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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3090 of 3528

510(k) clearances, page 3090 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K841025	Top Disposable Infusion Set	Top Surgical Manufacturers Co.	FPA	Class II	1984-03-30
K841012	Rionet Hearing Aid Hb-71M	Rion Acoustic Instruments, Inc.	ESD	Class I	1984-03-30
K840975	Rico Respiration Monitor	J.M. Laboratories, Inc.	BZK	Class II	1984-03-30
K840973	Cole Tube-Latex	Inmed Corp.	BTR	Class II	1984-03-30
K840952	Medevice V-80 Vacuum Pump	Berkeley Medevices	HHI	Class II	1984-03-30
K840942	Ivy Commandeer	Ivy Medical, Inc.	LDR	Class II	1984-03-30
K840878	Quik Lok	Abbott Medical	FPA	Class II	1984-03-30
K840871	Behind-the-Ear Hearing Aid 2000	Telex Communications, Inc.	ESD	Class I	1984-03-30
K840842	Hearing Aid Unitron Ue8	Unitron Industries, Inc.	ESD	Class I	1984-03-30
K840838	Mmg Connective Tubing	Medical Marketing Group	GAZ	Class II	1984-03-30
K840825	Series Mr in-the-Ear Custom Hearing Aid	Maico Hearing Instruments, Inc.	ESD	Class I	1984-03-30
K840805	Oral Safe	Great Lakes Orthodontics, Ltd.	JER	Class I	1984-03-30
K840790	Universal Oxygen Tubing Connector	Cherry Plastics, Inc.	BYX	Class I	1984-03-30
K840642	Thermocraft Porcelain	American Thermocraft Corp.	ELL	Class II	1984-03-30
K840616	Mini-Pump U-100	Advanced Bio Systems, Inc.	FRN	Class II	1984-03-30
K840559	In-the-Ear Hearing Aid	Emtronics, Inc.	ESD	Class I	1984-03-30
K840530	Supplies for Instrumentation Lab Flame	Shaban Mfg. Co.	JJO	Class I	1984-03-30
K840480	Behind the Ear Hearing Aid T-97	Bernafon LLC	ESD	Class I	1984-03-30
K840479	Behing-the-Ear Hearing Aid T-85D	Bernafon LLC	ESD	Class I	1984-03-30
K840468	Partial Press. Electrode Measurement	Shaban Mfg. Co.	CHL	Class II	1984-03-30
K840466	Nml Cortisol Ria	Nuclear Medical Laboratories, Inc.	CGR	Class II	1984-03-30
K840460	Cornings Magic Ferritin Radioimmuno-	Corning Medical & Scientific	JMG	Class II	1984-03-30
K840368	Durazyme Cholesterol	American Monitor Corp.	CHH	Class I	1984-03-30
K840301	Rianen Estriol Radioimmunoassay Kit	New England Nuclear	CGI	Class I	1984-03-30
K840291	Mcs Albumin Reagent	Medilab Corp.	CIX	Class II	1984-03-30
K840290	Mcs Total Protein Reagent	Medilab Corp.	CEK	Class II	1984-03-30
K840241	Thyroxine Emia	Collaborative Research, Inc.	KLI	Class II	1984-03-30
K840084	Coltene Brilliant Lux	Bauer, Cheng & Associates, Inc.	EBF	Class II	1984-03-30
K840014	Chemodent Ceramic Metal	Chemodent Metal Co.	EJS	Class II	1984-03-30
K834569	Ventilatory Frequency Monitor	Cryo Corp.	BZO	Class I	1984-03-30
K834564	Menstrual Pads	Probel-U.S., Inc.	HHL	Class II	1984-03-30
K834545	Pocketip 4414	Vipont Laboratories, Inc.	EFS	Class I	1984-03-30
K834437	Keates Irrigation/aspiration/vitreous	Frigitronics of Connecticut, Inc.	HQE	Class II	1984-03-30
K834311	Night Trainer	Maddak, Inc.	KPN	Class II	1984-03-30
K834214	Wescor 5500 Vapor Pressure Osmometer	ELITechGroup Inc	JJM	Class I	1984-03-30
K833915	Vascular Access Cath. Repair Kit	Cormed, Inc., Sub. C.R.Bard, Inc.	LJS	Class II	1984-03-30
K833773	Canal Hearing Aid	Siemens Hearing Instruments, Inc.	ESD	Class I	1984-03-30
K833725	Pre-Loaded C-R Tubes for Syringe	Centrix, Inc.	EBF	Class II	1984-03-30
K833304	Hypo Brand Dispos. Dental Needles-Plast	Smith & Nephew, Mpl Division	DZM	Class I	1984-03-30
K833158	Bsd-200	Bsd Medical Corp.	FLL	Class II	1984-03-30
K832904	Intravenous Needle	Yolan R. Guttman	FMI	Class II	1984-03-30
K841072	Irrigation, Aspiration Tubing Sets	Innovative Surgical Products, Inc.	HQC	Class II	1984-03-29
K840207	Double & Single Tantalum Clips	Storz Instrument Co.	HQW	Class II	1984-03-29
K840995	Acupuncture Insoles	Lu LU Enterprise Co., Ltd.	BWK	Unclassified	1984-03-27
K840983	Pulselife Stimulator	Pulse Life, Inc.	BWK	Unclassified	1984-03-27
K840619	i.v. Start Kit	Marwood Medical, Inc.	FPA	Class II	1984-03-27
K840343	Pdi Prepmaster Wet Pack Vaginal-X21477	Nice-Pak Products, LLC	KGO	Class I	1984-03-27
K840342	Pdi Prepmaster Wet Pack Patient Prep Kit	Nice-Pak Products, LLC	FRG	Class II	1984-03-27
K833981	Shiley Dispos. Temp. Probes	Shiley, Inc.	FLL	Class II	1984-03-27
K833681	Porocoat Hps II Hip Prosthesis	Depuy, Inc.	LPH	Class II	1984-03-27