Cleared Abbreviated

MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU (K050263) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K050263 · M.O. Com S.R.L. · General Hospital
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Optimized for regulatory review, auditing and printing
Nov 2006
Decision
655d
Days
Class 2
Risk

K050263 is an FDA 510(k) clearance for the MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by M.O. Com S.R.L. (Buccinasco (Mi), IT). The FDA issued a Cleared decision on November 21, 2006 after a review of 655 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6880 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: High-complexity regulatory submission. Standards-verified equivalence. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all M.O. Com S.R.L. devices

Submission Details

510(k) Number K050263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2005
Decision Date November 21, 2006
Days to Decision 655 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
526d slower than avg
Panel avg: 129d · This submission: 655d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code FLE Sterilizer, Steam
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6880
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FLE Sterilizer, Steam

All 183
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