LHIClass II

Set, I.V. Fluid Transfer

21 CFR 880.5440 / General Hospital

LHI is the FDA product code for Set, I.V. Fluid Transfer, a class II device type, regulated under 21 CFR 880.5440. As of 2026-09-10, FDA records hold 206 510(k) clearances under this code, the most recent dated 2026-06-12, and 61 recalls.

Classification record

Product code: LHI
Device name: Set, I.V. Fluid Transfer
Regulation: 21 CFR 880.5440
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: 206
Ingested recalls: 62

Clearances, product code LHI

By decision year

206 clearances under product code LHI with a decision year between 1981 and 2026, 1985 the highest year at 12.

Show the numbers

510(k) clearances under FDA product code LHI by decision year
Year	Clearances
1981	1
1982	1
1983	5
1984	2
1985	12
1986	7
1987	1
1988	2
1989	3
1990	10
1991	5
1992	6
1993	5
1994	5
1995	1
1996	8
1997	9
1998	3
1999	2
2000	6
2001	4
2002	5
2003	3
2004	7
2005	4
2006	2
2007	3
2008	4
2009	8
2010	5
2011	3
2012	5
2013	4
2014	6
2015	3
2016	3
2017	5
2018	1
2019	4
2020	3
2021	3
2022	5
2023	5
2024	9
2025	6
2026	2

Applicants with the most clearances

Product code LHI

Applicants holding the most 510(k) clearances under product code LHI
Applicant	Clearances
West Pharma. Services IL, Ltd.	16
Baxter Healthcare Corporation	12
B.Braun Medical, Inc.	9
Abbott Medical	8
Yukon Medical, LLC	8
Baxa Corp., Sub. of Cook Group, Inc.	7
Carmel Pharma AB.	7
Laboratorios Grifols, S.A.	7
Acacia, Inc.	5
Excel Medical, Inc.	4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 137 companies shown, in name order