510(k) · Cleared
ClearedPresygen/si-1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Christie Medical Holdings, Inc. · MUD Oximeter, Tissue Saturation
Cleared on Aug 9, 2018 as substantially equivalent to K113507 (Kent Imaging, Inc., 2012) after a 468-day review. Its family tree reaches back 8 generations to 1998.
- Decided
- Aug 9, 2018
- Review
- 468 days
- Class
- Class II
- Product code
- MUD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K963903 (1998). No later device cites it as a predicate yet.
- Root · 8 generations backK963903 Biospectrometer-NB Oximeter IiiiHutchinson Technology, Inc. · 1998
- 7 generations backK012759 Inspectra Tissue Spectrometer System (Inspectra), Model 325Hutchinson Technology, Inc. · 2002
- 6 generations backK023938 Modification to Inspectra Tissue Spectrometer System, Model 325Hutchinson Technology, Inc. · 2002
- 5 generations backK042020 Spectra Tissue Spectrometer System (Inspectra)Hutchinson Technology, Inc. · 2004
- 4 generations backK053618 Inspectra Tissue Spectrometer System, Model 325Hutchinson Technology, Inc. · 2006
- 3 generations backK061848 Hyperspectral Tissue Oxygenation Measurement System, Model Oxy VU1Hypermed, Inc. · 2006
- 2 generations backK073656 Oxyvu -1 Hyperspectral Tissue Oxygenation (Hto) Measurement SystemHypermed, Inc. · 2008
- 1 generation backK113507 Kent CameraKent Imaging, Inc. · 2012
- This deviceK171245 Presygen/si-1Christie Medical Holdings, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K963903 | Biospectrometer-NB Oximeter Iiii | Hutchinson Technology, Inc. | 1998 | — |
| −7 | K012759 | Inspectra Tissue Spectrometer System (Inspectra), Model 325 | Hutchinson Technology, Inc. | 2002 | — |
| −6 | K023938 | Modification to Inspectra Tissue Spectrometer System, Model 325 | Hutchinson Technology, Inc. | 2002 | — |
| −5 | K042020 | Spectra Tissue Spectrometer System (Inspectra) | Hutchinson Technology, Inc. | 2004 | — |
| −4 | K053618 | Inspectra Tissue Spectrometer System, Model 325 | Hutchinson Technology, Inc. | 2006 | — |
| −3 | K061848 | Hyperspectral Tissue Oxygenation Measurement System, Model Oxy VU1 | Hypermed, Inc. | 2006 | — |
| −2 | K073656 | Oxyvu -1 Hyperspectral Tissue Oxygenation (Hto) Measurement System | Hypermed, Inc. | 2008 | — |
| −1 | K113507 | Kent Camera | Kent Imaging, Inc. | 2012 | — |
| 0 (this device) | K171245 | Presygen/si-1 | Christie Medical Holdings, Inc. | 2018 | — |
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 |
|---|---|---|---|
| * | K113507 | Kent CameraSummary page 4…MUD Panel: Cardiovascular 3. PREDICATE DEVICE AND REFERENCE DEVICE The predicate device is Kent Camera (Kent Imaging, Inc., K113507). The reference device is T.Ox™ (Vioptix, Inc., K042657). 4. DESCRIPTION OF THE DEVICE Presygen™/si-1 is a standalone, non-c… | 2012 |
| † | K042657 | Vioptix Odissey Tissue Oximeter Tissue Oximeter, Model Oxy-2 | 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 20 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- None of the 8 ancestors has a recall.
- 1 other device also cites its predicate K113507.
How does its category compare?
All MUD devicesMUD Oximeter, Tissue Saturation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
Presygen™/si-1 is indicated for use in hospital facilities, along with clinical assessment of signs and symptoms, by healthcare professionals for non-invasive and non-diagnostic measure of relative temporal variation in oxygen saturation (StO2) in superficial tissue. Presygen™/si-1 displays two-dimensional color-coded images of tissue oxygenation of the scanned surface and reports tissue oxygenation measurements in selected tissue regions. Presygen™/si-1 is intended for adults only (22 and over).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171245 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171245: Presygen/si-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171245
Report an extraction error
Are you the manufacturer?
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