# K981541: Clearstar Enteral Nutrition Pump

- Pathway: 510(k) (Traditional)
- Applicant: Frantz Medical Development, Ltd.
- Decided: Aug 13, 1998 after 106 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K060316: Compat GO Enteral Feeding Pump and Administration Sets (2006), 0 descendants of its own

## Recalls of this device
- Jun 21, 2007 · Not classified · Z-1142-2007: The transducer adapter bracket on the pump could crack or break and potentially result in under delivery of the enteral product.

## Indications for use
The ClearStar pump can be used for adult and pediatric patients provided the patients can tolerate a feeding range within the pump operational specifications. Those specifications are: * The flow rate range is 1-300 mL/hr in 1 mL/hr increments * The flow rate accuracy is ± 10% or ± 0.5 mL/hr, whichever is greater * The occlusion pressure limit is 26-30 psi. If these specifications are not appropriate for a given patient, the ClearStar pump should not be used. Precautions All enteral pumps have the potential to bolus-feed or over deliver, which is an important consideration in feeding volume-sensitive patients. In these patients, a volume of product no more than four times the hourly feeding rate should be hung. Confirm proper placement and function. Confirm proper placement and function of patient’s enteral feeding tube (nasogastric, jejunostomy, gastrostomy, etc.), and verify the following before initiating feeding: A ClearStar Pump Set is being used. Cassette is properly seated in pump. When on AC power, pump is fully seated in charger. Flow rate is set at the prescribed mL/hr. Pump dial is turned to RUN. Note: The Power Supply Cord is the DISCONNECT DEVICE.

Source page: https://510kreport.com/device/K981541
Methodology: https://510kreport.com/methodology