510(k) Report

510(k) · Cleared

Cleared

Edwards Algorithm for Measurement of Blood Hemoglobin

K230612510(k) TraditionalCleared Nov 17, 2023256-day reviewClass II21 CFR 870.2700

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

Edwards Lifesciences, LLC · MUD Oximeter, Tissue Saturation

Cleared on Nov 17, 2023 as substantially equivalent to K223127 (Edwards Lifeciences, LLC, 2022) after a 256-day review. Its family tree reaches back 30 generations to 1994. 1 of the 254 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.

Decided
Nov 17, 2023
Review
256 days
Class
Class II
Product code
MUD
Recalls
None
Predicates
1

Its longest line of descent runs back 30 generations to K941811 (1994). 248 ancestors in all, the oldest K822055 (1982). 5 later devices descend from it, 1 citing it directly. 1 of the 254 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2015: 1 other ancestor2021: 1 other ancestor2020: 1 other ancestor2019: 2 other ancestors2014: 3 other ancestors2012: 2 other ancestors2018: 3 other ancestors2010: 6 other ancestors2009: 5 other ancestors2017: 1 other ancestor2016: 1 other ancestor, 1 with a Class I recall12008: 9 other ancestors2005: 4 other ancestors2006: 9 other ancestors2004: 19 other ancestors2003: 9 other ancestors2002: 17 other ancestors2000: 22 other ancestors1998: 16 other ancestors1997: 7 other ancestors1996: 10 other ancestors2013: 1 other ancestor2011: 1 other ancestor2001: 9 other ancestors1999: 10 other ancestors1994: 3 other ancestors1992: 7 other ancestors1991: 7 other ancestors1988: 2 other ancestors1986: 1 other ancestor2007: 2 other ancestors1995: 7 other ancestors1993: 7 other ancestors1990: 6 other ancestors1989: 2 other ancestors1987: 1 other ancestor1985: 3 other ancestors1982: 1 other ancestor2024: 1 descendant cleared2025: 3 descendants cleared2026: 1 descendant clearedReference device: K113216 · Rapidpoint 500 Blood Gas Analyer · Siemens Healthcare Diagnostics · 2012 · recalledReference device: K193626 · Masimo Rad-97 Pulse CO-Oximeter and Accessories · Masimo Corporation · 2020K941811 · 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 · 2021×2: 2 generations cleared close together, K213682 (2022), K223127 (2022) 19801990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor3 generations back: 6 other ancestors4 generations back: 5 other ancestors5 generations back: 10 other ancestors, 1 with a Class I recall16 generations back: 20 other ancestors7 generations back: 38 other ancestors8 generations back: 65 other ancestors9 generations back: 24 other ancestors10 generations back: 18 other ancestors11 generations back: 18 other ancestors12 generations back: 11 other ancestors13 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 2 descendants K223127 · HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable · Edwards Lifeciences, LLC · 2022K213682 · HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere ClearSight Module, HemoSphere Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen Hypotension Prediction Index Feature, Acumen Assisted Fluid Management Feature, Viewfinder Remote · Edwards Lifesciences, LLC · 2022K203687 · 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. · 1994−30−25−20−15−10−50
  1. Root · 30 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 26 generations between
  3. 3 generations backK203687 HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen…Edwards Lifesciences, LLC · 2021
  4. 2 generations backK213682 HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere…Edwards Lifesciences, LLC · 2022
  5. 1 generation backK223127 HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight…Edwards Lifeciences, LLC · 2022
  6. This deviceK230612 Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC · 2023
  7. Descendant · cites it directly · 4 of its ownK242451 HemoSphere Alta Advanced Monitoring Platform…Edwards Lifesciences · 2024
  8. Descendant · 2 generations on · 2 of its ownK243781 HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module…Edwards Lifesciences · 2025 · Recalled
  9. Descendant · 3 generations on · 0 of its ownK253186 HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC · 2026
  10. Descendant · 2 generations on · 0 of its ownK252533 HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1…Edwards Lifesciences · 2025
  11. Descendant · 3 generations on · 0 of its ownK253034 HemoSphere Stream ModuleEdwards Lifesciences · 2025
Show all 30 generations
  1. Root · 30 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 29 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
  3. 28 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
  4. 27 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
  5. 26 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
  6. 25 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
  7. 24 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
  8. 23 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
  9. 22 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
  10. 21 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
  11. 20 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
  12. 19 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
  13. 18 generations backK040304 Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 2004
  14. 17 generations backK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
  15. 16 generations backK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
  16. 15 generations backK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
  17. 14 generations backK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
  18. 13 generations backK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
  19. 12 generations backK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
  20. 11 generations backK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
  21. 10 generations backK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
  22. 9 generations backK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
  23. 8 generations backK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
  24. 7 generations backK062283 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90…Philips Medical Systems North America, Inc. · 2006
  25. 6 generations backK180881 HemoSphere Advanced Monitor, HemoSphere Pressure CableEdwards Lifesciences, LLC · 2018
  26. 5 generations backK190205 HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC · 2019
  27. 4 generations backK201446 HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC · 2020 · Recalled
  28. 3 generations backK203687 HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen…Edwards Lifesciences, LLC · 2021
  29. 2 generations backK213682 HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere…Edwards Lifesciences, LLC · 2022
  30. 1 generation backK223127 HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight…Edwards Lifeciences, LLC · 2022
  31. This deviceK230612 Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC · 2023

Class I recalls in this family

  • K160552 EV1000 Clinical Platform with ClearSight Finger…5 generations back · 2016

