510(k) · Cleared
ClearedFore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cas Medical Systems, Inc. · DQA Oximeter
Cleared on Mar 19, 2009 as substantially equivalent to K061960 (Cas Medical Systems, Inc., 2006) and 9 other predicates after an 80-day review. Its family tree reaches back 8 generations to 1993. 58 later devices descend from it.
- Decided
- Mar 19, 2009
- Review
- 80 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 8 generations to K931154 (1993). 36 ancestors in all, the oldest K850978 (1985). 58 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 7 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 6 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 5 generations backK002231 LF-DP Gastrointestinal and Sigmoid Fiberscope, Accessories and…Olympus Optical Co., Ltd. · 2001
- 4 generations backK011869 Xenf-DP Rhino-Laryngofiberscope, Its Accessories and Ancillary…The Olympus Optical Co. · 2001
- 3 generations backK040684 T-Stat Microvascular Tissue Oximeter, Model 303Spectros Corporation · 2004
- 2 generations backK051257 Adult Cerebral Oximeter, Model 2040Cas Medical Systems, Inc. · 2005
- 1 generation backK061960 Fore-Sight Cerebral Oximeter Monitor, Model 2040Cas Medical Systems, Inc. · 2006
- This deviceK083892 Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030)Cas Medical Systems, Inc. · 2009
- Descendant · cites it directly · 57 of its ownK091452 Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030)Cas Medical Systems, Inc. · 2009
- Descendant · 2 generations on · 53 of its ownK094030 Fore-Sight Absolute Cerebral and Somatic Oximeter, MC 2000 Series…Cas Medical Systems, Inc. · 2010
- Descendant · 2 generations on · 53 of its ownK102715 Regional OximeterNonin Medical, Inc. · 2010
- Descendant · 3 generations on · 47 of its ownK112820 Fore-Sight Absolute Tissue OximeterCas Medical Systems, Inc. · 2012
- Descendant · 3 generations on · 44 of its ownK133879 Fore-Sight Elite Absolute Tissue OximeterCas Medical Systems, Inc. · 2014
Showing 5 of 58 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 58 · See all- K091452Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030)Cas Medical Systems, Inc. · 2009 · cites it directly57descendants
- K094030Fore-Sight Absolute Cerebral and Somatic Oximeter, MC 2000 Series, Models MC2000…Cas Medical Systems, Inc. · 2010 · 2 generations on53descendants
- K102715Regional OximeterNonin Medical, Inc. · 2010 · 2 generations on53descendants
- K112820Fore-Sight Absolute Tissue OximeterCas Medical Systems, Inc. · 2012 · 3 generations on47descendants
- K133879Fore-Sight Elite Absolute Tissue OximeterCas Medical Systems, Inc. · 2014 · 3 generations on44descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −7 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −6 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −5 | K002231 | LF-DP Gastrointestinal and Sigmoid Fiberscope, Accessories and Ancillary… | Olympus Optical Co., Ltd. | 2001 | — |
| −4 | K011869 | Xenf-DP Rhino-Laryngofiberscope, Its Accessories and Ancillary Equipment | The Olympus Optical Co. | 2001 | — |
| −3 | K040684 | T-Stat Microvascular Tissue Oximeter, Model 303 | Spectros Corporation | 2004 | — |
| −2 | K051257 | Adult Cerebral Oximeter, Model 2040 | Cas Medical Systems, Inc. | 2005 | — |
| −1 | K061960 | Fore-Sight Cerebral Oximeter Monitor, Model 2040 | Cas Medical Systems, Inc. | 2006 | — |
| 0 (this device) | K083892 | Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030) | Cas Medical Systems, Inc. | 2009 | — |
| +1 | K091452 | Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030) | Cas Medical Systems, Inc. | 2009 | — |
| +2 | K094030 | Fore-Sight Absolute Cerebral and Somatic Oximeter, MC 2000 Series, Models… | Cas Medical Systems, Inc. | 2010 | — |
| +2 | K102715 | Regional Oximeter | Nonin Medical, Inc. | 2010 | — |
| +3 | K112820 | Fore-Sight Absolute Tissue Oximeter | Cas Medical Systems, Inc. | 2012 | — |
| +3 | K133879 | Fore-Sight Elite Absolute Tissue Oximeter | Cas Medical Systems, Inc. | 2014 | — |
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 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 7 | 0 |
| 2022 | 6 | 0 |
| 2023 | 8 | 0 |
| 2024 | 6 | 0 |
| 2025 | 6 | 0 |
| 2026 | 3 | 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 DQA? 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 DQA device
- #1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (10)
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 |
|---|---|---|---|
| * | K061960 | Fore-Sight Cerebral Oximeter Monitor, Model 2040Summary page 2…The FORE-SIGHT® Cerebral Oximeter Monitor, Model MC-2000 is equivalent to the following devices: oo CAS Adult Cerebral Oximeter Model 2000 (K061960 / K073036) *- Somanetics INVOS® 5100C / 3100A Cerebral Oximeter (K001842 / K960614 / K051274 / K0807… | 2006 |
| * | K073036 | Fore-Sight, MC-2000 SeriesSummary page 2…he FORE-SIGHT® Cerebral Oximeter Monitor, Model MC-2000 is equivalent to the following devices: oo CAS Adult Cerebral Oximeter Model 2000 (K061960 / K073036) *- Somanetics INVOS® 5100C / 3100A Cerebral Oximeter (K001842 / K960614 / K051274 / K080769);… | 2008 |
