# K161613: Hang&Go PAC

- Pathway: 510(k) (Traditional)
- Applicant: Rand S.R.L.
- Decided: Dec 28, 2016 after 201 days
- Product code: LGZ (Warmer, Thermal, Infusion Fluid)
- 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
Longest line of descent: 3 generations back to K993330 (1999). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120026: Performer HT/ Hang&GO HT Basic, Rand S.R.L. (2012) Summary page 4.

## Recalls of this device
- Apr 30, 2021 · Class II · Z-2048-2021: The sterilization contractor informed the company of a quality issue possibly affecting the sterilization process of a certain number of products. It was determined that some lots may not be sterile.

## Indications for use
Disposable device intended to recirculate, filtrate and perfuse physiologically compatible sterile solution (i.e. saline solution) in the thoracic or abdominal cavity. The device is intended for use in a single procedure.

Source page: https://510kreport.com/device/K161613
Methodology: https://510kreport.com/methodology