Cleared Traditional

K842601 - PRE-OPERATIVE OPHTHALMIC DRESSING TRAY

K842601 is an FDA 510(k) clearance for PRE-OPERATIVE OPHTHALMIC DRESSING TRAY, manufactured by Ophthalmic Resources, Inc.. The device is a Class 2 Ophthalmic device with 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

FDA 510(k) Submission Details - K842601

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.

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 34
Devices cleared under the same product code (HOZ) and FDA review panel - the closest regulatory comparables to K842601.
ALCON SURGICAL SPONGE
K896004 · Alcon Laboratories · Nov 1989
FLUID DRAINAGE WICK
K885232 · Visitec Co. · Feb 1989
AMPCO OPTHALMIC TRAY
K842983 · Associated Medical Products Co. · May 1985
STERILE EYE SURGERY KITS
K842990 · Biological & Environmental Control Laboratories · May 1985
PMS OPHTHALMOLOGY PACK-PMS EYE TRAY/PACK
K850050 · Professional Medical Services · Apr 1985
SCLERAL SPONGE II, OLK DESIGN, E5395-10 & E5395-11
K850883 · Storz Instrument Co. · Mar 1985