SurgiCount+ System
K252282Stryker Instruments · cleared 2026-03-16 · product code PBZ · General Hospital
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.5)
“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 in operating and recovery rooms, procedure rooms, and surgical centers.”
AlgorithmAI algorithm that analyzes the image of each sponge
source quote (p.5)
“The Triton AI software configuration estimates the hemoglobin (Hb) mass contained on used surgical sponges using an AI algorithm that analyzes the image of each sponge.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this
Validation studies (1)
Bench
sample size not stated
Reported performance (0 observations)
FDA source did not state a quantitative performance metric — non-reporting is itself the signal.
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
0
recalls in product code, 24mo
6
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).