510(k) Report

510(k) · Cleared

Cleared

Global Hypoperfusion Index (GHI) Algorithm

K231038510(k) TraditionalCleared Jul 26, 2023105-day reviewClass II21 CFR 870.2210

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Edwards Lifesciences, LLC · QNL Medium-Term Adjunctive Predictive Cardiovascular Indicator

Cleared on Jul 26, 2023 as substantially equivalent to K203687 (Edwards Lifesciences, LLC, 2021) and 1 other predicate after a 105-day review. Its family tree reaches back 28 generations to 1994. 1 of the 252 devices in its family, counting itself, has a Class I recall. 6 later devices descend from it.

Decided
Jul 26, 2023
Review
105 days
Class
Class II
Product code
QNL
Recalls
None
Predicates
2

Its longest line of descent runs back 28 generations to K941811 (1994). 245 ancestors in all, the oldest K822055 (1982). 6 later devices descend from it, 1 citing it directly. 1 of the 252 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2021: 1 other ancestor2019: 2 other ancestors2018: 3 other ancestors2017: 1 other ancestor2016: 1 other ancestor, 1 with a Class I recall12015: 1 other ancestor2010: 6 other ancestors2014: 3 other ancestors2012: 2 other ancestors2008: 9 other ancestors2004: 19 other ancestors2003: 9 other ancestors2002: 17 other ancestors1998: 16 other ancestors1997: 7 other ancestors1996: 10 other ancestors2013: 1 other ancestor2011: 1 other ancestor2009: 5 other ancestors2006: 9 other ancestors2001: 9 other ancestors2000: 22 other ancestors1999: 10 other ancestors1992: 7 other ancestors1991: 7 other ancestors2007: 2 other ancestors2005: 4 other ancestors1995: 7 other ancestors1994: 3 other ancestors1993: 7 other ancestors1990: 6 other ancestors1989: 2 other ancestors1987: 1 other ancestor1988: 2 other ancestors1986: 1 other ancestor1985: 3 other ancestors1982: 1 other ancestor2023: 1 descendant cleared2024: 1 descendant cleared2025: 3 descendants cleared2026: 1 descendant clearedK941811 · HP M1175A, M1176A, Component Monitoring System · Hewlett-Packard Co. · 1994K960934 · HP M1205A Omnicare Component Monitor System Model 24 · Hewlett-Packard Co. · 1996×3: 3 generations cleared close together, K981376 (1999), K990125 (1999), K990972 (1999) ×19: 19 generations cleared close together, K013199 (2001), K020531 (2002), K021778 (2002), K023871 (2002), K030038 (2003), K031481 (2003), K032858 (2003), K040304 (2004), K041235 (2004), K042845 (2004), K050141 (2005), K050762 (2005), K051106 (2005), K052801 (2005), K053522 (2006), K060221 (2006), K060541 (2006), K061052 (2006), K062283 (2006) K180881 · HemoSphere Advanced Monitor, HemoSphere Pressure Cable · Edwards Lifesciences, LLC · 2018K190205 · HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module · Edwards Lifesciences, LLC · 2019K201446 · HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module · Edwards Lifesiences, LLC · 2020 · recalledK203687 · HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index · Edwards Lifesciences, LLC · 202119801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors3 generations back: 7 other ancestors, 1 with a Class I recall14 generations back: 15 other ancestors5 generations back: 33 other ancestors6 generations back: 59 other ancestors7 generations back: 29 other ancestors8 generations back: 28 other ancestors9 generations back: 25 other ancestors10 generations back: 17 other ancestors11 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 2 descendants4 generations forward: 2 descendants K203687 · HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index · Edwards Lifesciences, LLC · 2021K201446 · HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module · Edwards Lifesiences, LLC · 2020 · recalledK190205 · HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module · Edwards Lifesciences, LLC · 2019K180881 · HemoSphere Advanced Monitor, HemoSphere Pressure Cable · Edwards Lifesciences, LLC · 2018K062283 · The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient Monitors · Philips Medical Systems North America, Inc. · 2006K061052 · The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90 · Philips Medical Systems North America, Inc. · 2006K060541 · The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient Monitors · Philips Medizin Systeme Boblingen GmbH · 2006 · recalledK060221 · The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient Monitors · Philips Medizin Systeme Boeblingen GmbH · 2006K053522 · Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00 · Philips Medizin Systeme Boeblingen GmbH · 2006K052801 · Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 · Philips Medizin Systeme Boeblingen GmbH · 2005K051106 · The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors · Philips Medizin Systeme Boeblingen GmbH · 2005K050762 · Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90 · Philips Medizin Systeme Boeblingen GmbH · 2005K050141 · The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient Monitors · Philips Medizin Systeme Boeblingen GmbH · 2005K042845 · The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient Monitors · Philips Medizin Systeme Boblingen GmbH · 2004K041235 · Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors · Philips Medizin Systeme Boeblingen GmbH · 2004K040304 · Philips Intellivue Patient Monitor, Models MP40 & MP50 · Philips Medizin Systeme Boeblingen GmbH · 2004K032858 · The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors, Release B.O. · Philips Medizin Systeme Boblingen GmbH · 2003K031481 · The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 · Philips Medizin Systeme Boblingen GmbH · 2003K030038 · Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology and M3185 Opt C41 Wireless Bedside Adaptr · Philips Medical Systems, Inc. · 2003K023871 · M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue Patient Monitor with Portal Technology · Philips Medical Systems · 2002K021778 · Philips Component Compact Monitor, Release a.04, Model #M1275B · Philips Medical Systems · 2002K020531 · Philips Multi-Parameter Module, Model M3001A; Philips Component Compact Monitor, Release a.02, Model M1275B · Philips Medical Systems · 2002K013199 · Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276B · Philips Medical Systems, Inc. · 2001K990972 · HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia Multi-Measurement Server and Compact Portable T · Hewlett-Packard GmbH · 1999K990125 · HP Viridia Component Monitoring System, Model Rev. K · Hewlett-Packard GmbH · 1999K981376 · Hewlett-Packard M1205A Viridia 24 CT · Hewlett-Packard Co. · 1999K960934 · HP M1205A Omnicare Component Monitor System Model 24 · Hewlett-Packard Co. · 1996K941811 · HP M1175A, M1176A, Component Monitoring System · Hewlett-Packard Co. · 1994−25−20−15−10−50
  1. Root · 28 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 24 generations between
  3. 3 generations backK190205 HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC · 2019
  4. 2 generations backK201446 HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC · 2020 · Recalled
  5. 1 generation backK203687 HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen…Edwards Lifesciences, LLC · 2021
  6. This deviceK231038 Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC · 2023
  7. Descendant · cites it directly · 5 of its ownK232294 HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™…Edwards Lifesciences, LLC · 2023
  8. Descendant · 2 generations on · 4 of its ownK242451 HemoSphere Alta Advanced Monitoring Platform…Edwards Lifesciences · 2024
  9. Descendant · 3 generations on · 2 of its ownK243781 HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module…Edwards Lifesciences · 2025 · Recalled
  10. Descendant · 4 generations on · 0 of its ownK253186 HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC · 2026
  11. Descendant · 3 generations on · 0 of its ownK252533 HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1…Edwards Lifesciences · 2025
Show all 28 generations
  1. Root · 28 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 27 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
  3. 26 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
  4. 25 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
  5. 24 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
  6. 23 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
  7. 22 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
  8. 21 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
  9. 20 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
  10. 19 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
  11. 18 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
  12. 17 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
  13. 16 generations backK040304 Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 2004
  14. 15 generations backK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
  15. 14 generations backK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
  16. 13 generations backK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
  17. 12 generations backK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
  18. 11 generations backK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
  19. 10 generations backK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
  20. 9 generations backK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
  21. 8 generations backK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
  22. 7 generations backK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
  23. 6 generations backK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
  24. 5 generations backK062283 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90…Philips Medical Systems North America, Inc. · 2006
  25. 4 generations backK180881 HemoSphere Advanced Monitor, HemoSphere Pressure CableEdwards Lifesciences, LLC · 2018
  26. 3 generations backK190205 HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC · 2019
  27. 2 generations backK201446 HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC · 2020 · Recalled
  28. 1 generation backK203687 HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen…Edwards Lifesciences, LLC · 2021
  29. This deviceK231038 Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC · 2023