Most influential descendants

Showing 5 of 5 · See all
  • K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences · 2024 · cites it directly4descendants
  • K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences · 2025 · 2 generations on2descendants
  • K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC · 2026 · 3 generations on0descendants
  • K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences · 2025 · 2 generations on0descendants
  • K253034HemoSphere Stream ModuleEdwards Lifesciences · 2025 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−30K941811HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co.1994—
−29K960934HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co.1996—
−28K981376Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co.1999—
−27K990125HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH1999—
−26K990972HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH1999—
−25K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model…Philips Medical Systems, Inc.2001—
−24K020531Philips Multi-Parameter Module, Model M3001A; Philips Component Compact…Philips Medical Systems2002—
−23K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems2002—
−22K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue…Philips Medical Systems2002—
−21K030038Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology…Philips Medical Systems, Inc.2003—
−20K031481The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20Philips Medizin Systeme Boblingen GmbH2003—
−19K032858The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH2003—
−18K040304Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH2004—
−17K041235Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH2004—
−16K042845The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient…Philips Medizin Systeme Boblingen GmbH2004—
−15K050141The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH2005—
−14K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70…Philips Medizin Systeme Boeblingen GmbH2005—
−13K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2005—
−12K052801Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH2005—
−11K053522Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors…Philips Medizin Systeme Boeblingen GmbH2006—
−10K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2006—
−9K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient…Philips Medizin Systeme Boblingen GmbH20062
−8K061052The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc.2006—
−7K062283The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient…Philips Medical Systems North America, Inc.2006—
−6K180881HemoSphere Advanced Monitor, HemoSphere Pressure CableEdwards Lifesciences, LLC2018—
−5K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC2019—
−4K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC20201
−3K203687HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension…Edwards Lifesciences, LLC2021—
−2K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry…Edwards Lifesciences, LLC2022—
−1K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC2022—
0 (this device)K230612Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC2023—
+1K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1)…Edwards Lifesciences2024—
+2K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10)…Edwards Lifesciences20251
+3K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC2026—
+2K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences2025—
+3K253034HemoSphere Stream ModuleEdwards 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
202010
202110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202410
202530
202610
FIG. 1 — Lineage of K230612, 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 MUD device

  1. #1 K223651 Cerebral Adaptive Index (CAI) Algorithmscore 19.8 · 29 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? (1)

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
*K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable
Summary page 4
…eter Cable (FSOC) on the HemoSphere Advanced Monitoring Platform, manufactured by Edwards Lifesciences, most recently cleared under K223127 on November 07, 2022, is being utilized as the Primary Predicate to establish substantial equivalence to the…
Edwards Lifeciences, LLC2022—
†K113216Rapidpoint 500 Blood Gas AnalyerSiemens Healthcare Diagnostics201212
†K193626Masimo Rad-97 Pulse CO-Oximeter and AccessoriesMasimo Corporation2020—

What descends from it? (5)

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

NumberDeviceApplicantDecidedDescendants
K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244

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 · 5 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 10 companies; a new generation was cleared every 4 months on median.
  • 35 of the 248 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K242451 (Edwards Lifesciences, 2024) has gone furthest, with 4 descendants of its own.

How does its category compare?

All MUD devices

MUD Oximeter, Tissue Saturation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · MUD

2in 2025

2008: 42009: 42010: 42011: 22012: 62013: 22014: 52015: 32016: 42017: 32018: 32019: 72020: 22021: 22022: 22023: 22024: 52025: 22026 (partial year): 1
2007high 7 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MUD

124in 2024

2008: 72 days median2009: 96 days median2010: 59 days median2012: 211 days median2014: 109 days median2015: 107 days median2016: 167 days median2017: 249 days median2018: 128 days median2019: 88 days median2024: 124 days median
2007high 249 (2017) · low 59 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MUD

1in 2023

2009: 12022: 22023: 12026 (partial year): 1
2007high 2 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MUD

131in 2025

2008: 22009: 72010: 12011: 22012: 32013: 82014: 42016: 92017: 242018: 382019: 1072020: 502021: 272022: 522023: 732024: 1402025: 131
2007high 140 (2024) · low 0 (2007)2025

MAUDE reports naming product code MUD, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
200847202
200949617
201045901
20112—02
2012621103
20132—08
2014510904
2015310700
2016416709
20173249024
20183128038
20197880107
20202—050
20212—027
20222—252
20232—173
202451240140
20252—0131
20261—1—

What is it indicated for?

The Edwards Algorithm for Measurement of Blood Hemoglobin is indicated for continuously monitoring changes to hemoglobin concentration in the circulating blood of adults ≥ 40 kg receiving advanced hemodynamic monitoring using HemoSphere ForeSight Oximeter Cable and non-invasive ForeSight sensors (large) in cerebral locations.

Indications for use as stated in the FDA summary.

More from Edwards Lifesciences, LLC

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

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  • 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 MUD

The MUD category page

  • K254129Spectrum-2Neko Health AB · 2026
  • K243324Masimo O3 Regional OximeterMasimo Corporation · 2025
  • K250519Lap.Ox™ Laparoscopic Tissue OximeterVioptix, Inc. · 2025
  • K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences · 2024
  • K241393ODI-TechOdi Medical AS · 2024

https://510kreport.com/device/K230612 · printed Nov 4, 2026

Cite this page

510(k) Report. “K230612: Edwards Algorithm for Measurement of Blood Hemoglobin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230612

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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