# K163507: Triton Sponge System

- Pathway: 510(k) (Traditional)
- Applicant: Gauss Surgical, Inc.,
- Decided: Apr 25, 2017 after 132 days
- Product code: PBZ (Image Processing Device For Estimation Of External Blood Loss)
- Device class: 2
- Regulation: 21 CFR 880.2750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN130015 (2014). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160338: Triton System, Gauss Surgical, Inc., (2016) Summary page 4.

## Most influential descendants
- K232250: SurgiCount+ System (2024), 1 descendant of its own
- K252282: SurgiCount+ System (2026), 0 descendants of its own

## Indications for use
The Triton Sponge System is a software application intended to be used as an adjunct in the estimation of blood loss and management of surgical sponges. The Triton Sponge System is intended to be used with surgical sponges, software, hardware and accessory devices which have been validated for use with the Triton Sponge System to estimate the hemoglobin (Hb) mass contained on used surgical sponges. The Triton Sponge System is also intended to calculate an estimate of blood volume on used surgical sponges from the estimated Hb mass and a user-entered patient serum Hb value. The validated surgical sponges, hardware, software, accessory devices and Hb mass ranges are listed in the Instructions for Use. The Triton Sponge System is also indicated for use to aid in counting surgical sponges and may be used to record and display case-specific blood components infused over time. The Triton Sponge System is additionally indicated for use to aid in managing surgical sponges, including providing a visual record of sponge images, and to record the user-entered weight of used surgical sponges in order to calculate an estimate of fluid volume on the sponges.

Source page: https://510kreport.com/device/K163507
Methodology: https://510kreport.com/methodology