Cleared Traditional

LECTROSTILL DISTILLED WATER U.S.P. (K854764) - FDA 510(k) Clearance

K854764 · Electrified Companies, Inc. · Ophthalmic device
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Dec 1985
Decision
33d
Days
-
Risk

K854764 is an FDA 510(k) clearance for the LECTROSTILL DISTILLED WATER U.S.P..

Submitted by Electrified Companies, Inc. (East Orange, US). The FDA issued a Cleared decision on December 30, 1985 after a review of 33 days - a notably fast clearance 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: 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 Electrified Companies, Inc. devices

Submission Details

510(k) Number K854764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1985
Decision Date December 30, 1985
Days to Decision 33 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 110d · This submission: 33d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -