510(k) · Cleared
Recalled · Class II · 2022FORE-SIGHT ELITE Module Tissue Oximeter
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 May 10, 2018 as substantially equivalent to K143675 (Cas Medical Systems, Inc., 2015) after a 128-day review. Its family tree reaches back 14 generations to 1993. 29 later devices descend from it. It has been recalled once.
- Decided
- May 10, 2018
- Review
- 128 days
- Class
- Class II
- Product code
- MUD
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 14 generations to K931154 (1993). 52 ancestors in all, the oldest K850978 (1985). 29 later devices descend from it, 2 citing it directly.
- Root · 14 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 10 generations between
- 3 generations backK112820 Fore-Sight Absolute Tissue OximeterCas Medical Systems, Inc. · 2012
- 2 generations backK133879 Fore-Sight Elite Absolute Tissue OximeterCas Medical Systems, Inc. · 2014
- 1 generation backK143675 FORE-SIGHT Elite Absolute Tissue OximeterCas Medical Systems, Inc. · 2015 · Recalled
- This deviceK180003 FORE-SIGHT ELITE Module Tissue OximeterCas Medical Systems, Inc. · 2018
- Descendant · cites it directly · 27 of its ownK201446 HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC · 2020 · Recalled
- Descendant · 2 generations on · 18 of its ownK203687 HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen…Edwards Lifesciences, LLC · 2021
- Descendant · 2 generations on · 15 of its ownK211465 HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced…Edwards Lfesciences · 2021
- Descendant · cites it directly · 15 of its ownK190270 FORE-SIGHT ELITE Tissue Oximeter ModuleCas Medical Systems, Inc. · 2019
- Descendant · 2 generations on · 14 of its ownK213682 HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere…Edwards Lifesciences, LLC · 2022
Show all 14 generations
- Root · 14 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 13 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 12 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 11 generations backK002231 LF-DP Gastrointestinal and Sigmoid Fiberscope, Accessories and…Olympus Optical Co., Ltd. · 2001
- 10 generations backK011869 Xenf-DP Rhino-Laryngofiberscope, Its Accessories and Ancillary…The Olympus Optical Co. · 2001
- 9 generations backK040684 T-Stat Microvascular Tissue Oximeter, Model 303Spectros Corporation · 2004
- 8 generations backK051257 Adult Cerebral Oximeter, Model 2040Cas Medical Systems, Inc. · 2005
- 7 generations backK061960 Fore-Sight Cerebral Oximeter Monitor, Model 2040Cas Medical Systems, Inc. · 2006
- 6 generations backK083892 Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030)Cas Medical Systems, Inc. · 2009
- 5 generations backK091452 Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030)Cas Medical Systems, Inc. · 2009
- 4 generations backK094030 Fore-Sight Absolute Cerebral and Somatic Oximeter, MC 2000 Series…Cas Medical Systems, Inc. · 2010
- 3 generations backK112820 Fore-Sight Absolute Tissue OximeterCas Medical Systems, Inc. · 2012
- 2 generations backK133879 Fore-Sight Elite Absolute Tissue OximeterCas Medical Systems, Inc. · 2014
- 1 generation backK143675 FORE-SIGHT Elite Absolute Tissue OximeterCas Medical Systems, Inc. · 2015 · Recalled
- This deviceK180003 FORE-SIGHT ELITE Module Tissue OximeterCas Medical Systems, Inc. · 2018
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC · 2020 · cites it directly27descendants
- K203687HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction…Edwards Lifesciences, LLC · 2021 · 2 generations on18descendants
- K211465HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring PlatformEdwards Lfesciences · 2021 · 2 generations on15descendants
- K190270FORE-SIGHT ELITE Tissue Oximeter ModuleCas Medical Systems, Inc. · 2019 · cites it directly15descendants
- K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable…Edwards Lifesciences, LLC · 2022 · 2 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −13 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −12 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −11 | K002231 | LF-DP Gastrointestinal and Sigmoid Fiberscope, Accessories and Ancillary… | Olympus Optical Co., Ltd. | 2001 | — |
| −10 | K011869 | Xenf-DP Rhino-Laryngofiberscope, Its Accessories and Ancillary Equipment | The Olympus Optical Co. | 2001 | — |
