510(k) · Cleared
ClearedSurgiCount+ System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Instruments · PBZ Image Processing Device For Estimation Of External Blood Loss
Cleared on Jan 11, 2024 as substantially equivalent to K163507 (Gauss Surgical, Inc.,, 2017) after a 167-day review. Its family tree reaches back 3 generations to 2014. 1 later device descends from it.
- Decided
- Jan 11, 2024
- Review
- 167 days
- Class
- Class II
- Product code
- PBZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN130015 (2014). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backDEN130015 Pixel 3 SystemGauss Surgical, Inc., · 2014
- 2 generations backK160338 Triton SystemGauss Surgical, Inc., · 2016
- 1 generation backK163507 Triton Sponge SystemGauss Surgical, Inc., · 2017
- This deviceK232250 SurgiCount+ SystemStryker Instruments · 2024
- Descendant · cites it directly · 0 of its ownK252282 SurgiCount+ SystemStryker Instruments · 2026
Most influential descendants
Showing 1 of 1 · See all- K252282SurgiCount+ SystemStryker Instruments · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN130015 | Pixel 3 System | Gauss Surgical, Inc., | 2014 | — |
| −2 | K160338 | Triton System | Gauss Surgical, Inc., | 2016 | — |
| −1 | K163507 | Triton Sponge System | Gauss Surgical, Inc., | 2017 | — |
| 0 (this device) | K232250 | SurgiCount+ System | Stryker Instruments | 2024 | — |
| +1 | K252282 | SurgiCount+ System | Stryker Instruments | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
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
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K163507 | Triton Sponge SystemSummary page 4…Regulatory Class: II Product Code: PBZ IV. Predicate Device Pixel 3 Sponge System K163507 The predicate device has not been subject to a design related recall. No reference devices were used in this submission. V.… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252282 | SurgiCount+ System | 2026 | 0 |
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?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K252282 (Stryker Instruments, 2026) has gone furthest, with 0 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. 2024, 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 SurgiCount+ System Software is a multifunctional software application intended to be used as an adjunct in the estimation of blood loss and management of surgical sponges and other absorbent items. The system incorporates three distinct software configurations: Triton AI, SC+ Sponge Counting, and Triton QBL. Additionally, combined workflows (SC+ AI and SC+QBL) are provided for use in clinical environments that require both the tracking of absorbent…
Read the full statement (246 words)
The SurgiCount+ System Software is a multifunctional software application intended to be used as an adjunct in the estimation of blood loss and management of surgical sponges and other absorbent items. The system incorporates three distinct software configurations: Triton AI, SC+ Sponge Counting, and Triton QBL. Additionally, combined workflows (SC+ AI and SC+QBL) are provided for use in clinical environments that require both the tracking of absorbent surgical items and estimation of patient blood loss.
The Triton AI configuration is intended to be used with surgical sponges, software, hardware and accessory devices that have been validated for use with the application to estimate the hemoglobin (Hb) mass contained on used surgical sponges. The configuration is also intended to calculate an estimate of blood volume on used surgical sponges from the estimated Hb mass and a user-entered patient Hb value. The validated surgical sponges, hardware, software, accessory devices and Hb mass ranges are listed in the Instructions for Use.
The SC+ Sponge Counting configuration is intended for use as an adjunctive technology for augmenting the manual process of counting, displaying and recording the number of RFID-tagged absorbent articles used during surgical procedures, and providing a non-invasive means of locating RFID-tagged absorbent articles within an operating room and surgical sites.
The Triton QBL (Quantification of Blood Loss) configuration is intended to be used to record the weight of used surgical sponges and other absorbent items in order to calculate the quantity of fluid volume on the sponges/absorbent items.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232250 · printed Nov 5, 2026
Cite this page
510(k) Report. “K232250: SurgiCount+ System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K232250
Report an extraction error
Are you the manufacturer?
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