# K913958: Flexiflo Quantum Enteral Nutrition Pump

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Feb 7, 1992 after 155 days
- Product code: LZH (Pump, Infusion, Enteral)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 1 (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
- Sep 4, 2009 · Not classified · Z-2252-2009: The firm initiated this voluntary recall because some of its Flexiflo Quantum Enteral Pumps, have a 110-volt AC power cord plug that may crack or fail. This potential power cord plug failure may cause

Source page: https://510kreport.com/device/K913958
Methodology: https://510kreport.com/methodology