510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K023390Substantially Equivalent

My Breast Friend, Breast Self-Exam Pad

Mbf Sales, LLC, Rockville MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K023390 is the FDA 510(k) clearance record for MY BREAST FRIEND, BREAST SELF-EXAM PAD, a class I device, cleared for Mbf Sales, LLC on under FDA product code IXH (Camera, Focal Spot, Radiographic). FDA records list one 510(k) clearance for Mbf Sales, LLC. As of , FDA records show no recalls naming K023390.

Clearance record

Decision date
Received
(48 days to decision)
Product code
IXH Camera, Focal Spot, Radiographic
Regulation
21 CFR 892.1940
Device class
Class I
Review panel
Radiology
Applicant
Mbf Sales, LLC 7361 Calhoun Pl., Suite 500, Rockville MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IXH

Trailing 12 months

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

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