FMIClass II

Needle, Hypodermic, Single Lumen

21 CFR 880.5570 / General Hospital

FMI is the FDA product code for Needle, Hypodermic, Single Lumen, a class II device type, regulated under 21 CFR 880.5570. As of 2026-09-10, FDA records hold 693 510(k) clearances under this code, the most recent dated 2026-08-25, and 309 recalls.

Classification record

Product code: FMI
Device name: Needle, Hypodermic, Single Lumen
Regulation: 21 CFR 880.5570
Device class: Class II
Review panel: General Hospital
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 694
Ingested recalls: 311

Clearances, product code FMI

By decision year

694 clearances under product code FMI with a decision year between 1976 and 2026, 1994 the highest year at 56.

Show the numbers

510(k) clearances under FDA product code FMI by decision year
Year	Clearances
1976	1
1977	8
1978	1
1979	5
1980	4
1981	3
1982	7
1983	12
1984	22
1985	8
1986	14
1987	14
1988	16
1989	13
1990	12
1991	15
1992	6
1993	10
1994	56
1995	31
1996	22
1997	25
1998	19
1999	9
2000	18
2001	24
2002	8
2003	6
2004	11
2005	16
2006	12
2007	15
2008	10
2009	7
2010	15
2011	12
2012	17
2013	11
2014	14
2015	10
2016	20
2017	8
2018	20
2019	12
2020	10
2021	18
2022	23
2023	18
2024	3
2025	11
2026	12

Applicants with the most clearances

Product code FMI

Applicants holding the most 510(k) clearances under product code FMI
Applicant	Clearances
Becton Dickinson & Co	22
BD Becton Dickinson Vacutainer Systems Preanalytic	20
Teleflex Medical	17
Terumo Europe N.V.	15
Sherwood Medical Co.	13
Abbott Medical	13
Promisemed Hangzhou Meditech Co.,Ltd.	12
Novo Nordisk a/S	10
Baxter Healthcare Corporation	8
Ypsomed AG	8

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 400 companies shown, in name order