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 2632 of 3530

510(k) clearances, page 2632 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K892566	Patient Examination Gloves (Latex)	Foodhandler, Inc.	LYY	Class I	1989-06-23
K892442	Kendall Curity Urethral Catheters	The Kendal Co.	GBM	Class II	1989-06-23
K892439	Kendall Curity Stomach Tubes	The Kendal Co.	KNT	Class II	1989-06-23
K892437	Kendall Kenguard Urinary Leg Bags	The Kendal Co.	KNX	Class II	1989-06-23
K892408	Nsd 8Cs8 - TENS Device	Future Medical Products, Inc.	GZJ	Class II	1989-06-23
K892372	Spin-Clean Cleaning Unit	Willmar Contact Lens Co.	LYL	Class II	1989-06-23
K892364	Kaltostat(tm) Wound Dressing	Calgon Vestal Div.	FRO	Unclassified	1989-06-23
K892289	Patient Examination Gloves (Latex)	Ansell, Inc.	LYY	Class I	1989-06-23
K892266	Patient Examination Gloves (Latex)	Jenn Jiag Ent. Co., Ltd. C/O Rosyn Products, Inc.	LYY	Class I	1989-06-23
K892117	Gentlehaler(r)	Schering Research	CCQ	Class I	1989-06-23
K892062	Ps3500 Arthroscopic Surgical System	Dyonics, Inc.	HRX	Class II	1989-06-23
K891771	Victor Medical Oxygen Therapy Regulator, Modified	Thermadyne Holings Corp.	CAN	Class I	1989-06-23
K891760	Magnetic Resonance System, Model Bmt 1100,Modified	Bruker Medical Imaging, Inc.	LNH	Class II	1989-06-23
K891543	Magnaview Mobile MRI Version 110 Fhm	Instrumentarium Imaging, Inc.	LNH	Class II	1989-06-23
K891456	Heyer-Schulte (Csf) Ventri Access(reserv/antecham	Baxter Healthcare Corporation	JXG	Class II	1989-06-23
K891410	Nasogastric Ph Suction Catheter, St-5001	Sensatronix Medical Systems, Inc.	FFT	Class I	1989-06-23
K891393	Orgenics Immunocomb(tm) Cmv Igg Antibody Test Kit	Orgenics, Ltd.	LFZ	Class II	1989-06-23
K891352	Marlow Anal Speculum	Simpson/Basye, Inc.	KOA	Class I	1989-06-23
K891164	Samuels - Micro -Scler Catheter	Polyval, Inc.	FPA	Class II	1989-06-23
K891146	Terumo Surflo(r) Injection Plug	Terumo Medical Corp.	FPA	Class II	1989-06-23
K891087	Terumo Surflo(r) i.v. Catheter	Terumo Medical Corp.	FOZ	Class II	1989-06-23
K891063	Surflo(r) Winged Infusion Set	Terumo Medical Corp.	FPA	Class II	1989-06-23
K890931	Patient Examination Glove	Phutex Products Co., Ltd.	LYY	Class I	1989-06-23
K890782	Grieshaber Soft Tip Needle (20 & 19 Gauges)	Grieshaber & Co.	HMX	Class I	1989-06-23
K890733	Medsurg Epidural Tray/19 Gage Open End Tuohy 1012	Medsurg Industries, Inc.	CAZ	Class II	1989-06-23
K890732	Medsurg Epidural Tray/bullet Tip/17 Ga Tuohy 1002E	Medsurg Industries, Inc.	CAZ	Class II	1989-06-23
K890731	Medsurg Epidural Tray/19 Ga/bul Tip/17ga Tuo 1002	Medsurg Industries, Inc.	CAZ	Class II	1989-06-23
K890610	Vironostika(tm) Anti-Cmv Igm Microelisa System	bioMerieux, Inc.	LFZ	Class II	1989-06-23
K890533	Item #352/#Cs352* Contact Lens Cases	FGX International Inc.	LRX	Class II	1989-06-23
K890360	Greer Dermapik System	Greer Laboratories Inc	SCL	Class II	1989-06-23
K890092	Hi Standard Magnetic Resonance Diagnostic Device	Health Images, Inc.	LNH	Class II	1989-06-23
K890032	Imx Toxo Igm Antibody Assay	Abbott Medical	LGD	Class II	1989-06-23
K890031	Imx Toxo Igg Antibody Assay	Abbott Medical	LGD	Class II	1989-06-23
K885297	Imx Rubella Igg, Microparticle Enzyme Immunoassay	Abbott Medical	LFX	Class II	1989-06-23
K885295	Imx Rubella Igm, Micropart. Enzyme Immunoassay	Abbott Medical	LFX	Class II	1989-06-23
K885115	Imd 7Gx	Medical Dental Technology Co.	EFB	Class I	1989-06-23
K885107	Thrombostin Ifa*	Investigacion Farmaceutica S.A. de C.V.	GJS	Class II	1989-06-23
K885015	Coi 72 Hr Collagen Shield	Chiron Ophthalmics	MOE	Class I	1989-06-23
K884969	Bio-Mate(tm) Epidural Catheter	Medevice, Inc.	BSO	Class II	1989-06-23
K884927	Be #1100 Moisture Trap & Be #1102/50 Disp Canister	Instrumentation Industries, Incorporated	CAN	Class I	1989-06-23
K884925	The Great Wall Condom	Pacific Sales & Development Corp.	HIS	Class II	1989-06-23
K884625	Dpx Bone Densitometer for Total Body Bone Density	Lunar Corp.	KGI	Class II	1989-06-23
K883809	Newport Ventilator Model E150	Newport Medical Instruments, Inc.	CBK	Class II	1989-06-23
K882384	Deluxe Contact Lens Holder (Hard & Soft) #283	FGX International Inc.	LRX	Class II	1989-06-23
K893772	Tissue Embedding Medium	Stephens Scientific	KEO	Class I	1989-06-22
K893708	Fluidized Air Bed	Gsi Development Co.	IOQ	Class II	1989-06-22
K893706	Cold/hot Fluid Radiation Pad Neutech	Burke, Inc.	ILO	Class II	1989-06-22
K893614	Aeromat Mrs-1000	Integrated Therapy Products, Inc.	IOQ	Class II	1989-06-22
K893531	Cuff Speculum	Mountain Medical Equipment, Inc.	KPL	Class II	1989-06-22
K893491	Model M2-150/I-150/M2-150T/m3-150/M2-150,300-300	Cuda Products Co.	FST	Class II	1989-06-22