Cleared Traditional

K955366 - TRANS-AIRE RIGID GAS PERMABLE CONTACT LENS

K955366 is an FDA 510(k) clearance for TRANS-AIRE RIGID GAS PERMABLE CONTACT LENS, manufactured by Rand Scientific Corp.. The device is a Class 2 Ophthalmic device with product code HQD cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K955366 · Rand Scientific Corp. · Ophthalmic device
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Mar 1996
Decision
127d
Days
Class 2
Risk

K955366 is an FDA 510(k) clearance for the TRANS-AIRE RIGID GAS PERMABLE CONTACT LENS. Classified as Lens, Contact (other Material) - Daily (product code HQD), Class II - Special Controls.

Submitted by Rand Scientific Corp. (Sacramento, US). The FDA issued a Cleared decision on March 28, 1996 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5916 - 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 Rand Scientific Corp. devices

FDA 510(k) Submission Details - K955366

510(k) Number K955366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1995
Decision Date March 28, 1996
Days to Decision 127 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
17d slower than avg
Panel avg: 110d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQD Device Classification - Class 2, Special Controls

Product Code HQD Lens, Contact (other Material) - Daily
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5916
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 - HQD Lens, Contact (other Material) - Daily

All 30
Devices cleared under the same product code (HQD) and FDA review panel - the closest regulatory comparables to K955366.
BOSTON ES (ENFLUFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON XO (HEXAFOCON A) RIGID GAS PERMEABLE CONTACT LENSES
K053124 · Bausch & Lomb, Incorporated · Jan 2006
BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS
K022128 · Bausch & Lomb, Incorporated · Aug 2002
RIGID GAS PERMEABLE CONTACT LENS
K013762 · Bausch & Lomb, Incorporated · Apr 2002