510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K221901Substantially Equivalent

EleGARD

Advancedcpr Solutions, LLC, Edina MN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K221901 is the FDA 510(k) clearance record for EleGARD, a class I device, cleared for Advancedcpr Solutions, LLC on under FDA product code FOA (Board, Cardiopulmonary). FDA records list one 510(k) clearance for Advancedcpr Solutions, LLC. As of , FDA records show no recalls naming K221901.

Clearance record

Decision date
Received
(29 days to decision)
Product code
FOA Board, Cardiopulmonary
Regulation
21 CFR 880.6080
Device class
Class I
Review panel
General Hospital
Applicant
Advancedcpr Solutions, LLC 5201 Eden Ave., Suite 300, Edina MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FOA

Trailing 12 months

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

FDA records show no clearances under product code FOA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FOA, 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