510(k) · Cleared
ClearedSenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface
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 2, 2019 as substantially equivalent to K102715 (Nonin Medical, Inc., 2010) and 1 other predicate after a 58-day review. Its family tree reaches back 12 generations to 1993.
- Decided
- May 2, 2019
- Review
- 58 days
- Class
- Class II
- Product code
- MUD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K931154 (1993). 42 ancestors in all, the oldest K850978 (1985). No later device cites it as a predicate yet.
- Root · 12 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 8 generations between
- 3 generations backK091452 Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030)Cas Medical Systems, Inc. · 2009
- 2 generations backK102715 Regional OximeterNonin Medical, Inc. · 2010
- 1 generation backK151305 SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40…Nonin Medical, Inc. · 2015
- This deviceK190560 SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart…Nonin Medical, Inc. · 2019
Show all 12 generations
- Root · 12 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 11 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 10 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 9 generations backK002231 LF-DP Gastrointestinal and Sigmoid Fiberscope, Accessories and…Olympus Optical Co., Ltd. · 2001
- 8 generations backK011869 Xenf-DP Rhino-Laryngofiberscope, Its Accessories and Ancillary…The Olympus Optical Co. · 2001
- 7 generations backK040684 T-Stat Microvascular Tissue Oximeter, Model 303Spectros Corporation · 2004
- 6 generations backK051257 Adult Cerebral Oximeter, Model 2040Cas Medical Systems, Inc. · 2005
- 5 generations backK061960 Fore-Sight Cerebral Oximeter Monitor, Model 2040Cas Medical Systems, Inc. · 2006
- 4 generations backK083892 Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030)Cas Medical Systems, Inc. · 2009
- 3 generations backK091452 Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030)Cas Medical Systems, Inc. · 2009
- 2 generations backK102715 Regional OximeterNonin Medical, Inc. · 2010
- 1 generation backK151305 SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40…Nonin Medical, Inc. · 2015
- This deviceK190560 SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart…Nonin Medical, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −11 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −10 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −9 | K002231 | LF-DP Gastrointestinal and Sigmoid Fiberscope, Accessories and Ancillary… | Olympus Optical Co., Ltd. | 2001 | — |
| −8 | K011869 | Xenf-DP Rhino-Laryngofiberscope, Its Accessories and Ancillary Equipment | The Olympus Optical Co. | 2001 | — |
| −7 | K040684 | T-Stat Microvascular Tissue Oximeter, Model 303 | Spectros Corporation | 2004 | — |
| −6 | K051257 | Adult Cerebral Oximeter, Model 2040 | Cas Medical Systems, Inc. | 2005 | — |
| −5 | K061960 | Fore-Sight Cerebral Oximeter Monitor, Model 2040 | Cas Medical Systems, Inc. | 2006 | — |
| −4 | K083892 | Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030) | Cas Medical Systems, Inc. | 2009 | — |
| −3 | K091452 | Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030) | Cas Medical Systems, Inc. | 2009 | — |
| −2 | K102715 | Regional Oximeter | Nonin Medical, Inc. | 2010 | — |
| −1 | K151305 | SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg… | Nonin Medical, Inc. | 2015 | — |
| 0 (this device) | K190560 | SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI… | Nonin Medical, Inc. | 2019 | — |
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 |
| 2009 | 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? (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 4…ace are predicated on Nonin’s Model 8004CA Regional Oximetry Sensor and Model 8204CA Regional Oximetry Sensor cleared under K102715 (December 17, 2010) and K151305 (August 27, 2015), respectively. Device Descriptio… | 2010 |
| * | K151305 | SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model…Summary page 4…del 8004CA Regional Oximetry Sensor and Model 8204CA Regional Oximetry Sensor cleared under K102715 (December 17, 2010) and K151305 (August 27, 2015), respectively. Device Description: The Model 8006CA Reusable Regional Oximetry Senso… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 7 companies; a new generation was cleared every 2.5 years on median.
- 8 of the 42 ancestors have a recall of any class.
- 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. 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 Model 8006CA reusable, non-sterile, regional oximetry sensor is intended for use as an absolute realtime adjunct monitor of regional hemoglobin oxygen saturation (rS02) of blood underneath the sensor of adult and pediatric patients weighing ~ 88 pounds (~ 40 kilograms). The sensor and/or the patient interface may be repositioned or replaced with another 8006CA sensor without baseline re-establishment.
Nonin's Model 8006PI single patient use, non-sterile disposable patient interface is designed for use with Noni n's Model 8006CA sensor.
The sensor and patient interface is intended for use in hospitals, long-term care, medical faci lities, sleep laboratories, and subacute environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190560 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190560: SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190560
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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