# MEA: Pump, Infusion, Pca

- Device class: 2; regulation: 21 CFR 880.5725; FDA's rule: 510(k) required
- FDA decisions: 31
- Recalls: 30 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2000: 2
- 2002: 2
- 2003: 6
- 2004: 3
- 2005: 1
- 2008: 1
- 2009: 1
- 2013: 1
- 2016: 1
- 2017: 2

## Most-cited predicates
- K002434: Palm Pump (2000), cited by 4
- K032233: Medley Pca Module, Model 8120 (2003), cited by 3
- K022203: Abbott Lifecare Pca 3 Infuser, Model 12384 (2002), cited by 3
- K042800: Lifecare Pca Infusion System with Hospira Mednet Software (2004), cited by 3
- K051253: Modification to: Multirate Infusor SV )with and Without PCM), Multirate Infusor LV (with and Without PCM) (2005), cited by 2
- K170982: CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM) (2017), cited by 2
- K982839: Cadd-Legacy Pca Ambulatory Infusion System, Model 6300 (1998), cited by 2
- K943310: Model 6100 Ambulatory Infusion System (1995), cited by 2
- K072144: Cadd -Solis Ambulatory Infusion Pump and Cadd -Solis Medication Safety Software - Administrator (2008), cited by 2
- K934551: Verifuse  Ambulatory Pump (1994), cited by 1

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