510(k) · Cleared
ClearedAHI System
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
Cleared on Dec 3, 2021 as substantially equivalent to DEN200022 (Fifth Eye, Inc., 2021) and 1 other predicate after a 140-day review. Its family tree reaches back 27 generations to 1994. 1 of the 243 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Dec 3, 2021
- Review
- 140 days
- Class
- Class II
- Product code
- QNV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 27 generations to K941811 (1994). 241 ancestors in all, the oldest K822055 (1982). 1 later device descends from it, 1 citing it directly. 1 of the 243 devices in this family, counting this one, has a Class I recall.
- Root · 27 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 23 generations between
- 3 generations backK180881 HemoSphere Advanced Monitor, HemoSphere Pressure CableEdwards Lifesciences, LLC · 2018
- 2 generations backK190205 HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC · 2019
- 1 generation backK200717 CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical, Ltd. · 2021
- This deviceK212219 AHI SystemFifth Eye, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK221203 AHI SystemFifth Eye, Inc. · 2022
Show all 27 generations
- Root · 27 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 26 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 25 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 24 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 23 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 22 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 21 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 20 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- 19 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- 18 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- 17 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
- 16 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
- 15 generations backK040304 Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 2004
- 14 generations backK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
- 13 generations backK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
- 12 generations backK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
- 11 generations backK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
- 10 generations backK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
- 9 generations backK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
- 8 generations backK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
- 7 generations backK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
- 6 generations backK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
- 5 generations backK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
- 4 generations backK062283 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90…Philips Medical Systems North America, Inc. · 2006
- 3 generations backK180881 HemoSphere Advanced Monitor, HemoSphere Pressure CableEdwards Lifesciences, LLC · 2018
- 2 generations backK190205 HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC · 2019
- 1 generation backK200717 CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical, Ltd. · 2021
- This deviceK212219 AHI SystemFifth Eye, Inc. · 2021
Class I recalls in this family
- K160552 EV1000 Clinical Platform with ClearSight Finger…4 generations back · 2016
Most influential descendants
Showing 1 of 1 · See all- K221203AHI SystemFifth Eye, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −27 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −26 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −25 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −24 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −23 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −22 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −21 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −20 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| −19 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
| −18 | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology… | Philips Medical Systems, Inc. | 2003 | — |
| −17 | K031481 | The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −16 | K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors… | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −15 | K040304 | Philips Intellivue Patient Monitor, Models MP40 & MP50 | Philips Medizin Systeme Boeblingen GmbH | 2004 | — |
| −14 | K041235 | Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors | Philips Medizin Systeme Boeblingen GmbH | 2004 | — |
| −13 | K042845 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient… | Philips Medizin Systeme Boblingen GmbH | 2004 | — |
| −12 | K050141 | The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −11 | K050762 | Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −10 | K051106 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −9 | K052801 | Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −8 | K053522 | Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −7 | K060221 | The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −6 | K060541 | The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient… | Philips Medizin Systeme Boblingen GmbH | 2006 | 2 |
| −5 | K061052 | The Philips Intellivue Patient Monitors, Models… | Philips Medical Systems North America, Inc. | 2006 | — |
| −4 | K062283 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient… | Philips Medical Systems North America, Inc. | 2006 | — |
| −3 | K180881 | HemoSphere Advanced Monitor, HemoSphere Pressure Cable | Edwards Lifesciences, LLC | 2018 | — |
| −2 | K190205 | HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module | Edwards Lifesciences, LLC | 2019 | — |
| −1 | K200717 | CLEWICU System (ClewICUServer and ClewICUnitor) | Clew Medical, Ltd. | 2021 | — |
| 0 (this device) | K212219 | AHI System | Fifth Eye, Inc. | 2021 | — |
| +1 | K221203 | AHI System | Fifth Eye, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1985 | 3 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 2 | 0 |
| 1990 | 6 | 0 |
| 1991 | 7 | 0 |
| 1992 | 7 | 0 |
| 1993 | 7 | 0 |
| 1994 | 3 | 0 |
| 1995 | 7 | 0 |
| 1996 | 10 | 0 |
| 1997 | 7 | 0 |
| 1998 | 16 | 0 |
| 1999 | 10 | 0 |
| 2000 | 22 | 0 |
| 2001 | 9 | 0 |
| 2002 | 17 | 0 |
| 2003 | 9 | 0 |
| 2004 | 19 | 0 |
| 2005 | 4 | 0 |
| 2006 | 9 | 0 |
| 2007 | 2 | 0 |
| 2008 | 9 | 0 |
| 2009 | 5 | 0 |
| 2010 | 6 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 1 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
Sources: FDA 510(k) 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.
1 device in this family has a Class I recall. 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 K221203 AHI Systemscore 11.8 · 28 generations · no Class I recall
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN200022 | Analytic for Hemodynamic Instability (AHI)Summary page 4…y Product Code: QNV Subsequent Product Code: QNL 3. PREDICATE DEVICE Predicate Device: Analytic for Hemodynamic Instability (AHI) - DEN200022 Secondary Predicate Device: CLEWICU System (ClewICUServer And ClewICUnitor) – K200717 === Page 5… | 2021 |
| * | K200717 | CLEWICU System (ClewICUServer and ClewICUnitor)Summary page 4…Analytic for Hemodynamic Instability (AHI) - DEN200022 Secondary Predicate Device: CLEWICU System (ClewICUServer And ClewICUnitor) – K200717 510(k) Summary K212219 Page 2 of 7 4.… | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221203 | AHI System | 2022 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K160552EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC · 2016 · 4 generations back · ◆ in the 2016 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 27 years and passes through 10 companies; a new generation was cleared every 4 months on median.
- 33 of the 241 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K221203 (Fifth Eye, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate DEN200022.
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 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…
Read the full statement (187 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K212219 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212219: AHI System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212219
Report an extraction error
Are you the manufacturer?
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