# K940555: Sandoz Nutrition Compat Enteral Feed Pump W/Hydration

- Pathway: 510(k) (Traditional)
- Applicant: Sandoz Nutrition
- Decided: Feb 1, 1995 after 359 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.
13 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K080340: Compat Dualflo Enteral Delivery Pump Set with Spikeright Piercing Spike and 1000 ML Waer Bag (2008), 10 descendants of its own
- K140581: Cedic Enteral Distal End Enfit Transition Connector, Cedic Enteral Enfit Transition Connector for Medication Port (2014), 8 descendants of its own
- K150034: AMT Enteral Transition Adapters (2015), 1 descendant of its own
- K011587: Sentinel Enteral Feeding Pump, LH2001 Enteral Feeding Pump (2001), 1 descendant of its own
- K253268: Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap (2026), 0 descendants of its own

## Recalls of this device
- Jan 27, 2003 · Not classified · Z-0609-03: Some of the sets may leak or disconnect near the pump adapter during use. The patient could ingest air and vomit causing a safety concern.

Source page: https://510kreport.com/device/K940555
Methodology: https://510kreport.com/methodology