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2023: 12024: 12025: 32026: 1
2023high 3 (2025) · low 1 (2023)2026

Class I recalls in this family

  • K160552 EV1000 Clinical Platform with ClearSight Finger…3 generations back · 2016

Most influential descendants

Showing 5 of 6 · See all
  • K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC · 2023 · cites it directly5descendants
  • K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences · 2024 · 2 generations on4descendants
  • K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences · 2025 · 3 generations on2descendants
  • K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC · 2026 · 4 generations on0descendants
  • K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences · 2025 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−28K941811HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co.1994—
−27K960934HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co.1996—
−26K981376Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co.1999—
−25K990125HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH1999—
−24K990972HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH1999—
−23K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model…Philips Medical Systems, Inc.2001—
−22K020531Philips Multi-Parameter Module, Model M3001A; Philips Component Compact…Philips Medical Systems2002—
−21K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems2002—
−20K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue…Philips Medical Systems2002—
−19K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology…Philips Medical Systems, Inc.2003—
−18K031481The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20Philips Medizin Systeme Boblingen GmbH2003—
−17K032858The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH2003—
−16K040304Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH2004—
−15K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH2004—
−14K042845The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient…Philips Medizin Systeme Boblingen GmbH2004—
−13K050141The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2005—
−12K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70…Philips Medizin Systeme Boeblingen GmbH2005—
−11K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2005—
−10K052801Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH2005—
−9K053522Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors…Philips Medizin Systeme Boeblingen GmbH2006—
−8K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2006—
−7K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient…Philips Medizin Systeme Boblingen GmbH20062
−6K061052The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc.2006—
−5K062283The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient…Philips Medical Systems North America, Inc.2006—
−4K180881HemoSphere Advanced Monitor, HemoSphere Pressure CableEdwards Lifesciences, LLC2018—
−3K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC2019—
−2K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC20201
−1K203687HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension…Edwards Lifesciences, LLC2021—
0 (this device)K231038Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC2023—
+1K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced…Edwards Lifesciences, LLC2023—
+2K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1)…Edwards Lifesciences2024—
+3K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10)…Edwards Lifesciences20251
+4K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC2026—
+3K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198210
198530
198610
198710
198820
198920
199060
199170
199270
199370
199430
199570
1996100
199770
1998160
1999100
2000220
200190
2002170
200390
2004190
200540
200690
200720
200890
200950
201060
201110
201220
201310
201430
201510
201611
201710
201830
201920
202110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202310
202410
202530
202610
FIG. 1 — Lineage of K231038, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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 QNL device

