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 Mar 16, 2026 as substantially equivalent to K232250 (Stryker Instruments, 2024) after a 237-day review. Its family tree reaches back 4 generations to 2014.
- Decided
- Mar 16, 2026
- Review
- 237 days
- Class
- Class II
- Product code
- PBZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN130015 (2014). No later device cites it as a predicate yet.
- Root · 4 generations backDEN130015 Pixel 3 SystemGauss Surgical, Inc., · 2014
- 3 generations backK160338 Triton SystemGauss Surgical, Inc., · 2016
- 2 generations backK163507 Triton Sponge SystemGauss Surgical, Inc., · 2017
- 1 generation backK232250 SurgiCount+ SystemStryker Instruments · 2024
- This deviceK252282 SurgiCount+ SystemStryker Instruments · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN130015 | Pixel 3 System | Gauss Surgical, Inc., | 2014 | — |
| −3 | K160338 | Triton System | Gauss Surgical, Inc., | 2016 | — |
| −2 | K163507 | Triton Sponge System | Gauss Surgical, Inc., | 2017 | — |
| −1 | K232250 | SurgiCount+ System | Stryker Instruments | 2024 | — |
| 0 (this device) | K252282 | SurgiCount+ System | Stryker Instruments | 2026 | — |
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 K232250 SurgiCount+ Systemscore 10.3 · 3 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 |
|---|---|---|---|
| * | K232250 | SurgiCount+ SystemSummary page 5…21 CFR §880.2750 Device Class: II Product Code(s): PBZ 807.92(a)(3) – Predicate Device SurgiCount+ System – K232250 The predicate device has not been subject to a design-related recall. 807.92(a)(4) – Device Description The SurgiCount+ System… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
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 12 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- None of the 4 ancestors has a recall.
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. 2026, 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 multi-functional software application intended to be used as an adjunct in the estimation of blood loss and management of surgical sponges and other absorbent items in operating and recovery rooms, procedure rooms, and surgical centers. 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…
Read the full statement (251 words)
The SurgiCount+ System Software is a multi-functional software application intended to be used as an adjunct in the estimation of blood loss and management of surgical sponges and other absorbent items in operating and recovery rooms, procedure rooms, and surgical centers. 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 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/K252282 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252282: SurgiCount+ System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252282
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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