Cleared Traditional

K852055 - ASCON OPHTHALMIC SPONGE

K852055 is an FDA 510(k) clearance for ASCON OPHTHALMIC SPONGE, manufactured by Ascon Medical Instruments, Ltd.. The device is a Class 2 Ophthalmic device with product code HOZ cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K852055 · Ascon Medical Instruments, Ltd. · Ophthalmic device
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Sep 1985
Decision
118d
Days
Class 2
Risk

K852055 is an FDA 510(k) clearance for the ASCON OPHTHALMIC SPONGE. Classified as Sponge, Ophthalmic (product code HOZ), Class II - Special Controls.

Submitted by Ascon Medical Instruments, Ltd. (Westmont, US). The FDA issued a Cleared decision on September 4, 1985 after a review of 118 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 Ascon Medical Instruments, Ltd. devices

FDA 510(k) Submission Details - K852055

510(k) Number K852055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1985
Decision Date September 04, 1985
Days to Decision 118 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 110d · This submission: 118d
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 K852055.
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
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