Cleared Traditional

K843115 - STERILE SOLUTION BOWL (FDA 510(k) Clearance)

Class I Neurology device.

K843115 · E.M. Adams · Neurology device
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Sep 1984
Decision
30d
Days
Class 1
Risk

K843115 is an FDA 510(k) clearance for the STERILE SOLUTION BOWL. Classified as Kit, Surgical Instrument, Disposable (product code KDD), Class I - General Controls.

Submitted by E.M. Adams (Mchenry, US). The FDA issued a Cleared decision on September 7, 1984 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 878.4800 - the FDA neurology 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.

View all E.M. Adams devices

Submission Details

510(k) Number K843115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1984
Decision Date September 07, 1984
Days to Decision 30 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 148d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KDD Kit, Surgical Instrument, Disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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.