510(k) · Cleared
ClearedParatrend 7 Intravascular Blood Gas Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomedical Sensors, Inc. · CCC Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling
Cleared on Nov 4, 1997 after an 810-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 29 later devices descend from it.
- Decided
- Nov 4, 1997
- Review
- 810 days
- Class
- Class II
- Product code
- CCC
- Recalls
- None
- Predicates
- 0
29 later devices descend from it, 2 citing it directly.
- This deviceK953893 Paratrend 7 Intravascular Blood Gas Monitoring SystemBiomedical Sensors, Inc. · 1997
- Descendant · cites it directly · 27 of its ownK980380 Neurotrend Multiparameter Sensor, C7004S, to Operate with Paratrend…Diametrics Medical, Ltd. · 1999
- Descendant · 2 generations on · 17 of its ownK050702 Neurosystems 1TM MonitorNeurosystems, LLC · 2005
- Descendant · 3 generations on · 15 of its ownK061640 Integra Mobius Multi-Modality Monitoring SystemIntegra LifeSciences Corporation · 2006
- Descendant · 4 generations on · 14 of its ownK080217 Component Neuromonitoring SystemMoberg Research, Inc. · 2008 · Recalled
- Descendant · 5 generations on · 7 of its ownK092573 Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc. · 2010
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K980380Neurotrend Multiparameter Sensor, C7004S, to Operate with Paratrend 7+ Multiparameter…Diametrics Medical, Ltd. · 1999 · cites it directly27descendants
- K050702Neurosystems 1TM MonitorNeurosystems, LLC · 2005 · 2 generations on17descendants
- K061640Integra Mobius Multi-Modality Monitoring SystemIntegra LifeSciences Corporation · 2006 · 3 generations on15descendants
- K080217Component Neuromonitoring SystemMoberg Research, Inc. · 2008 · 4 generations on14descendants
- K092573Nihon Kohden QP-160AK Eeg Trend ProgramNihon Kohden America, Inc. · 2010 · 5 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K953893 | Paratrend 7 Intravascular Blood Gas Monitoring System | Biomedical Sensors, Inc. | 1997 | — |
| +1 | K980380 | Neurotrend Multiparameter Sensor, C7004S, to Operate with Paratrend 7+… | Diametrics Medical, Ltd. | 1999 | — |
| +2 | K050702 | Neurosystems 1TM Monitor | Neurosystems, LLC | 2005 | — |
| +3 | K061640 | Integra Mobius Multi-Modality Monitoring System | Integra LifeSciences Corporation | 2006 | — |
| +4 | K080217 | Component Neuromonitoring System | Moberg Research, Inc. | 2008 | 1 |
| +5 | K092573 | Nihon Kohden QP-160AK Eeg Trend Program | Nihon Kohden America, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (29)
See all 292 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K980380 (Diametrics Medical, Ltd., 1999) has gone furthest, with 27 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 | — |
https://510kreport.com/device/K953893 · printed Nov 6, 2026
Cite this page
510(k) Report. “K953893: Paratrend 7 Intravascular Blood Gas Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K953893
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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