Cleared Traditional

K853728 - KESTREL CONTACT LENS STORAGE CASE(NORYL)

K853728 · Ryder Intl. Corp. · Ophthalmic device
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Dec 1985
Decision
98d
Days
-
Risk

K853728 is an FDA 510(k) clearance for the KESTREL CONTACT LENS STORAGE CASE(NORYL). Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Ryder Intl. Corp. (Arab, US). The FDA issued a Cleared decision on December 13, 1985 after a review of 98 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K853728

510(k) Number K853728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1985
Decision Date December 13, 1985
Days to Decision 98 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 110d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

HPX Device Classification - Class 0,

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

Regulatory Peers - HPX Lens, Contact (polymethylmethacrylate)

All 73
Devices cleared under the same product code (HPX) and FDA review panel - the closest regulatory comparables to K853728.
ALL-IN-ONE HARD CONTACT LENS SOLUTION
K853807 · Maurry Biological Co. · Dec 1985
WETTING SOLUTION FOR HARD CONTACT LENSES
K853810 · Maurry Biological Co. · Dec 1985
HARD CONTACT LENS SOAKING SOLUTION
K853811 · Maurry Biological Co. · Dec 1985
KESTREL CONTACT LENS STORAGE CASE(POLYSTYRENE)
K853729 · Ryder Intl. Corp. · Dec 1985
EASY EYES TM LENS CARRYING CASE
K853870 · Applied Laboratories, Inc. · Dec 1985
IN A WINK LUBRICATING & REWETTING DROPS
K853445 · Ciba Vision Care · Nov 1985
K853728 · KESTREL CONTACT LENS STORAGE CASE(NORYL)
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