# K140783: Halo Ambulatory Infusion System

- Pathway: 510(k) (Abbreviated)
- Applicant: Zyno Medical, LLC
- Decided: Oct 17, 2014 after 200 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K832284 (1983). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
4 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982839: Cadd-Legacy Pca Ambulatory Infusion System, Model 6300, Sims Deltec, Inc. (1998) Summary page 4.
- K033325: Ambit Continuous Ambulatory Infusion Pump, Sorenson Medical, Inc. (2003) 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.

## Most influential descendants
- K153193: Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System) (2016), 0 descendants of its own

## Recalls of this device
- 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

## Indications for use
The Halo 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. The device is intended for subcutaneous, perineural, epidural and intravenous infusion. The device is intended for 240 hours or1500mL of infusion, whichever limit is reached first.

Source page: https://510kreport.com/device/K140783
Methodology: https://510kreport.com/methodology