Cleared Traditional

K904961 - ARTIFICIAL SCLERAL SHELL

K904961 is an FDA 510(k) clearance for ARTIFICIAL SCLERAL SHELL, manufactured by Midwest Eye Laboratories, Inc.. The device is a Class 2 Ophthalmic device with product code HQT cleared through the Traditional 510(k) pathway after a 298-day FDA review.

K904961 · Midwest Eye Laboratories, Inc. · Ophthalmic device
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Aug 1991
Decision
298d
Days
Class 2
Risk

K904961 is an FDA 510(k) clearance for the ARTIFICIAL SCLERAL SHELL. Classified as Shell, Scleral (product code HQT), Class II - Special Controls.

Submitted by Midwest Eye Laboratories, Inc. (Minneapolis, US). The FDA issued a Cleared decision on August 30, 1991 after a review of 298 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.3800 - 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 Midwest Eye Laboratories, Inc. devices

FDA 510(k) Submission Details - K904961

510(k) Number K904961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1990
Decision Date August 30, 1991
Days to Decision 298 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
188d slower than avg
Panel avg: 110d · This submission: 298d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQT Device Classification - Class 2, Special Controls

Product Code HQT Shell, Scleral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.3800
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.