Cleared Traditional

K832589 - ELMED WMC 10 AND BC 50 M/M (FDA 510(k) Clearance)

K832589 · Elmed, Inc. · Ophthalmic device
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Apr 1984
Decision
265d
Days
-
Risk

K832589 is an FDA 510(k) clearance for the ELMED WMC 10 AND BC 50 M/M.

Submitted by Elmed, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 23, 1984 after a review of 265 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Elmed, Inc. devices

Submission Details

510(k) Number K832589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1983
Decision Date April 23, 1984
Days to Decision 265 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
155d slower than avg
Panel avg: 110d · This submission: 265d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -