# K212219: AHI System

- Pathway: 510(k) (Traditional)
- Applicant: Fifth Eye, Inc.
- Decided: Dec 3, 2021 after 140 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: 27 generations back to K941811 (1994). 241 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 243 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN200022: Analytic for Hemodynamic Instability (AHI), Fifth Eye, Inc. (2021) Summary page 4.
- K200717: CLEWICU System (ClewICUServer and ClewICUnitor), Clew Medical, Ltd. (2021) Summary page 4.

## Most influential descendants
- K221203: AHI System (2022), 0 descendants of its own

## 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-1I 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 HI. An episode of HI is defined as 10 continuous minutes or more where HI 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/K212219
Methodology: https://510kreport.com/methodology