Cleared Traditional

K946016 - IVALON OPHTHALMIC SPONGE

K946016 is an FDA 510(k) clearance for IVALON OPHTHALMIC SPONGE, manufactured by Ivalon. The device is a Class 2 Ophthalmic device with product code HOZ cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K946016 · Ivalon · Ophthalmic device
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Mar 1995
Decision
103d
Days
Class 2
Risk

K946016 is an FDA 510(k) clearance for the IVALON OPHTHALMIC SPONGE. Classified as Sponge, Ophthalmic (product code HOZ), Class II - Special Controls.

Submitted by Ivalon (San Diego, US). The FDA issued a Cleared decision on March 22, 1995 after a review of 103 days - within the typical 510(k) review window.

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 Ivalon devices

FDA 510(k) Submission Details - K946016

510(k) Number K946016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1994
Decision Date March 22, 1995
Days to Decision 103 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
7d faster than avg
Panel avg: 110d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HOZ Device Classification - Class 2, Special Controls

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.

Regulatory Peers - HOZ Sponge, Ophthalmic

All 33
Devices cleared under the same product code (HOZ) and FDA review panel - the closest regulatory comparables to K946016.
DEROYAL INDUSTRIES, INC. SURGICAL EYE SPEAR
K972693 · Deroyal Industries, Inc. · Sep 1997
IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK
K971832 · M-Pact Worldwide Management Corp. · Jul 1997
EXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIELD
K964855 · Shippert Medical Technologies Corp. · Mar 1997
OPHTHALMIC SPONGES
K950241 · Oasis Medical, Inc. · Feb 1995
SURGI-WIPE
K942642 · Surgin Surgical Instrumentation, Inc. · Jul 1994
VISI-SPEAR EYE SPONGE
K933872 · Visitec Co. · Dec 1993