# MEB: Pump, Infusion, Elastomeric

- Device class: 2; regulation: 21 CFR 880.5725; FDA's rule: 510(k) required
- FDA decisions: 88
- 510(k) review time 2021–2025: median 161 days (middle half 118–203)
- Recalls: 87 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2006: 6
- 2007: 5
- 2008: 2
- 2009: 1
- 2013: 1
- 2014: 1
- 2016: 1
- 2019: 1
- 2024: 2
- 2026: 1

## Most-cited predicates
- K982946: Painbuster Infusion Kit (1998), cited by 7
- K980558: Painbuster Infusion System (1998), cited by 7
- K040337: I-Flow Elastomeric Pump (on-Q, Painbuster, C-Bloc, Homepump) (2004), cited by 6
- K033039: Modification to: Accufuser, Accufuser Plus, Standard Procedure Kits (2003), cited by 5
- K991543: Intraop Catheter (1999), cited by 5
- K984502: Nerve Block Infusion Kit (1999), cited by 4
- K021964: Alpha Infusion Pump and Catheters (2002), cited by 4
- K063530: ON-Q, Painbuster, C-Bloc, Select-a-Flow, Ondemand, Homepump, Eclipse, C-Series, One-Step Kvo, Easypump (2007), cited by 3
- K151650: SMARTez elastomeric infusion pump (2016), cited by 3
- K023098: Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser Infusion Kit (2002), cited by 3

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