# K153193: Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)

- Pathway: 510(k) (Abbreviated)
- Applicant: Zyno Medical, LLC
- Decided: Aug 30, 2016 after 301 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 5 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K832284 (1983). 13 ancestors in all.
No later device cites it as a predicate yet.
4 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140783: Halo Ambulatory Infusion System, Zyno Medical, LLC (2014) Summary page 4.
- K111275: Cadd Solis Vip Ambulatory Infusion Pump and Cadd Solis Medication Safety Software, Smiths Medical Asd, Inc. (2013) Summary page 4.
- K120685: Zyno Medical Administration Set, Zyno Medical, LLC (2012) Summary page 4.

## Recalls of this device
- Apr 18, 2024 · Class I · Z-1811-2024: Nimbus II Plus, Infusion Pump Systems, manufactured by InfuTronix, are being removed the from the market due to multiple potential failure modes, including battery failure, upstream occlusion, system 
- Feb 21, 2024 · Class I · Z-1285-2024: InfuTronix is removing the Nimbus Infusion Pump Systems from the market due to multiple potential failure modes, including battery failure, upstream occlusion, system errors, drug product leakage, hig
- Feb 21, 2024 · Class I · Z-1286-2024: InfuTronix is removing the Nimbus Infusion Pump Systems from the market due to multiple potential failure modes, including battery failure, upstream occlusion, system errors, drug product leakage, hig
- Oct 19, 2021 · Class II · Z-0832-2022: An unreleased Version 4 Protocol Library was installed on Nimbus PainPro (H) infusion pumps in error that may impact patient safety if used on patients.
- May 28, 2019 · Class II · Z-2055-2019: Potential for tube leakage

## Indications for use
The Halo II Ambulatory Infusion System is intended to deliver medications and/or fluids to a patient under the direction or supervision of physician or other certified healthcare professional in clinical or nonclinical environments, such as homes. The device is intended for subcutaneous, percutaneous, perineural, epidural and intravenous infusion, including but not limited to patient controlled analgesia (PCA) delivery.

Source page: https://510kreport.com/device/K153193
Methodology: https://510kreport.com/methodology