510(k) · Cleared
ClearedMulti-Parameter Mobile Careguide 3100 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 Jul 19, 2013 as substantially equivalent to K970906 (Diametrics Medical, Ltd., 1997) and 5 other predicates after a 186-day review. Its family tree reaches back 10 generations to 1998. 2 later devices descend from it.
- Decided
- Jul 19, 2013
- Review
- 186 days
- Class
- Class II
- Product code
- MUD
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 10 generations to K963903 (1998). 24 ancestors in all, the oldest K853990 (1985). 2 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK963903 Biospectrometer-NB Oximeter IiiiHutchinson Technology, Inc. · 1998
- 6 generations between
- 3 generations backK103613 Inpectra STO2 Spot CheckHutchinson Technology, Inc. · 2011
- 2 generations backK113656 Careguide OximeterReflectance Medical, Inc. · 2012
- 1 generation backK122645 Mobile Careguide 2100 OximeterReflectance Medical, Inc. · 2012
- This deviceK130079 Multi-Parameter Mobile Careguide 3100 OximeterReflectance Medical, Inc. · 2013
- Descendant · cites it directly · 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 10 generations
- Root · 10 generations backK963903 Biospectrometer-NB Oximeter IiiiHutchinson Technology, Inc. · 1998
- 9 generations backK012759 Inspectra Tissue Spectrometer System (Inspectra), Model 325Hutchinson Technology, Inc. · 2002
- 8 generations backK023938 Modification to Inspectra Tissue Spectrometer System, Model 325Hutchinson Technology, Inc. · 2002
- 7 generations backK042020 Spectra Tissue Spectrometer System (Inspectra)Hutchinson Technology, Inc. · 2004
- 6 generations backK053618 Inspectra Tissue Spectrometer System, Model 325Hutchinson Technology, Inc. · 2006
- 5 generations backK061619 Inspectra STO2 Tissue Oxygenation MonitorHutchinson Technology, Inc. · 2006
- 4 generations backK100915 Inspectra STO2 Tissue Oxygenation Monitor, Model 650Hutchinson Technology, Inc. · 2010
- 3 generations backK103613 Inpectra STO2 Spot CheckHutchinson Technology, Inc. · 2011
- 2 generations backK113656 Careguide OximeterReflectance Medical, Inc. · 2012
- 1 generation backK122645 Mobile Careguide 2100 OximeterReflectance Medical, Inc. · 2012
- This deviceK130079 Multi-Parameter Mobile Careguide 3100 OximeterReflectance Medical, Inc. · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K963903 | Biospectrometer-NB Oximeter Iiii | Hutchinson Technology, Inc. | 1998 | — |
| −9 | K012759 | Inspectra Tissue Spectrometer System (Inspectra), Model 325 | Hutchinson Technology, Inc. | 2002 | — |
| −8 | K023938 | Modification to Inspectra Tissue Spectrometer System, Model 325 | Hutchinson Technology, Inc. | 2002 | — |
| −7 | K042020 | Spectra Tissue Spectrometer System (Inspectra) | Hutchinson Technology, Inc. | 2004 | — |
| −6 | K053618 | Inspectra Tissue Spectrometer System, Model 325 | Hutchinson Technology, Inc. | 2006 | — |
| −5 | K061619 | Inspectra STO2 Tissue Oxygenation Monitor | Hutchinson Technology, Inc. | 2006 | — |
| −4 | K100915 | Inspectra STO2 Tissue Oxygenation Monitor, Model 650 | Hutchinson Technology, Inc. | 2010 | — |
| −3 | K103613 | Inpectra STO2 Spot Check | Hutchinson Technology, Inc. | 2011 | — |
| −2 | K113656 | Careguide Oximeter | Reflectance Medical, Inc. | 2012 | — |
| −1 | K122645 | Mobile Careguide 2100 Oximeter | Reflectance Medical, Inc. | 2012 | — |
| 0 (this device) | K130079 | Multi-Parameter Mobile Careguide 3100 Oximeter | Reflectance Medical, Inc. | 2013 | — |
| +1 | 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 |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (6)
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 |
|---|---|---|---|
| * | K970906 | Paratrend 7 Multiparameter Senior and Satellite Monitor System with Paratrend 7 Plus…Summary page 4…he Multi-Parameter CareGuide 3100 has the same principle of operation (an optical technological platform that relies on light absorption) as the Paratrend 7 Sensor (pH) (K970906) predicate device. The Multi-Parameter Mobile CareGuide 3100 includes a sensor and monitor and, outputs a numeric trend like thes… | 1997 |
