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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2712 of 3530

510(k) clearances, page 2712 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K882713	Rebuilding Sterilizers	Mdt Corp., Inc.	FLE	Class II	1988-08-12
K882578	Astra Dental Implant System	Astra Meditec AB	DZE	Class II	1988-08-12
K882482	Triad Orthodontic Gel	Dentsply Intl.	EBI	Class II	1988-08-12
K882221	Over the Needle Catheter, Arterial Catheter Needle	Argon Medical Corp.	DYB	Class II	1988-08-12
K882197	Minimon 7131B Patient Monitor	Kontron Instruments, Inc.	DPS	Class II	1988-08-12
K882158	Modified Toray Filtryzer Dialyzers	Toray Industries (America), Inc.	FJI	Class II	1988-08-12
K882137	Extended Shelf Life for Intersept* Arterial 20/40	Medtronic Blood Systems, Inc.	DTM	Class II	1988-08-12
K882102	Provider One Infusion System	Pancretec, Inc.	FRN	Class II	1988-08-12
K881723	Genesis II 7.5Mhz Ultrasound Transducer	Biosound, Inc.	JOP	Class II	1988-08-12
K881667	Kendall Curity & Kenguard Red Rubber Urethral Cath	The Kendal Co.	GBM	Class II	1988-08-12
K880830	Sentorr Arterial Pressure Sensor	GE Healthcare	DXO	Class II	1988-08-12
K874749	Binax Equate Glycohemoglobin	Binax, Inc.	LCP	Class II	1988-08-12
K874544	Snap(r) Campylobacter Culture Ident Diagnostic Kit	Molecular Biosystems, Inc.	LGO	Class I	1988-08-12
K882690	Imprint Vinyl Polysiloxane Impression Material	3M Company	ELW	Class II	1988-08-11
K882205	Viewpoint	Philips North America LLC	LLZ	Class II	1988-08-11
K882176	Vtr-12	Eigen	JAA	Class II	1988-08-11
K882136	Intersept* Oxygen Gas Line Filter	Medtronic Blood Systems, Inc.	KRD	Class II	1988-08-11
K882125	Centrix Tri-Laminate Post System	Centrix, Inc.	ELR	Class I	1988-08-11
K882107	Perfusor Secura Syringe Pump	Burron Medical, Inc.	FRN	Class II	1988-08-11
K882106	Perfusor M Syringe Pump	Burron Medical, Inc.	FRN	Class II	1988-08-11
K882047	Entrust(tm) Model 800	Avi, Inc.	FRN	Class II	1988-08-11
K882032	Model 90Dx Multitest Meter	Mesa Medical, Inc.	FLB	Class II	1988-08-11
K881736	Surgitek CO2 Delivery System	Medical Engineering Corp.	FAP	Class II	1988-08-11
K881708	Indicatens 4X4	Acudata Software	GZJ	Class II	1988-08-11
K881678	Self Adhesive Urinary External Cath. W/remove. Tip	Hollister, Inc.	KNX	Class II	1988-08-11
K881665	Omnitron Remote Controlled Radionuclide Applicator	Omnitron Intl., Inc.	JAQ	Class II	1988-08-11
K881624	Pleural Biopsy Punch Needle	E.G. Dick & Assoc.	GDM	Class I	1988-08-11
K881480	First American, Radionic, Jkr, Model Ac	JKR Laboratories, Inc.	ESD	Class I	1988-08-11
K881017	Dps-33,000 with Centor Option	Philips North America LLC	LLZ	Class II	1988-08-11
K880767	Mic Needle Jejunostomy Tube Kit	Medical Innovations, Inc.	KNT	Class II	1988-08-11
K880581	Ambul. Ph & Motility Recorder for Measure of Para.	Synectics-Dantec	FFX	Class II	1988-08-11
K883193	Casf Sterilization Tray	Terray Manufacturing, Inc.	FSM	Class I	1988-08-10
K883125	Casf Sterilization Tray	Terray Manufacturing, Inc.	FSM	Class I	1988-08-10
K883094	Mx350 (Series) Control Syringe	Medex, Inc.	FMF	Class II	1988-08-10
K882883	C-Mask(flat)	Promedica Products, Inc.	FXX	Class II	1988-08-10
K882882	C-Mask	Promedica Products, Inc.	FXX	Class II	1988-08-10
K882744	Effner Illuminated Nasal Tracheostoma Speculum	Effner, Inc.	EOB	Class II	1988-08-10
K882651	Centrix Needletube	Centrix, Inc.	EKJ	Class I	1988-08-10
K882644	Huntleigh Double Bubble Air-O-Pad-Aop5	Huntleigh Technology, Inc.	FNM	Class II	1988-08-10
K881899	Specific Allergen Modules for Alastat(tm) Ige Sys.	Siemens Healthcare Diagnostics Inc.	DHB	Class II	1988-08-10
K881471	Kimguard (Regular & Heavy Duty) Sterile Wrap	Kimberly-Clark Corporation	FRG	Class II	1988-08-10
K881295	Laminaria Curex	Harold W. Berger Co.	HDY	Class II	1988-08-10
K870587	Lasermatic Surgilaser Model 5050	Lasermatic, Inc.	EWG	Class II	1988-08-10
K883074	Elgiloy	Dale T. Dupuis	EBL	Class I	1988-08-09
K882880	Safety, Blood Collection Tube Holder	Ryan Medical, Inc.	FMI	Class II	1988-08-09
K882739	Intertech Large Volume Water Trap (Lvw)	Intertech Resources, Inc.	BYH	Class I	1988-08-09
K882614	Monoject(r) Snap-Over Safety Cap	Sherwood Medical Co.	JKA	Class II	1988-08-09
K882519	X-Ray Marker	Karlin Technology, Inc.	JAC	Class I	1988-08-09
K882448	Multilumen Central Venous Cath. W/vitacuff Device	BD Becton Dickinson Vacutainer Systems Preanalytic	LJS	Class II	1988-08-09
K882375	Hearing Aid, Unitron Model Ui5	Unitron Industries, Inc.	ESD	Class I	1988-08-09