510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K252751Substantially Equivalent

Earflo (EF001)

Earflo Company, San Carlos CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K252751 is the FDA 510(k) clearance record for Earflo (EF001), cleared for Earflo, Inc. on under FDA product code MJV (Device, Inflation, Middle Ear). FDA records list one 510(k) clearance for Earflo, Inc. As of , FDA records show no recalls naming K252751.

Clearance record

Decision date
Received
(165 days to decision)
Product code
MJV Device, Inflation, Middle Ear
Device class
Unclassified
Review panel
Unknown
Applicant
Earflo, Inc. 848 Knoll Dr., San Carlos CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MJV

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