Cleared Traditional

K760492 - BASIN, LARGE OR SMALL (FDA 510(k) Clearance)

Class I General Hospital device.

K760492 · Landmark Plastics · General Hospital
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Nov 1976
Decision
81d
Days
Class 1
Risk

K760492 is an FDA 510(k) clearance for the BASIN, LARGE OR SMALL. Classified as Basin, Emesis (product code FNY), Class I - General Controls.

Submitted by Landmark Plastics (Mchenry, US). The FDA issued a Cleared decision on November 12, 1976 after a review of 81 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6730 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K760492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1976
Decision Date November 12, 1976
Days to Decision 81 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
47d faster than avg
Panel avg: 128d · This submission: 81d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FNY Basin, Emesis
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6730
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.