Cleared Traditional

DECONTAMINATING MACHINES, LS-850, LS-76, DW/T-216, T-21 (K911120) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K911120 · Hamo USA, Inc. · General Hospital
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Feb 1994
Decision
1060d
Days
Class 2
Risk

K911120 is an FDA 510(k) clearance for the DECONTAMINATING MACHINES, LS-850, LS-76, DW/T-216, T-21. Classified as Disinfector, Medical Devices (product code MEC), Class II - Special Controls.

Submitted by Hamo USA, Inc. (Miami, US). The FDA issued a Cleared decision on February 3, 1994 after a review of 1060 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6992 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. 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 Hamo USA, Inc. devices

Submission Details

510(k) Number K911120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1991
Decision Date February 03, 1994
Days to Decision 1060 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
931d slower than avg
Panel avg: 129d · This submission: 1060d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MEC Disinfector, Medical Devices
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6992
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.