510(k) · Cleared
ClearedVisor System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cerebrotech Medical Systems, Inc. · QAF Impedance Plethysmograph, Cranial
Cleared on Nov 23, 2018 as substantially equivalent to K171186 (Cerebrotech Medical Systems, 2017) after a 28-day review. Its family tree reaches back 6 generations to 1991. 1 later device descends from it.
- Decided
- Nov 23, 2018
- Review
- 28 days
- Class
- Class II
- Product code
- QAF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K904109 (1991). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK904109 Bio-Impedance AnalyzerXitron Technologies, Inc. · 1991
- 5 generations backK052319 Impedimed - Body Composition Analyzer, Model Imp SFB7Impedimed Pty, Ltd. · 2006
- 4 generations backK080825 Impedimed Extra Cellular Fluid Analysis, Model L-Dex U400Impedimed Pty, Ltd. · 2008
- 3 generations backK100811 Impedimed - Extracellular Fluid Analyzer Model: L-Dex U400ImpediMed Limited · 2011
- 2 generations backK130338 Impedimed - Bis Extra Cellular Fluid AnalysisImpediMed Limited · 2013
- 1 generation backK171186 Cerebrotech CMS-5000Cerebrotech Medical Systems · 2017
- This deviceK182967 Visor SystemCerebrotech Medical Systems, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK253840 STEDI Scan DeviceStroke DX · 2026
Most influential descendants
Showing 1 of 1 · See all- K253840STEDI Scan DeviceStroke DX · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K904109 | Bio-Impedance Analyzer | Xitron Technologies, Inc. | 1991 | — |
| −5 | K052319 | Impedimed - Body Composition Analyzer, Model Imp SFB7 | Impedimed Pty, Ltd. | 2006 | — |
| −4 | K080825 | Impedimed Extra Cellular Fluid Analysis, Model L-Dex U400 | Impedimed Pty, Ltd. | 2008 | — |
| −3 | K100811 | Impedimed - Extracellular Fluid Analyzer Model: L-Dex U400 | ImpediMed Limited | 2011 | — |
| −2 | K130338 | Impedimed - Bis Extra Cellular Fluid Analysis | ImpediMed Limited | 2013 | — |
| −1 | K171186 | Cerebrotech CMS-5000 | Cerebrotech Medical Systems | 2017 | — |
| 0 (this device) | K182967 | Visor System | Cerebrotech Medical Systems, Inc. | 2018 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K171186 | Cerebrotech CMS-5000Summary page 4…lation: Classification Panel: Neurology Product Code: QAF Device Class: Class II 3. Predicate Device K171186, Cerebrotech CMS-5000, Impedance Plethysmograph, Cranial 4. Device Description The Visor… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253840 | STEDI Scan Device | 2026 | 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?
- The line of descent spans 27 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K253840 (Stroke DX, 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QAF devicesQAF Impedance Plethysmograph, Cranial: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Visor System is a bioimpedance spectroscopy device indicated to measure impedance ratios to aid in the assessment of cerebral fluid volume asymmetry between the cerebral hemispheres in adult patients undergoing neurologic assessment.
The Visor System is an adjunct to standard methodologies for clinical evaluation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182967 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182967: Visor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182967
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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