510(k) · Cleared
ClearedKhuri Regional Tissue PH Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vascular Technology Incorporated · CBZ Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
Cleared on Jun 25, 1986 after a 22-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Jun 25, 1986
- Review
- 22 days
- Class
- Class II
- Product code
- CBZ
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK862114 Khuri Regional Tissue PH MonitorVascular Technology Incorporated · 1986
- Descendant · cites it directly · 3 of its ownK020967 Terumo Khuri Myocardial PH Monitoring SystemTerumo Cardiovascular Systems Corp. · 2002 · Recalled
- Descendant · 2 generations on · 2 of its ownK130079 Multi-Parameter Mobile Careguide 3100 OximeterReflectance Medical, Inc. · 2013
- Descendant · 3 generations on · 1 of its ownK133923 Multi-Parameter Mobile Careguide 3100 Oximeter with TabletReflectance Medical, Inc. · 2014
- Descendant · 3 generations on · 0 of its ownK141496 Multi-Parameter Mobile Careguide 4100 OximeterReflectance Medical, Inc. · 2014
Most influential descendants
Showing 4 of 4 · See all- K020967Terumo Khuri Myocardial PH Monitoring SystemTerumo Cardiovascular Systems Corp. · 2002 · cites it directly3descendants
- K130079Multi-Parameter Mobile Careguide 3100 OximeterReflectance Medical, Inc. · 2013 · 2 generations on2descendants
- K133923Multi-Parameter Mobile Careguide 3100 Oximeter with TabletReflectance Medical, Inc. · 2014 · 3 generations on1descendant
- K141496Multi-Parameter Mobile Careguide 4100 OximeterReflectance Medical, Inc. · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K862114 | Khuri Regional Tissue PH Monitor | Vascular Technology Incorporated | 1986 | — |
| +1 | K020967 | Terumo Khuri Myocardial PH Monitoring System | Terumo Cardiovascular Systems Corp. | 2002 | 1 |
| +2 | K130079 | Multi-Parameter Mobile Careguide 3100 Oximeter | Reflectance Medical, Inc. | 2013 | — |
| +3 | K133923 | Multi-Parameter Mobile Careguide 3100 Oximeter with Tablet | Reflectance Medical, Inc. | 2014 | — |
| +3 | K141496 | Multi-Parameter Mobile Careguide 4100 Oximeter | Reflectance Medical, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CBZ? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020967 | Terumo Khuri Myocardial PH Monitoring System | 2002 | 3 |
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?
- Of its descendants, K020967 (Terumo Cardiovascular Systems Corp., 2002) has gone furthest, with 3 descendants of its own.
How does its category compare?
All CBZ devicesCBZ Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CBZ
FDA has decided no CBZ device since 2007.
Median 510(k) review, days · CBZ
Too few CBZ 510(k)s in any year since 2007 to give a median.
Recalls per year · CBZ
No recall names CBZ since 2007.
Adverse event reports per year · CBZ
1in 2024
MAUDE reports naming product code CBZ, 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 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 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 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K862114 · printed Nov 4, 2026
Cite this page
510(k) Report. “K862114: Khuri Regional Tissue PH Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K862114
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026