# DEN200022: Analytic for Hemodynamic Instability (AHI)

- Pathway: De Novo (Direct)
- Applicant: Fifth Eye, Inc.
- Decided: Mar 1, 2021 after 332 days
- Product code: QNV (Adjunctive Hemodynamic Indicator With Decision Point)
- Device class: 2
- Regulation: 21 CFR 870.2220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K212219: AHI System (2021), 1 descendant of its own
- K233249: Appraise-Hri (2024), 0 descendants of its own
- K221203: AHI System (2022), 0 descendants of its own

## Indications for use
The AHI software is intended for use by healthcare professionals managing in-hospital patients 18 years or older who are receiving continuous physiological monitoring with electrocardiography (ECG). AHI provides a frequently updated binary output over time based on pattern analysis of a lead-II ECG waveform intended to describe a patient's hemodynamic status and indicate if a patient is showing signs of hemodynamic stability or instability. Signs of hemodynamic instability are defined as hypotension (systolic blood pressure <90 mmHg or mean arterial pressure (MAP) <70 mmHg) combined with tachycardia (heart rate ≥ 100 bpm). The goal of this adjunctive monitoring method is to enable identification of patients who are showing signs of hemodynamic instability and to allow clinicians an opportunity to increase vigilance. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.

Source page: https://510kreport.com/device/DEN200022
Methodology: https://510kreport.com/methodology