510(k) · Cleared
ClearedModel 7600 Regional Oximeter System with Equanox Technology
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nonin Medical, Inc. · MUD Oximeter, Tissue Saturation
Cleared on May 14, 2012 as substantially equivalent to K102715 (Nonin Medical, Inc., 2010) and 1 other predicate after a 195-day review. Its family tree reaches back 11 generations to 1993. 42 later devices descend from it.
- Decided
- May 14, 2012
- Review
- 195 days
- Class
- Class II
- Product code
- MUD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K931154 (1993). 47 ancestors in all, the oldest K850978 (1985). 42 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 7 generations between
- 3 generations backK083892 Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030)Cas Medical Systems, Inc. · 2009
- 2 generations backK091452 Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030)Cas Medical Systems, Inc. · 2009
- 1 generation backK102715 Regional OximeterNonin Medical, Inc. · 2010
- This deviceK113215 Model 7600 Regional Oximeter System with Equanox TechnologyNonin Medical, Inc. · 2012
- Descendant · cites it directly · 37 of its ownK143675 FORE-SIGHT Elite Absolute Tissue OximeterCas Medical Systems, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 34 of its ownK190205 HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC · 2019
- Descendant · 2 generations on · 29 of its ownK180003 FORE-SIGHT ELITE Module Tissue OximeterCas Medical Systems, Inc. · 2018 · Recalled
- Descendant · 3 generations on · 27 of its ownK201446 HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC · 2020 · Recalled
- Descendant · 4 generations on · 18 of its ownK203687 HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen…Edwards Lifesciences, LLC · 2021
Show all 11 generations
- Root · 11 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 10 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 9 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 8 generations backK002231 LF-DP Gastrointestinal and Sigmoid Fiberscope, Accessories and…Olympus Optical Co., Ltd. · 2001
- 7 generations backK011869 Xenf-DP Rhino-Laryngofiberscope, Its Accessories and Ancillary…The Olympus Optical Co. · 2001
- 6 generations backK040684 T-Stat Microvascular Tissue Oximeter, Model 303Spectros Corporation · 2004
- 5 generations backK051257 Adult Cerebral Oximeter, Model 2040Cas Medical Systems, Inc. · 2005
- 4 generations backK061960 Fore-Sight Cerebral Oximeter Monitor, Model 2040Cas Medical Systems, Inc. · 2006
- 3 generations backK083892 Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030)Cas Medical Systems, Inc. · 2009
- 2 generations backK091452 Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030)Cas Medical Systems, Inc. · 2009
- 1 generation backK102715 Regional OximeterNonin Medical, Inc. · 2010
- This deviceK113215 Model 7600 Regional Oximeter System with Equanox TechnologyNonin Medical, Inc. · 2012
Showing 5 of 42 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 42 · See all- K143675FORE-SIGHT Elite Absolute Tissue OximeterCas Medical Systems, Inc. · 2015 · cites it directly37descendants
- K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC · 2019 · 2 generations on34descendants
- K180003FORE-SIGHT ELITE Module Tissue OximeterCas Medical Systems, Inc. · 2018 · 2 generations on29descendants
- K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC · 2020 · 3 generations on27descendants
- K203687HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction…Edwards Lifesciences, LLC · 2021 · 4 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −10 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −9 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −8 | K002231 | LF-DP Gastrointestinal and Sigmoid Fiberscope, Accessories and Ancillary… | Olympus Optical Co., Ltd. | 2001 | — |
| −7 | K011869 | Xenf-DP Rhino-Laryngofiberscope, Its Accessories and Ancillary Equipment | The Olympus Optical Co. | 2001 | — |
| −6 | K040684 | T-Stat Microvascular Tissue Oximeter, Model 303 | Spectros Corporation | 2004 | — |
| −5 | K051257 | Adult Cerebral Oximeter, Model 2040 | Cas Medical Systems, Inc. | 2005 | — |
| −4 | K061960 | Fore-Sight Cerebral Oximeter Monitor, Model 2040 | Cas Medical Systems, Inc. | 2006 | — |
| −3 | K083892 | Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030) | Cas Medical Systems, Inc. | 2009 | — |
| −2 | K091452 | Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030) | Cas Medical Systems, Inc. | 2009 | — |
| −1 | K102715 | Regional Oximeter | Nonin Medical, Inc. | 2010 | — |
