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 2164 of 3531

510(k) clearances, page 2164 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K934759	Culturia Macconkey-Mug	Clinical Convenience Products, Inc.	JXA	Class I	1994-09-09
K934125	Gonochek-II, Modification	E-Y Laboratories, Inc.	JTO	Class I	1994-09-09
K933486	Fascount Systme	Becton Dickinson Immunocytometry Systems	GKZ	Class II	1994-09-09
K932522	Amsco Sterile Recoveries Surgical Packs	Amsco Sterile Recoveries, Inc.	LRD	Class I	1994-09-09
K924565	Sbs Model 1615	Stand-By-Systems, Inc.	CAW	Class II	1994-09-09
K944124	Spirobac Adapters	Mallinckrodt Medical	CAH	Class II	1994-09-08
K944045	Surgi-Link Endoscopic Bipolar Forceps	Unimed Surgical Products, Inc.	GEI	Class II	1994-09-08
K943663	Navarre 600 Ml Drainage Bag	Navarre Biomedical, Ltd.	EXF	Class II	1994-09-08
K943495	Disposable Esophageal Stethoscope	Coast Medical Corp.	BZT	Class II	1994-09-08
K943298	Ms Classique Balloon Catheter	Meadox Medicals, Div. Boston Scientific Corp.	LIT	Class II	1994-09-08
K942916	Octopaque Universal	Octostop, Inc.	IXQ	Class II	1994-09-08
K942494	Lifestyle Multivue-S (Polymacon) Soft Hydrophilic Contact Lens	Permeable Technologies, Inc.	LPL	Class II	1994-09-08
K942177	Foley Catheterization Tray	Customed, Inc	FCM	Class II	1994-09-08
K941688	Innovative Technologies Hydrocolloid Wound Dressings	Innovative Technologies, Ltd.	FRO	Unclassified	1994-09-08
K934741	Liquid Fibrinogen Fdp Control Level 1 & 2	Clinical Controls, Inc.	GIL	Class II	1994-09-08
K934072	Convenience Contour Kits Redi Nurse System	Contour Fabricators of Florida, Inc.	KNY	Class II	1994-09-08
K933237	Medi-Stim, Modification	Mid-Canada Medical	GZJ	Class II	1994-09-08
K932295	Non-Balloon Replacement Gastrostomy Kit	Biosearch Medical Products, Inc.	KNT	Class II	1994-09-08
K931143	Amsco Sterile Recoveries Absorbent Towels	Amsco Sterile Recoveries, Inc.	KKX	Class II	1994-09-08
K923656	Lighting Source System	Galenica Enterprises, Inc.	HIC	Class II	1994-09-08
K944116	Freedom Aspirator, Model 6000	Stackhouse, Inc.	BTA	Class II	1994-09-07
K943976	Sabre Ultimate Shielded Trocar	Endoscopic Concepts, Inc.	GCJ	Class II	1994-09-07
K943958	Monopolar Endoscopic Reposable Tip Surgical Instruments	Tnco, Inc.	GCJ	Class II	1994-09-07
K943913	Max Frame Design	Noble Optic	HQZ	Class I	1994-09-07
K943205	Human Igg Subclasses Rid Combi Kit (Modification)	Research Diagnostics, Inc.	DAS	Class I	1994-09-07
K943122	Surgical Drapes	Mallinckrodt Group, Inc.	KKX	Class II	1994-09-07
K943098	Human Igg Subclasses Elisa Combi Kit	Research Diagnostics, Inc.	DAS	Class I	1994-09-07
K942660	Hall Microchoice Electric Powered System	Hall Surgical, Division of Zimmer, Inc.	HWE	Class I	1994-09-07
K942638	Simultrac Lh/fsh Radioummunoassay Kit	BD Becton Dickinson Vacutainer Systems Preanalytic	CEP	Class I	1994-09-07
K941878	Octeia Intact Pth	I.D.S.	CEW	Class II	1994-09-07
K941195	Cedia Dau Opiate Assay	Microgenics Corporation	DJG	Class II	1994-09-07
K941168	Clinical Assays Gammacoat [125] Estradiol Radioimmunoassay Kit	Incstar Corp.	CHP	Class I	1994-09-07
K940842	Unipower Rechargeable Battery Pack	Unipower Corp.	LDD	Class II	1994-09-07
K940833	Access(r) Total T3	Bio-Rad Laboratories Inc.	CDP	Class II	1994-09-07
K940427	Karl Storz Thoracic Surgery Instruments	Karl Storz Endoscopy-America, Inc.	GCJ	Class II	1994-09-07
K940243	Ventana Ema Primary Andibody	Ventana Medical Systems Inc	DHF	Class I	1994-09-07
K936079	Ecactech Porous Coated Finned Tibial Tray Compnent	Exactech, Inc.	JWH	Class II	1994-09-07
K935737	Stone Extractor, Grasping Forceps	Boston Scientific Corporation	FFL	Class II	1994-09-07
K935163	Continuous Irrigation Cystourethroscope	Richard Wolf Medical Instruments Corp.	FBO	Class II	1994-09-07
K935019	Infinity 252	Siemens Hearing Instruments, Inc.	ESD	Class I	1994-09-07
K934752	Siemens Model 584 P-2	Siemens Hearing Instruments, Inc.	ESD	Class I	1994-09-07
K934166	Nuffield Total Knee Uhmwpe Tibia (One Piece) Modification	Corin Orthopedic Products	JWH	Class II	1994-09-07
K933802	Cutaneous Electrode	Cadwell Laboratories, Inc.	GXY	Class II	1994-09-07
K933681	Gambro Lundia Pro 100, 500, 600 Dialyzers	Cobe Renal Care, Inc.	FJG	Class II	1994-09-07
K932210	Ortholoc Advantim Revision Femoral Component	Dow Corning Wright	JWH	Class II	1994-09-07
K915166	Microcycler	Medical Inventors Corp., Inc.	FCN	Class II	1994-09-07
K944015	Harpo Sunbed, Sun Tanning Machine	Harpo Industries	LEJ	Class II	1994-09-06
K943970	Disposable Laparoscopic Swab with Reusable Handle	Cook Ob/Gyn	GCJ	Class II	1994-09-06
K943840	(Brand Name0 Mondain	Chan'S Plastic Manufactory Co., Ltd.	HQY	Class I	1994-09-06
K943423	Spectacle Frames	Galilee Optics	HQZ	Class I	1994-09-06