# K142801: Triton Canister System

- Pathway: 510(k) (Traditional)
- Applicant: Gauss Surgical, Inc.,
- Decided: Mar 12, 2015 after 164 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: 4 (0 Class I)
- 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.
No later device cites it as a predicate yet.
0 of 2 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.
- DEN130015: Pixel 3 System, Gauss Surgical, Inc., (2014) Summary page 4.

## Recalls of this device
- Jan 25, 2023 · Class II · Z-1186-2023: Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can lead to confusion and could potentially result in either delayed re
- Jan 25, 2023 · Class II · Z-1184-2023: Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can lead to confusion and could potentially result in either delayed re
- Jan 25, 2023 · Class II · Z-1185-2023: Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can lead to confusion and could potentially result in either delayed re
- Jan 22, 2020 · Class II · Z-1402-2022: Some Canister Scanning Labels used to calibrate the Triton Canister System have a color variance. Based on a comprehensive analysis, blood loss estimates obtained using these Canister Scanning Labels 

## Indications for use
The Triton Canister System is a software application intended to be used as an adjunct in the estimation of blood loss. The Triton Canister System is intended to be used with blood bearing canisters, software, hardware, and accessory items which have been validated for use with the Triton Canister System to estimate the hemoglobin (Hb) mass contained within canisters with the input of the total volume in each canister. The Triton Canister System is also intended to calculate an estimate of blood volume in blood bearing canisters from the estimated Hb mass and a user-entered patient serum Hb value. The validated canister types, hardware, software, accessory devices, and Hb mass ranges are listed in the Instructions for Use.

Source page: https://510kreport.com/device/K142801
Methodology: https://510kreport.com/methodology