Cleared Traditional

K841896 - EZ EYE DROP AID (FDA 510(k) Clearance)

K841896 · Buckman Co., Inc. · Ophthalmic device
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Nov 1984
Decision
185d
Days
-
Risk

K841896 is an FDA 510(k) clearance for the EZ EYE DROP AID.

Submitted by Buckman Co., Inc. (Martinez, US). The FDA issued a Cleared decision on November 8, 1984 after a review of 185 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 Buckman Co., Inc. devices

Submission Details

510(k) Number K841896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1984
Decision Date November 08, 1984
Days to Decision 185 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 110d · This submission: 185d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -