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 2196 of 3531

510(k) clearances, page 2196 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K935866	Comfit Powered Examination Gloves(beaded, Hypoallerg)	Wembley Rubber Products (M) Sdn Bhd	LYY	Class I	1994-05-18
K935826	Laparoscopic/suction/irrigation Probe	Core Dynamics, Inc.	GCJ	Class II	1994-05-18
K935638	Nitinol, Niti	G & H Wire Company	DZC	Class I	1994-05-18
K935150	Soniplak	American Dentronics, Inc.	JEQ	Class I	1994-05-18
K934863	Flexsure Hp	Smithkline Diagnostics, Inc.	LYR	Class I	1994-05-18
K934694	Kirschner Zirconia Femoral Head	Kirschner Medical Corp.	LZO	Class II	1994-05-18
K934531	Auto Suture Disposable Light Cable	United States Surgical, A Division of Tyco Healthc	FCW	Class II	1994-05-18
K934430	Bon Apatite Ha Particles	Bio-Interfaces, Inc.	LYC	Class II	1994-05-18
K934080	Urinary Drainage Bag	Kit Pak, Inc.	EYT	Class I	1994-05-18
K933652	Freedom 60 Syringe Infusion Pump System with Syringe Set & Tubing	Repro-Med Systems, Inc.	FRN	Class II	1994-05-18
K933499	Consensus Hip System- Non-Porous Titanium Femoral Stem	U.S. Medical Products, Inc.	LZO	Class II	1994-05-18
K932405	Nitrile Rubber Examination Gloves (Powered)	Safeskin Corp.	FMC	Class I	1994-05-18
K932404	Nitrile Rubber Powder-Free Examination Glove	Safeskin Corp.	FMC	Class I	1994-05-18
K931676	S-Rom(r) Ztt(tm) Acetabular Cup-Apical Hole Plug	Joint Medical Products Corp.	JDL	Class III	1994-05-18
K925055	Pollenex Hepa Air Cleaners	Pollenex Corp.	FRF	Class II	1994-05-18
K923694	Duo Dent	Pdc Management Services, Inc.	DZE	Class II	1994-05-18
K942183	E2550 Reusable Handswitching Pencil	Medtronic, Inc.	GEI	Class II	1994-05-17
K942002	Retractor	Automated Medical Products Corp.	GAD	Class I	1994-05-17
K941930	Sunglasses	Sunvista Import, Inc.	HQY	Class I	1994-05-17
K941829	Sun Filters/shields	Klinger Eye Shields, Inc.	HOY	Class I	1994-05-17
K941811	Hp M1175a, M1176a, Component Monitoring System	Hewlett-Packard Co.	DPS	Class II	1994-05-17
K941786	Sunglasses	Modo Eyewear USA	HQY	Class I	1994-05-17
K941732	Sunglasses	Pacific Eyes & T'S	HQY	Class I	1994-05-17
K941682	Cool Kids Beads and Shades	Ja-Ru, Inc.	HQY	Class I	1994-05-17
K941668	Sunglasses	Yon'S Jay Enterprise Co.	HQY	Class I	1994-05-17
K941648	Blue Planet Lens Fog Reduction & Cleaning Kit	Blue Planet Industries, Inc.	FEB	Class II	1994-05-17
K941638	Sunglasses	Sun Coast Merchandise Corp.	HQY	Class I	1994-05-17
K941629	Sunglasses	Kuang Yauh Optical Co., Ltd.	HQY	Class I	1994-05-17
K941590	Sunglasses	Avon Products, Inc.	HQY	Class I	1994-05-17
K941524	Model 2100 Mild Intermittent Suction Pump	Product & Educational Services	JCX	Class II	1994-05-17
K941523	Spectacle Frames	Amore Mio, Inc.	HQZ	Class I	1994-05-17
K941502	Sunglasses	Asia Pacific Trading Co., Inc.	HQY	Class I	1994-05-17
K941410	Chin Hsieu Cheng	Large River Industrial Co., Ltd.	HQY	Class I	1994-05-17
K941380	Sunglasses	Spare Parts Accessories	HQY	Class I	1994-05-17
K941369	Avon Cat Sunglasses	Siegel,Mandell & Davidson,P.C.	HQY	Class I	1994-05-17
K941340	Borrion Enterprise Co	Borrion Enterprise Co.	HQY	Class I	1994-05-17
K941338	Chang Cheng Chung	Designer Brass Corp.	HQY	Class I	1994-05-17
K941313	Stanbio Alkaline Phosphatase (Liquicolor) Test Set	Stanbio Laboratory	CJE	Class II	1994-05-17
K941307	Spectacle Frames	Eyemart Express, LLC	HQZ	Class I	1994-05-17
K941280	Sunglasses (Non Prescription)	Autotime Industry, Inc.	HQY	Class I	1994-05-17
K941186	Non-Prescription Sunglasses	Sungold Ent., Ltd.	HQY	Class I	1994-05-17
K941110	Parakit	Hardy Diagnostics	LKS	Class I	1994-05-17
K941085	Lipase-Ps Assay Procedure No. 805	Sigma Diagnostics, Inc.	CHI	Class I	1994-05-17
K941060	Alpina Eyewear	Alpina High Tech Sports Eyewear	HQY	Class I	1994-05-17
K940945	Sunglasses	Hi-Shine Ent. Co., Ltd.	HQY	Class I	1994-05-17
K940943	Sunglasses	Kendward Industrial Corp.	HQY	Class I	1994-05-17
K940728	None-Generic	Dyer Intl.	HQY	Class I	1994-05-17
K940705	86 Hqy Sunglasses	Firestar, Inc.	HQY	Class I	1994-05-17
K940649	Cedia Dau Multi-Level Thc Assay, Hitachi 911 Reagent/ and the Hitachi 747 Reagent	Microgenics Corporation	LDJ	Class II	1994-05-17
K940609	Touch Corp	Touch Corp.	HQY	Class I	1994-05-17