Cleared Traditional

K841881 - EASY EYES TM LENS CARRYING CASE

K841881 · Eaton Medical Corp. · Ophthalmic device
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Dec 1984
Decision
210d
Days
-
Risk

K841881 is an FDA 510(k) clearance for the EASY EYES TM LENS CARRYING CASE. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Eaton Medical Corp. (Memphis, US). The FDA issued a Cleared decision on December 3, 1984 after a review of 210 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 Eaton Medical Corp. devices

Submission Details

510(k) Number K841881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1984
Decision Date December 03, 1984
Days to Decision 210 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d slower than avg
Panel avg: 110d · This submission: 210d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HPX Lens, Contact (polymethylmethacrylate)
Device Class -

Regulatory Peers - HPX Lens, Contact (polymethylmethacrylate)

All 17
Devices cleared under the same product code (HPX) and FDA review panel - the closest regulatory comparables to K841881.
LENSKEEPER CONTACT LENS CARRYING CASE
K861642 · Allergan, Inc. · May 1986
BAUSCH & LOMB LENS CARRYING CASE
K854968 · Bausch & Lomb, Inc. · Apr 1986
SIGHT SAVER ALL PURPOSE LENS CARRYING CASE
K852384 · Bausch & Lomb, Inc. · Jul 1985
SENSITIVE EYES
K832706 · Bausch & Lomb, Inc. · Oct 1983
CLERZ LUBRICATING & REWETTING EYE DROPS
K830740 · CooperVision, Inc. · Jun 1983
PRE-SERT
K822706 · Allergan, Inc. · Oct 1982