Cleared Traditional

REMOVER, SOFT-SERT CONTACT LENS (K782140) - FDA 510(k) Clearance

Class I Ophthalmic device.

K782140 · Mcmurray and Pendergost · Ophthalmic device
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Feb 1979
Decision
47d
Days
Class 1
Risk

K782140 is an FDA 510(k) clearance for the REMOVER, SOFT-SERT CONTACT LENS. Classified as Inserter/remover Contact Lens (product code KYE), Class I - General Controls.

Submitted by Mcmurray and Pendergost (Mchenry, US). The FDA issued a Cleared decision on February 12, 1979 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5420 - the FDA ophthalmic device framework. 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 Mcmurray and Pendergost devices

Submission Details

510(k) Number K782140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1978
Decision Date February 12, 1979
Days to Decision 47 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 110d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KYE Inserter/remover Contact Lens
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.5420
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.