510(k) · Cleared
ClearedTrendcare Calibrator Model Scu 7007
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 Nov 23, 1999 after a 438-day review. The FDA summary names no predicate by number.
- Decided
- Nov 23, 1999
- Review
- 438 days
- Class
- Class II
- Product code
- CCC
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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?
The FDA summary names no predicate by number.
What descends from it?
No later submission names this one as a predicate yet.
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.
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 TrendCare Calibrator is an accessory for use with the TrendCare Monitors. Sensors and Patient Data Modules calibrated with the TrendCare Calibrator may be used with the TrendCare Satellite Monitor (TCM6000) or TrendCare Senior Monitor (TCM7000).
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/K983198 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983198: Trendcare Calibrator Model Scu 7007.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983198
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026