| 0 (this device) | K113215 | Model 7600 Regional Oximeter System with Equanox Technology | Nonin Medical, Inc. | 2012 | — |
| +1 | K143675 | FORE-SIGHT Elite Absolute Tissue Oximeter | Cas Medical Systems, Inc. | 2015 | 1 |
| +2 | K190205 | HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module | Edwards Lifesciences, LLC | 2019 | — |
| +2 | K180003 | FORE-SIGHT ELITE Module Tissue Oximeter | Cas Medical Systems, Inc. | 2018 | 1 |
| +3 | K201446 | HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module | Edwards Lifesiences, LLC | 2020 | 1 |
| +4 | K203687 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension… | Edwards Lifesciences, LLC | 2021 | — |
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 | 2 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 7 | 0 |
| 2022 | 5 | 0 |
| 2023 | 8 | 0 |
| 2024 | 6 | 0 |
| 2025 | 5 | 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? (2)
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 |
|---|---|---|---|
| * | K102715 | Regional OximeterSummary page 1…y equivalent to the Model 8004CA Oximetry Sensor cleared with the Model 7600 Regional Oximeter System cleared by the FDA in K102715 on 12/17/2010, and the FORE-SIGHT® Oximeter MC-2000 Series Cerebral Oximeter manufa… | 2010 |
| * | K094030 | Fore-Sight Absolute Cerebral and Somatic Oximeter, MC 2000 Series, Models MC2000…Summary page 4…alent to the FORE-SIGHT® Oximeter MC-2000 Series Cerebral Oximeter manufactured by GAS Medical Systems Inc. that was cleared by the FDA under K094030 on 12/23/10. The conclusion drawn is that the revised indications for use and labeling are substanti… | 2010 |
What descends from it? (42)
See all 422 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 19 years and passes through 7 companies; a new generation was cleared every 1.4 years on median.
- 8 of the 47 ancestors have a recall of any class.
- Of its descendants, K143675 (Cas Medical Systems, Inc., 2015) has gone furthest, with 37 descendants of its own.
- 5 other devices also cite its predicate K102715.
How does its category compare?
All MUD devicesMUD Oximeter, Tissue Saturation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 8004CB Single-Patient use, Non-Sterile, Disposable Regional Oximetry Sensor is intended for use as an absolute real-time adjunct monitor of hemoglobin oxygen saturation of blood underneath the sensor at cerebral and somatic sites. The sensor is for spot-checking and continuous monitoring of neonate, infant, and pediatric patients weighing less than 88 pounds (40 kilograms).. The sensor may be repositioned or replaced with another 8004CB sensor…
Read the full statement (254 words)
The 8004CB Single-Patient use, Non-Sterile, Disposable Regional Oximetry Sensor is intended for use as an absolute real-time adjunct monitor of hemoglobin oxygen saturation of blood underneath the sensor at cerebral and somatic sites. The sensor is for spot-checking and continuous monitoring of neonate, infant, and pediatric patients weighing less than 88 pounds (40 kilograms).. The sensor may be repositioned or replaced with another 8004CB sensor without baseline re-establishment. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long term care and mobile environments.
The 8004CB-NA Non-Adhesive, Single-Patient use, Non-Sterile, Disposable Regional Oximetry Sensor is intended for use as an absolute real-time adjunct monitor of hemoglobin oxygen saturation of blood underneath the sensor at cerebral and somatic sites. The sensor is for spot-checking and continuous monitoring of neonate, infant, and pediatric Patients weighing less than 88 pounds (40 kilograms). The sensor may be repositioned or replaced with another 8004CB-NA sensor without baseline re-establishment. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long term care and mobile environments.
Nonin's non-invasive Model 7600 4- Channel Regional Oximeter System is intended for use as an absolute real-time adjunct monitor of hemoglobin oxygen saturation of blood underneath the sensor at cerebral and somatic sites. It is intended for spot-checking or continuous monitoring of adult, or neonate, infant and pediatric patients. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care and mobile environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113215 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113215: Model 7600 Regional Oximeter System with Equanox Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113215
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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