510(k) · Cleared
ClearedParatrend 7 Neotrend Multiparameter/Sensor with Paratrend 7 Multiparameter Senior and Satellite Monitor System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diametrics Medical, Ltd. · CCC Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling
Cleared on Dec 19, 1997 after a 182-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Dec 19, 1997
- Review
- 182 days
- Class
- Class II
- Product code
- CCC
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK972314 Paratrend 7 Neotrend Multiparameter/Sensor with Paratrend 7…Diametrics Medical, Ltd. · 1997
- Descendant · cites it directly · 3 of its ownK071013 RedsenseRedsense Medical AB · 2007
- Descendant · 2 generations on · 2 of its ownK092955 Redsense-Home UseRedsense Medical AB · 2010
- Descendant · 2 generations on · 1 of its ownK103242 Redsense-Alarm Unit and SensorRedsense Medical AB · 2011
- Descendant · 2 generations on · 0 of its ownK130554 Redsense Alarm SystemRedsense Medical AB · 2013
Most influential descendants
Showing 4 of 4 · See all- K071013RedsenseRedsense Medical AB · 2007 · cites it directly3descendants
- K092955Redsense-Home UseRedsense Medical AB · 2010 · 2 generations on2descendants
- K103242Redsense-Alarm Unit and SensorRedsense Medical AB · 2011 · 2 generations on1descendant
- K130554Redsense Alarm SystemRedsense Medical AB · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972314 | Paratrend 7 Neotrend Multiparameter/Sensor with Paratrend 7 Multiparameter… | Diametrics Medical, Ltd. | 1997 | — |
| +1 | K071013 | Redsense | Redsense Medical AB | 2007 | — |
| +2 | K092955 | Redsense-Home Use | Redsense Medical AB | 2010 | — |
| +2 | K103242 | Redsense-Alarm Unit and Sensor | Redsense Medical AB | 2011 | — |
| +2 | K130554 | Redsense Alarm System | Redsense Medical AB | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 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 CCC? 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 Multiparameter Blood Gas Monitoring System Named without a submission number | |
| * | — | Optex Blood Gas Monitoring System Named without a submission number | |
| * | — | Neocath 1000 Umbilical Artery Oxygen Monitoring System Named without a submission number |
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 |
|---|---|---|---|
| K071013 | Redsense | 2007 | 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, K071013 (Redsense Medical AB, 2007) has gone furthest, with 3 descendants of its own.
How does its category compare?
All CCC devicesCCC Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CCC
1in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · CCC
Too few CCC 510(k)s in any year since 2007 to give a median.
Recalls per year · CCC
No recall names CCC since 2007.
Adverse event reports per year · CCC
2in 2007
MAUDE reports naming product code CCC, 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 | 1 | — | 0 | 2 |
| 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 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Neotrend Multiparameter Sensor is inserted via an intravascular access device into the vascular system, e.g. umbilical artery (neonates), femoral artery (paediatrics, adults). It is intended to be used in the management of critically ill patients of any age, but especially neonates, by providing continuous blood gas data while permitting the simultaneous monitoring of blood pressure via an external transducer. The Neotrend sensor is designed for use…
Read the full statement (125 words)
The Neotrend Multiparameter Sensor is inserted via an intravascular access device into the vascular system, e.g. umbilical artery (neonates), femoral artery (paediatrics, adults). It is intended to be used in the management of critically ill patients of any age, but especially neonates, by providing continuous blood gas data while permitting the simultaneous monitoring of blood pressure via an external transducer.
The Neotrend sensor is designed for use in conjunction only with the custom umbilical artery catheter supplied when the umbilical artery is to be the access site.
The sensor is used in conjunction with the Paratrend 7 Multiparameter Senior and/or Satellite Monitor systems.
Completion of Monitoring and Sensor Withdrawal
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/K972314 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972314: Paratrend 7 Neotrend Multiparameter/Sensor with Paratrend 7 Multiparameter Senior and Satellite Monitor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972314
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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