510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
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K123904Substantially Equivalent

Prothelial

Mueller Medical International, LLC, Foster RI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K123904 is the FDA 510(k) clearance record for PROTHELIAL, cleared for Mueller Medical International, LLC on under FDA product code FRO (Dressing, Wound, Drug). FDA records list one 510(k) clearance for Mueller Medical International, LLC. As of , FDA records show no recalls naming K123904.

Clearance record

Decision date
Received
(231 days to decision)
Product code
FRO Dressing, Wound, Drug
Device class
Unclassified
Review panel
Unknown
Applicant
Mueller Medical International, LLC 48a Moosup Valley Rd., Foster RI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FRO

Trailing 12 months
19 clearances under product code FRO in the twelve months to October 2026, January 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code FRO, trailing twelve months
MonthClearances
November 20251
December 20251
January 20264
February 20261
March 20263
April 20261
May 20261
June 20263
July 20260
August 20262
September 20262
October 20260