Cleared Traditional

K832589 - ELMED WMC 10 AND BC 50 M/M

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

FDA 510(k) Submission Details - K832589

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
155d slower than avg
Panel avg: 110d · This submission: 265d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -