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 3207 of 3528

510(k) clearances, page 3207 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K822414	Tracor Ra400 Audiometer	Tracor Instruments, Inc.	EWO	Class II	1982-08-30
K822412	Reinforcing Pin	Filhol	EBL	Class I	1982-08-30
K822282	Fiberoptic Light Carriers	Kelleher Corp.	EQH	Class I	1982-08-30
K822280	ENT Knife Handles	Kelleher Corp.	KTG	Class I	1982-08-30
K822274	Myle's Guillotine	Kelleher Corp.	KBO	Class I	1982-08-30
K822273	ENT Currettes	Kelleher Corp.	JYG	Class I	1982-08-30
K822261	Laryngeal Mirrors	Kelleher Corp.	KAI	Class I	1982-08-30
K822205	Knives, ENT	Kelleher Corp.	KTG	Class I	1982-08-30
K822196	Ear Scissors	Kelleher Corp.	JZB	Class I	1982-08-30
K821979	Sterile Foley Catheterization Kits	Medical Devices Inc.	KNX	Class II	1982-08-30
K821025	Neodontics Dental Implant	Neodontics Inc	DZE	Class II	1982-08-30
K822446	Aes Stockings	Rampon Products	DWL	Class II	1982-08-27
K822401	St. Mark's Rectal Biopsy Forceps	Keymed, Inc.	KOA	Class I	1982-08-27
K822381	Syva Lab Processor 6000	Syva Co.	JQP	Class I	1982-08-27
K822365	Centurion Skin Staple Remover	Tri-State	GDT	Class I	1982-08-27
K822359	Spi-Rise	Certified Respiratory Services, Inc.	BWF	Class II	1982-08-27
K822318	Argyle Mediastinal Drain	Sherwood Medical Co.	GBS	Class I	1982-08-27
K822312	Raichem Ldh-L Reagent	Reagents Applications, Inc.	CFJ	Class II	1982-08-27
K822291	Quantimune Htsh Irma	Bio-Rad	JLW	Class II	1982-08-27
K822286	Autocuff (Photos Enclosed with 510K	Partamed, Inc.	KZD	Class I	1982-08-27
K822283	Ts-000 Arteriovenous Blood Tubing Set	Extracorporeal Medical Specialities, Inc.	KOC	Class II	1982-08-27
K822278	ENT Forceps	Kelleher Corp.	GEN	Class I	1982-08-27
K822251	Examination & Treatment Chairs	Kelleher Corp.	GBB	Class I	1982-08-27
K822233	Abt 4000 Ventilator	Kontron Instruments, Inc.	CBK	Class II	1982-08-27
K822209	Autolancet	BD Becton Dickinson Vacutainer Systems Preanalytic	FMK	Class II	1982-08-27
K822208	Cavro Iq-190 Sample Processor	Cavro Scientific Instruments, Inc.	JQW	Class I	1982-08-27
K822194	Endoscopic Sponge Carrier	Kelleher Corp.	FGS	Class II	1982-08-27
K822181	Binocular Oper. Microscopes & Accessor	Kelleher Corp.	FSO	Class I	1982-08-27
K822125	Model 57000 Naso-Conjunctiva Isol. Mask	Welch Allyn Inc			1982-08-27
K822099	Biorem 2000	Biorem	LIL	Unclassified	1982-08-27
K822050	Stirring Assembly for Digispec X Spectro	Helena Laboratories, Corp.	JJQ	Class I	1982-08-27
K821999	Endoscopic Sclerotherapy Balloon	Retech	GCP	Class II	1982-08-27
K821975	Ortho*-Bi-Level Assayed Whole Blood Tox	Ortho Diagnostic Systems, Inc.	DIF	Class I	1982-08-27
K821949	Ortho* Alternative Pathway Compl. Test	Ortho Diagnostic Systems, Inc.	DAK	Class II	1982-08-27
K821941	Rheumatoid Factor Reference Prepara.	Armkel, LLC	DHR	Class II	1982-08-27
K821150	Nu-Gauze Sponge	Johnson & Johnson Professionals, Inc.	EFQ	Unclassified	1982-08-27
K822392	Myocur Blade Pac	Myocure, Inc.	HMN	Class III	1982-08-25
K822382	U.v.a.c. Handler Set	American Hospital Supply	HHK	Class II	1982-08-25
K822377	Haemophilus Id Plate	Granite Diagnostics, Inc.	JSH	Class I	1982-08-25
K822347	Lidocaine Fluorescent Immunoassay	American Diagnostic Corp.	KLR	Class II	1982-08-25
K822344	Antimicrobial Removal Device (Ard)	Marion Laboratories, Inc.	LJF	Class I	1982-08-25
K822292	Disposable Dispensing-Spread Pipets	American Dade	LIB	Class I	1982-08-25
K822279	Lancets for Ear Surgery	Kelleher Corp.	KTG	Class I	1982-08-25
K822277	Rosen's Stapes Needle Explorer	Kelleher Corp.	KAK	Class I	1982-08-25
K822262	Adenotomes	Kelleher Corp.	KBH	Class I	1982-08-25
K822258	Esophageal Bougies	Kelleher Corp.	KCD	Class I	1982-08-25
K822255	Rigid Suction Tips	Kelleher Corp.	KTR	Class II	1982-08-25
K822253	Rasps	Kelleher Corp.	JYY	Class I	1982-08-25
K822238	Disposable Taiyang Syringe	S.D. Sunnyland Enterprises, Inc.	FMF	Class II	1982-08-25
K822199	Ear Snares	Kelleher Corp.	JZD	Class I	1982-08-25