Cleared Traditional

K850340 - EYE PROCEDURE PACK

K850340 is an FDA 510(k) clearance for EYE PROCEDURE PACK, manufactured by Marwood Medical, Inc.. The device is a Class 2 Ophthalmic device with product code HOZ cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K850340 · Marwood Medical, Inc. · Ophthalmic device
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May 1985
Decision
114d
Days
Class 2
Risk

K850340 is an FDA 510(k) clearance for the EYE PROCEDURE PACK. Classified as Sponge, Ophthalmic (product code HOZ), Class II - Special Controls.

Submitted by Marwood Medical, Inc. (Greensboro, US). The FDA issued a Cleared decision on May 22, 1985 after a review of 114 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 Marwood Medical, Inc. devices

FDA 510(k) Submission Details - K850340

510(k) Number K850340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1985
Decision Date May 22, 1985
Days to Decision 114 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 110d · This submission: 114d
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 K850340.
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