510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K243566Substantially Equivalent

CardioTag™

Cardiosense, Inc., Chicago IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K243566 is the FDA 510(k) clearance record for CardioTag™, a class II device, cleared for Cardiosense, Inc. on under FDA product code DXR (Ballistocardiograph). FDA records list 2 510(k) clearances for Cardiosense, Inc., from to . As of , FDA records show no recalls naming K243566.

Clearance record

Decision date
Received
(246 days to decision)
Product code
DXR Ballistocardiograph
Regulation
21 CFR 870.2320
Device class
Class II
Review panel
Cardiovascular
Applicant
Cardiosense, Inc. 400 N Aberdeen St. Suite 900, Chicago IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DXR

Trailing 12 months

FDA records hold no clearances under product code DXR in the trailing twelve months.

FDA records show no clearances under product code DXR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DXR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260