510(k) · Cleared
ClearedNiro-200NX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hamamatsu Photonics K.K. · MUD Oximeter, Tissue Saturation
Cleared on Jul 31, 2015 as substantially equivalent to K082327 (Somanetics Corp., 2009) and 2 other predicates after a 263-day review. Its family tree reaches back 4 generations to 2000. 1 later device descends from it.
- Decided
- Jul 31, 2015
- Review
- 263 days
- Class
- Class II
- Product code
- MUD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K001842 (2000). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- 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 deviceK143219 Niro-200NXHamamatsu Photonics K.K. · 2015
- Descendant · cites it directly · 0 of its ownK162117 Niro-200NX DPHamamatsu Photonics K.K. · 2016
Most influential descendants
Showing 1 of 1 · See all- K162117Niro-200NX DPHamamatsu Photonics K.K. · 2016 · cites it directly0descendants
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) | K143219 | Niro-200NX | Hamamatsu Photonics K.K. | 2015 | — |
| +1 | K162117 | Niro-200NX DP | Hamamatsu Photonics K.K. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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? (3)
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 4…ommon Name: Oximeter Product Code: MUD Subsequent Product Code: DQA Classification: Class II per 21 C.F.R. § 870.2700 Predicate Device: Somanetics INVOS 5100C (K082327), Hitachi ETG-100 (K011320) and ETG-4000 (K042501) Device Description: The NIRO-200NX is a reusable piece of equipment tha… | 2009 |
| * | K011320 | Etg-100 Optical Encephalography SystemSummary page 4…e: MUD Subsequent Product Code: DQA Classification: Class II per 21 C.F.R. § 870.2700 Predicate Device: Somanetics INVOS 5100C (K082327), Hitachi ETG-100 (K011320) and ETG-4000 (K042501) Device Description: The NIRO-200NX is a reusable piece of equipment that uses near i… | 2001 |
| * | K042501 | Etg-4000 Optical Topography SystemSummary page 4…uct Code: DQA Classification: Class II per 21 C.F.R. § 870.2700 Predicate Device: Somanetics INVOS 5100C (K082327), Hitachi ETG-100 (K011320) and ETG-4000 (K042501) Device Description: The NIRO-200NX is a reusable piece of equipment that uses near infrared light for non-i… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162117 | Niro-200NX DP | 2016 | 0 |
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 5.1 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K162117 (Hamamatsu Photonics K.K., 2016) has gone furthest, with 0 descendants of its own.
- 9 other devices also cite its predicate K082327.
How does its category compare?
All MUD devicesMUD Oximeter, Tissue Saturation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 NIR0-200NX is intended for use as an adjunct trend monitor of regional hemoglobin oxygen saturation and relative level of oxygenated hemoglobin and deoxygenated hemoglobin of blood in brain or in other tissue beneath the probes in any individual. The clinical value of trend data has not been demonstrated in disease states. The NIR0-200NX should not be used as the sole basis for diagnosis or therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143219 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143219: Niro-200NX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143219
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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