510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253840Substantially Equivalent

STEDI Scan Device

Stroke DX, Culver City CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253840 is the FDA 510(k) clearance record for STEDI Scan Device, a class II device, cleared for Stroke DX on under FDA product code QAF (Impedance Plethysmograph, Cranial). FDA's definition for product code QAF reads: "Detect or measure variations in volume in the cranium, using tissue impedance properties". FDA records list one 510(k) clearance for Stroke DX. As of , FDA records show no recalls naming K253840.

Clearance record

Decision date
Received
(233 days to decision)
Product code
QAF Impedance Plethysmograph, Cranial
Regulation
21 CFR 870.2770
Device class
Class II
Review panel
Cardiovascular
Applicant
Stroke DX 300 Corporate Pt.E, Culver City CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QAF

Trailing 12 months
1 clearance under product code QAF in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QAF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260