# K252282: SurgiCount+ System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Instruments
- Decided: Mar 16, 2026 after 237 days
- Product code: PBZ (Image Processing Device For Estimation Of External Blood Loss)
- Device class: 2
- Regulation: 21 CFR 880.2750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to DEN130015 (2014). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232250: SurgiCount+ System, Stryker Instruments (2024) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K252282
Methodology: https://510kreport.com/methodology