# K221203: AHI System

- Pathway: 510(k) (Special)
- Applicant: Fifth Eye, Inc.
- Decided: Jul 14, 2022 after 79 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
Longest line of descent: 28 generations back to K941811 (1994). 242 ancestors in all.
No later device cites it as a predicate yet.
1 of 243 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212219: AHI System, Fifth Eye, Inc. (2021) Summary page 4.

## Indications for use
The AHI System is intended for use by healthcare professionals managing patients 18 years or older who are receiving continuous physiological monitoring with electrocardiography (ECG) in hospitals. AHI provides a frequently updated binary output over time based on pattern analysis of a lead-I| 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 (HI) are defined as hypotension (systolic blood pressure <90 mmHg or mean arterial pressure (MAP) <70 mmHg) combined with tachycardia (heart rate = 100 bpm). AHI-PI provides the clinician with physiological insight into a patient’s likelihood of a future episode of HIl. An episode of Hl is defined as 10 continuous minutes or more where Hl is present. The goal of this adjunctive monitoring method is to enable identification of patients who are showing HI or are likely to experience a future episode of HI, 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/K221203
Methodology: https://510kreport.com/methodology