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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 870 of 3530

510(k) clearances, page 870 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K122130	Winx Sleep Therapy System	Apnicure, Inc.	OZR	Class II	2012-10-31
K122078	Lofric Primo, Lofric Hydro-Kit	Astra Tech, Inc.	EZD	Class II	2012-10-31
K121862	Rex Anterior Cervical Plate System	Dio Medical Co., Ltd.	KWQ	Class II	2012-10-31
K121768	Cosense	Capnia Inc	CCJ	Class II	2012-10-31
K121732	Canopy Laminoplasty Fixation System	Globus Medical, Inc.	NQW	Class II	2012-10-31
K113602	Aap Loqteq Proximal Lateral Tibia Plate 4.5 System	AAP Implantate AG	HRS	Class II	2012-10-31
K112121	Ergoselect/ge	Ergoline GmbH	ISD	Class II	2012-10-31
K121973	Biopro Hemi-Edge Toe System	Biopro, Inc.	KWD	Class II	2012-10-30
K123024	Torque Device	Boston Scientific Corporation	DQX	Class II	2012-10-26
K123001	Acuson X700 Diagnstic Ultrasound System	Siemens Medical Solutions USA, Inc.	IYN	Class II	2012-10-26
K122985	Columbus Revision Knee System	Aesculap Implant System, Inc.	JWH	Class II	2012-10-26
K122642	Abl90 Flex	Radiometer Medical ApS	CHL	Class II	2012-10-26
K122472	Variant II Turbo Hba1c Kit-2.0 Variant II Turbo Hemoglobin Testing System	Bio-Rad Laboratories, Inc., Clinical Systems Divis	LCP	Class II	2012-10-26
K122446	Liquidband Flow Control	Advanced Medical Solutions (Plymouth), Ltd.	MPN	Class II	2012-10-26
K122325	Skintemp II	Human Biosciences, Inc.	KGN	Unclassified	2012-10-26
K122215	Navigator Delivery System (Navigator Ds)	Carticept Medical, Inc.	FRN	Class II	2012-10-26
K122137	Cyberknife Robotic Radiosurgery System Cyberknife Vsi Robotic Radiosurgery System	Accuray Incorporated	IYE	Class II	2012-10-26
K122003	Renew Insert	Renew Medical, Inc.	PBP	Class II	2012-10-26
K121781	Echonavigator Release 1	Philips Medical Systems Nederland B.V.	LLZ	Class II	2012-10-26
K121561	Flow2, Swing	Thyssenkrupp Accessibility B.V.	ILK	Class II	2012-10-26
K121201	Savie-Aqua 55Uv (Methafilcon a) Tinnted Blue Soft (Hydrophilic) Contact Lens	St. Shine Optical Co., Ltd.	LPL	Class II	2012-10-26
K120930	Chg Antibacterial Foam Dressing, Chg Antibacterial Patch, Chg Antibacterial Foam Patch, Chg Patch, Chg Dressing	Medtrade Products Ltd.	FRO	Unclassified	2012-10-26
K120796	Superdimension Nitinol/gold Fiducial Marker	Medtronic, Inc.	JAK	Class II	2012-10-26
K120406	Zoll Fully Automatic AED Plus	ZOLL Medical Corporation	MKJ	Class III	2012-10-26
K120127	Swan Valley Medical Tranurethral Suprapubic Endo-Cystostomy (T-Spec) Surgical System	Swan Valley Medical, Incorporated	KOB	Class II	2012-10-26
K113786	Spermfreeze Solution	Vitrolife Sweden AB	MQL	Class II	2012-10-26
K112139	The Canary System	Quantum Dental Technologies, Inc.	NBL	Class II	2012-10-26
K111588	Legacy-500	Mt Tables, LLC	JFB	Class II	2012-10-26
K123141	Enseal Trio Tissue Sealing Device	Ethicon Endo-Surgery Inc	GEI	Class II	2012-10-25
K123043	Irma C02 Model 200101; Irma Ax 200601	Phasein AB	CCK	Class II	2012-10-25
K122987	Stealth 360 Orbital Pad System	Cardiovascular Systems Incorporated	MCW	Class II	2012-10-25
K122971	Clickfine Pen Needle	P/L Biomedical	FMI	Class II	2012-10-25
K122969	Clickfine Pen Needle	P/L Biomedical	FMI	Class II	2012-10-25
K122956	Fuselox Lumbar Interbody Fusion Device	CAPTIVA SPINE, Inc.	MAX	Class II	2012-10-25
K122712	Digital Electrocardiograph	Shenzhen Biocare Electronics Co., Ltd.	DPS	Class II	2012-10-25
K122694	Ge 8Ch Foot Ankle Coil	GE Hangwei Medical Systems, Co. Ltd	MOS	Class II	2012-10-25
K122299	Spider Surgical Instruments, Flexible Monopolar Grasper Wavy Ratcheted, Spider Surgical Instruments, Flexible Monopolar	Asensus Surgical, Inc.	GCJ	Class II	2012-10-25
K122262	Orthopat Advance Perioperative Autotransfusion System	Haemonetics Corporation	CAC	Class II	2012-10-25
K121993	Spectralis Hra + Oct and Variants, Spectralis Fa+ Oct, Spectralis Icga +Oct, Spectralis Oct Blue Peak, Spectralis Oct	Heidelberg Engineering GmbH	OBO	Class II	2012-10-25
K121921	Intuitive Surgical Onsite for Da Vinci Surgical Systems	Intuitive Surgical, Inc.	NAY	Class II	2012-10-25
K121637	Auto-Disable Sterile Safty Syring for Single Use	Sunwell Biotech Co., Ltd.	MEG	Class II	2012-10-25
K121594	Colored Powder Free Latex Examination Glove (White and Blue)	Tekmedic (M) Sdn Bhd	LYY	Class I	2012-10-25
K120869	Anchor-L Lumbar Cage	Howmedica Osteonics Corp	OVD	Class II	2012-10-25
K120785	Omni 3 Oxygen System	Caire, Inc.	CAW	Class II	2012-10-25
K113020	Immulisa Enhanced (Tm) Cardiolipin Iga, Igg, Igm and Iga/igg/igm Antibody (Aca) Elisas	Immco Diagnostics, Inc.	MID	Class II	2012-10-25
K123012	Smith & Nephew Smf Hip Stem	Smith & Nephew, Inc.	LPH	Class II	2012-10-24
K122989	Biomet Lateral Spacer System	Biomet Spine (Aka Ebi, LLC)	MAX	Class II	2012-10-24
K122972	Cdc Zirconia Blanks	Continental Dental Ceramics, Inc. (dba Continental	EIH	Class II	2012-10-24
K122924	Cre Fixed Wire Ballon Dilation Catheter	Boston Scientific Corporation	KNQ	Class II	2012-10-24
K122422	Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx Slide Valved Peelable Introducer	Care Fusion	PNG	Class II	2012-10-24