510(k) · Cleared
ClearedParatrend 7 Multiparameter Senior and Satellite Monitor System with Paratrend 7 Plus Multiparameter Sensor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diametrics Medical, Ltd. · CBZ Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
Cleared on Sep 23, 1997 after a 195-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.
- Decided
- Sep 23, 1997
- Review
- 195 days
- Class
- Class II
- Product code
- CBZ
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 4 citing it directly.
- This deviceK970906 Paratrend 7 Multiparameter Senior and Satellite Monitor System with…Diametrics Medical, Ltd. · 1997
- Descendant · cites it directly · 3 of its ownK060155 15.5FR Decathlon Coated Twin Lumen Chronic Hemodialysis Catheter…Spire Biomedical, Inc. · 2006 · Recalled
- Descendant · cites it directly · 2 of its ownK130079 Multi-Parameter Mobile Careguide 3100 OximeterReflectance Medical, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK133923 Multi-Parameter Mobile Careguide 3100 Oximeter with TabletReflectance Medical, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK141496 Multi-Parameter Mobile Careguide 4100 OximeterReflectance Medical, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK073093 Decathlon Gold Twin Lumen Hemodialysis Catheter with Separated Tips…Spire Biomedical, Inc. · 2008
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K06015515.5FR Decathlon Coated Twin Lumen Chronic Hemodialysis Catheter with Separated TipsSpire Biomedical, Inc. · 2006 · cites it directly3descendants
- K130079Multi-Parameter Mobile Careguide 3100 OximeterReflectance Medical, Inc. · 2013 · cites it directly2descendants
- K133923Multi-Parameter Mobile Careguide 3100 Oximeter with TabletReflectance Medical, Inc. · 2014 · 2 generations on1descendant
- K141496Multi-Parameter Mobile Careguide 4100 OximeterReflectance Medical, Inc. · 2014 · 2 generations on0descendants
- K073093Decathlon Gold Twin Lumen Hemodialysis Catheter with Separated Tips, Models DEC19SH24…Spire Biomedical, Inc. · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970906 | Paratrend 7 Multiparameter Senior and Satellite Monitor System with Paratrend… | Diametrics Medical, Ltd. | 1997 | — |
| +1 | K060155 | 15.5FR Decathlon Coated Twin Lumen Chronic Hemodialysis Catheter with… | Spire Biomedical, Inc. | 2006 | 47 |
| +1 | K130079 | Multi-Parameter Mobile Careguide 3100 Oximeter | Reflectance Medical, Inc. | 2013 | — |
| +2 | K133923 | Multi-Parameter Mobile Careguide 3100 Oximeter with Tablet | Reflectance Medical, Inc. | 2014 | — |
| +2 | K141496 | Multi-Parameter Mobile Careguide 4100 Oximeter | Reflectance Medical, Inc. | 2014 | — |
| +2 | K073093 | Decathlon Gold Twin Lumen Hemodialysis Catheter with Separated Tips, Models… | Spire Biomedical, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 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 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? (4)
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 |
|---|---|---|---|
| * | — | Paratrend 7 Intravascular Blood Gas Monitoring System Named without a submission number | |
| * | — | Paratrend 7 Satellite Multi Parameter Blood Gas Monitoring System Named without a submission number | |
| * | — | Optex Blood Gas Monitoring System Named without a submission number | |
| * | — | Baxter Swan-Ganz Continuous Cardiac Output Oximetry Named without a submission number |
What descends from it? (7)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060155 | 15.5FR Decathlon Coated Twin Lumen Chronic Hemodialysis Catheter with Separated Tips | 2006 | 3 |
| K130079 | Multi-Parameter Mobile Careguide 3100 Oximeter | 2013 | 2 |
| K063441 | 15.5FR Alta Gold, Coated Hemodialysis Catheter, Model ALC19SH24, ALC23SH28, ALC27SH32… | 2007 | 0 |
| K063431 | 15.5 FR Decathlon Gold, Funnel Tips, Coated Hemodialysis Catheter, DFC19SH24, DFC23SH28… | 2007 | 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?
- Of its descendants, K060155 (Spire Biomedical, Inc., 2006) 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 | — |
What is it indicated for?
The Paratrend 7+ System is intended to be used in the management of the critically ill patient by providing continuous blood gas data while permitting the simultaneous monitoring of blood pressure via an external transducer. The Paratrend 7+ Multiparameter Sensor is inserted via an intravascular access device into the vascular system (e.g. radial, femoral arteries).
Within the United States market, the use of this device should be limited to 72 hours.
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/K970906 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970906: Paratrend 7 Multiparameter Senior and Satellite Monitor System with Paratrend 7 Plus Multiparameter Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970906
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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