510(k) · Cleared
ClearedFORE-SIGHT ELITE Tissue Oximeter Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cas Medical Systems, Inc. · MUD Oximeter, Tissue Saturation
Cleared on Oct 21, 2019 as substantially equivalent to K180003 (Cas Medical Systems, Inc., 2018) after a 255-day review. Its family tree reaches back 15 generations to 1993. 15 later devices descend from it.
- Decided
- Oct 21, 2019
- Review
- 255 days
- Class
- Class II
- Product code
- MUD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K931154 (1993). 53 ancestors in all, the oldest K850978 (1985). 15 later devices descend from it, 1 citing it directly.
- Root · 15 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 11 generations between
- 3 generations backK133879 Fore-Sight Elite Absolute Tissue OximeterCas Medical Systems, Inc. · 2014
- 2 generations backK143675 FORE-SIGHT Elite Absolute Tissue OximeterCas Medical Systems, Inc. · 2015 · Recalled
- 1 generation backK180003 FORE-SIGHT ELITE Module Tissue OximeterCas Medical Systems, Inc. · 2018 · Recalled
- This deviceK190270 FORE-SIGHT ELITE Tissue Oximeter ModuleCas Medical Systems, Inc. · 2019
- Descendant · cites it directly · 14 of its ownK213682 HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere…Edwards Lifesciences, LLC · 2022
- Descendant · 2 generations on · 7 of its ownK223865 HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen…Edwards Lifesciences, LLC · 2023
- Descendant · 2 generations on · 6 of its ownK223651 Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC · 2023
- Descendant · 2 generations on · 6 of its ownK223127 HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight…Edwards Lifeciences, LLC · 2022
- Descendant · 3 generations on · 5 of its ownK230612 Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC · 2023
Show all 15 generations
- Root · 15 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 14 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 13 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 12 generations backK002231 LF-DP Gastrointestinal and Sigmoid Fiberscope, Accessories and…Olympus Optical Co., Ltd. · 2001
- 11 generations backK011869 Xenf-DP Rhino-Laryngofiberscope, Its Accessories and Ancillary…The Olympus Optical Co. · 2001
- 10 generations backK040684 T-Stat Microvascular Tissue Oximeter, Model 303Spectros Corporation · 2004
- 9 generations backK051257 Adult Cerebral Oximeter, Model 2040Cas Medical Systems, Inc. · 2005
- 8 generations backK061960 Fore-Sight Cerebral Oximeter Monitor, Model 2040Cas Medical Systems, Inc. · 2006
- 7 generations backK083892 Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030)Cas Medical Systems, Inc. · 2009
- 6 generations backK091452 Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030)Cas Medical Systems, Inc. · 2009
- 5 generations backK094030 Fore-Sight Absolute Cerebral and Somatic Oximeter, MC 2000 Series…Cas Medical Systems, Inc. · 2010
- 4 generations backK112820 Fore-Sight Absolute Tissue OximeterCas Medical Systems, Inc. · 2012
- 3 generations backK133879 Fore-Sight Elite Absolute Tissue OximeterCas Medical Systems, Inc. · 2014
- 2 generations backK143675 FORE-SIGHT Elite Absolute Tissue OximeterCas Medical Systems, Inc. · 2015 · Recalled
- 1 generation backK180003 FORE-SIGHT ELITE Module Tissue OximeterCas Medical Systems, Inc. · 2018 · Recalled
- This deviceK190270 FORE-SIGHT ELITE Tissue Oximeter ModuleCas Medical Systems, Inc. · 2019
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable…Edwards Lifesciences, LLC · 2022 · cites it directly14descendants
- K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid…Edwards Lifesciences, LLC · 2023 · 2 generations on7descendants
- K223651Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC · 2023 · 2 generations on6descendants
- K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC · 2022 · 2 generations on6descendants
- K230612Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC · 2023 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −14 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −13 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −12 | K002231 | LF-DP Gastrointestinal and Sigmoid Fiberscope, Accessories and Ancillary… | Olympus Optical Co., Ltd. | 2001 | — |
| −11 | K011869 | Xenf-DP Rhino-Laryngofiberscope, Its Accessories and Ancillary Equipment | The Olympus Optical Co. | 2001 | — |
| −10 | K040684 | T-Stat Microvascular Tissue Oximeter, Model 303 | Spectros Corporation | 2004 | — |
| −9 | K051257 | Adult Cerebral Oximeter, Model 2040 | Cas Medical Systems, Inc. | 2005 | — |
| −8 | K061960 | Fore-Sight Cerebral Oximeter Monitor, Model 2040 | Cas Medical Systems, Inc. | 2006 | — |
| −7 | K083892 | Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030) | Cas Medical Systems, Inc. | 2009 | — |
| −6 | K091452 | Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030) | Cas Medical Systems, Inc. | 2009 | — |
| −5 | K094030 | Fore-Sight Absolute Cerebral and Somatic Oximeter, MC 2000 Series, Models… | Cas Medical Systems, Inc. | 2010 | — |
| −4 | K112820 | Fore-Sight Absolute Tissue Oximeter | Cas Medical Systems, Inc. | 2012 | — |
| −3 | K133879 | Fore-Sight Elite Absolute Tissue Oximeter | Cas Medical Systems, Inc. | 2014 | — |
| −2 | K143675 | FORE-SIGHT Elite Absolute Tissue Oximeter | Cas Medical Systems, Inc. | 2015 | 1 |
| −1 | K180003 | FORE-SIGHT ELITE Module Tissue Oximeter | Cas Medical Systems, Inc. | 2018 | 1 |
| 0 (this device) | K190270 | FORE-SIGHT ELITE Tissue Oximeter Module | Cas Medical Systems, Inc. | 2019 | — |
| +1 | K213682 | HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry… | Edwards Lifesciences, LLC | 2022 | — |
| +2 | K223865 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted… | Edwards Lifesciences, LLC | 2023 | — |
| +2 | K223651 | Cerebral Adaptive Index (CAI) Algorithm | Edwards Lifesciences, LLC | 2023 | — |
| +2 | K223127 | HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable | Edwards Lifeciences, LLC | 2022 | — |
| +3 | K230612 | Edwards Algorithm for Measurement of Blood Hemoglobin | Edwards Lifesciences, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 2 | 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.
