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 1285 of 3531

510(k) clearances, page 1285 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K051400	Datex-Ohmeda S/5 Anesthesia Monitor with L-Aneo5 and L-Aneo5a Software, Using F-Cu8 or F-Cu5(p) Monitor Frame Options	GE Healthcare	MHX	Class II	2006-01-20
K060051	Specimen Retrieval System	Applied Medical Resources Corp	GCJ	Class II	2006-01-19
K053433	Cautery Tip Cleaner, Model 30500	Xodus Medical Inc	GEI	Class II	2006-01-19
K053350	Modification to Codman Hakim Shunt Systems	Cerenovus, Inc.	JXG	Class II	2006-01-19
K053321	Light Guard Light Handle and Light Handle Cover	Xodus Medical Inc	FTA	Class II	2006-01-19
K053292	Davantis/antelys Vertebral Body Replacements	Scien'Tx USA, Inc.	MQP	Class II	2006-01-19
K053171	Merit Impress Diagnostic Catheter	Merit Medical Systems, Inc.	DQO	Class II	2006-01-19
K053107	Codman Hakim Programmable Valve W/wo Siphonguard	Cerenovus, Inc.	JXG	Class II	2006-01-19
K053056	Harmonic Scalpel Blades and Shears	Ethicon Endo-Surgery Inc	LFL	Unclassified	2006-01-19
K052985	Powder Free Vinyl Examination Glove	Tg Medical (China) Incorporation	LYZ	Class I	2006-01-19
K052955	Nitrile Blue Powdered Examination Gloves	Great Glove Sdn Bhd	LZA	Class I	2006-01-19
K052830	Sportmesh	Artimplant AB	FTL	Class II	2006-01-19
K052729	Powdered Vinyl Patient Examination Gloves, White (Non-Colored)	Shijiazhuang Brilliant Ocean Plastic Co., Ltd.	LYZ	Class I	2006-01-19
K052651	C-Flex System Single Use Disposable Injector, Model R-Inj-02	Rayner Surgical, Inc.	MSS	Class I	2006-01-19
K052575	Luminary Cannulator Bideflectable Catheter with Lumen	Abbott Medical	DRA	Class II	2006-01-19
K052357	Pathway - Ats/cheps	Medoc Ltd. Advanced Medical Systems	NTU	Class II	2006-01-19
K052323	Versatrek Myco Pza Kit	Trek Diagnostic Systems, Ltd.	MJA	Class II	2006-01-19
K052004	Vascon Neuropath Guiding Catheter	Vascon, LLC	DQY	Class II	2006-01-19
K051435	Esensor Cystic Fibrosis Carrier Detection Test , Esensor 4800 DNA Detection System, Model 4800	Clinical Micro Sensors, Inc.	NUA	Class II	2006-01-19
K042504	Cathy Sterile Disposable i.v. Cannula with Catheter	Myco Medical Supplies Inc	FOZ	Class II	2006-01-19
K060003	Excelart Vantage Zgv	Toshibamedical Systems Corporation	LNH	Class II	2006-01-18
K053526	Microspeed Uni Motor System	Aesculap Inc	HBC	Class II	2006-01-18
K053462	3160 MRI Patient Monitoring System	Invivo Corporation	MWI	Class II	2006-01-18
K053438	Glass Ceramics	3M Espe AG Dental Products	EIH	Class II	2006-01-18
K053380	Contour Thread Synthetic Absorbable Pdo Barbed Suture	Surgical Specialties Corp	NEW	Class II	2006-01-18
K053259	Disposable PVC Examination Glove, Powdered and Powder-Free	Practical Protective Plastic Manufactory, Ltd.	LYZ	Class I	2006-01-18
K053161	Sirolaser	Sirona Dental Systems GmbH	GEX	Class II	2006-01-18
K053158	Optilene Mesh Lp	Aesculap Inc	FTL	Class II	2006-01-18
K051145	Critiview	Critisense, Ltd.	DPW	Class II	2006-01-18
K053634	Computed Radiography System with Nx 1.0 Workstation	Agfa Corp.	MQB	Class II	2006-01-17
K053529	Onetouch Ultra 2 Blood Glucose Monitoring System	Lifescan, Inc.	NBW	Class II	2006-01-17
K053169	Rm3 Renal Preservation System	Waters Instruments, Inc.	KDK	Class II	2006-01-17
K052642	Suturing Washer	First Call, Inc.	MAB	Class II	2006-01-17
K052570	Tandemheart Transseptal Cannula Set-Ef, Model 5140-6221	Cardiacassist, Inc.	DWF	Class II	2006-01-17
K052557	Super Sheath Introducer Sheath	Togo Medikit Co., Ltd.	DRE	Class II	2006-01-17
K052485	Sherlock Microbial Identification System for Biodef	Midi, Inc.	NWZ	Class II	2006-01-17
K051566	Proton Phc 8731 10 Second Digital Thermometer; Proton Phc 109 Ear Thermometer; Proton 889 Ear Thermometer	Proton Healthcare, Ltd.	FLL	Class II	2006-01-17
K060059	Aloka Sd-3500 Ultrasound System	Aloka Co., Ltd.	IYN	Class II	2006-01-13
K053588	Profemur Lx Hip Stem	Wrightmedicaltechnologyinc	KWA	Class III	2006-01-13
K053528	Short Citation Femoral Stem	Stryker Orthopaedics	MEH	Class II	2006-01-13
K053513	T-Pin	Union Surgical, LLC	JDW	Class II	2006-01-13
K053501	Powerpicc	Bard Access Systems, Inc.	LJS	Class II	2006-01-13
K053499	Hemosil Pros	Instrumentation Laboratory Co.	GGP	Class II	2006-01-13
K053460	Modification to Silverhawk Peripheral Plaque Excision System, Models 02550, 04800, 05200, 06002, 02406, 04706, 04300,	Medtronic, Inc.	MCW	Class II	2006-01-13
K053436	Surgifrost 6Cm, 7Cm and 10 Cm Cryosurgical Devices Plus Frostbyte Clamp and Cryosurgical Console	Medtronic CryoCath LP	OCL	Class II	2006-01-13
K053427	Fresh, Dental Impression Material	Exacta Dental Products, Inc.	ELW	Class II	2006-01-13
K053362	Cell-Chex Auto	Streck LLC	JPK	Class II	2006-01-13
K053267	Endius Atavi System	Endius, Inc.	HRX	Class II	2006-01-13
K053247	Validate Cardiac Marker (Cm1) Calibration Verification Test Set	Maine Standards Co.	JJY	Class I	2006-01-13
K053227	Luxenon 150-300 Watt Medical Fiberoptic Light Source Illuminating Headlights, Spotlights, Refractors and Endoscopes	Medical Illumination International, Inc	FST	Class II	2006-01-13