# FPD: Tube, Feeding

- Device class: 2; regulation: 21 CFR 876.5980; FDA's rule: 510(k) required
- FDA decisions: 59
- 510(k) review time 2021–2025: median 51 days (middle half 51–51)
- Recalls: 6 (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)
- 2006: 1
- 2007: 1
- 2008: 4
- 2009: 4
- 2010: 4
- 2011: 2
- 2012: 1
- 2013: 2
- 2019: 1
- 2024: 1

## Most-cited predicates
- K060944: Nutrisafe 2 (2006), cited by 7
- K072881: NEOMED Enteral FEEDING TUBE (2008), cited by 3
- K083210: Corflo Anti IV Enteral Feeding Tube (2008), cited by 3
- K082238: Neomed Polyurethane Feeding Tube (2008), cited by 2
- K083786: Corflo Anti-IV Enteral Feeding Extension Set, Models 20-1006AIV-LB and 20-1030AIV-LB (2009), cited by 2
- K100099: Oral/Enteral Syringes (2010), cited by 2
- K131590: Innersense Esophageal Temperature Probe / Feeding Tube (2013), cited by 1
- K180236: VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES) (2019), cited by 1
- K972437: Ross Enteral Feeding Tube (1998), cited by 1
- K083791: Corflo Anti IV Enteral Feeding Set, Model: 20-1060AIV-S (2009), cited by 1

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