Cleared Traditional

K972693 - DEROYAL INDUSTRIES, INC. SURGICAL EYE SPEAR

K972693 is an FDA 510(k) clearance for DEROYAL INDUSTRIES, manufactured by Deroyal Industries, Inc.. The device is a Class 2 Ophthalmic device with product code HOZ cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K972693 · Deroyal Industries, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1997
Decision
74d
Days
Class 2
Risk

K972693 is an FDA 510(k) clearance for the DEROYAL INDUSTRIES, INC. SURGICAL EYE SPEAR. Classified as Sponge, Ophthalmic (product code HOZ), Class II - Special Controls.

Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on September 30, 1997 after a review of 74 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 Deroyal Industries, Inc. devices

FDA 510(k) Submission Details - K972693

510(k) Number K972693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1997
Decision Date September 30, 1997
Days to Decision 74 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 110d · This submission: 74d
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 32
Devices cleared under the same product code (HOZ) and FDA review panel - the closest regulatory comparables to K972693.
THE FREMSTAD RING
K982599 · Ophthalmic Solutions, LLC · Feb 1999
HYDROFERA SURGICAL SPEAR
K974313 · Hydrofera, LLC · Mar 1998
ULTRACELL SUCTION SPONGE
K972633 · Ultracell Medical Technologies, Inc. · Dec 1997
IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK
K971832 · M-Pact Worldwide Management Corp. · Jul 1997
EXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIELD
K964855 · Shippert Medical Technologies Corp. · Mar 1997
OPHTHALMIC SPONGES
K950241 · Oasis Medical, Inc. · Feb 1995