# K100705: Zyno Z-800 Infusion System Model Z-800

- Pathway: 510(k) (Abbreviated)
- Applicant: Zyno Medical, LLC
- Decided: Jul 8, 2010 after 118 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 8 (5 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K950766 (1995). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071545: Z-800 Volumetric  Infusion Pump, Zyno Medical, LLC (2007) Summary page 1.
- K003029: Infusomat P, B.Braun Medical, Inc. (2000) Summary page 1.
- K950766: Sigma 8000 and Sigma 8002, Sigma Intl. General Medical Apparatus, Inc. (1995) Summary page 1.
- K991501: Acclaim Infusion Pump, Abbott Laboratories (1999) Summary page 1.

## Most influential descendants
- K130690: Z-800 Infusion System (2013), 0 descendants of its own

## 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 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 system is intended to provide intravenous infusion of parenteral fluids, blood and blood products to a human patient under the direction or supervision of physician or other certified health care professional.

Source page: https://510kreport.com/device/K100705
Methodology: https://510kreport.com/methodology