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 2296 of 3531

510(k) clearances, page 2296 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K932105	Hearing Aids	Katz Hearing Aid Center	ESD	Class I	1993-06-14
K931724	Electrophysiology (Ep) Table Ep 2000 Series	Continental X-Ray Corp.	KXJ	Class II	1993-06-14
K931459	Kenguard Urinary Drainage Bag W/antireflux Chamber	Kendall Healthcare Products Co. Div.Of Tyco Health	KNX	Class II	1993-06-14
K931170	Sony Cardiac Analysis and Review Station (Cars)	Sony Medical Systems	IZI	Class II	1993-06-14
K925965	Picture Archiving and Communication Systems	Advanced Light Imaging Technologies, Ltd.	IYO	Class II	1993-06-14
K924991	Micro Masker	Associated Hearing Instruments	KLW	Class II	1993-06-14
K924231	Interspec Apogee Cla	Interspec, Inc.	IYO	Class II	1993-06-14
K923734	Total Hip Prothesis Femoral Component	Intermedics Orthopedics	LZO	Class II	1993-06-14
K932003	N-Pac Style C (D-Stat o.r. Protective Gown)	National Healthcare Linen Service	FYA	Class II	1993-06-11
K930324	Ez Mover	Prime Ideas, Inc.	IYO	Class II	1993-06-11
K930209	Synelisa Ro ABS / La ABS	Elias U.S.A., Inc.	LJM	Class II	1993-06-11
K926337	Bone Lavage System	Innovative Surgical Devices Corp.	FQH	Class II	1993-06-11
K922358	Sterling Powder Free Patient Examination Gloves	Perlink USA, Inc.	LYY	Class I	1993-06-11
K925852	Terumo Coronary Guide Wire	Terumo Medical Corp.	DQX	Class II	1993-06-10
K925347	Model 1148T Transvenous, Screw-in Lead	Siemens-Pacesetter, Inc.	DTB	Class III	1993-06-10
K925067	Simpla Trident Leg Bag + Simpla S6 Bag	Simport Plastics, Ltd.	KNX	Class II	1993-06-10
K923781	Mxr-2000 Flowmeter	Precision Fluidics Division Parker Hannifin Corp.	CAX	Class I	1993-06-10
K922576	Aesculap Manual Endoscopic Instruments	Aesculap Inc	GEI	Class II	1993-06-10
K931302	Sas Pregnancy Strip	SA Scientific, Ltd	JHI	Class II	1993-06-09
K931182	Vesitec Drill Guide	Vesitec Medical, Inc.	JDR	Class II	1993-06-09
K931148	Model 5500 Coulochem Electrode Array System	Esa, Inc.	CHQ	Class I	1993-06-09
K930984	Access(r) Total Ige Assay	Bio-Rad Laboratories Inc.	DGC	Class II	1993-06-09
K930349	Stone Retrieval Basket	Endomedix	FFL	Class II	1993-06-09
K930201	Acecut Sutomatic Biopsy System	Meadox Surgimed, Inc.	KNW	Class II	1993-06-09
K925885	Afp 17 X 4 Automatic Film Processor	Afp Imaging Corp.	IXW	Class II	1993-06-09
K925673	Airway Pressure Monitor Cm 5000 Ngan	Canadian Monaghan, Ltd.	CAP	Class II	1993-06-09
K925265	Imageview 46000	Canberra Industries, Inc.	LMC	Class II	1993-06-09
K923375	Playskool Sunglasses	Playtime Products, Inc.	HQY	Class I	1993-06-09
K923374	Various Sunglasses	Playtime Products, Inc.	HQY	Class I	1993-06-09
K921498	Ver Med A10011 Pns Dual Element Electrode	Vermont Medical, Inc.	BXM	Class II	1993-06-09
K912551	Anti-Endomysial Antibody Test	Immco Diagnostics, Inc.	DBL	Class II	1993-06-09
K911230	Rs-1000	Cp Medical	KOC	Class II	1993-06-09
K931984	Perfect Ear/pe	Perfect Ear	ESD	Class I	1993-06-08
K931283	Microvision Fast Detail Intensifying Screen	E.I. Dupont de Nemours & Co., Inc.	EAM	Class I	1993-06-08
K931259	Endoscopic or Thorascopic Forceps	T. Korossurgical Instruments Corp.	GCJ	Class II	1993-06-08
K931074	Du Pont Mv Darkroom Cassette	E.I. Dupont de Nemours & Co., Inc.	IXA	Class II	1993-06-08
K931002	Fuji Computed Radiograp Hi-C654 Dms Crt Image Cons	FUJIFILM Healthcare Americas Corporation	IXK	Class II	1993-06-08
K930428	Penn-Pet Scanner	Ugm Medical Systems, Inc.	KPS	Class II	1993-06-08
K930355	Microsurge Suction/irrigation System Cannulas	Microsurge, Inc.	GEI	Class II	1993-06-08
K930352	Harmonic Scalpel Reusable Laporascopic Blade Syst.	Ultracision, Inc.	GCJ	Class II	1993-06-08
K930330	Endoscopic Needleholder, Modification	Holmed LLC	FHQ	Class I	1993-06-08
K930089	Sms Balance Performance Monitor	Sms Technologies, Ltd.	KHX	Class I	1993-06-08
K926133	Cort-Ex	General Electric Co.	KPS	Class II	1993-06-08
K925714	Breast Simulation System	Severn Research, Inc.	IYE	Class II	1993-06-08
K924495	Philips Rtnet Radiotherapy Networking System	Philips North America LLC	IYE	Class II	1993-06-08
K924400	Clotting Factor-11,-VII, -X Deficient Plasma	Behring Diagnostics, Inc.	GJT	Class II	1993-06-08
K923225	Lorrex Health Products - Clinical Mercury Thermome	Lorrex Health Products	FLK	Class II	1993-06-08
K923069	Restore Tunnel Plug	Depuy, Inc.	HRX	Class II	1993-06-08
K922846	Mrh-1500	FUJIFILM Healthcare Americas Corporation	LNH	Class II	1993-06-08
K921422	Latex Examination Gloves	Vas Latex Co., Ltd.	LYY	Class I	1993-06-08