De Novo · Granted
GrantedAnalytic for Hemodynamic Instability (AHI)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fifth Eye, Inc. · QNV Adjunctive Hemodynamic Indicator With Decision Point
Granted on Mar 1, 2021 as a new device type through De Novo after a 332-day review. 3 later devices descend from it.
- Decided
- Mar 1, 2021
- Review
- 332 days
- Class
- Class II
- Product code
- QNV
- Recalls
- None
3 later devices descend from it, 2 citing it directly.
- This deviceDEN200022 Analytic for Hemodynamic Instability (AHI)Fifth Eye, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK212219 AHI SystemFifth Eye, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK233249 Appraise-HriThe Surgeon General, Department of the Army (TSG-DA) · 2024
- Descendant · 2 generations on · 0 of its ownK221203 AHI SystemFifth Eye, Inc. · 2022
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN200022 | Analytic for Hemodynamic Instability (AHI) | Fifth Eye, Inc. | 2021 | — |
| +1 | K212219 | AHI System | Fifth Eye, Inc. | 2021 | — |
| +1 | K233249 | Appraise-Hri | The Surgeon General, Department of the Army (TSG-DA) | 2024 | — |
| +2 | K221203 | AHI System | Fifth Eye, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QNV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QNV device
- #1 K212219 AHI Systemscore 13.2 · 27 generations · no Class I recall
- #2 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K212219 (Fifth Eye, Inc., 2021) has gone furthest, with 1 descendant of its own.
How does its category compare?
All QNV devicesQNV Adjunctive Hemodynamic Indicator With Decision Point: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · QNV
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · QNV
Too few QNV 510(k)s in any year since 2007 to give a median.
Recalls per year · QNV
No recall names QNV since 2007.
Adverse event reports per year · QNV
No MAUDE report names QNV since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (145 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN200022 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN200022: Analytic for Hemodynamic Instability (AHI).” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN200022
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026