SurgiCount+ System

K252282

Stryker Instruments · cleared 2026-03-16 · product code PBZ · General Hospital

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“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.”
AlgorithmAI algorithm that analyzes the image of each sponge
source quote (p.4)
“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)No
source quote (p.6)
“The subject device and predicate device have identical technological characteristics, and there have been no changes to the design, software, and fundamental scientific technology.”
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

Recalls attributed to this device

  • Recalling firm matches this device's applicant (Stryker Instruments Div. of Stryker Corporation) — same firm and product code, not necessarily this device · initiated 2020-01-22

    Some Canister Scanning Labels used to calibrate the Triton Canister System have a color variance. Based on a comprehensive analysis, blood loss estimates obtained using these Canister Scanning Labels may result in lower than expected results.

    recall event 90464 (openFDA)

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the General Hospital panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K252282