510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K920240Substantially Equivalent

Solumbra Sun Protective Clothing

Wetmore Assoc., Inc., Seattle WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K920240 is the FDA 510(k) clearance record for SOLUMBRA SUN PROTECTIVE CLOTHING, cleared for Wetmore Assoc., Inc. on under FDA product code MIW. FDA records list one 510(k) clearance for Wetmore Assoc., Inc. As of , FDA records show no recalls naming K920240.

Clearance record

Decision date
Received
(117 days to decision)
Product code
MIW
Review panel
Unknown
Applicant
Wetmore Assoc., Inc. 310 W. Prospect St., Seattle WA
510(k) summary
Statement
Third party review
No

Clearances, product code MIW

Trailing 12 months

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

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