Planning a device in MUD? 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 K223651 Cerebral Adaptive Index (CAI) Algorithmscore 19.8 · 29 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K180003 | FORE-SIGHT ELITE Module Tissue OximeterSummary page 5…Page 5 === EQUIVALENCE (Predicate Device) The FORE-SIGHT ELITE® Tissue Oximeter Module is equivalent to the following device: FORE-SIGHT ELITE Tissue Oximeter Module (K180003); REFERENCE DEVICE • Hamamatsu Photonics Niro-200NX (K143219); DESCRIPTION The FORE-SIGHT ELITE Tissue Oximeter Modul… | 2018 |
| † | K143219 | Niro-200NX | 2015 |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213682 | HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable… | 2022 | 14 |
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?
- The line of descent spans 26 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 10 of the 53 ancestors have a recall of any class.
- Of its descendants, K213682 (Edwards Lifesciences, LLC, 2022) has gone furthest, with 14 descendants of its own.
- 1 other device also cites its predicate K180003.
How does its category compare?
All MUD devicesMUD Oximeter, Tissue Saturation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · MUD
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUD
124in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUD
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUD
131in 2025
MAUDE reports naming product code MUD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 4 | 72 | 0 | 2 |
| 2009 | 4 | 96 | 1 | 7 |
| 2010 | 4 | 59 | 0 | 1 |
| 2011 | 2 | — | 0 | 2 |
| 2012 | 6 | 211 | 0 | 3 |
| 2013 | 2 | — | 0 | 8 |
| 2014 | 5 | 109 | 0 | 4 |
| 2015 | 3 | 107 | 0 | 0 |
| 2016 | 4 | 167 | 0 | 9 |
| 2017 | 3 | 249 | 0 | 24 |
| 2018 | 3 | 128 | 0 | 38 |
| 2019 | 7 | 88 | 0 | 107 |
| 2020 | 2 | — | 0 | 50 |
| 2021 | 2 | — | 0 | 27 |
| 2022 | 2 | — | 2 | 52 |
| 2023 | 2 | — | 1 | 73 |
| 2024 | 5 | 124 | 0 | 140 |
| 2025 | 2 | — | 0 | 131 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The noninvasive FORE-SIGHT ELITE Tissue Oximeter “Module” is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced flow or no-flow ischemic states. The Module is also intended for use as an adjunct monitor of relative changes of oxygenated hemoglobin, deoxygenated hemoglobin, and their summation, total hemoglobin, of blood under the sensors. The Module is…
Read the full statement (152 words)
The noninvasive FORE-SIGHT ELITE Tissue Oximeter “Module” is intended for use as an adjunct monitor of absolute
regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced flow or no-flow
ischemic states. The Module is also intended for use as an adjunct monitor of relative changes of oxygenated hemoglobin,
deoxygenated hemoglobin, and their summation, total hemoglobin, of blood under the sensors. The Module is intended to
allow for the display of StO2 and regional hemoglobin on a third party display/patient monitor and is indicated for use as
follows:
When used with large sensors, the Module is indicated for use on adults and transitional adolescents >40 kg. When used
with medium sensors, the Module is indicated for use on pediatric subjects >3 kg. When used with small sensors, the
Module is indicated for cerebral use on pediatric subjects <8 kg and non-cerebral use on pediatric subjects < 5kg,
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/K190270 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190270: FORE-SIGHT ELITE Tissue Oximeter Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190270
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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