# FRN: Pump, Infusion

- Device class: 2; regulation: 21 CFR 880.5725; FDA's rule: 510(k) required
- FDA decisions: 849
- 510(k) review time 2021–2025: median 207 days (middle half 82–323)
- Recalls: 485 (37 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: 3
- 2018: 3
- 2019: 2
- 2020: 1
- 2021: 2
- 2022: 6
- 2023: 7
- 2024: 5
- 2025: 8
- 2026: 2

## Most-cited predicates
- K030459: Medley System with Medication Management System (MMS) (2003), cited by 9
- K896422: Burron Ambulatory Drug Delivery System (1990), cited by 8
- K972284: Fluid Management System (1997), cited by 6
- K923875: Sidekick 50 Plus and Sidekick 100 Plus (1993), cited by 6
- K042081: Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3 Infusion System with Hospira Mednet Software (2004), cited by 6
- K994374: Soaker Catheter (2000), cited by 6
- K011975: Horizon Outlook with Dosecom (2001), cited by 5
- K915522: Flo-Gard (R) 6201 (1992), cited by 5
- K173084: Spectrum IQ Infusion System, Dose IQ Safety Software (2018), cited by 5
- K123049: Sapphire Infusion Pump (2013), cited by 5

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