AHI System

K212219

Fifth Eye Inc. · cleared 2021-12-03 · product code QNV · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“Software-as-a-medical-device”
AlgorithmThe AHI System is a multiparameter system designed to meet clinicians' need to identify patient hemodynamic status and predict patient hemodynamic instability episodes using two analytics: 1. Analytic for Hemodynamic Instability (AHI) (as granted in DEN200022): Utilizing data from a single existing lead of a non-invasive electrocardiograph (ECG), AHI analyzes heart rate variability (HRV) and ECG morphology features to rapidly detect signs of hemodynamic stability or instability and categorize each window of data as either “AHI Stable” or “AHI Unstable.” Time trending of AHI outputs is also provided. 2. Analytic for Hemodynamic Instability Predictive Indicator (AHI-PI): Utilizing AHI outputs from up to the most recent 30 minutes of ECG data, AHI-PI indicates the likelihood of a future episode of hemodynamic instability, defined as ten continuous minutes or more where signs of hemodynamic instability are present. Uses analysis of patient data (ECG-II) to detect current signs of a hemodynamic condition (AHI) and combines patient data from patient monitors to produce a single value (AHI-PI) that estimates the likelihood of a future adverse cardiovascular event or condition from a single model mathematically derived from AHI inputs.
source quote (p.5)
“The AHI System is a multiparameter system designed to meet clinicians' need to identify patient hemodynamic status and predict patient hemodynamic instability episodes using two analytics: 1. Analytic for Hemodynamic Instability (AHI) (as granted in DEN200022): Utilizing data from a single existing lead of a non-invasive electrocardiograph (ECG), AHI analyzes heart rate variability (HRV) and ECG morphology features to rapidly detect signs of hemodynamic stability or instability and categorize each window of data as either “AHI Stable” or “AHI Unstable.” Time trending of AHI outputs is also provided. 2. Analytic for Hemodynamic Instability Predictive Indicator (AHI-PI): Utilizing AHI outputs from up to the most recent 30 minutes of ECG data, AHI-PI indicates the likelihood of a future episode of hemodynamic instability, defined as ten continuous minutes or more where signs of hemodynamic instability are present. Uses analysis of patient data (ECG-II) to detect current signs of a hemodynamic condition (AHI) and combines patient data from patient monitors to produce a single value (AHI-PI) that estimates the likelihood of a future adverse cardiovascular event or condition from a single model mathematically derived from AHI inputs.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Bench

n=30 other

Retrospective clinical

n=65,969 cases · 1 site(s)

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
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) K221203 (decision 2022-07-14) from Fifth Eye Inc. for a matching device line ("AHI System") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K221203

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/K212219