Cleared Traditional

K994170 - HYLASHIELD CL

K994170 is an FDA 510(k) clearance for HYLASHIELD CL, manufactured by Biomatrix, Inc.. The device is a Class 2 Ophthalmic device with product code MRC cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K994170 · Biomatrix, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
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Mar 2000
Decision
83d
Days
Class 2
Risk

K994170 is an FDA 510(k) clearance for the HYLASHIELD CL. Classified as Products, Contact Lens Care, Rigid Gas Permeable (product code MRC), Class II - Special Controls.

Submitted by Biomatrix, Inc. (Ridgefield, US). The FDA issued a Cleared decision on March 2, 2000 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5918 - 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 Biomatrix, Inc. devices

FDA 510(k) Submission Details - K994170

510(k) Number K994170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1999
Decision Date March 02, 2000
Days to Decision 83 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 110d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MRC Device Classification - Class 2, Special Controls

Product Code MRC Products, Contact Lens Care, Rigid Gas Permeable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5918
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 - MRC Products, Contact Lens Care, Rigid Gas Permeable

All 15
Devices cleared under the same product code (MRC) and FDA review panel - the closest regulatory comparables to K994170.
AQUIFY LENS COMFORT DROPS
K013204 · Ciba Vision Corporation · Apr 2002
SOLO-CARE BRAND HARD SOLUTION
K000607 · Ciba Vision Corporation · May 2000
RGP MULTI-PURPOSE SOLUTION ID 100136
K000148 · Alcon Laboratories · Apr 2000
SOLO-CARE BRAND HARD SOLUTION
K993949 · Ciba Vision Corporation · Jan 2000
SOLO-CARE BRAND MULTI-PURPOSE SOLUTION
K983291 · Ciba Vision Corporation · Nov 1998