# K130690: Z-800 Infusion System

- Pathway: 510(k) (Special)
- Applicant: Zyno Medical, LLC
- Decided: Jun 12, 2013 after 90 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 9 (5 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K950766 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
3 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100705: Zyno Z-800 Infusion System Model Z-800, Zyno Medical, LLC (2010) Summary page 1.

## Recalls of this device
- May 7, 2025 · Class I · Z-1867-2025: Unreleased software versions were installed on distributed devices without verification or validation.
- May 7, 2025 · Class I · Z-1868-2025: Unreleased software versions were installed on distributed devices without verification or validation.
- May 7, 2025 · Class I · Z-1865-2025: Unreleased software versions were installed on distributed devices without verification or validation.
- May 7, 2025 · Class I · Z-1866-2025: Unreleased software versions were installed on distributed devices without verification or validation.
- Oct 18, 2024 · Class II · Z-0506-2025: Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains.
- Sep 30, 2024 · Class III · Z-0523-2025: For the Z-800WF pumps, the WiFi software was not compatible with the pump software that had been loaded in accordance with ongoing correction Z-1183-2024.
- Sep 13, 2024 · Class I · Z-0005-2025: There is a defect in the air-in-line software algorithm.
- Jun 4, 2024 · Class II · Z-2263-2024: Zyno Medical has found that certain Z800, Z800F, Z800W, and Z800WF pumps have faulty power supply modules that will not provide a charge to the rechargeable battery within the pump. This may lead to t
- Dec 20, 2023 · Class II · Z-1183-2024: When utlizing the patient query feature on the Zyno Medical Z-800WF pumps with software version 5.2.05, the alarm volume may inadvertently revert from a higher volume setting to a low one, causing pot

## Indications for use
The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient under the direction or supervision of physician or other certified health care professional.

Source page: https://510kreport.com/device/K130690
Methodology: https://510kreport.com/methodology