FDA product code LHI: Set, I.V. Fluid Transfer
LHI is the FDA product code for set, i.v. fluid transfer. It is a Class II device, regulated under 21 CFR 880.5440 and reviewed by the General Hospital panel. FDA has cleared 206 510(k) submissions under LHI, 27 in the last five years, from 105 different applicants. The average 510(k) review took 124 days (median 89); 181 days on average over the last three years. FDA has posted 62 recalls for LHI devices, 12 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Set, I.V. Fluid Transfer |
| Device class | Class II |
| Regulation | 21 CFR 880.5440 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for LHI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 5 | 130 |
| 2018 | 1 | 199 |
| 2019 | 4 | 258 |
| 2020 | 3 | 196 |
| 2021 | 3 | 364 |
| 2022 | 5 | 264 |
| 2023 | 5 | 138 |
| 2024 | 9 | 154 |
| 2025 | 6 | 193 |
| 2026 | 2 | 196 |
Compare with all 510(k) review times · Search every LHI clearance
Top LHI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medimop Medical Projects, Ltd. | 11 | 2016-05-04 |
| Baxter Healthcare Corp | 10 | 2004-10-08 |
| B.Braun Medical, Inc. | 9 | 2020-12-09 |
| Laboratorios Grifols, S.A. | 7 | 2017-10-19 |
| Carmel Pharma Ab. | 7 | 2011-04-12 |
100 more applicants have LHI clearances. See the full list in Caduvo.
Most recent LHI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252987 | Epic Medical Pte. , Ltd. | ADRx Admixture Device | 2026-06-12 | 267 |
| K260301 | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | Vial Adapter | 2026-06-05 | 126 |
| K250345 | Medline Industries, LP | Medline Bag Decanter | 2025-10-24 | 260 |
| K251715 | Asset Medikal | FlowArt® Vial Access Device Vented | 2025-10-14 | 132 |
| K251676 | Microtek Medical, LLC | Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S) | 2025-09-16 | 109 |
Recalls for LHI devices
62 product recalls in 35 recall events; 12 initiated in the last five years and 11 still open. Most recent: 2026-08-20.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 7 |
| 2019 | 1 |
| 2022 | 3 |
| 2023 | 2 |
| 2024 | 5 |
| 2025 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code LHI?
LHI is the FDA product code for set, i.v. fluid transfer. It is a Class II device, regulated under 21 CFR 880.5440 and reviewed by the General Hospital panel.
What device class is LHI?
Class II, regulation 21 CFR 880.5440. Typical premarket route: 510(k).
How long does a 510(k) take for product code LHI?
Across 206 cleared submissions the average was 124 days from receipt to decision (median 89).
Which companies have the most LHI clearances?
Medimop Medical Projects, Ltd. (11); Baxter Healthcare Corp (10); B.Braun Medical, Inc. (9); Laboratorios Grifols, S.A. (7); Carmel Pharma Ab. (7).
Have LHI devices been recalled?
Yes: 62 product recalls across 35 recall events; the most recent began 2026-08-20.
Next steps
- Run an FDA pathway report with predicate devices for product code LHI
- Run a recall and safety report across every LHI manufacturer
- Watch product code LHI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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