510(k) · Cleared
ClearedFore-Sight Cerebral Oximeter Monitor, Model 2040
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 Sep 5, 2006 as substantially equivalent to K051257 (Cas Medical Systems, Inc., 2005) and 3 other predicates after a 56-day review. Its family tree reaches back 7 generations to 1993. 59 later devices descend from it.
- Decided
- Sep 5, 2006
- Review
- 56 days
- Class
- Class II
- Product code
- MUD
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K931154 (1993). 26 ancestors in all, the oldest K850978 (1985). 59 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 6 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 5 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 4 generations backK002231 LF-DP Gastrointestinal and Sigmoid Fiberscope, Accessories and…Olympus Optical Co., Ltd. · 2001
- 3 generations backK011869 Xenf-DP Rhino-Laryngofiberscope, Its Accessories and Ancillary…The Olympus Optical Co. · 2001
- 2 generations backK040684 T-Stat Microvascular Tissue Oximeter, Model 303Spectros Corporation · 2004
- 1 generation backK051257 Adult Cerebral Oximeter, Model 2040Cas Medical Systems, Inc. · 2005
- This deviceK061960 Fore-Sight Cerebral Oximeter Monitor, Model 2040Cas Medical Systems, Inc. · 2006
- Descendant · cites it directly · 58 of its ownK083892 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
Showing 5 of 59 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 59 · See all- K083892Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030)Cas Medical Systems, Inc. · 2009 · cites it directly58descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −6 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −5 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −4 | K002231 | LF-DP Gastrointestinal and Sigmoid Fiberscope, Accessories and Ancillary… | Olympus Optical Co., Ltd. | 2001 | — |
| −3 | K011869 | Xenf-DP Rhino-Laryngofiberscope, Its Accessories and Ancillary Equipment | The Olympus Optical Co. | 2001 | — |
| −2 | K040684 | T-Stat Microvascular Tissue Oximeter, Model 303 | Spectros Corporation | 2004 | — |
| −1 | K051257 | Adult Cerebral Oximeter, Model 2040 | Cas Medical Systems, Inc. | 2005 | — |
| 0 (this device) | K061960 | Fore-Sight Cerebral Oximeter Monitor, Model 2040 | Cas Medical Systems, Inc. | 2006 | — |
| +1 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 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 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? (4)
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 |
|---|---|---|---|
| * | K051257 | Adult Cerebral Oximeter, Model 2040Summary page 2…The FORE-SIGHTr' Cerebral Oximeter Monitor, Model 2040 is equivalent to the following devices: :, CAS Adult Cerebral Oximetei Model 2040 (K051257) :o Soranetics INVOS® 5100/ .100A Cerebral Oximeter (K001842/ K960614); -% Spectros T-SMtTM 303 Microv… | 2005 |
| * | K001842 | Adult/Pediatric Cerebral Oximeter, Model Invos 5100Summary page 2…ent to the following devices: :, CAS Adult Cerebral Oximetei Model 2040 (K051257) :o Soranetics INVOS® 5100/ .100A Cerebral Oximeter (K001842/ K960614); -% Spectros T-SMtTM 303 Microvascular Tissue Oximeter (K040684); - DESCRIPTION The Ce… | 2000 |
| * | K960614 | Somanetics Invos 3100A Cerebral Oximeter (Invos)Summary page 2…e following devices: :, CAS Adult Cerebral Oximetei Model 2040 (K051257) :o Soranetics INVOS® 5100/ .100A Cerebral Oximeter (K001842/ K960614); -% Spectros T-SMtTM 303 Microvascular Tissue Oximeter (K040684); - DESCRIPTION The Cerebral Ox… | 1996 |
| * | K040684 | T-Stat Microvascular Tissue Oximeter, Model 303Summary page 2…l 2040 (K051257) :o Soranetics INVOS® 5100/ .100A Cerebral Oximeter (K001842/ K960614); -% Spectros T-SMtTM 303 Microvascular Tissue Oximeter (K040684); - DESCRIPTION The Cerebral Oximneter Monitor measures ce ebral tissue oxygen saturation allowing the clinic… | 2004 |
What descends from it? (59)
See all 592 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)
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 13 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 4 of the 26 ancestors have a recall of any class.
- Of its descendants, K083892 (Cas Medical Systems, Inc., 2009) has gone furthest, with 58 descendants of its own.
- 2 other devices also cite its predicate K051257.
How does its category compare?
All MUD devicesMUD Oximeter, Tissue Saturation: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 non-invasive FORE-SIGHT Cerebral Oximeter Monitor, model 2040 should be used as an adjunct monitor of regional hemoglobin oxygen saturation of blood in the brain. When used with FORE-SIGHT Large sensors, the Cerebral Oximeter Monitor is indicated for use with adults and children over 40 Kg. When used with FORE-SIGHT Small sensors, the Cerebral Oximeter Monitor is indicated for infants. The Cerebral Oximeter Monitor should not be used as the sole basis for decisions as to the diagnosis or therapy. The value of data from the Cerebral Oximeter Monitor has not been demonstrated in disease states.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061960 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061960: Fore-Sight Cerebral Oximeter Monitor, Model 2040.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061960
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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