510(k) Report

510(k) · Cleared

Cleared

Triton System

K160338510(k) TraditionalCleared Aug 5, 2016179-day reviewClass II21 CFR 880.2750

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Gauss Surgical, Inc., · PBZ Image Processing Device For Estimation Of External Blood Loss

Cleared on Aug 5, 2016 as substantially equivalent to DEN130015 (Gauss Surgical, Inc.,, 2014) after a 179-day review. Its family tree reaches back 1 generation to 2014. 3 later devices descend from it.

Decided
Aug 5, 2016
Review
179 days
Class
Class II
Product code
PBZ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to DEN130015 (2014). 3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2017: 1 descendant cleared2024: 1 descendant cleared2026: 1 descendant clearedReference device: K142801 · Triton Canister System · Gauss Surgical, Inc., · 2015 · recalledDEN130015 · Pixel 3 System · Gauss Surgical, Inc., · 20142010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant DEN130015 · Pixel 3 System · Gauss Surgical, Inc., · 20140
  1. Root · 1 generation backDEN130015 Pixel 3 SystemGauss Surgical, Inc., · 2014
  2. This deviceK160338 Triton SystemGauss Surgical, Inc., · 2016
  3. Descendant · cites it directly · 2 of its ownK163507 Triton Sponge SystemGauss Surgical, Inc., · 2017
  4. Descendant · 2 generations on · 1 of its ownK232250 SurgiCount+ SystemStryker Instruments · 2024
  5. Descendant · 3 generations on · 0 of its ownK252282 SurgiCount+ SystemStryker Instruments · 2026

Most influential descendants

Showing 3 of 3 · See all
  • K163507Triton Sponge SystemGauss Surgical, Inc., · 2017 · cites it directly2descendants
  • K232250SurgiCount+ SystemStryker Instruments · 2024 · 2 generations on1descendant
  • K252282SurgiCount+ SystemStryker Instruments · 2026 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1DEN130015Pixel 3 SystemGauss Surgical, Inc.,2014—
0 (this device)K160338Triton SystemGauss Surgical, Inc.,2016—
+1K163507Triton Sponge SystemGauss Surgical, Inc.,2017—
+2K232250SurgiCount+ SystemStryker Instruments2024—
+3K252282SurgiCount+ SystemStryker Instruments2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
202410
202610
FIG. 1 — Lineage of K160338, 2014–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in PBZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new PBZ device

  1. #1 K252282 SurgiCount+ Systemscore 11.9 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*DEN130015Pixel 3 System
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.
Gauss Surgical, Inc.,2014—
†K142801Triton Canister SystemGauss Surgical, Inc.,20154

Also cleared against DEN130015: 1 other device →

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K163507Triton Sponge SystemGauss Surgical, Inc.,20172

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K163507 (Gauss Surgical, Inc.,, 2017) has gone furthest, with 2 descendants of its own.
  • 1 other device also cites its predicate DEN130015.

How does its category compare?

All PBZ devices

PBZ Image Processing Device For Estimation Of External Blood Loss: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · PBZ

1in 2024

2014: 12015: 12016: 12017: 12024: 12026 (partial year): 1
2007high 1 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PBZ

Too few PBZ 510(k)s in any year since 2007 to give a median.

Recalls per year · PBZ

No recall names PBZ since 2007.

Adverse event reports per year · PBZ

6in 2025

2022: 22023: 2462024: 92025: 6
2007high 246 (2023) · low 0 (2007)2025

MAUDE reports naming product code PBZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20141—00
20151—00
20161—00
20171—00
20180—00
20190—00
20200—00
20210—00
20220—02
20230—0246
20241—09
20250—06
20261—0—

What is it indicated for?

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…

Read the full statement (182 words)

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.

Indications for use as stated in the FDA summary.

Also cleared against DEN130015

1 other device cites the same predicate.

  • K142801Triton Canister SystemGauss Surgical, Inc., · 20154 recalls

More from Gauss Surgical, Inc.,

6 FDA decisions under this applicant name. See the company

  • K163507Triton Sponge SystemGauss Surgical, Inc., · 2017
  • K142801Triton Canister SystemGauss Surgical, Inc., · 20154 recalls
  • DEN130015Pixel 3 SystemGauss Surgical, Inc., · 2014
  • K121274Pixel AppGauss Surgical, Inc., · 2012
  • K120473Pixel AppGauss Surgical, Inc., · 2012

Recent decisions in PBZ

The PBZ category page

  • K252282SurgiCount+ SystemStryker Instruments · 2026
  • K232250SurgiCount+ SystemStryker Instruments · 2024
  • K163507Triton Sponge SystemGauss Surgical, Inc., · 2017
  • K142801Triton Canister SystemGauss Surgical, Inc., · 20154 recalls
  • DEN130015Pixel 3 SystemGauss Surgical, Inc., · 2014

https://510kreport.com/device/K160338 · printed Nov 6, 2026

Cite this page

510(k) Report. “K160338: Triton System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160338

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026