-17
K042335	Architect Free Psa Mastercheck, Model 6C07-05; Architect Tital Psa Mastercheck, Model 6C06-05	Bio-Rad Laboratories Inc.	JJY	Class I	2004-09-17