510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K050263Substantially Equivalent

Millennium Series, Including Millennium B, B+, B2 and Bu

M.O. Com S.r.l., Buccinasco (Mi), IT / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050263 is the FDA 510(k) clearance record for MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU, a class II device, cleared for M.O. Com S.R.L. on under FDA product code FLE (Sterilizer, Steam). FDA records list one 510(k) clearance for M.O. Com S.R.L. As of , FDA records show no recalls naming K050263.

Clearance record

Decision date
Received
(655 days to decision)
Product code
FLE Sterilizer, Steam
Regulation
21 CFR 880.6880
Device class
Class II
Review panel
General Hospital
Applicant
M.O. Com S.R.L. Via Delle Azalee 1, Buccinasco (Mi), IT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FLE

Trailing 12 months
4 clearances under product code FLE in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FLE, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20261
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260