# K160338: Triton System

- Pathway: 510(k) (Traditional)
- Applicant: Gauss Surgical, Inc.,
- Decided: Aug 5, 2016 after 179 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: 1 generation back to DEN130015 (2014). 1 ancestor in all.
3 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)
- DEN130015: Pixel 3 System, Gauss Surgical, Inc., (2014). Our reading of the summary gave K130190, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN130015, Pixel 3 System (Gauss Surgical, Inc.,), granted May 9, 2014; older De Novo requests were first filed under a 510(k) number, so this links to the grant. Summary page 4.

## Most influential descendants
- K163507: Triton Sponge System (2017), 2 descendants of its own
- K232250: SurgiCount+ System (2024), 1 descendant of its own
- K252282: SurgiCount+ System (2026), 0 descendants of its own

## Indications for use
The Triton 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 System is intended to be used with surgical sponges, software, hardware and accessory devices which have been validated for use with the Triton System to estimate the hemoglobin (Hb) mass contained on used surgical sponges. The Triton 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 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 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/K160338
Methodology: https://510kreport.com/methodology