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 2026-10-08, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3430 of 3526

510(k) clearances, page 3430 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K781430	Pregelled Disposable e.k.g. Electrode	Vermont Medical, Inc.	DRX	Class II	1978-10-31
K781393	Variable Stiffness Wire Guide	Cook, Inc.	DQX	Class II	1978-10-30
K781776	Pacing Leads Model Ul-811 and Ul-813	Pacesetter Systems	DTB	Class III	1978-10-27
K781761	Kendrick Extrication Device	Medi-Ked, Inc.	IQF	Class I	1978-10-27
K781717	Monitor, Gravity Irrigation Drip	Syntel, Inc.	FLN	Class II	1978-10-27
K781697	Pressure, Low/high Model C1070	Timeter Instrument Corp.	CAP	Class II	1978-10-27
K781690	L-Cysteine Hydrochloride	Fisher Scientific Company L.L.C.	JHS	Class II	1978-10-27
K781685	Ria Kit, Lh	Amersham Corp.	CEP	Class I	1978-10-27
K781646	Srd-2	Dynatech Laboratories, Inc.	JQW	Class I	1978-10-27
K781645	Autodiluter 2	Dynatech Laboratories, Inc.	JQW	Class I	1978-10-27
K781629	Seri-Sep Serum/plasma Islolator	Wako Intl., Inc.	JKA	Class II	1978-10-27
K781628	Hemo-W System	Coulter Electronics, Inc.	GKL	Class II	1978-10-27
K781484	Castle Model 3146 Gas Aerator	Castle Co.	FLI	Class II	1978-10-27
K781352	Strain Gauge Plethysmograph	Medimatic S.r.l.	DSB	Class II	1978-10-27
K781707	Filter, Arterial Blood W/tubing Bypass	Surgikos, Inc.	DTM	Class II	1978-10-26
K781553	Mediastinal Drainage Tube Set Mdt-36Tc2	Sorensen Research	CAC	Class II	1978-10-26
K781552	Mediastinal Drainage Tube Set Mdt-32Tc2	Sorensen Research	CAC	Class II	1978-10-26
K781551	Trauma Drainage Set 72T-32Ttc	Sorensen Research	CAC	Class II	1978-10-26
K781550	Trauma Drainage Set 72T-28Ttc	Sorensen Research	CAC	Class II	1978-10-26
K781297	Intra-Alert	Pan-Tech Research, Inc.	FLN	Class II	1978-10-25
K781735	Endoprosthesis System, Vario-Head	Waldemar Link GmbH & Co. KG	KWY	Class II	1978-10-24
K781734	Sodium Chloride, 0.85%	Bioscientific			1978-10-24
K781729	Tracheotomy Tubes	Tracoe Medical GmbH	BTO	Class II	1978-10-24
K781716	Blade, 20 Angle/micro Blade Holder	Edward Weck, Inc.	GES	Class I	1978-10-24
K781711	Evaluskop	Siemens Corp.	JAA	Class II	1978-10-24
K781710	Buffer, Collagen Reagent and Diluent	Diagnostica, Inc.	JBX	Class II	1978-10-24
K781709	Scanner, Linear	Philips North America LLC	IYO	Class II	1978-10-24
K781705	Mobil Xr	Siemens Corp.	IZL	Class II	1978-10-24
K781699	Eagle Pac/visible Seal	American Sterilizer Co.	KCT	Class II	1978-10-24
K781684	Sterilizer, Eagle 2000	American Sterilizer Co.	FLE	Class II	1978-10-24
K781660	Ria, Digoxin	E. R. Squibb & Sons, Inc.	DON	Class II	1978-10-24
K781659	Assay System, Gammaflo, Automated	E. R. Squibb & Sons, Inc.			1978-10-24
K781639	Shiley Cricothyrotomy Tube	Shiley, Inc.	EQN	Class II	1978-10-24
K781611	Cholesterol Det. in Serum	Fisher Scientific Company L.L.C.	CGO	Class I	1978-10-24
K781610	Bilirubin Determintaiton in Serum	Fisher Scientific Company L.L.C.	CIG	Class II	1978-10-24
K781609	Alkaline Phosphatase in Serum	Fisher Scientific Company L.L.C.	CJE	Class II	1978-10-24
K781547	Microsurgury Visibility Background	Ethicon, Inc			1978-10-24
K781543	Orbiograph	Sonometrics Systems, Inc.	HLT	Class II	1978-10-24
K781534	Surg-O-Pak Prep Pad	Convertors	KKX	Class II	1978-10-24
K781511	Lectroswitch Model E2502b	Medtronic, Inc.	GEI	Class II	1978-10-24
K781510	Disposable Lectroswitch, Model E2503	Medtronic, Inc.	GEI	Class II	1978-10-24
K781459	Monoject Scale Magnifier	Sherwood Medical Industries	HJY	Class I	1978-10-24
K781453	Model 770 Argon Laser	Spectra-Physics, Inc.	GEX	Class II	1978-10-24
K781452	Baylow Visual Acuity Tester	Cerenovus, Inc.	HOX	Class I	1978-10-24
K781392	Cytomegilish Test Kit	Microbiological Assoc.	GOK	Class II	1978-10-24
K781333	Central Catheter Tray	Argon Medical Corp.	KGC	Class II	1978-10-24
K781156	Dialysis Sys., Pds 400 & Ro 400	Physio Control, Inc.	DJC	Class II	1978-10-24
K780959	Mueller Hinton Agar with Thymidine	Pittsburgh Micro-Media, Inc.	JTZ	Class II	1978-10-24
K780958	Mueller Hinton Agar with 5% Sheep Blood	Pittsburgh Micro-Media, Inc.	JTZ	Class II	1978-10-24
K781669	Respiratory Exercisor, Volume Pulse	BD Becton Dickinson Vacutainer Systems Preanalytic	BWF	Class II	1978-10-23