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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2961 of 3529

510(k) clearances, page 2961 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K850984	Marlin Soft Lens Handler	Marlin Industries	KYE	Class I	1985-09-10
K850983	Marlin Soft Lens Tweezer	Marlin Industries	KYE	Class I	1985-09-10
K851643	Remote Control Module	Circadian, Inc.	DPS	Class II	1985-09-09
K851223	Copal Digital Sphygmomanometer Ua-560	Takeda Medical, Inc.	DXN	Class II	1985-09-09
K841811	Bentley-Trantec Dispos. Domes D-260-	American Bentley	DRS	Class II	1985-09-09
K853616	Apl Chlamydospore Agar	Apl Medical Supplies	JSH	Class I	1985-09-06
K853615	Apl Bile Esculin/azide Agar	Apl Medical Supplies	JSH	Class I	1985-09-06
K853614	Apl Fluid Thioglycollate Medium	Apl Medical Supplies	JSH	Class I	1985-09-06
K853613	Apl Gn Broth	Apl Medical Supplies	JSH	Class I	1985-09-06
K853612	Apl Dnase Test Agar	Apl Medical Supplies	JSH	Class I	1985-09-06
K853546	Abbott Cation Supplement Solution	Abbott Medical	JSK	Class I	1985-09-06
K853494	Reusable End Cutters in 3.5 & 4.2Mm Configuation	Chattanooga Group, Inc.			1985-09-06
K853493	Reusable Bullet Nose Cutters in 3.5 & 4.2Mm Config	Chattanooga Group, Inc.			1985-09-06
K853492	Reusable Trimmer Blades in 3.5/4.2/5.5Mm Configuat	Chattanooga Group, Inc.			1985-09-06
K853491	Reusable Dextra Synovial Resectors in 3.5/4.5/5.5M	Chattanooga Group, Inc.			1985-09-06
K853490	Reusable Abrader Tips in 3.5Mm & 5.5Mm Configuatio	Chattanooga Group, Inc.			1985-09-06
K853487	Patient Breathing Circuit	Infrasonics Corp.	BZD	Class II	1985-09-06
K853428	CPR Prompt	Hutchins Tool & Engineering Co., Inc.			1985-09-06
K853413	Rennew-D Sporicide/disinfectant for Hemodialyzers	Alcide Corp.	LIF	Class II	1985-09-06
K853368	H-H Shunt Introducer	Holter-Hausner Intl.	GYK	Class I	1985-09-06
K853267	Day Staple	Protek, Inc.	JDR	Class II	1985-09-06
K853173	Internation Model Ss Stock Canal in the Ear H.a.	Int'L Hearing Aids, Inc.	ESD	Class I	1985-09-06
K853093	Psp Temp - Tray	PSP Dental Co., Ltd.	EBH	Class I	1985-09-06
K853045	Ally Portable Not Pack/pad Disposable	Actin International, Inc.	IMD	Class I	1985-09-06
K853000	Scented Always Pantiliners	Procter & Gamble Mfg. Co.	HHL	Class II	1985-09-06
K852953	#Sm-3001 Ophtha Otosc Set Subsets Sold	Design Med. Corp.	HLJ	Class II	1985-09-06
K852885	Filtral Hemodialyzer	Hospal Medical Corp.	KDI	Class II	1985-09-06
K852721	Bozeman Uterine Forceps, Straight, 10+410 0R 420	The Huxley Instrument Corp.	HCZ	Class II	1985-09-06
K852175	Patient Data Systems Cva	Patient Data Systems	BSZ	Class II	1985-09-06
K852174	Merivaara Obstetric Chair/bed Model 358	Daun International, Inc.	KNC	Class II	1985-09-06
K851305	Non/gel Fully Adhesive Dispersive Electrode 3428,	Richards Medical Co., Inc.	GEI	Class II	1985-09-06
K851304	Non/gel Adhesive Dispersive Electrode 3427,33-4270	Richards Medical Co., Inc.	GEI	Class II	1985-09-06
K851171	Combibag Manual Resuscitator	Frontline Medical	BTM	Class II	1985-09-06
K844184	D300 Port Ultrasound Lin Scan W/3.5 & 5.0 Mhz Prob	D.R.G.	IYO	Class II	1985-09-06
K853558	Dosimetric Release/radiation Steriliz. Absorb Gauz	American White Cross, Inc.			1985-09-05
K853544	Quad Ferm +	Analytical Products, Inc.	JSX	Class I	1985-09-05
K853507	Steri-Grip	Clinical Technology Inc.			1985-09-05
K853495	Reusable Jacobs Drill Chuck	Chattanooga Group, Inc.			1985-09-05
K853479	Skytron Elite 300 Surgery Table	Skytron, LLC	FWW	Class I	1985-09-05
K853475	Gram-Ma Neonatal Sc	Kentec Medical, LLC	FRW	Class I	1985-09-05
K853460	Endo L 300 Light, Illuminating Wound Rectractor	Heraeus, Inc.			1985-09-05
K853454	Sure Count 5 & 10 Sponge Counter	Kleen Test Products Corporation			1985-09-05
K853374	Correct-a-Count	Dermacare Products, Inc.			1985-09-05
K853365	H-H Fifth Ventricle	Holter-Hausner Intl.	JXG	Class II	1985-09-05
K853364	H-H Rickham Type Reservoir	Holter-Hausner Intl.	JXG	Class II	1985-09-05
K853347	Mai Sterile Utility Drape	Medical Assoc. Intl., Inc.	KKX	Class II	1985-09-05
K853204	Churchill Vented IV Set	Churchill Corp.	FPA	Class II	1985-09-05
K853151	Reliance 5000	F. & F. Koenigkramer	HME	Class I	1985-09-05
K853150	Reliance 6100	F. & F. Koenigkramer	HME	Class I	1985-09-05
K853149	Reliance 1000, Reliance 1500, Reliance 2000	F. & F. Koenigkramer	HME	Class I	1985-09-05