CLEWICU System (ClewICUServer and ClewICUnitor)

K200717

CLEW Medical Ltd. · cleared 2021-01-09 · product code QNL · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“The CLEWICU System is a stand-alone analytical software product that includes the ClewICUServer and the ClewICUnitor. It uses models derived from machine learning to calculate the likelihood of occurrence of certain clinically significant events for patients in the intensive care unit (ICU). ClewICUServer and ClewICUnitor are software-only devices that are installed on user-provided hardware.”
Algorithmmodels derived from machine learning
source quote (p.4)
“It uses models derived from machine learning to calculate the likelihood of occurrence of certain clinically significant events for patients in the intensive care unit (ICU).”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedYes
source quote (p.5)
“The CLEWICU was subjected to extensive software verification and validation testing, as well as risk analysis and cybersecurity review.”

Validation studies (1)

Retrospective clinical

sample size not stated · 2 site(s)

endpoints: likelihood of hemodynamic instability requiring vasopressor / inotrope support; indication that the patient is at "low risk” for deterioration

Reported performance (4 observations)

sensitivity0.606CI 56.9%-63.9%
source quote (p.6)
“Sensitivity 60.6% 95% Lower Cl 56.9% 95% Upper CI 63.9%”
specificity0.957CI 94.8%-96.6%
source quote (p.6)
“Specificity 95.7% 95% Lower Cl 94.8% 95% Upper CI 96.6%”
ppvas written: “Positive Predictive Value”0.223CI 20.7%-24.3%
source quote (p.6)
“Positive Predictive Value 22.3% 95% Lower Cl 20.7% 95% Upper CI 24.3%”
sensitivityas written: “Sensitivity (Low Risk model)”0.214CI 21.2%-21.6%
source quote (p.6)
“Sensitivity 21.4% 95% Lower Cl 21.2% 95% Upper CI 21.6%”

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
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
1
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K233216 (decision 2024-01-13) from Clew Medical Ltd. for a matching device line ("CLEWICU System") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K233216

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/K200717