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 2356 of 3531

510(k) clearances, page 2356 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K922002	Suction Irrigation Cautery Probe	Megadyne Medical Products, Inc	GEI	Class II	1992-09-02
K921949	Cotube Pth Irma	Bio-Rad	CEW	Class II	1992-09-02
K921685	Solaz	Solarchromic, Inc.	HQY	Class I	1992-09-02
K921395	Hot Sack	C.F. Electronics, Inc.	LGZ	Class II	1992-09-02
K921391	Solution Administration Set	Douglas Medical Products, Inc	FPA	Class II	1992-09-02
K921024	Uro-Tote Leg Bag	Neotech Products, LLC	KNX	Class II	1992-09-02
K920291	Moni-Trol-L and Moni-Trol-Xl	Medical Analysis Systems, Inc.	JJY	Class I	1992-09-02
K915407	Pharmetrix Medipump Model 524	Pharmetrix, Inc.	FRN	Class II	1992-09-02
K915266	Visor Sunglasses/lens/novelty Visor	Janlin Ent.	HQY	Class I	1992-09-02
K914892	Saliva-Stim	Orion Diagnostica, Inc.	EGD	Class I	1992-09-02
K914150	Jansen-Anderson Insemination Set	Cook Ob/Gyn	MFD	Class II	1992-09-02
K913990	Ktp/532 & Ktp/yag	Laserscope	GEX	Class II	1992-09-02
K924110	Leocor Corflo Pump -- Modification	Leocor, Inc.	DQI	Class II	1992-09-01
K923457	Showerfloss	Summit Marketing Group, Inc.	EFS	Class I	1992-09-01
K923300	Deroyal Eye Dressing	DeRoyal Industries, Inc.	KGX	Class I	1992-09-01
K923120	Microguide Lesion Marking System	Angiodynamics, Div. E-Z-Em, Inc.	GDF	Class I	1992-09-01
K923119	Wallstent Esophageal Prothesis	Schneider U.S. Stent Div.	ESW	Class II	1992-09-01
K923090	Saf-T Holder Multi Sample Luer Adapter W/ Blood	Ryan Medical, Inc.	JKA	Class II	1992-09-01
K922879	Meadox Surgimed Biopsy Gun III	Meadox Medicals, Div. Boston Scientific Corp.	KNW	Class II	1992-09-01
K922254	Lukens 2-0 Braided Silk Sutures	Quinton, Inc.	DQO	Class II	1992-09-01
K921174	Composite Resin Core Paste Material	Centrix, Inc.	EBF	Class II	1992-09-01
K921010	Stern Era Alignment Correction Implant Abutment	Apm Stern Gold	DZE	Class II	1992-09-01
K920893	Lite Fill II P	Shofu Dental Corp.	EBF	Class II	1992-09-01
K920892	Lite Fil II a	Shofu Dental Corp.	EBF	Class II	1992-09-01
K920846	Central Venous Catheter, Dressing Change Kit, Ster	Trinity Laboratories, Inc.	FXX	Class II	1992-09-01
K920080	Continuum Knee System	Techmedica, Inc.	JWH	Class II	1992-09-01
K922687	Opthalmic Frames	Optique Forte, Ltd.	HQZ	Class I	1992-08-31
K922681	Cutinova Foam	Jobst Institute, Inc.	KMF	Class I	1992-08-31
K922595	Modified Site Macrobore Phaco Needle	Chiron Vision Corp.	HQC	Class II	1992-08-31
K921189	Therma-H	Zewa, Inc.	LKX	Unclassified	1992-08-31
K920593	Ceramic Femoral Head	Dow Corning Wright	LZO	Class II	1992-08-31
K920590	Ohmeda Model 5250 Rgm Monitor	GE Healthcare	CCK	Class II	1992-08-31
K923027	Neuray Surgical Patties and Strips	Martland Healthcare, Inc.	HBA	Class II	1992-08-28
K922922	Abl50 Blood Gas System	Radiometer America, Inc	CHL	Class II	1992-08-28
K922804	Awos Angiographic Workstation	Siemens Medical Solutions USA, Inc.	IZI	Class II	1992-08-28
K923202	Q3 (Light and Universal) Impression Material	Jeneric/Pentron, Inc.	ELW	Class II	1992-08-27
K923150	Silon Transparent Wound Dressings	Bio Med Sciences, Inc.	MGP	Unclassified	1992-08-27
K923124	Glenroe Golden Orthodontic Bracket	Glenroe, LLC	EJF	Class I	1992-08-27
K923044	Monad Nuclear Imaging System	Trionix Research Laboratory, Inc.	KPS	Class II	1992-08-27
K922991	Abbott Tdx/tdxflx and Tdxflx Theophylline	Abbott Medical	LGS	Class II	1992-08-27
K921573	Rubella Igm	Trinity Biotech USA	LFX	Class II	1992-08-27
K921425	Scd-105 and Scd-125 Capacitor Discharge Mobile X-R	Acoma Medical Imaging, Inc.	IZL	Class II	1992-08-27
K921281	Tracheostomy Care Kit	Trinity Laboratories, Inc.	BTO	Class II	1992-08-27
K920338	Companion Retrofit Oxygen Concentration Indicator	Medtronic, Inc.	CCL	Class II	1992-08-27
K920281	Tracheostomy Care Kit, Sterile, Disposable	Trinity Laboratories, Inc.	BTO	Class II	1992-08-27
K915365	Ap-6Cr Cineradiographic Film Processor	The Allen Products Co.	IXX	Class II	1992-08-27
K913853	Fissure Sealer	Ortho Source	EBC	Class II	1992-08-27
K905434	Angulated Abutment, Complete,titanium Sdca 102	Nobelpharma USA, Inc.	DZE	Class II	1992-08-27
K923784	Starkey Sm Series Bte Hearing Aids	Starkey Laboratories, Inc.	ESD	Class I	1992-08-26
K923569	Paramax Total Iron Binding Capacity Pretreatment	Baxter Diagnostics, Inc.	JMO	Class I	1992-08-26