Cleared Traditional

POWERED EYE WASH (K893829) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K893829 · Sacks Model Makers · Ophthalmic device
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Nov 1989
Decision
174d
Days
Class 3
Risk

K893829 is an FDA 510(k) clearance for the POWERED EYE WASH. Classified as Solution, Cleaning / Lubricating, Artificial Eye (product code MSI), Class III - Premarket Approval.

Submitted by Sacks Model Makers (Ringwood, US). The FDA issued a Cleared decision on November 14, 1989 after a review of 174 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel. 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. High regulatory complexity profile. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K893829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1989
Decision Date November 14, 1989
Days to Decision 174 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 110d · This submission: 174d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MSI Solution, Cleaning / Lubricating, Artificial Eye
Device Class Class 3 - Premarket Approval
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.