510(k) · Cleared
ClearedCerebrotech CMS-5000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cerebrotech Medical Systems · QAF Impedance Plethysmograph, Cranial
Cleared on Dec 8, 2017 as substantially equivalent to K130338 (ImpediMed Limited, 2013) after a 228-day review. Its family tree reaches back 5 generations to 1991. 2 later devices descend from it.
- Decided
- Dec 8, 2017
- Review
- 228 days
- Class
- Class II
- Product code
- QAF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K904109 (1991). 7 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK904109 Bio-Impedance AnalyzerXitron Technologies, Inc. · 1991
- 4 generations backK052319 Impedimed - Body Composition Analyzer, Model Imp SFB7Impedimed Pty, Ltd. · 2006
- 3 generations backK080825 Impedimed Extra Cellular Fluid Analysis, Model L-Dex U400Impedimed Pty, Ltd. · 2008
- 2 generations backK100811 Impedimed - Extracellular Fluid Analyzer Model: L-Dex U400ImpediMed Limited · 2011
- 1 generation backK130338 Impedimed - Bis Extra Cellular Fluid AnalysisImpediMed Limited · 2013
- This deviceK171186 Cerebrotech CMS-5000Cerebrotech Medical Systems · 2017
- Descendant · cites it directly · 1 of its ownK182967 Visor SystemCerebrotech Medical Systems, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK253840 STEDI Scan DeviceStroke DX · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K904109 | Bio-Impedance Analyzer | Xitron Technologies, Inc. | 1991 | — |
| −4 | K052319 | Impedimed - Body Composition Analyzer, Model Imp SFB7 | Impedimed Pty, Ltd. | 2006 | — |
| −3 | K080825 | Impedimed Extra Cellular Fluid Analysis, Model L-Dex U400 | Impedimed Pty, Ltd. | 2008 | — |
| −2 | K100811 | Impedimed - Extracellular Fluid Analyzer Model: L-Dex U400 | ImpediMed Limited | 2011 | — |
| −1 | K130338 | Impedimed - Bis Extra Cellular Fluid Analysis | ImpediMed Limited | 2013 | — |
| 0 (this device) | K171186 | Cerebrotech CMS-5000 | Cerebrotech Medical Systems | 2017 | — |
| +1 | K182967 | Visor System | Cerebrotech Medical Systems, Inc. | 2018 | — |
| +2 | K253840 | STEDI Scan Device | Stroke DX | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2026 | 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 QAF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QAF device
- #1 K253840 STEDI Scan Devicescore 13.5 · 7 generations · no Class I recall
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K130338 | Impedimed - Bis Extra Cellular Fluid AnalysisSummary page 5…Class: Class II K171186 - Page 2 of 5 3. Predicate Device K130338, Impedimed L-Dex U400, Impedance Plethysmograph 4. Device Description The CMS-5000 is a bioimpedance spectroscopy device use… | 2013 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182967 | Visor System | 2018 | 1 |
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?
- The line of descent spans 26 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K182967 (Cerebrotech Medical Systems, Inc., 2018) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K130338.
How does its category compare?
All QAF devicesQAF Impedance Plethysmograph, Cranial: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · QAF
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · QAF
Too few QAF 510(k)s in any year since 2007 to give a median.
Recalls per year · QAF
No recall names QAF since 2007.
Adverse event reports per year · QAF
No MAUDE report names QAF since 2007.
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 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 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 | 1 | — | 0 | — |
What is it indicated for?
The CMS-5000 is a bioimpedance spectroscopy device for use on adult human patients utilizing impedance ratios that are displayed as a B-DEX ratio as an aid in the assessment of fluid volume differences between the cerebral hemispheres in patients undergoing neurologic assessment.
The CMS-5000 is an adjunct to standard methodologies routinely used in the clinical evaluation of intracranial fluid distribution and is not intended to be a sole determinant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171186 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171186: Cerebrotech CMS-5000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171186
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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