510(k) · Cleared
ClearedAdult Cerebral-Somatic Oximetry Sensor, Pediatric Cerebral-Somatic Oximetry Sensor Model HHS-Safb-SM, HHS-SPFB-Usa
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hygia Health Services, Inc. · NMD Oximeter, Tissue Saturation, Reprocessed
Cleared on May 4, 2010 as substantially equivalent to K082327 (Somanetics Corp., 2009) and 5 other predicates after a 69-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- May 4, 2010
- Review
- 69 days
- Class
- Class II
- Product code
- NMD
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 4 generations to K001842 (2000). 8 ancestors in all, the oldest K863784 (1986). No later device cites it as a predicate yet.
- Root · 4 generations backK001842 Adult/Pediatric Cerebral Oximeter, Model Invos 5100Somanetics Corp. · 2000
- 3 generations backK051274 Invos SystemSomanetics Corp. · 2005
- 2 generations backK080769 Invos Cerebral/Somatic Oximeter System, Model 5100CSomanetics Corp. · 2008
- 1 generation backK082327 Invos Cerebral/Somatic Oximeter System, Model: 5100CSomanetics Corp. · 2009
- This deviceK100523 Adult Cerebral-Somatic Oximetry Sensor, Pediatric Cerebral-Somatic…Hygia Health Services, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001842 | Adult/Pediatric Cerebral Oximeter, Model Invos 5100 | Somanetics Corp. | 2000 | — |
| −3 | K051274 | Invos System | Somanetics Corp. | 2005 | — |
| −2 | K080769 | Invos Cerebral/Somatic Oximeter System, Model 5100C | Somanetics Corp. | 2008 | — |
| −1 | K082327 | Invos Cerebral/Somatic Oximeter System, Model: 5100C | Somanetics Corp. | 2009 | — |
| 0 (this device) | K100523 | Adult Cerebral-Somatic Oximetry Sensor, Pediatric Cerebral-Somatic Oximetry… | Hygia Health Services, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 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 NMD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K082327 | Invos Cerebral/Somatic Oximeter System, Model: 5100CSummary page 1…Corresponding Somanetics oximetry sensors legally marketed under various 5 10(k) premarket notifications: Somanetics Corp. K082327 Somanetics Corp. K080769 Sonmanetics Corp. K051274 Somane… | 2009 |
| * | K080769 | Invos Cerebral/Somatic Oximeter System, Model 5100CSummary page 1…arketed under various 5 10(k) premarket notifications: Somanetics Corp. K082327 Somanetics Corp. K080769 Sonmanetics Corp. K051274 Somanetics Corp. KOO01842 Soman… | 2008 |
| * | K051274 | Invos SystemSummary page 1…s: Somanetics Corp. K082327 Somanetics Corp. K080769 Sonmanetics Corp. K051274 Somanetics Corp. KOO01842 Somanetics Corp. K97 1628 Soma… | 2005 |
| * | K001842 | Adult/Pediatric Cerebral Oximeter, Model Invos 5100 | 2000 |
| * | K971628 | Somanetics Invos 3100A Cerebral Oximeter (Invos)Summary page 1…69 Sonmanetics Corp. K051274 Somanetics Corp. KOO01842 Somanetics Corp. K97 1628 Somanetics Corp. K960614… | 1997 |
| * | K960614 | Somanetics Invos 3100A Cerebral Oximeter (Invos)Summary page 1…4 Somanetics Corp. KOO01842 Somanetics Corp. K97 1628 Somanetics Corp. K960614 3-2 4. Device D… | 1996 |
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 10 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- None of the 8 ancestors has a recall.
- 9 other devices also cite its predicate K082327.
How does its category compare?
All NMD devicesNMD Oximeter, Tissue Saturation, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · NMD
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · NMD
Too few NMD 510(k)s in any year since 2007 to give a median.
Recalls per year · NMD
No recall names NMD since 2007.
Adverse event reports per year · NMD
2in 2024
MAUDE reports naming product code NMD, 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 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Hygia Health Services Reprocessed Pediatric and Adult Cerebral-Somnatic Oximetry Sensors are indicated for use when continuous noninvasive oxygen saturation is required for pediatric patients weighing < 40 kg and adult patients weighing > 40 kg, respectively. The Hygia reprocessed sensor has been validated with the OEM's Cerebral/Somatic Oximeter, Model 51OOC and is intended to be used with the Cerebral/Somatic Oximeter, Model 51 OOC only. The…
Read the full statement (150 words)
The Hygia Health Services Reprocessed Pediatric and Adult Cerebral-Somnatic Oximetry Sensors are indicated for use when continuous noninvasive oxygen saturation is required for pediatric patients weighing < 40 kg and adult patients weighing > 40 kg, respectively. The Hygia reprocessed sensor has been validated with the OEM's Cerebral/Somatic Oximeter, Model 51OOC and is intended to be used with the Cerebral/Somatic Oximeter, Model 51 OOC only.
The noninvasive 5 100C Cerebral/Somatic Oximeter is intended for use as an adjunct trend monitor of regional hemoglobin oxygen saturation of blood in the brain or in other tissue beneath the sensor. It is intended for use in any individual at risk for reduced-flow or no-flow ischemic states. The prospective clinical value of data from thie IOOC Cerebral/Somatic Oximeter has not been demonstrated in disease states. The OEM suggests the 51OOC Cerebral/Somnatic Oximeter should not be used as the sole basis for diagnosis or therapy.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K100523 · printed Nov 4, 2026
Cite this page
510(k) Report. “K100523: Adult Cerebral-Somatic Oximetry Sensor, Pediatric Cerebral-Somatic Oximetry Sensor Model HHS-Safb-SM, HHS-SPFB-Usa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K100523
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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