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 2208 of 3531

510(k) clearances, page 2208 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K941088	Stryker Back-Saver Stretcher Chair Model 6320	Stryker Corp.	IOR	Class I	1994-04-15
K940678	Autotransfusion Suction Reservoir with Filter	Baxter Healthcare Corporation	CAC	Class II	1994-04-15
K940590	Minto Skin Traction Motor	Minto Research & Development, Inc.	ITH	Class II	1994-04-15
K940513	Optibond	Kerr Corporation (Danbury)	KLE	Class II	1994-04-15
K940180	Forte US	Chattanooga Group, Inc.	IMG	Class II	1994-04-15
K940147	Auto Syringe As40a Infusion Pump	Baxter SA	FRN	Class II	1994-04-15
K940075	Shaver Blade Set	Arthrex GmbH	HRX	Class II	1994-04-15
K940055	Multiset	Puritas Health Care, Inc.	BRZ	Class II	1994-04-15
K940054	Measured Volume Solution Administration Set	Puritas Health Care, Inc.	FPA	Class II	1994-04-15
K936184	Vigil Prx Chemistry Control	Beckman-Diagnostic Systems Group	JJY	Class I	1994-04-15
K936031	One Step Pregnancy Test	Teco Diagnostics	JHI	Class II	1994-04-15
K935836	Bone or Interference Screw	Endo Surgical Concepts, Inc.	HWC	Class II	1994-04-15
K935757	Greenleaf Eval System/ Greenleaf Solosystem	Greenleaf Medical Systems, Inc.	LBB	Class II	1994-04-15
K935395	Neuron II and Microtens	Datran Corp.	GZJ	Class II	1994-04-15
K935381	Kaps Positioning Arm	Andronic Devices, Ltd.	FWZ	Class I	1994-04-15
K934847	Ngbcd & Ngbcdp Cardioplegia Delivery Systems	Sorin Biomedical, Inc.	DTN	Class II	1994-04-15
K934763	Sorin Blood Cardioplegia System	Sorin Biomedical, Inc.	DTN	Class II	1994-04-15
K934666	Pds Ultraclean	Medical Polymers, Inc.	FLG	Class I	1994-04-15
K934379	Linvatec Powerlink Surgical Shaving System	Linvatec Corporation	HRX	Class II	1994-04-15
K933933	Ceboplane	Synvasive Technology, Inc.	HTZ	Class I	1994-04-15
K933143	Model Eli 300 Electrocardiograph	Mortara Instrument, Inc.	LOS		1994-04-15
K932255	Young D'granulator	Young Dental Manufacturing Co 1, LLC.	KMW	Class II	1994-04-15
K932137	Fluidshield Surgical/procedure Mask/m. with Visor	Tecnol Medical Products, Inc.	FXX	Class II	1994-04-15
K932120	Blom-Singer Indwelling Low Pressure Voice Prosthes	Freudenberg Medical, LLC	EWL	Class II	1994-04-15
K931755	Riwolith 2280 Probes	Richard Wolf Medical Instruments Corp.	FFK	Class II	1994-04-15
K931173	Primary Admin Set W/univ Sp-Man Below/abv Pump Ch	Imed Corp.	FPA	Class II	1994-04-15
K930344	Silicone Foley Catheter	Cook Incorporated	EZL	Class II	1994-04-15
K926187	Posicast Immobilization System	Huestis Machine Corp.	IYE	Class II	1994-04-15
K924596	Ses-2012 Automatic Steam Sterilizer	Precision Fluidics Division Parker Hannifin Corp.	FLE	Class II	1994-04-15
K921119	Arthrex Arthroscope	Arthrex GmbH	HRX	Class II	1994-04-15
K941005	Dermassist(tm) Xeroform Petrolatum Dressing	Wilshire Medical Products	FRO	Unclassified	1994-04-14
K940904	Kittner Dissector/peanut/cherry/stick/triangle Sponge/gauze Rosebud	Medical Insights, Inc.	EFQ	Unclassified	1994-04-14
K940903	Tonsil Sponge, Gauze Dissector, Cylindrical Sponges	Medical Insights, Inc.	KBM	Class I	1994-04-14
K940692	Plain Gauze Dressing	Medtrax Industries, Inc.	EFQ	Unclassified	1994-04-14
K940405	Teletom	Berchtold Holding GmbH	KMI	Class I	1994-04-14
K940352	Storz N5941 Series Medical Grade Tubing	Storz Instrument Co.	GBX	Class I	1994-04-14
K935257	Medicom Non-Woven Sponges	A.R. Medicom, Inc.	EFQ	Unclassified	1994-04-14
K922527	Bard Urodynamic Catheterization Procedure Tray	C.R. Bard Inc	KOD	Class II	1994-04-14
K941124	Structur 2	Voco GmbH	EBG	Class II	1994-04-13
K941024	Aesculap Trocar Collar	Aesculap Inc	GCJ	Class II	1994-04-13
K940329	Natracare Menstrual Pads	Natracare, LLC.	HHD	Class I	1994-04-13
K935562	Panty Liners	Lady'S Care, Inc.	HHD	Class I	1994-04-13
K934974	Fluid Resistant Mask with Wrap Around Eye Shield	Mid America Medical, Inc.	FXX	Class II	1994-04-13
K934914	Ics 9400 Ultraviolet Air Purifier	Medair, Inc.	FRA	Class II	1994-04-13
K934624	Acs Rotating Hemostatic Valve & Acs Duostat Rotating Hemostatic Valve	Advanced Cardiovascular Systems, Inc.	DYB	Class II	1994-04-13
K934415	File-Eze	Ultradent Products Inc.	KJJ	Unclassified	1994-04-13
K934124	Autoquot Automated Aliquotting System	Andronic Devices, Ltd.	JQW	Class I	1994-04-13
K933950	Lady's Care Maxi Pads	Lady'S Care, Inc.	HHD	Class I	1994-04-13
K933787	Porocoat Porous Coating/aml Proximally-Coated Stem	Depuy, Inc.	LPH	Class II	1994-04-13
K932165	Intravascular Administration Set	Mcgaw, Inc.	FPA	Class II	1994-04-13