Cleared Traditional

K842601 - PRE-OPERATIVE OPHTHALMIC DRESSING TRAY

K842601 is the FDA 510(k) clearance for PRE-OPERATIVE OPHTHALMIC DRESSING TRAY by Ophthalmic Resources, Inc.. It is a Class 2 Ophthalmic device (product code HOZ) cleared through the Traditional 510(k) pathway after a 309-day FDA review.

K842601 · Ophthalmic Resources, Inc. · Ophthalmic device
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May 1985
Decision
309d
Days
Class 2
Risk

K842601 is an FDA 510(k) clearance for the PRE-OPERATIVE OPHTHALMIC DRESSING TRAY. Classified as Sponge, Ophthalmic (product code HOZ), Class II - Special Controls.

Submitted by Ophthalmic Resources, Inc. (St. Petersburg, US). The FDA issued a Cleared decision on May 10, 1985 after a review of 309 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Ophthalmic Resources, Inc. devices

Submission Details

510(k) Number K842601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1984
Decision Date May 10, 1985
Days to Decision 309 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
199d slower than avg
Panel avg: 110d · This submission: 309d
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.

Regulatory Peers - HOZ Sponge, Ophthalmic

All 12
Devices cleared under the same product code (HOZ) and FDA review panel - the closest regulatory comparables to K842601.
VISITEC MICRO-SPONGE SPEARS
K896705 · Visitec Co. · Jan 1990
ALCON SURGICAL SPONGE
K896004 · Alcon Laboratories · Nov 1989
FLUID DRAINAGE WICK
K885232 · Visitec Co. · Feb 1989
SCLERAL SPONGE II, OLK DESIGN, E5395-10 & E5395-11
K850883 · Storz Instrument Co. · Mar 1985
OPERAID SURGICAL DRAIN
K841721 · Jedmed Instrument Co. · Nov 1984
EYE SPONGE OR SPEAR
K834356 · Jedmed Instrument Co. · Mar 1984