# LHI: Set, I.V. Fluid Transfer

- Device class: 2; regulation: 21 CFR 880.5440; FDA's rule: 510(k) required
- FDA decisions: 207
- 510(k) review time 2021–2025: median 215 days (middle half 90–285)
- Recalls: 49 (6 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 5
- 2018: 1
- 2019: 4
- 2020: 3
- 2021: 3
- 2022: 6
- 2023: 5
- 2024: 9
- 2025: 6
- 2026: 2

## Most-cited predicates
- K980381: Phaseal, Closed System Forhandling of Parenteral Drugs, Additional Administration Devices. C80 Infusion Adapter, A10 Pro (1998), cited by 7
- K001293: Modification to Mixject Dispensing Pin/with Detachable Vial Holder/with Detachable Vial Holder and Pre-Attached Needle (2000), cited by 7
- K925401: IV Fluid Transfer Pin (1993), cited by 6
- K963583: Mixject Dispensing Pin/with Detachable Vial Holder/with Detachable Vial Holder and Preattached Needle (1996), cited by 6
- K001368: Protector 21, Protector 50, Protector 14, Injector Luer Lock, Infusion Adapter (2000), cited by 5
- K002705: Exacta-Mix 2400 Compounding System, Model Exacta-Mix 2400 (2001), cited by 5
- K040456: Fleboset Multiple (2004), cited by 5
- K171796: Vial Adapter 15mm (2017), cited by 4
- K013087: Single Dose Dispensing Pin, Model 2201 (2001), cited by 4
- K201415: Vial2Bag Advanced 20mm Admixture Device (2020), cited by 4

Source page: https://510kreport.com/product-code/LHI
Data by year (CSV): https://510kreport.com/product-code/LHI.csv