510(k) · Cleared
ClearedSTEDI Scan Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stroke DX · QAF Impedance Plethysmograph, Cranial
Cleared on Jul 22, 2026 as substantially equivalent to K182967 (Cerebrotech Medical Systems, Inc., 2018) after a 233-day review. Its family tree reaches back 7 generations to 1991.
- Decided
- Jul 22, 2026
- Review
- 233 days
- Class
- Class II
- Product code
- QAF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K904109 (1991). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK904109 Bio-Impedance AnalyzerXitron Technologies, Inc. · 1991
- 6 generations backK052319 Impedimed - Body Composition Analyzer, Model Imp SFB7Impedimed Pty, Ltd. · 2006
- 5 generations backK080825 Impedimed Extra Cellular Fluid Analysis, Model L-Dex U400Impedimed Pty, Ltd. · 2008
- 4 generations backK100811 Impedimed - Extracellular Fluid Analyzer Model: L-Dex U400ImpediMed Limited · 2011
- 3 generations backK130338 Impedimed - Bis Extra Cellular Fluid AnalysisImpediMed Limited · 2013
- 2 generations backK171186 Cerebrotech CMS-5000Cerebrotech Medical Systems · 2017
- 1 generation backK182967 Visor SystemCerebrotech Medical Systems, Inc. · 2018
- This deviceK253840 STEDI Scan DeviceStroke DX · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K904109 | Bio-Impedance Analyzer | Xitron Technologies, Inc. | 1991 | — |
| −6 | K052319 | Impedimed - Body Composition Analyzer, Model Imp SFB7 | Impedimed Pty, Ltd. | 2006 | — |
| −5 | K080825 | Impedimed Extra Cellular Fluid Analysis, Model L-Dex U400 | Impedimed Pty, Ltd. | 2008 | — |
| −4 | K100811 | Impedimed - Extracellular Fluid Analyzer Model: L-Dex U400 | ImpediMed Limited | 2011 | — |
| −3 | K130338 | Impedimed - Bis Extra Cellular Fluid Analysis | ImpediMed Limited | 2013 | — |
| −2 | K171186 | Cerebrotech CMS-5000 | Cerebrotech Medical Systems | 2017 | — |
| −1 | K182967 | Visor System | Cerebrotech Medical Systems, Inc. | 2018 | — |
| 0 (this device) | 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 |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K182967 | Visor SystemSummary page 6…TE DEVICE Name Manufacturer 510(k)# Visor System Cerebrotech Medical Systems K182967 This Predicate has not been subject to a design-related recall. No reference devices were used in this submission. IV. DEVIC… | 2018 |
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.
What does this lineage say?
- The line of descent spans 35 years and passes through 6 companies; a new generation was cleared every 3.1 years on median.
- None of the 9 ancestors has a recall.
How does its category compare?
All QAF devicesQAF Impedance Plethysmograph, Cranial: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 STEDI Scan Device 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 neurological assessment
The STEDI Scan Device is an adjunct to standard methodologies for clinical evaluation
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/K253840 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253840: STEDI Scan Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253840
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026