Cleared Traditional

K021248 - ICASE

K021248 is an FDA 510(k) clearance for ICASE, manufactured by Ikeeps, Inc.. The device is a Class 2 Ophthalmic device with product code LRX cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K021248 · Ikeeps, Inc. · Ophthalmic device
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Sep 2002
Decision
158d
Days
Class 2
Risk

K021248 is an FDA 510(k) clearance for the ICASE. Classified as Case, Contact Lens (product code LRX), Class II - Special Controls.

Submitted by Ikeeps, Inc. (Crofton, US). The FDA issued a Cleared decision on September 24, 2002 after a review of 158 days - an extended review 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: 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 Ikeeps, Inc. devices

FDA 510(k) Submission Details - K021248

510(k) Number K021248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2002
Decision Date September 24, 2002
Days to Decision 158 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 110d · This submission: 158d
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.

Regulatory Peers - LRX Case, Contact Lens

All 36
Devices cleared under the same product code (LRX) and FDA review panel - the closest regulatory comparables to K021248.
EYE CARE CURE CONTACT LENS CASE
K112832 · Eye Care and Cure · Dec 2011
SOFT GRIP CONTACT LENS CASE, DELUXE CONTACT LENS CASE, ECONO-MATE CONTACT LENS CASE
K111856 · Apothecary Products, Inc. · Jul 2011
SOLO-CARE AQUA ANTIMICROBIAL LENS CASE
K041820 · Ciba Vision Corporation · Sep 2005
CYBERCASES BY BAUSCH & LOMB
K013232 · Bausch & Lomb, Inc. · Nov 2001
BONASSE CONTACT LENS CASE
K991206 · Bonasse Ent. Co., Ltd. · Jun 2000
PARAGON LENS CARRIER
K993486 · Paragon Vision Sciences · Dec 1999