WAVE Clinical Platform

K171056

Excel Medical Electronics, LLC · cleared 2018-01-04 · product code MWI · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“The WAVE Clinical Platform is software intended to route, store, and display data, alarms, results and diagnostic information from medical devices, Electronic Medical Records (EMR), and Clinical Information Systems (CIS).”
AlgorithmFDA source did not state this
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

13
recalls in product code, 24mo
342
MAUDE reports in code, 12mo
+138%
vs code's own 3-yr baseline
5
drift signals on this device
  • adverse_event_inflection

    MAUDE adverse-event reports for product code MWI: 342 in the 12 months ending 2026-06, vs a 143.7/12mo average over the prior 3 windows (+138%). Code-level count — reports are not attributed to this specific device.

    first seen 2026-07-08 · openFDA /device/event.json count=date_received product_code=MWI

  • recall_reason_pattern

    Software/algorithm-related recall in product code MWI (CHANGE HEALTHCARE CANADA COMPANY, initiated 2025-05-22): "Due to complaints, software update may cause software to unexpectedly shutdown." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:97046

  • recall_reason_pattern

    Software/algorithm-related recall in product code MWI (Spectrum Medical Ltd. Harrier 4, Meteor Business Park Cheltenham Road East Gloucester United Kingdom, initiated 2025-03-19): "Medical device software marketed without FDA clearance ." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:96616

  • recall_reason_pattern

    Software/algorithm-related recall in product code MWI (GE Medical Systems, LLC, initiated 2024-12-06): "There is a software issue that can result in the loss of patient monitoring on the Portrait Central Viewer Application after 425 days of continuous run-time." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:96027

  • recall_reason_pattern

    Software/algorithm-related recall in product code MWI (A L I Technologies Ltd, initiated 2024-12-02): "Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s)." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:96025

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 Cardiovascular 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/K171056