510(k) · Cleared
ClearedOxiplexTS200
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iss Medical, Inc. · MUD Oximeter, Tissue Saturation
Cleared on Mar 1, 2024 as substantially equivalent to K100915 (Hutchinson Technology, Inc., 2010) and 1 other predicate after a 205-day review. Its family tree reaches back 7 generations to 1998.
- Decided
- Mar 1, 2024
- Review
- 205 days
- Class
- Class II
- Product code
- MUD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K963903 (1998). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK963903 Biospectrometer-NB Oximeter IiiiHutchinson Technology, Inc. · 1998
- 6 generations backK012759 Inspectra Tissue Spectrometer System (Inspectra), Model 325Hutchinson Technology, Inc. · 2002
- 5 generations backK023938 Modification to Inspectra Tissue Spectrometer System, Model 325Hutchinson Technology, Inc. · 2002
- 4 generations backK042020 Spectra Tissue Spectrometer System (Inspectra)Hutchinson Technology, Inc. · 2004
- 3 generations backK053618 Inspectra Tissue Spectrometer System, Model 325Hutchinson Technology, Inc. · 2006
- 2 generations backK061619 Inspectra STO2 Tissue Oxygenation MonitorHutchinson Technology, Inc. · 2006
- 1 generation backK100915 Inspectra STO2 Tissue Oxygenation Monitor, Model 650Hutchinson Technology, Inc. · 2010
- This deviceK232385 OxiplexTS200Iss Medical, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K963903 | Biospectrometer-NB Oximeter Iiii | Hutchinson Technology, Inc. | 1998 | — |
| −6 | K012759 | Inspectra Tissue Spectrometer System (Inspectra), Model 325 | Hutchinson Technology, Inc. | 2002 | — |
| −5 | K023938 | Modification to Inspectra Tissue Spectrometer System, Model 325 | Hutchinson Technology, Inc. | 2002 | — |
| −4 | K042020 | Spectra Tissue Spectrometer System (Inspectra) | Hutchinson Technology, Inc. | 2004 | — |
| −3 | K053618 | Inspectra Tissue Spectrometer System, Model 325 | Hutchinson Technology, Inc. | 2006 | — |
| −2 | K061619 | Inspectra STO2 Tissue Oxygenation Monitor | Hutchinson Technology, Inc. | 2006 | — |
| −1 | K100915 | Inspectra STO2 Tissue Oxygenation Monitor, Model 650 | Hutchinson Technology, Inc. | 2010 | — |
| 0 (this device) | K232385 | OxiplexTS200 | Iss Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 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 |
|---|---|---|---|
| * | K100915 | Inspectra STO2 Tissue Oxygenation Monitor, Model 650Summary page 5…e: 74MUD f. CFR Reference: 21 CFR 870.2700 g. Identification of Equivalent Devices: InSpectra StO2Tissue Oxygenation Monitor, Model 650 (k100915) ViOptix ODISsey Tissue Oximeter (k042657) 3. Device Description The ISS Medical non-invasive tissue oximet… | 2010 |
| * | K042657 | Vioptix Odissey Tissue Oximeter Tissue Oximeter, Model Oxy-2Summary page 5…g. Identification of Equivalent Devices: InSpectra StO2Tissue Oxygenation Monitor, Model 650 (k100915) ViOptix ODISsey Tissue Oximeter (k042657) 3. Device Description The ISS Medical non-invasive tissue oximeter, OxiplexTS200, is intended for use as an adjunct… | 2005 |
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 2 companies; a new generation was cleared every 1.8 years on median.
- None of the 8 ancestors has a recall.
- 2 other devices also cite its predicate K100915.
How does its category compare?
All MUD devicesMUD Oximeter, Tissue Saturation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 OxiplexTS200 tissue oximeter is intended to non-invasively estimate the percent oxygen saturation (StO2) in a
volume of tissue. It is indicated for monitoring patients during circulatory or perfusion examinations of skeletal muscle or
when there is a suspicion of compromised circulation. The device can be used for monitoring in Medical Clinics,
laboratories and outpatient facilities.
The OxiplexTS200 should not be used as the sole basis for diagnosis or therapy. The value of these measurements in
disease states has not been demonstrated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232385 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232385: OxiplexTS200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232385
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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