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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3183 of 3528

510(k) clearances, page 3183 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K823054	Drape, Surgical Angiography	Triad Medical Division	KKX	Class II	1983-01-12
K823049	Engstrom Eliza CO2 Analyzer	Lkb Instruments, Inc.	CCK	Class II	1983-01-12
K822925	Boundary Single-Use Gowns	The Buckeye Cellulose Corp.	FYA	Class II	1983-01-12
K821717	Gore-Tes Expanded PTFE Patch	W. L. Gore & Associates, Inc.	DXZ	Class II	1983-01-12
K830134	Q-Check Reagent Standards	Lab Ability, Inc.	LJG	Class I	1983-01-09
K823924	Model Sse4 Electrosurgical Generator	Medtronic, Inc.	GEI	Class II	1983-01-09
K823902	Eagle Steriset	American Sterilizer Co.	FRG	Class II	1983-01-09
K823888	3M Frascia Stapling System	3M Company	GEF	Class I	1983-01-09
K823851	Orthodaptic* Bonding Adhesive	Johnson & Johnson Professionals, Inc.	DYH	Class II	1983-01-09
K823818	Catheter Holder	Danek Medical, Inc.	KOD	Class II	1983-01-09
K823785	Api Mds*	Analytical Products, Inc.	JQP	Class I	1983-01-09
K823721	Flow-Pac Ldh Reagent Set	Amresco, Inc.	CFJ	Class II	1983-01-09
K823676	Disc Needle Set #Tx-8220	Today'S Machining & Design, Inc.	EMI	Class I	1983-01-09
K823673	Lite Guard	Devon Industries, Inc.			1983-01-09
K823671	No-Gauze Laparotomy Sponge	Surgilite Intl., Inc.	GDY	Class I	1983-01-09
K823480	Il 943 Flame Photometer	Instrumentation Laboratory Co.	JJO	Class I	1983-01-09
K823300	Bun-Un Centrifichum 500, #65080/81	EMD Millipore Corporation	CDQ	Class II	1983-01-09
K823768	Clirans Te08 Hollow Fiber Dialyzer	Terumo Medical Corp.	HRN	Class II	1983-01-08
K823767	Erg-Jet Electrode	Life-Tech Intl., Inc.	HLF	Class I	1983-01-08
K823452	Electrode Lead of Silicone Elastometer	Telectronics, Inc.	DTB	Class III	1983-01-08
K823388	TENS Max	Fujisawa Electronics Co.	GFK	Class II	1983-01-08
K823291	Communitrach Tube	Implant Technology, Inc.	BTO	Class II	1983-01-08
K823242	Programalith Programmer	Pacesetter Systems	KNG	Class II	1983-01-08
K822857	Cpi Printer	Cardiac Pacemakers, Inc.	KAG	Class I	1983-01-08
K827819	Laser Photocoagulator	American Laser Corp.			1983-01-07
K823800	Azlocillin 75Mcg Sensi-Disc	BD Becton Dickinson Vacutainer Systems Preanalytic	JTN	Class II	1983-01-07
K823789	Elastic Compression Anklet	Orthopaedic Resources Corp.	FQL	Class I	1983-01-07
K823778	Gamma Sterilized Capillary Flow Dialyz	Travenol Laboratories, S.A.	KOC	Class II	1983-01-07
K823777	Sterile, Dispos. Spike Protector-5C4138	Travenol Laboratories, S.A.	FKX	Class II	1983-01-07
K823749	Low Pressure Blom-Singer Voice Prosthes	Bivona Medical Technologies	EWL	Class II	1983-01-07
K823745	Advance Emit-AED Ethosuximide	Syva Co.	DLF	Class II	1983-01-07
K823741	Advance Emit-AED Primedone Assay	Syva Co.	LFT	Class II	1983-01-07
K823738	Gram Negative Bacterial Identif- Panels	Micro-Media Systems, Inc.	JTO	Class I	1983-01-07
K823720	Spectrophotometer	Macomb Chemical Co.	JJQ	Class I	1983-01-07
K823714	Disposable Non-Rebreathing Anes. Circuit	Marquest Medical Products, Inc.	CAI	Class I	1983-01-07
K823709	Triglyceride Reagent (UV)	Gilford Diagnostics	CDT	Class I	1983-01-07
K823706	Ats Afb Stain Control Slide	Alpha-Tec Systems, Inc.	LJG	Class I	1983-01-07
K823705	Ats Parasitology Stain Control Slide	Alpha-Tec Systems, Inc.	LJG	Class I	1983-01-07
K823704	Ats Gram Stain Control Slide	Alpha-Tec Systems, Inc.	LJG	Class I	1983-01-07
K823703	Esophageal Stethoscope	Rsp, Inc.	BZW	Class I	1983-01-07
K823702	Epidural Catheter	Rsp, Inc.	BSO	Class II	1983-01-07
K823694	Vascu-Statt Approximator	Scanlan Intl., Inc.	HRQ	Class I	1983-01-07
K823692	Spinal Needle	Ocean Medical Products, Ltd.	BSP	Class II	1983-01-07
K823691	Phosphorus Reagent Set	Omega Medical Electronics	CEO	Class I	1983-01-07
K823687	Bio Interference Blanking Material	American Monitor Corp.	JJX	Class I	1983-01-07
K823682	Beta Ffirm Test	Organon LLC	JHJ	Class II	1983-01-07
K823679	Nml 6000 CT	Nuclear Medical Laboratories, Inc.	JQP	Class I	1983-01-07
K823580	Cobas Reagent for Inorganic Phosphorus	Hoffmann-La Roche, Inc.	CEO	Class I	1983-01-07
K823579	Cobas Reagent for Total Protein	Hoffmann-La Roche, Inc.	CEK	Class II	1983-01-07
K823578	Cobas Standards for Calcium-in-Organic	Hoffmann-La Roche, Inc.	CIO	Class II	1983-01-07