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 2177 of 3531

510(k) clearances, page 2177 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K941995	Nce Replacement Batteries	National Custom Ent., Inc.	LDD	Class II	1994-07-26
K941654	Sarns Filtered Venous Reservior Modification	3M Health Care, Sarns	DTP	Class II	1994-07-26
K941349	Dental Tray	Cush Medical Products	EIA	Class I	1994-07-26
K940931	Asep(tm) Plus Surgical Gown	Angelica Uniform Group, Inc.	FYA	Class II	1994-07-26
K940681	Clearview Uterine Manipulator	Clinical Innovations, LLC	LKF	Class II	1994-07-26
K940436	Sponge, Laparotomy, Various Size	Shawnee Products, Inc.	GDY	Class I	1994-07-26
K940237	Theraplan V05b/ Tp-11 V09b	Theratronics, Inc.	IYE	Class II	1994-07-26
K935772	Hp M177xa Cardiographs	Hewlett-Packard Co.	LOS		1994-07-26
K934335	Phoresor II Auto, Model Pm800 Modification	Iomed, Inc.	EGJ	Class II	1994-07-26
K934292	William Harvey Hf5000 Membrane Oxygenator	Medivators Inc	DTZ	Class II	1994-07-26
K933807	Ground Plate Electrode	Cadwell Laboratories, Inc.	GXY	Class II	1994-07-26
K932621	Rh-801/Gs Model Transq(r)1	Iomed, Inc.	EGJ	Class II	1994-07-26
K932620	Rh-806/Gs Model Transq(r)2	Iomed, Inc.	EGJ	Class II	1994-07-26
K930740	Surgical Suture, Nonabsorable Stainless Steel	Deknatel, Inc.	GAQ	Class II	1994-07-26
K930739	Sutures Polyprop., Polyetheline, Nylon & Silk	Deknatel, Inc.	GAP	Class II	1994-07-26
K930738	Surgical Sutures, Pgl, Gut, Deklene, Opthamend Etc	Deknatel, Inc.	GAL	Class II	1994-07-26
K926338	Pleur-Evac Cardiotomy Reservoir # Cr-9400 & 9400F	Deknatel, Inc.	CAC	Class II	1994-07-26
K943115	Auto Suture Pituitary Spinal Rongeur	United States Surgical, A Division of Tyco Healthc	HAO	Class I	1994-07-25
K943084	Spectacle Frame	Samil Enterprise Company	HQZ	Class I	1994-07-25
K942952	Orvis World Finest Polarized Clip Ons	The Orvis Co., Inc.	HQY	Class I	1994-07-25
K942772	A-200 Multi-Use Airway Adapter	Pryon Corp.	CCK	Class II	1994-07-25
K942755	Nil	Ever Great International, Ltd.	HQY	Class I	1994-07-25
K942750	Spectacle Frames	Aspex Eyewear, Inc.	HQZ	Class I	1994-07-25
K942673	Non-Prescription Sunglasses	Angel Eyewear	HQY	Class I	1994-07-25
K942518	Cassette System for Site	Surgin Surgical Instrumentation, Inc.	HQC	Class II	1994-07-25
K942517	10-K Cassette	Surgin Surgical Instrumentation, Inc.	HQC	Class II	1994-07-25
K942516	10-0 Cassette	Surgin Surgical Instrumentation, Inc.	HQC	Class II	1994-07-25
K942515	Phaco Kit	Surgin Surgical Instrumentation, Inc.	HQC	Class II	1994-07-25
K942489	Electrosurgical Cutting & Coagulation Device	Megadyne Medical Products, Inc	GEI	Class II	1994-07-25
K942152	Candela Q-Switched, Frequency Doubled Nd;yag Laser Sy	Candela Corporation	GEX	Class II	1994-07-25
K942067	Sam Sung Optical	Sam Sung Optical	HQY	Class I	1994-07-25
K942038	Sunglasses	Golden Year Supply Co.	HQY	Class I	1994-07-25
K942037	Sunglasses	Golden Year Supply Co.	HQY	Class I	1994-07-25
K942018	R&d Batteries, Part No. 5025, 5128 and 5183	R & D Batteries, Inc.	FCO	Class I	1994-07-25
K942001	Sunglasses	Hung Wai Optical Co.	HQY	Class I	1994-07-25
K941944	Tahoe Surgical Instruments Ligature Device	Tahoe Surgical Instruments P.R., Inc.	HET	Class II	1994-07-25
K941874	Sunglasses	The Fair Optical Ent.Co., Ltd.	HQY	Class I	1994-07-25
K941859	Miracle-Ear Ear Impression Material	Miracle-Ear/Dahlberg, Inc.	ESD	Class I	1994-07-25
K941581	Happy Eyes Optical Co. Sunglasses	Happy Eye Optical Co.	HQY	Class I	1994-07-25
K941087	Pos-T-Vac-Avp-1000	Pos-T-Vac, LLC	LKY	Class II	1994-07-25
K940925	Sunglasses	Gold Link Design, Ltd.	HQY	Class I	1994-07-25
K940400	Lysol I.c. Brand Disinfectant Spray	L&F Products	LRJ	Class I	1994-07-25
K940381	Lysol I.c. Brand Quaternary Cleaner Disinfectant	National Laboratories	LRJ	Class I	1994-07-25
K940372	Sunglasses, Spectacle Frames	Giorgio Nannini SRL	HQY	Class I	1994-07-25
K935405	Arterial Embolectomy	J-Lloyd Medical, Inc.	DXE	Class II	1994-07-25
K935083	Pediatric Defib K-Pads	Katecho LLC	LDD	Class II	1994-07-25
K934749	Freeway Lite Nebulizer Compressor	Medic-Aid, Ltd.	CAF	Class II	1994-07-25
K932867	Life Pulse Resuscitation Timer	Green Field Medical Sourcing, Inc.	PMK	Class I	1994-07-25
K932484	Mars Sunglasses	Mars Promotional Services, Inc.	HQY	Class I	1994-07-25
K932258	Opticom M600	Clement Clarke, Inc.	HPT	Class I	1994-07-25