Cleared Traditional

KESTREL CONTACT LENS STORAGE CASE(POLYSTYRENE) (K853729) - FDA 510(k) Clearance

K853729 · Ryder Intl. Corp. · Ophthalmic device
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Dec 1985
Decision
98d
Days
-
Risk

K853729 is an FDA 510(k) clearance for the KESTREL CONTACT LENS STORAGE CASE(POLYSTYRENE). 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.

View all Ryder Intl. Corp. devices

Submission Details

510(k) Number K853729 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.

Device Classification

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