Cleared Traditional

K091240 - ALPHAMED SURGICAL SPEAR

K091240 is the FDA 510(k) clearance for ALPHAMED SURGICAL SPEAR by Alphamed, Inc.. It is a Class 2 Ophthalmic device (product code HOZ) cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K091240 · Alphamed, Inc. · Ophthalmic device
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Oct 2009
Decision
179d
Days
Class 2
Risk

K091240 is an FDA 510(k) clearance for the ALPHAMED SURGICAL SPEAR, MODEL 70-5000. Classified as Sponge, Ophthalmic (product code HOZ), Class II - Special Controls.

Submitted by Alphamed, Inc. (El Paso, US). The FDA issued a Cleared decision on October 23, 2009 after a review of 179 days - an extended review 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: 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 Alphamed, Inc. devices

Submission Details

510(k) Number K091240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2009
Decision Date October 23, 2009
Days to Decision 179 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 110d · This submission: 179d
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 12
Devices cleared under the same product code (HOZ) and FDA review panel - the closest regulatory comparables to K091240.
MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES
K011191 · Medtronic Xomed, Inc. · Jun 2001
DEROYAL INDUSTRIES, INC. SURGICAL EYE SPEAR
K972693 · Deroyal Industries, Inc. · Sep 1997
VISI-SPEAR EYE SPONGE
K933872 · Visitec Co. · Dec 1993
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