510(k) · Cleared
ClearedMobile Careguide 2100 Oximeter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Reflectance Medical, Inc. · MUD Oximeter, Tissue Saturation
Cleared on Dec 5, 2012 as substantially equivalent to K113656 (Reflectance Medical, Inc., 2012) after a 97-day review. Its family tree reaches back 9 generations to 1998. 3 later devices descend from it.
- Decided
- Dec 5, 2012
- Review
- 97 days
- Class
- Class II
- Product code
- MUD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K963903 (1998). 11 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK963903 Biospectrometer-NB Oximeter IiiiHutchinson Technology, Inc. · 1998
- 5 generations between
- 3 generations backK100915 Inspectra STO2 Tissue Oxygenation Monitor, Model 650Hutchinson Technology, Inc. · 2010
- 2 generations backK103613 Inpectra STO2 Spot CheckHutchinson Technology, Inc. · 2011
- 1 generation backK113656 Careguide OximeterReflectance Medical, Inc. · 2012
- This deviceK122645 Mobile Careguide 2100 OximeterReflectance Medical, Inc. · 2012
- Descendant · cites it directly · 2 of its ownK130079 Multi-Parameter Mobile Careguide 3100 OximeterReflectance Medical, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK133923 Multi-Parameter Mobile Careguide 3100 Oximeter with TabletReflectance Medical, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK141496 Multi-Parameter Mobile Careguide 4100 OximeterReflectance Medical, Inc. · 2014
Show all 9 generations
- Root · 9 generations backK963903 Biospectrometer-NB Oximeter IiiiHutchinson Technology, Inc. · 1998
- 8 generations backK012759 Inspectra Tissue Spectrometer System (Inspectra), Model 325Hutchinson Technology, Inc. · 2002
- 7 generations backK023938 Modification to Inspectra Tissue Spectrometer System, Model 325Hutchinson Technology, Inc. · 2002
- 6 generations backK042020 Spectra Tissue Spectrometer System (Inspectra)Hutchinson Technology, Inc. · 2004
- 5 generations backK053618 Inspectra Tissue Spectrometer System, Model 325Hutchinson Technology, Inc. · 2006
- 4 generations backK061619 Inspectra STO2 Tissue Oxygenation MonitorHutchinson Technology, Inc. · 2006
- 3 generations backK100915 Inspectra STO2 Tissue Oxygenation Monitor, Model 650Hutchinson Technology, Inc. · 2010
- 2 generations backK103613 Inpectra STO2 Spot CheckHutchinson Technology, Inc. · 2011
- 1 generation backK113656 Careguide OximeterReflectance Medical, Inc. · 2012
- This deviceK122645 Mobile Careguide 2100 OximeterReflectance Medical, Inc. · 2012
Most influential descendants
Showing 3 of 3 · See all- K130079Multi-Parameter Mobile Careguide 3100 OximeterReflectance Medical, Inc. · 2013 · cites it directly2descendants
- K133923Multi-Parameter Mobile Careguide 3100 Oximeter with TabletReflectance Medical, Inc. · 2014 · 2 generations on1descendant
- K141496Multi-Parameter Mobile Careguide 4100 OximeterReflectance Medical, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K963903 | Biospectrometer-NB Oximeter Iiii | Hutchinson Technology, Inc. | 1998 | — |
| −8 | K012759 | Inspectra Tissue Spectrometer System (Inspectra), Model 325 | Hutchinson Technology, Inc. | 2002 | — |
| −7 | K023938 | Modification to Inspectra Tissue Spectrometer System, Model 325 | Hutchinson Technology, Inc. | 2002 | — |
| −6 | K042020 | Spectra Tissue Spectrometer System (Inspectra) | Hutchinson Technology, Inc. | 2004 | — |
| −5 | K053618 | Inspectra Tissue Spectrometer System, Model 325 | Hutchinson Technology, Inc. | 2006 | — |
| −4 | K061619 | Inspectra STO2 Tissue Oxygenation Monitor | Hutchinson Technology, Inc. | 2006 | — |
| −3 | K100915 | Inspectra STO2 Tissue Oxygenation Monitor, Model 650 | Hutchinson Technology, Inc. | 2010 | — |
| −2 | K103613 | Inpectra STO2 Spot Check | Hutchinson Technology, Inc. | 2011 | — |
| −1 | K113656 | Careguide Oximeter | Reflectance Medical, Inc. | 2012 | — |
| 0 (this device) | K122645 | Mobile Careguide 2100 Oximeter | Reflectance Medical, Inc. | 2012 | — |
| +1 | K130079 | Multi-Parameter Mobile Careguide 3100 Oximeter | Reflectance Medical, Inc. | 2013 | — |
| +2 | K133923 | Multi-Parameter Mobile Careguide 3100 Oximeter with Tablet | Reflectance Medical, Inc. | 2014 | — |
| +1 | K141496 | Multi-Parameter Mobile Careguide 4100 Oximeter | Reflectance Medical, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K113656 | Careguide Oximeter | 2012 |
What descends from it? (3)
2 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 14 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K130079 (Reflectance Medical, Inc., 2013) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K113656.
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 Mobile CareGuide T' 2100 Oximeter is intended for use as an adjunct, non-invasive monitor of the hemoglobin oxygen saturation of microvascular blood in a region of skeletal muscle tissue beneath the sensor. The sensor may be positioned on pigmented skin. The Mobile CareGuide 2100 Oximeter is intended to allow for display of SmO2 data on a third party device, which would interface with the Mobile CareGuide 2100 Oximeter via USB or CAN connection. The…
Read the full statement (151 words)
The Mobile CareGuide T' 2100 Oximeter is intended for use as an adjunct, non-invasive monitor of the hemoglobin oxygen saturation of microvascular blood in a region of skeletal muscle tissue beneath the sensor. The sensor may be positioned on pigmented skin. The Mobile CareGuide 2100 Oximeter is intended to allow for display of SmO2 data on a third party device, which would interface with the Mobile CareGuide 2100 Oximeter via USB or CAN connection. The Mobile CareGuide 2100 Oximeter is intended for prescriptive use (Rx only) by a trained healthcare professional in a hospital. The Mobile CareGuide 2100 Oximeter provides output of the most recent value of SmO2, as well as operational device information. The Mobile CareGuide 2100 Oximeter should not be used as the sole basis for diagnosis or therapy. Note: The prospective clinical value of data from the Mobile CareGuide 2100 Oximeter has not been demonstrated in disease states.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122645 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122645: Mobile Careguide 2100 Oximeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122645
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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