# DEN130015: Pixel 3 System

- Pathway: De Novo (Direct)
- Applicant: Gauss Surgical, Inc.,
- Decided: May 9, 2014 after 459 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
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K160338: Triton System (2016), 3 descendants of its own
- 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
- K142801: Triton Canister System (2015), 0 descendants of its own

Source page: https://510kreport.com/device/DEN130015
Methodology: https://510kreport.com/methodology