| * | K001842 | Adult/Pediatric Cerebral Oximeter, Model Invos 5100Summary page 2…following devices: oo CAS Adult Cerebral Oximeter Model 2000 (K061960 / K073036) *- Somanetics INVOS® 5100C / 3100A Cerebral Oximeter (K001842 / K960614 / K051274 / K080769); + Spectros T-StatfM 303 Microvascular Tissue Oximeter (K040684);… | 2000 |
| * | K960614 | Somanetics Invos 3100A Cerebral Oximeter (Invos)Summary page 2…ollowing devices: oo CAS Adult Cerebral Oximeter Model 2000 (K061960 / K073036) *- Somanetics INVOS® 5100C / 3100A Cerebral Oximeter (K001842 / K960614 / K051274 / K080769); + Spectros T-StatfM 303 Microvascular Tissue Oximeter (K040684); o+… | 1996 |
| * | K051274 | Invos SystemSummary page 2…oo CAS Adult Cerebral Oximeter Model 2000 (K061960 / K073036) *- Somanetics INVOS® 5100C / 3100A Cerebral Oximeter (K001842 / K960614 / K051274 / K080769); + Spectros T-StatfM 303 Microvascular Tissue Oximeter (K040684); o+t Nellcor N395/N595 Pulse… | 2005 |
| * | K080769 | Invos Cerebral/Somatic Oximeter System, Model 5100CSummary page 2…S Adult Cerebral Oximeter Model 2000 (K061960 / K073036) *- Somanetics INVOS® 5100C / 3100A Cerebral Oximeter (K001842 / K960614 / K051274 / K080769); + Spectros T-StatfM 303 Microvascular Tissue Oximeter (K040684); o+t Nellcor N395/N595 Pulse Oximeter (… | 2008 |
| * | K040684 | T-Stat Microvascular Tissue Oximeter, Model 303Summary page 2…netics INVOS® 5100C / 3100A Cerebral Oximeter (K001842 / K960614 / K051274 / K080769); + Spectros T-StatfM 303 Microvascular Tissue Oximeter (K040684); o+t Nellcor N395/N595 Pulse Oximeter (K991823 / K012891); 4 Masimo SET Radical Pulse Oximeter (K031330)… | 2004 |
| * | K991823 | N-395 Pulse Oximeter, Model N-395Summary page 2…0614 / K051274 / K080769); + Spectros T-StatfM 303 Microvascular Tissue Oximeter (K040684); o+t Nellcor N395/N595 Pulse Oximeter (K991823 / K012891); 4 Masimo SET Radical Pulse Oximeter (K031330); DESCRIPTION The Cerebral Oximeter Monitor measures cere… | 1999 |
| * | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables…Summary page 2…K051274 / K080769); + Spectros T-StatfM 303 Microvascular Tissue Oximeter (K040684); o+t Nellcor N395/N595 Pulse Oximeter (K991823 / K012891); 4 Masimo SET Radical Pulse Oximeter (K031330); DESCRIPTION The Cerebral Oximeter Monitor measures cerebral tissu… | 2002 |
| * | K031330 | Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of…Summary page 2…tatfM 303 Microvascular Tissue Oximeter (K040684); o+t Nellcor N395/N595 Pulse Oximeter (K991823 / K012891); 4 Masimo SET Radical Pulse Oximeter (K031330); DESCRIPTION The Cerebral Oximeter Monitor measures cerebral tissue oxygen saturation allowing the clinician to accurately de… | 2003 |
What descends from it? (58)
See all 581 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091452 | Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030) | 2009 | 57 |
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 16 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- 7 of the 36 ancestors have a recall of any class.
- Of its descendants, K091452 (Cas Medical Systems, Inc., 2009) has gone furthest, with 57 descendants of its own.
- 1 other device also cites its predicate K061960.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · DQA
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQA
182in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQA
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQA
399in 2025
MAUDE reports naming product code DQA, 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 | 20 | 122 | 6 | 325 |
| 2008 | 22 | 97 | 5 | 312 |
| 2009 | 35 | 117 | 29 | 281 |
| 2010 | 29 | 127 | 4 | 185 |
| 2011 | 15 | 195 | 1 | 164 |
| 2012 | 14 | 120 | 0 | 322 |
| 2013 | 15 | 182 | 0 | 468 |
| 2014 | 11 | 175 | 2 | 1,124 |
| 2015 | 13 | 158 | 1 | 2,082 |
| 2016 | 14 | 246 | 0 | 1,775 |
| 2017 | 9 | 200 | 0 | 1,190 |
| 2018 | 18 | 260 | 32 | 694 |
| 2019 | 19 | 158 | 0 | 548 |
| 2020 | 15 | 126 | 0 | 426 |
| 2021 | 10 | 174 | 0 | 553 |
| 2022 | 20 | 265 | 0 | 478 |
| 2023 | 13 | 317 | 0 | 392 |
| 2024 | 14 | 285 | 3 | 545 |
| 2025 | 15 | 182 | 0 | 399 |
| 2026 | 8 | 187 | 0 | — |
What is it indicated for?
The FORE-SIGHT® Cerebral Oximeter, Model MC-2000 Series is indicated for the continuous noninvasive monitoring of regional hemoglobin oxygen saturation of blood in the brain (SctO2). It is intended for use in any individual at risk for reduced-flow or no-flow ischemic states. The FORE-SIGHT should not be used as the sole basis for decisions as to the diagnosis or therapy. The value of data from the FORE-SIGHT has not been demonstrated in disease states.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083892 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083892: Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083892
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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