# PHC: Infusion Safety Management Software

- Device class: 2; regulation: 21 CFR 880.5725; FDA's rule: 510(k) required
- FDA decisions: 10
- 510(k) review time 2021–2025: median 326 days (middle half 265–406)
- Recalls: 4 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2014: 2
- 2019: 1
- 2022: 2
- 2023: 1
- 2024: 1
- 2025: 2
- 2026: 1

## Most-cited predicates
- K242117: LifeShield Infusion Safety Software Suite (2025), cited by 1
- K223606: LifeShield™ Infusion Safety Software Suite (2023), cited by 1
- K182092: BD Intelliport System (2019), cited by 1
- K141474: Becton Dickinson Intelliport System (2014), cited by 1

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