510(k) · Cleared
Recalled · Class II · 2023Triton Canister System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gauss Surgical, Inc., · PBZ Image Processing Device For Estimation Of External Blood Loss
Cleared on Mar 12, 2015 as substantially equivalent to DEN130015 (Gauss Surgical, Inc.,, 2014) and 1 other predicate after a 164-day review. Its family tree reaches back 1 generation to 2014. It has been recalled 4 times.
- Decided
- Mar 12, 2015
- Review
- 164 days
- Class
- Class II
- Product code
- PBZ
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 1 generation to DEN130015 (2014). No later device cites it as a predicate yet.
- Root · 1 generation backDEN130015 Pixel 3 SystemGauss Surgical, Inc., · 2014
- This deviceK142801 Triton Canister SystemGauss Surgical, Inc., · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN130015 | Pixel 3 System | Gauss Surgical, Inc., | 2014 | — |
| 0 (this device) | K142801 | Triton Canister System | Gauss Surgical, Inc., | 2015 | — |
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 K252282 SurgiCount+ Systemscore 11.9 · 4 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN130015 | Pixel 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. | 2014 |
| * | DEN130015 | Pixel 3 SystemSummary page 4…Loss (21 CFR §880.2750) Product Code: PBZ III. PREDICATE DEVICE INFORMATION Equivalent Devices: K130190 / DEN130015, 9 May 2014. This predicate device has not been subject to a recall. No reference devices were used… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 25, 2023 | Class II | Z-1186-2023 | Under Investigation by firm | 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 recognition or prolongation of… |
| Jan 25, 2023 | Class II | Z-1184-2023 | Under Investigation by firm | 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 recognition or prolongation of… |
| Jan 25, 2023 | Class II | Z-1185-2023 | Under Investigation by firm | 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 recognition or prolongation of… |
| Jan 22, 2020 | Class II | Z-1402-2022 | Process control | 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 may result in lower than expected… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate DEN130015.
How does its category compare?
All PBZ devicesPBZ Image Processing Device For Estimation Of External Blood Loss: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · PBZ
1in 2024
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
MAUDE reports naming product code PBZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 246 |
| 2024 | 1 | — | 0 | 9 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (118 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142801 · printed Nov 5, 2026
Cite this page
510(k) Report. “K142801: Triton Canister System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K142801
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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