Cleared Traditional

K130117 - NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K130117 · Network Medical Products, Ltd. · Ophthalmic device
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Oct 2013
Decision
286d
Days
Class 2
Risk

K130117 is an FDA 510(k) clearance for the NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS. Classified as Sponge, Ophthalmic (product code HOZ), Class II - Special Controls.

Submitted by Network Medical Products, Ltd. (Ripon, GB). The FDA issued a Cleared decision on October 29, 2013 after a review of 286 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4790 - 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 Network Medical Products, Ltd. devices

Submission Details

510(k) Number K130117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2013
Decision Date October 29, 2013
Days to Decision 286 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
176d slower than avg
Panel avg: 110d · This submission: 286d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HOZ Sponge, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4790
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.