EMXClass I

Balloon, Epistaxis

21 CFR 874.4100 / Ear, Nose, Throat

EMX is the FDA product code for Balloon, Epistaxis, a class I device type, regulated under 21 CFR 874.4100. As of 2026-09-10, FDA records hold 47 510(k) clearances under this code, the most recent dated 2022-11-14, and 4 recalls.

Classification record

Product code: EMX
Device name: Balloon, Epistaxis
Regulation: 21 CFR 874.4100
Device class: Class I
Review panel: Ear, Nose, Throat
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 47
Ingested recalls: 4

Clearances, product code EMX

By decision year

47 clearances under product code EMX with a decision year between 1978 and 2022, 1997 the highest year at 9.

Show the numbers

510(k) clearances under FDA product code EMX by decision year
Year	Clearances
1978	2
1980	1
1981	1
1982	1
1984	1
1990	4
1991	2
1992	2
1993	3
1994	3
1995	6
1996	4
1997	9
1998	1
1999	3
2000	2
2004	1
2022	1

Applicants with the most clearances

Product code EMX

Applicants holding the most 510(k) clearances under product code EMX
Applicant	Clearances
Summit Medical, LLC	5
Ultracell Medical Technologies, Inc.	5
Boston Medical Products, Inc.	4
Bivona Medical Technologies	2
Invotec International, Inc.	2
Les Laboratorires Brothier, S.A.	2
Merocel Corp.	2
Smith & Nephew Richards, Inc.	2
Surgitrend, Ltd.	2
American Custom Medical, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 44 companies shown, in name order