# K944669: Flexiflo Quantum Enteral Pump

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Mfg., Inc.
- Decided: Jul 24, 1995 after 314 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Aug 11, 2009 · Not classified · Z-0013-2010: Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.
- Oct 7, 2005 · Not classified · Z-0145-06: Pumps have the potential to malfunction and result in a significant over-under delivery of enteral formula.
- Aug 18, 2004 · Not classified · Z-0570-05: Pumps were manufactured with an incorrect circuit board that may cause an increase in the feed rate and flush frequency of fluids.

Source page: https://510kreport.com/device/K944669
Methodology: https://510kreport.com/methodology