# K071545: Z-800 Volumetric  Infusion Pump

- Pathway: 510(k) (Traditional)
- Applicant: Zyno Medical, LLC
- Decided: Oct 31, 2007 after 147 days
- Product code: FRN (Pump, Infusion)
- 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.
2 later devices descend from it; 1 cites it directly.
2 of 3 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
- K100705: Zyno Z-800 Infusion System Model Z-800 (2010), 1 descendant of its own
- K130690: Z-800 Infusion System (2013), 0 descendants of its own

## Recalls of this device
- Jun 13, 2011 · Class II · Z-1024-2013: Update Instruction For Use for Preventative Maintenance (PM) Schedule and addition of Odometer software to monitor accumulative fluid volume infused by the pump

## Indications for use
The Z-800 Infusion pump is intended to provide accurate delivery of parenteral fluids to a human patient under the direction or supervision of physician or other certified health care professional.

Source page: https://510kreport.com/device/K071545
Methodology: https://510kreport.com/methodology