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
K063681Substantially Equivalent

Tecno-Gaz Andromeda Vacuum Cs Autoclave

Mediline Italia S.r.l., Bethesda MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063681 is the FDA 510(k) clearance record for TECNO-GAZ ANDROMEDA VACUUM CS AUTOCLAVE, a class II device, cleared for Mediline Italia S.R.L. on under FDA product code FLE (Sterilizer, Steam). FDA records list one 510(k) clearance for Mediline Italia S.R.L. As of , FDA records show no recalls naming K063681.

Clearance record

Decision date
Received
(200 days to decision)
Product code
FLE Sterilizer, Steam
Regulation
21 CFR 880.6880
Device class
Class II
Review panel
General Hospital
Applicant
Mediline Italia S.R.L. 6512 Bannockburn Dr., Bethesda MD
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