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 2026-11-02, 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 1058 of 3531

510(k) clearances, page 1058 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K090757	Biomet Modular Femoral Revision System	Zimmer GmbH	KWA	Class III	2009-09-25
K090652	Alpha Duo Lap Insufflator	Hippokratec GmbH	HIF	Class II	2009-09-25
K090193	Conductor Coronary Guidewire	Concert Medical, LLC	DQX	Class II	2009-09-25
K090183	Hercules 3 Stage Wire Guided Dilation Balloon	Wilson-Cook Medical Inc.	KNQ	Class II	2009-09-25
K083868	Architect Anti-Ccp (100 Test), Architect Anti-Ccp (500 Test), Models 1P65-25, 1P65-35	Axis-Shield Diagnostics, Ltd.	NHX	Class II	2009-09-25
K083597	Sonowand Invite	Sonowand AS	HAW	Class II	2009-09-25
K082648	Powder-Free Vinyl Patient Examination Gloves	Tangshan Dar Plastic & Rubber Products Co., Ltd.	LYZ	Class I	2009-09-25
K092637	Pacscan Plus, Models 300P and 300Ap	Sonomed, Inc.	ITX	Class II	2009-09-24
K092610	Modification to Beacon Stabilization System	Globus Medical, Inc.	NKB	Class II	2009-09-24
K092132	Xio Rtp System	Elekta Limited	MUJ	Class II	2009-09-24
K092059	Rp Cutting Needle	Riverpoint Medical, LLC	KNW	Class II	2009-09-24
K091964	Crest Glide Clinical Gum Protection Dental Floss	Procter & Gamble Co.	JES	Class I	2009-09-24
K090932	Nexgen Peripheral Mechanical Retrieval Device - 200Cm, Model Mrd-1000; 80 Cm, Model Mrd-2000	Nexgen Medical Systems, Inc.	QEW	Class II	2009-09-24
K092680	Datex-Ohmeda S/5 Anesthesia Monitor with L-Aneo7 and L-Aneo7a Software Using F-Cu8 or F-Cu5 (P) Monitor Frame Options an	GE Healthcare Finland Oy	MHX	Class II	2009-09-23
K092671	Variax Elbow System Line Extension	Howmedica Osteonics Corp	HRS	Class II	2009-09-23
K092038	Aptus K-Wire System	Medartis AG	HTY	Class II	2009-09-23
K091972	Milscope Floating Mass Stethoscope, Model 300-01	Stethoscope Technologies, Inc.	DQD	Class II	2009-09-23
K091930	Anchor Laparoscopic Tissue Retrieval System, Model Trs100sb	Anchor Products Co.	GCJ	Class II	2009-09-23
K091818	Laurimed Spinal Injection System	Laurimed, LLC	BSP	Class II	2009-09-23
K091800	Lipoeze Laser Assisted Aspiration Cannula	Curve Medical	GEX	Class II	2009-09-23
K091060	Vesocclude Ligating Clip	Vesocclude Medical, LLC	FZP	Class II	2009-09-23
K090989	Zoll R Series with Nibp and Etco2 Options, Zoll R Series	ZOLL Medical Corporation	MKJ	Class III	2009-09-23
K090339	Belimed Steam Sterilizer Top 5000, Series 8, Models: 6-0-12 Vs1 and Vs2	Belimed Sauter AG	FLE	Class II	2009-09-23
K092742	Neuviz 16 Multi-Slice CT Scanner System	Neusoft Medical Systems Co., Ltd.	JAK	Class II	2009-09-22
K092495	Hyperglide Occlusion Balloon System, Model 104-4310, 104-4315	Medtronic, Inc.	MJN	Class II	2009-09-22
K092143	Excia Total Hip System M an Ml Femoral Stem	Aesculap Inc	MEH	Class II	2009-09-22
K092083	Extend Frame System, Model 1009633	Elekta Instrument AB	IWB	Class II	2009-09-22
K091980	Acl Top 700 Las	Instrumentation Laboratory Co.	GKP	Class II	2009-09-22
K091756	Nobelprocera Ti Abutment	Nobel Biocare AB	NHA	Class II	2009-09-22
K091572	Disposable Spo2 Sensor M1134a	Philips Medizinsysteme Boeblingen GmbH, Cardiac an	DQA	Class II	2009-09-22
K091343	MRI Neuro Drape	Surgivision, Inc.	KKX	Class II	2009-09-22
K091239	Astra Tech Implant System	Astra Tech, Inc.	DZE	Class II	2009-09-22
K092758	X-Cube	Saeshin Precision Co., Ltd.	EBW	Class I	2009-09-21
K092327	Micro-Touch Nitra Free	Ansell Healthcare Products LLC	LZA	Class I	2009-09-21
K092155	Heartway Power Mobility Scooter, S8	Heartway Medical Products Co., Ltd.	INI	Class II	2009-09-21
K092154	Heartway Power Mobility Scooter, S9	Heartway Medical Products Co., Ltd.	INI	Class II	2009-09-21
K092130	Rascal We Go 250 Powered Wheelchair	Electric Mobility	ITI	Class II	2009-09-21
K092051	Thermo Scientific Mas Chem Trak & Moni Trol H Liquid Assayed Chemistry Control, Model, Cha, Chu, M5155, M5158	Microgenics Corporation	JJY	Class I	2009-09-21
K091942	Powder-Free, Vinyl Patient Examination Gloves	Zibo Intco Medical Products Company Limited	LYZ	Class I	2009-09-21
K091883	T2 Spinal System	Medtronic Sofamor Danek USA Inc	MQP	Class II	2009-09-21
K091870	Tornier, Piton Fixation Implant System	TORNIER Inc.	MBI	Class II	2009-09-21
K091853	Wright Respirometer, Mark 8, and 14 Respirometer, Model 700-021, 700-008, 700-014	Nspire Health, Inc.	BZK	Class II	2009-09-21
K091647	Injectafil	Apex Dental Materials, Inc.	EBF	Class II	2009-09-21
K091553	Blood Pressure Monitor, Model Wa400 for Wrist Type and Model Aa300 for Upper Arm Type	Ningbo Diaier Electronic Co., Ltd.	DXN	Class II	2009-09-21
K091220	Healthanywhere System	Healthanywhere, an Igeacare System Company	DRG	Class II	2009-09-21
K090863	Personal Wheezometer	Karmelsonix	BZM	Class II	2009-09-21
K090752	Penumbra System (Pennumbra Reperfusion Catheter 054), Model Psc054; (Penumbra Separator 054), Model Pss054	Penumbra Inc.	NRY	Class II	2009-09-21
K090718	Bellus Shading Kit	3M Espe AG Dental Products	EIH	Class II	2009-09-21
K092719	Digital Blood Pressure Monitor	Shanghai Little Doctor Electronic Co., Ltd.	DXN	Class II	2009-09-18
K092653	Verisuite and Verisuite-Particle, Version 1.8	Medcom GmbH	LHN	Class II	2009-09-18