De Novo · Granted
GrantedPixel 3 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
Granted on May 9, 2014 as a new device type through De Novo after a 459-day review. 5 later devices descend from it.
- Decided
- May 9, 2014
- Review
- 459 days
- Class
- Class II
- Product code
- PBZ
- Recalls
- None
5 later devices descend from it, 2 citing it directly.
- This deviceDEN130015 Pixel 3 SystemGauss Surgical, Inc., · 2014
- Descendant · cites it directly · 3 of its ownK160338 Triton SystemGauss Surgical, Inc., · 2016
- Descendant · 2 generations on · 2 of its ownK163507 Triton Sponge SystemGauss Surgical, Inc., · 2017
- Descendant · 3 generations on · 1 of its ownK232250 SurgiCount+ SystemStryker Instruments · 2024
- Descendant · 4 generations on · 0 of its ownK252282 SurgiCount+ SystemStryker Instruments · 2026
- Descendant · cites it directly · 0 of its ownK142801 Triton Canister SystemGauss Surgical, Inc., · 2015 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K160338Triton SystemGauss Surgical, Inc., · 2016 · cites it directly3descendants
- K163507Triton Sponge SystemGauss Surgical, Inc., · 2017 · 2 generations on2descendants
- K232250SurgiCount+ SystemStryker Instruments · 2024 · 3 generations on1descendant
- K252282SurgiCount+ SystemStryker Instruments · 2026 · 4 generations on0descendants
- K142801Triton Canister SystemGauss Surgical, Inc., · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN130015 | Pixel 3 System | Gauss Surgical, Inc., | 2014 | — |
| +1 | K160338 | Triton System | Gauss Surgical, Inc., | 2016 | — |
| +2 | K163507 | Triton Sponge System | Gauss Surgical, Inc., | 2017 | — |
| +3 | K232250 | SurgiCount+ System | Stryker Instruments | 2024 | — |
| +4 | K252282 | SurgiCount+ System | Stryker Instruments | 2026 | — |
| +1 | K142801 | Triton Canister System | Gauss Surgical, Inc., | 2015 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA De Novo database (decision fields), 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K160338 (Gauss Surgical, Inc.,, 2016) has gone furthest, with 3 descendants of its own.
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. 2014, 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 | — |
https://510kreport.com/device/DEN130015 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN130015: Pixel 3 System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN130015
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026