Cleared Traditional

K901748 - KESTREL LENS CASE (208-12NT POLYSTYRENE)

K901748 is an FDA 510(k) clearance for KESTREL LENS CASE (208-12NT POLYSTYRENE), manufactured by Kestrel. The device is a Class 2 Ophthalmic device with product code LRX cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K901748 · Kestrel · Ophthalmic device
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May 1990
Decision
44d
Days
Class 2
Risk

K901748 is an FDA 510(k) clearance for the KESTREL LENS CASE (208-12NT POLYSTYRENE). Classified as Case, Contact Lens (product code LRX), Class II - Special Controls.

Submitted by Kestrel (Columbus, US). The FDA issued a Cleared decision on May 31, 1990 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5928 - 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 Kestrel devices

FDA 510(k) Submission Details - K901748

510(k) Number K901748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1990
Decision Date May 31, 1990
Days to Decision 44 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 110d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LRX Device Classification - Class 2, Special Controls

Product Code LRX Case, Contact Lens
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5928
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.