STEDI Scan Device— 510(k) K253840
Substantially EquivalentStroke DX
FDA 510(k) clearance K253840 for STEDI Scan Device, Substantially Equivalent on 2026-07-22. Applicant: Stroke DX. Device class: 2.
Summary
Stroke DX's STEDI Scan Device is filed under QAF, cranial impedance plethysmographs. The record doesn't expand "STEDI" or describe the device's outputs.
Class II, 21 CFR 870.2770. The Neurology review panel handled it as a Traditional 510(k), though the record lists Cardiovascular as the classification panel.
Stroke DX filed from Culver City, California. Review took 233 calendar days (December 1, 2025 to July 22, 2026).
Clearance details
- Applicant
- Stroke DX
- Product code
- Product code QAF
- Device class
- Class 2
- Regulation
- 21 CFR 870.2770
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Culver City, CA, US
Recent devices under product code QAF
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