| * | K020967 | Terumo Khuri Myocardial PH Monitoring SystemSummary page 2…i Myocardial pH Monitoring System Model #: N/A 510O(k) holder/Subm ifter: Terumo Cardiovascular Systems Corporation 510(k) Number: K020967 Product codes: CBZ. 868.1170, Anesthesiology Predicate Device #3: Masimo multigXarameter oximeter Trade… | 2002 |
| * | K080238 | Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set Rad 87 Pulse…Summary page 2…multigXarameter oximeter Trade namne of Device: Rainbow SET 1Radical 7 Co-oximeter 5 10O(k) holder/Submitter: Masimo Corporation 510O(k) Numbers: K080238, K061204 Product Codes: DQA, 21 CFR 870.2700, Anesthesiology JKS, 21 CFR 862.3220, C… | 2008 |
| * | K061204 | Masimo Set Radical 7 Pulse CO-OximeterSummary page 2…rameter oximeter Trade namne of Device: Rainbow SET 1Radical 7 Co-oximeter 5 10O(k) holder/Submitter: Masimo Corporation 510O(k) Numbers: K080238, K061204 Product Codes: DQA, 21 CFR 870.2700, Anesthesiology JKS, 21 CFR 862.3220, Clinical T… | 2006 |
| * | K113656 | Careguide OximeterSummary page 2…of Device: Mobile CareGuide Oximeter M~odel #: 1100,2100 510(k) Holder/Submitter: Reflectance Medical Inc. 510(k) Number: K 113656, CareGuide 1100 K 122645, CareGuide 2100 Product code: MUD, 21 CER 870.2700, Cardio… | 2012 |
| * | K122645 | Mobile Careguide 2100 OximeterSummary page 2…1100,2100 510(k) Holder/Submitter: Reflectance Medical Inc. 510(k) Number: K 113656, CareGuide 1100 K 122645, CareGuide 2100 Product code: MUD, 21 CER 870.2700, Cardiovascular Device Description The Multi-Parameter Mobile… | 2012 |
What descends from it? (2)
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 15 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- 4 of the 24 ancestors have a recall of any class.
- Of its descendants, K133923 (Reflectance Medical, Inc., 2014) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K970906.
How does its category compare?
All MUD devicesMUD Oximeter, Tissue Saturation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Multi-Parameter Mobile CareGuideTM 3100 Oximeter is intended for use as an adjunct, non-invasive monitor of the hemoglobin oxygen saturation and pH of microvascular blood in a region of skeletal muscle tissue beneath the sensor. The sensor may be positioned on pigmented skin. The Multi-Parameter Mobile CareGuide 3100 Oximeter is intended to allow for display of SmO2 and pHmn data on a third party device, which would interface with the Multi-Parameter…
Read the full statement (166 words)
The Multi-Parameter Mobile CareGuideTM 3100 Oximeter is intended for use as an adjunct, non-invasive monitor of the hemoglobin oxygen saturation and pH of microvascular blood in a region of skeletal muscle tissue beneath the sensor. The sensor may be positioned on pigmented skin. The Multi-Parameter Mobile CareGuide 3100 Oximeter is intended to allow for display of SmO2 and pHmn data on a third party device, which would interface with the Multi-Parameter Mobile CareGuide 3100 Oximeter via USB or CAN connection. The Multi-Parameter Mobile CareGuide 3100 Oximeter is intended for prescriptive use (Rx only) by a trained healthcare professional in a hospital. The Multi-Parameter Mobile CareGuide 3100 Oximeter provides output of the most recent values of SmO2 and pHm in a trend, as well as operational device information. The Multi-Parameter Mobile CareGuide 3100 Oximeter should not be used as the sole basis for diagnosis or therapy. Note: The prospective clinical value of data from the Multi-Parameter Mobile CareGuide 3100 Oximeter has not been demonstrated in disease states.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130079 · printed Nov 5, 2026
Cite this page
510(k) Report. “K130079: Multi-Parameter Mobile Careguide 3100 Oximeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K130079
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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