510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250922Substantially Equivalent

Edema Guard Monitor (EGM) CardioSet-001

Cardioset Medical, Ltd., Matan, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250922 is the FDA 510(k) clearance record for Edema Guard Monitor (EGM) CardioSet-001, a class II device, cleared for Cardioset Medical , Ltd. on under FDA product code DSB (Plethysmograph, Impedance). FDA records list one 510(k) clearance for Cardioset Medical , Ltd. As of , FDA records show no recalls naming K250922.

Clearance record

Decision date
Received
(166 days to decision)
Product code
DSB Plethysmograph, Impedance
Regulation
21 CFR 870.2770
Device class
Class II
Review panel
Cardiovascular
Applicant
Cardioset Medical , Ltd. Havazelet 26 St., Matan, IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DSB

Trailing 12 months
2 clearances under product code DSB in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DSB, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260