  1. #1 K200717 CLEWICU System (ClewICUServer and ClewICUnitor)score 20.1 · 26 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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.

TypeNumberDeviceApplicantDecidedRecalls
*K203687HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction…
Summary page 4
…Product Code QNL, Class II and Regulatory Class: Primary HemoSphere Advanced Monitoring Platform, manufactured by Edwards Predicate: Lifesciences, K203687 cleared May 28, 2021, is being utilized for substantial equivalence to the Acumen Hypotension Prediction Index (…
Edwards Lifesciences, LLC2021—
*K200717CLEWICU System (ClewICUServer and ClewICUnitor)
Summary page 4
…effective and does not raise different questions of safety and effectiveness from the primary predicate. Additional CLEWICU System (K200717, cleared January 9, 2021) manufactured by Predicates: CLEW Medical Ltd., is being utilized for substantial equivalence to th…
Clew Medical, Ltd.2021—

Also cleared against K203687: 3 other devices →

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235

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 · 3 generations back · ◆ in the 2016 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 29 years and passes through 9 companies; a new generation was cleared every 4 months on median.
  • 35 of the 245 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K232294 (Edwards Lifesciences, LLC, 2023) has gone furthest, with 5 descendants of its own.
  • 3 other devices also cite its predicate K203687.

How does its category compare?

All QNL devices

QNL Medium-Term Adjunctive Predictive Cardiovascular Indicator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · QNL

2in 2024

2021: 12023: 22024: 22026 (partial year): 1
2007high 2 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QNL

Too few QNL 510(k)s in any year since 2007 to give a median.

Recalls per year · QNL

No recall names QNL since 2007.

Adverse event reports per year · QNL

No MAUDE report names QNL since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20211—00
20220—00
20232—00
20242—00
20250—00
20261—0—

What is it indicated for?

The Global Hypoperfusion Index (GHI) algorithm provides the clinician with physiological insight into a patient's likelihood of future hemodynamic instability. The GHI algorithm provides the risk of a global hypoperfusion event (defined as SvO2 < 60% for at least 1 minute) occurring in the next 10-15 minutes. The GHI algorithm is intended for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring with the Swan-Ganz catheter.…

Read the full statement (116 words)

The Global Hypoperfusion Index (GHI) algorithm provides the clinician with physiological insight into a patient's likelihood of future hemodynamic instability. The GHI algorithm provides the risk of a global hypoperfusion event (defined as SvO2 < 60% for at least 1 minute) occurring in the next 10-15 minutes.

The GHI algorithm is intended for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring with the Swan-Ganz catheter.

The GHI algorithm is considered to provide additional information regarding the patient's predicted future risk for clinical deterioration, as well as identifying patients at low risk for deterioration. The product predictions are for reference only and no therapeutic decisions should be made based solely on the GHI algorithm predictions.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K203687

3 other devices cite the same predicate.

  • K230057Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLC · 2023
  • K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion Index (GHI)Edwards Lifesciences, LLC · 2022
  • K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure…Edwards Lifesciences, LLC · 2022

More from Edwards Lifesciences, LLC

1,326 FDA decisions under this applicant name. See the company

  • P140031/S202Edwards SAPIEN 3 Ultra™ RESILIA Transcatheter Heart ValveEdwards Lifesciences, LLC · 2026
  • P150048/S100INSPIRIS RESILIA Aortic Valve; MITRIS RESILIA Mitral ValveEdwards Lifesciences, LLC · 2026
  • P220003/S032PASCAL Precision Transcatheter Valve Repair SystemEdwards Lifesciences, LLC · 2026
  • P230013/S033EVOQUE Tricuspid Valve Replacement SystemEdwards Lifesciences, LLC · 2026
  • P220003/S029PASCAL Precision Transcatheter Valve Repair SystemEdwards Lifesciences, LLC · 2026

Recent decisions in QNL

The QNL category page

  • K260008Deterioration Index Version 2Epic Systems Corporation · 2026
  • K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc. · 2024
  • K233216CLEWICU SystemClew Medical, Ltd. · 2024
  • K230842SignalHF (IM008)Implicity, Inc. · 2023
  • K200717CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical, Ltd. · 2021

https://510kreport.com/device/K231038 · printed Nov 6, 2026

Cite this page

510(k) Report. “K231038: Global Hypoperfusion Index (GHI) Algorithm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231038

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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