510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K921547Substantially Equivalent

Advantage

Kci, San Antonio TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921547 is the FDA 510(k) clearance record for ADVANTAGE, a class II device, cleared for Kci on under FDA product code FMT (Warmer, Infant Radiant). FDA records list one 510(k) clearance for Kci. As of , FDA records show no recalls naming K921547.

Clearance record

Decision date
Received
(486 days to decision)
Product code
FMT Warmer, Infant Radiant
Regulation
21 CFR 880.5130
Device class
Class II
Review panel
General Hospital
Applicant
Kci P.O. Box 8588, San Antonio TX
510(k) summary
Statement
Third party review
No

Clearances, product code FMT

Trailing 12 months

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

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