| −9 | K040684 | T-Stat Microvascular Tissue Oximeter, Model 303 | Spectros Corporation | 2004 | — |
| −8 | K051257 | Adult Cerebral Oximeter, Model 2040 | Cas Medical Systems, Inc. | 2005 | — |
| −7 | K061960 | Fore-Sight Cerebral Oximeter Monitor, Model 2040 | Cas Medical Systems, Inc. | 2006 | — |
| −6 | K083892 | Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030) | Cas Medical Systems, Inc. | 2009 | — |
| −5 | K091452 | Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030) | Cas Medical Systems, Inc. | 2009 | — |
| −4 | K094030 | Fore-Sight Absolute Cerebral and Somatic Oximeter, MC 2000 Series, Models… | Cas Medical Systems, Inc. | 2010 | — |
| −3 | K112820 | Fore-Sight Absolute Tissue Oximeter | Cas Medical Systems, Inc. | 2012 | — |
| −2 | K133879 | Fore-Sight Elite Absolute Tissue Oximeter | Cas Medical Systems, Inc. | 2014 | — |
| −1 | K143675 | FORE-SIGHT Elite Absolute Tissue Oximeter | Cas Medical Systems, Inc. | 2015 | 1 |
| 0 (this device) | K180003 | FORE-SIGHT ELITE Module Tissue Oximeter | Cas Medical Systems, Inc. | 2018 | — |
| +1 | K201446 | HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module | Edwards Lifesiences, LLC | 2020 | 1 |
| +2 | K203687 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension… | Edwards Lifesciences, LLC | 2021 | — |
| +2 | K211465 | HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring… | Edwards Lfesciences | 2021 | — |
| +1 | K190270 | FORE-SIGHT ELITE Tissue Oximeter Module | Cas Medical Systems, Inc. | 2019 | — |
| +2 | K213682 | HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry… | Edwards Lifesciences, LLC | 2022 | — |
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 |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 5 | 0 |
| 2022 | 4 | 0 |
| 2023 | 8 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 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 |
|---|---|---|---|
| * | K143675 | FORE-SIGHT Elite Absolute Tissue OximeterSummary page 5…3 EQUIVALENCE (Predicate Device) The FORE-SIGHT ELITE® Module Tissue Oximeter is equivalent to the following device: FORE-SIGHT ELITE Absolute Tissue Oximeter Monitor (K143675); REFERENCE DEVICES e Multi-parameter Mobile Careguide 4100 Oximeter (K141496); e Mobile Careguide 2100 Oximeter (K122645) DESC… | 2015 |
| † | K141496 | Multi-Parameter Mobile Careguide 4100 Oximeter | 2014 |
| † | K122645 | Mobile Careguide 2100 Oximeter | 2012 |
What descends from it? (29)
See all 292 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 1, 2022 | Class II | Z-0835-2022 | Software in the Use Environment | The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter Module or the FORE-SIGHT ELITE Absolute Tissue Oximeter Monitor with the Fore-Sight Elite large sensor in certain somatic locations (arms and… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 9 of the 52 ancestors have a recall of any class.
- Of its descendants, K201446 (Edwards Lifesiences, LLC, 2020) has gone furthest, with 27 descendants of its own.
- 3 other devices also cite its predicate K143675.
How does its category compare?
All MUD devicesMUD Oximeter, Tissue Saturation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Module Tissue Oximeter 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 FORE-SIGHT ELITE Module Tissue Oximeter is intended to allow for the display of StO2 on a third party display/patient monitor. The FORE-SIGHT ELITE Module Tissue Oximeter when used with large sensors, is…
Read the full statement (128 words)
The noninvasive FORE-SIGHT ELITE Module Tissue Oximeter 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 FORE-SIGHT ELITE Module Tissue Oximeter is intended to allow for the display of StO2 on a third party display/patient monitor. The FORE-SIGHT ELITE Module Tissue Oximeter when used with large sensors, is indicated for use on adults and transitional adolescents ≥40 kg. When used with Medium Sensors, the FORE-SIGHT ELITE Module Tissue Oximeter is indicated for use on pediatric subjects ≥3 kg. When used with Small Sensors, the FORE-SIGHT ELITE Module Tissue Oximeter 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/K180003 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180003: FORE-SIGHT ELITE Module Tissue Oximeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180003
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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