Cleared Traditional

K897034 - K-SPONGE

K897034 is the FDA 510(k) clearance for K-SPONGE by Katena Products, Inc.. It is a Class 2 Ophthalmic device (product code HOZ) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K897034 · Katena Products, Inc. · Ophthalmic device
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Feb 1990
Decision
59d
Days
Class 2
Risk

K897034 is an FDA 510(k) clearance for the K-SPONGE. Classified as Sponge, Ophthalmic (product code HOZ), Class II - Special Controls.

Submitted by Katena Products, Inc. (Denville, US). The FDA issued a Cleared decision on February 15, 1990 after a review of 59 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Katena Products, Inc. devices

Submission Details

510(k) Number K897034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1989
Decision Date February 15, 1990
Days to Decision 59 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 110d · This submission: 59d
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 13
Devices cleared under the same product code (HOZ) and FDA review panel - the closest regulatory comparables to K897034.
OPERAID SURGICAL DRAIN W/ CORNEAL SHIELDS
K910707 · Jedmed Instrument Co. · Apr 1991
VISI-SWAB OPHTALMIC SPONGE
K902750 · Visitec Co. · Jul 1990
VISI-SORB ABSORBANT STICK
K900786 · Visitec Co. · May 1990
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